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Janssen Pharmaceuticals
Janssen Pharmaceuticals
Janssen Pharmaceuticals
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Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals) is a Belgian pharmaceutical company headquartered in Beerse, Belgium, and wholly owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.

Key Information

In 1961, Janssen Pharmaceuticals was purchased by New Jersey–based American corporation Johnson & Johnson, and became part of Johnson & Johnson Pharmaceutical Research and Development (J&J PRD), later renamed to Janssen Research and Development, LLC (JRD), which conducts research and development activities related to a wide range of human medical disorders, including mental illness, neurological disorders, anesthesia and analgesia, gastrointestinal disorders, fungal infection, HIV/AIDS, allergies and cancer. Janssen and Ortho-McNeil Pharmaceutical have been placed in the Ortho-McNeil-Janssen group within Johnson & Johnson Company.

Subsidiaries

[edit]

History

[edit]
Janssen (Leiden, 2021)

The roots of what would become Janssen Pharmaceuticals date back to 1933. In 1933, Constant Janssen, the father of Paul Janssen, acquired the right to distribute the pharmaceutical products of Richter, a Hungarian pharmaceutical company, for Belgium, the Netherlands and Belgian Congo. On 23 October 1934, he founded the N.V. Produkten Richter in Turnhout. In 1937, Constant Janssen acquired an old factory building in the Statiestraat 78 in Turnhout for his growing company, which he expanded during World War II into a four-story building. Still a student, Paul Janssen assisted in the development of paracetamol (USP: acetaminophen, often referred to generically under the trademark Tylenol) under the name Perdolan, which would later become well-known. After the war, the name for the company products was changed to Eupharma, although the company name Richter would remain until 1956.[3]

Paul Janssen founded his own research laboratory in 1953 on the third floor of the building in the Statiestraat, still within the Richter-Eupharma company of his father. In 1955, he and his team developed their first drug, Neomeritine (ambucetamide), an antispasmodic found to be particularly effective for the relief of menstrual pain. On 5 April 1956, the name of the company was changed to NV Laboratoria Pharmaceutica C. Janssen (named after Constant Janssen). On 27 April 1957, the company opened a new research facility in Beerse, but the move to Beerse would not be completed until 1971 to 1972. On 2 May 1958, the research department in Beerse became a separate legal entity, the N.V. Research Laboratorium C. Janssen.

On 25 October 1961, the company was acquired by the American corporation Johnson & Johnson. The negotiations with Johnson & Johnson were led by Frans Van den Bergh, head of the board of directors. On 10 February 1964, the name was changed to Janssen Pharmaceutica N.V. and the seat of the company in Turnhout was also transferred to Beerse. The company was led by Paul Janssen, Bob Stouthuysen and Frans Van Den Bergh. When, in 1971 to 1972 the pharmaceutical production also moved to Beerse, the move from Turnhout was completed. Between 1990 and 2004, Janssen expanded worldwide, and the company grew to about 28,000 employees worldwide.

From the beginning, Janssen emphasized research on new drug development as its core activity. The research department established in Beerse in 1957, developed into a large research campus. In 1987, the Janssen Research Foundation (JRF) was founded to perform research into new drugs at Beerse and in other laboratories around the globe. Janssen became the Flemish company with the largest budget for research and development. Beside the headquarters in Beerse with its research departments, pharmaceutical production and the administrative departments, Janssen Pharmaceutica still has offices in Belgium in Berchem (Janssen-Cilag), a chemical factory in Geel, and Janssen Biotech in Olen.

The chemical production plant in Geel makes active ingredients for the company's medicines. In 1975, the first plant of a new chemical factory Plant I was established in Geel, Plant II was opened in 1977, Plant III' in 1984, and Plant IV in 1995. In 1999 the remaining chemical production in Beerse was transferred to Geel. About 80% of its active components are manufactured there. The site in Geel also manufactures about two-thirds of the worldwide chemical production of the pharmaceutical sector of Johnson & Johnson. In 1995, the Center for Molecular Design (CMD) was founded by Paul Janssen and Paul Lewi.

In 1999, clinical research and non-clinical development become a global organization within Johnson & Johnson. In 2001, part of the research activities was transferred to the United States with the reorganization of research activities in the Johnson & Johnson Pharmaceutical Research Development (JJPRD) organization. The research activities of the Janssen Research Foundation (JRF) and the R.W. Johnson Pharmaceutical Research Institute (PRI) (United States) were merged into the new global research organization. A new building for pharmaceutical development was completed in Beerse in 2001. In 2002, a new logistics and informatics centre was opened at a new site, Beerse 2. In 2003 two new research buildings were constructed, the Discovery Research Center (DRC), and the Drug Safety Evaluation Center (DSEC). On 27 October 2004, the Paul Janssen Research Center, for discovery research, was inaugurated.

In 2011, Johnson & Johnson subsidiary Centocor became Janssen Biotech, part of Janssen Pharmaceuticals.[1]

Also in 2011, Johnson & Johnson acquired Crucell, and assigned it to Janssen. The acquisition of Crucell provided Janssen with a disease prevention arm. By 2014, Crucell was renamed Janssen Vaccines.[4][2]

In March 2015, Janssen licensed tipifarnib (a farnesyl transferase inhibitor) to Kura Oncology who will assume sole responsibility for developing and commercialising the anti-cancer drug.[5] Later in the same month the company announced that Galapagos Pharma had regained the rights to the anti-inflammatory drug candidate GLPG1690 as well as two other compounds including GLPG1205 (a first-in-class inhibitor of GPR84).[6]

In May 2016, the company launched a collaboration MacroGenics and the preclinical cancer treatment, MGD015. The deal could net MacroGenics more than $740 million.[7]

In September 2017 Janssen teamed up with the Biomedical Advanced Research and Development Authority (BARDA), a unit of the U.S. Department of Health and Human Services, to create pandemic flu vaccines. BARDA gave Janssen $43 million in the first year and $273 million over five years for the contract. One of the projects in the contract is the development of a universal flu vaccine. The intent of the vaccine would be to protect people against all or most flu strains.[8]

On 5 March 2019, the Food and Drug Administration approved Janssen's Spravato (esketamine nasal spray) for treatment-resistant major depressive disorder. This marked the first approval of a new type of antidepressant in decades.[9]

In 2021, Janssen became a defendant in a trial against several opioid manufacturers filed by New York Attorney General Letitia James.[10] The company was removed from the case after Johnson & Johnson agreed to a pay a $230 million settlement to New York State.[11]

Janssen Biotech

[edit]

The subsidiary Janssen Biotech, Inc. was founded in Philadelphia in 1979 as Centocor Biotech, Inc., with an initial goal to develop new diagnostic assays using monoclonal antibody technology.

Centocor Biotech

[edit]

In 1982, Centocor became a publicly traded company.[12] In the early 1980s, the company moved to Malvern, Pennsylvania.[12] In 1984, Centocor opened an overseas plant in Leiden, the Netherlands.[13]

In 1997, eighteen years after its foundation, Centocor achieved its first year of operating profitability.[14][15] In 1998, Centocor sold its diagnostic division to Fujirebio, Inc.[16]

In 1999, Centocor became a wholly owned subsidiary of Johnson & Johnson.[17]

In 2004, Centocor purchased a new manufacturing plant in St. Louis, Missouri, and is opening a new manufacturing facility in County Cork, Ireland. The Dutch plant has been expanded substantially with a $250 million investment in additional production facilities, which were opened in 2006.[citation needed]

In 2007, Centocor broke new ground in advertising by releasing Innerstate, believed to be the first theatrically released documentary film both created and entirely funded by a drug company, to promote Remicade (Infliximab).[18]

Centocor Ortho Biotech

[edit]

In 2008, Centocor, Inc. and Ortho Biotech Inc. merged to form Centocor Ortho Biotech Inc.

In June 2010, Centocor Ortho Biotech acquired RespiVert, a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases.[19]

As Janssen Biotech

[edit]

In June 2011, Centocor Ortho Biotech changed its name to Janssen Biotech, Inc. as part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity.[20]

In December 2014, the company announced it would co-develop MacroGenics cancer drug candidate (MGD011) which targets both CD19 and CD3 proteins in treating B-cell malignant tumours. This could net MacroGenics up to $700 million.[21]

In January 2015, the company announced it would use Ionis Pharmaceuticals' (formerly Isis Pharmaceuticals) RNA-targeting technology to discover and develop antisense drugs targeting autoimmune disorders of the gastrointestinal tract.[22]

In December 2019, XBiotech Inc. announced it would sell its novel antibody treatment (bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺) to Janssen Biotech, Inc.[23][24]

COVID-19 vaccine development

[edit]
Main article: Janssen COVID-19 vaccine

On 27 March 2020, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated $456 million for J&J (Janssen) to develop a vaccine against the novel coronavirus.[25][26]

In China

[edit]
Xi'an-Janssen

Janssen Pharmaceuticals was the first Western pharmaceutical company to set up a pharmaceutical factory in the People's Republic of China.[27]

In 1976, Paul Janssen met Ma Haide (born George Shafik Hatem), a Lebanese-American doctor who had started working in China in 1933. After three days of meetings, the two agreed to bring a modernized pharmaceutical business to China. When Deng Xiaoping opened China to the West in 1978, Janssen sent Paul Appermont and Joos Horsten to set up the project.[27]

In 1983, Janssen signed a cooperative contract to modernize production in an old chemical factory in the city of Hanzhong, in Shaanxi. This factory would soon produce the active compound of Janssen products such as mebendazole. In 1985, operating as Xian-Janssen Pharmaceuticals, a large factory was opened in the city of Xi'an, also in Shaanxi province.[27]

Drugs developed

[edit]
Risperdal tablets
R-code Name Brand name Synthesized Marketed
R5 ambucetamide Neomeritine 1953 1955
R79 isopropamide iodide Priamide-Janssen 1954 1955
R253 diisopromine Bilagol 1955 1956
R516 cinnarizine Stugeron 1955 1958
R875 dextromoramide Palfium 1955 1957
R1132 diphenoxylate Reasec 1956 1960
R1625 haloperidol Haldol 1958 1959
R2498 trifluperidol Triperidol 1959 1961
R3345 pipamperone Dipiperon 1960 1961
R3365 piritramide Dipidolor 1960 1967
R4263 fentanyl[28][29] Sublimaze 1960 1963
R4584 benperidol Frenactyl 1961 1965
R4749 droperidol[30] Dehydrobenzperidol 1961 1963
R4845 bezitramide Burgodin 1961 1971
R6218 fluspirilene Imap 1963 1971
R6238 pimozide Orap 1963 1970
R7904 lidoflazine Clinium 1964 1969
R11333 bromperidol Impromen 1966 1981
R12564 levamisole Ergamisol 1966 1969
R13672 haloperidol decanoate Haldol decanoas 1967 1981
R14889 miconazole nitrate Daktarin 1967 1971
R14950 flunarizine Sibelium 1967 1977
R15889 lorcainide Remivox 1968 1983
R16341 penfluridol Semap 1968 1973
R16470 dexetimide Tremblex 1968 1972
R16659 etomidate[31][32] Hypnomidate 1964 1977
R17635 mebendazole Vermox 1968 1972
R18553 loperamide Imodium 1969 1973
R33800 sufentanil[33] Sufenta 1974 1979
R33812 domperidone Motilium 1974 1978
R35443 oxatomide Tinset 1975 1981
R39209 alfentanil[34][35] Rapifen 1976 1983
R33799 carfentanil[36] Wildnil 1976 1980?
R41400 ketoconazole Nizoral 1976 1981
R43512 astemizole Hismanal 1977 1983
R46541 bromperidol decanoate Impromen decanoas 1978 1984
R49945 ketanserin tartrate Sufrexal 1980 1987
R50547 levocabastine Livostin/Livocab 1979 1989
R51211 itraconazole Sporanox 1980 1986
R51619 cisapride Prepulsid 1980 1989
R64766 risperidone Risperdal 1984 1993
R207910 bedaquiline Sirturo 2004 2012

Janssen Pharmaceuticals has developed and brought to the market about 70 new active substances (NCE), of which the most well-known are (name may differ):

WHO Model List of Essential Medicines

[edit]

Eight original Janssen drugs have been included on the WHO Model List of Essential Medicines:

Centocor products

[edit]

In 1984, Centocor developed their first product approved by the U.S. Food and Drug Administration (FDA) – a diagnostic test used to detect the rabies virus.[citation needed]

In 1998, the company launched its top-selling monoclonal antibody Remicade (infliximab) for its first FDA approved indication in Crohn's disease. Subsequently, Remicade's market has expanded with approvals for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, and pediatric Crohn's disease. Remicade was approved for plaque psoriasis in September 2006.

Centocor also markets ReoPro (abciximab), a biologic agent indicated as an adjunct to coronary angioplasty (PTCA).

In 2009, the U.S. FDA approved Simponi, a human monoclonal antibody for treatment for arthritis, which was co-developed with Medarex, Inc.[37]

Risperdal deception

[edit]

In 2004, the United States Department of Justice began investigating sales practices surrounding the antipsychotic drug risperidone (Risperdal). In 2010, the agency joined a whistleblower suit alleging that despite being warned by the U.S. Food and Drug Administration not to promote Risperdal as effective and safe for elderly patients, in whom it was known to be associated with early death, Johnson & Johnson and Janssen Pharmaceuticals paid pharmacists at Omnicare, the largest supplier of pharmaceuticals to nursing homes, tens of millions of dollars in bribes and kickbacks to promote the drug to physicians for this unapproved use.[38][39]

The lawsuit resulted in a 2012 provisional settlement totaling $2.3 billion,[40] with Omnicare having already settled for around $100 million.[40] Four states were awarded damages: Louisiana ($258 million in 2010), South Carolina ($327 million in 2011), Texas ($158 million in 2012), and Arkansas ($1.2 billion in 2012).[41]

Former head of sales and president of Janssen Alex Gorsky, who according to the Department of Justice "was actively involved" in the fraud, became CEO of Johnson & Johnson in 2012.[42]

See also

[edit]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Janssen Pharmaceuticals

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from Grokipedia

Janssen Pharmaceuticals, founded in 1953 by Dr. Paul Adriaan Jan Janssen in , is a multinational pharmaceutical focused on discovering, developing, and marketing innovative prescription medicines across therapeutic areas including , , , infectious diseases, and cardiopulmonary conditions. Acquired by in 1961, it expanded globally and rebranded as Johnson & Johnson Innovative Medicine in 2023 to reflect its integration within the parent 's pharmaceutical operations. Under its founder's direction, Janssen pioneered dozens of life-changing medications, holding over 100 patents and introducing breakthrough therapies such as , a cornerstone for treating and other psychotic disorders that advanced psychiatric care beyond earlier options like . The company's emphasis on scientific innovation has yielded first-in-class treatments in areas like and antifungals, contributing to global health initiatives, including preservation efforts using its products. Despite these achievements, Janssen has faced substantial controversies and litigation, including a $2.2 billion settlement in 2013 for improper promotion of (Risperdal) for unapproved uses, where the drug was linked to serious side effects such as in adolescent males, and additional settlements related to its role in the opioid crisis through aggressive marketing of opioid products. These cases highlight tensions between pharmaceutical innovation and in drug promotion and safety monitoring.

History

Founding and Early Innovations (1953–1961)

Janssen Pharmaceutica was established in 1953 by Dr. Paul Adriaan Jan Janssen, a and pharmacologist, in Beerse, , initially as a modest research laboratory on the third floor of his parents' pharmaceutical import firm, Richter-Eurpharma. At age 27, Janssen sought to build a fully independent, self-sustaining entity dedicated to , emphasizing rapid synthesis and testing of novel compounds rather than conventional . The lab's early operations focused on structure-activity relationships, producing hundreds of derivatives annually through systematic chemical modifications of known molecules like and . From 1953 to 1957, the laboratory prioritized and antihistamines, synthesizing over 1,000 compounds in its first years, though few reached commercialization immediately. Expansion accelerated in 1957 with the acquisition of a 65-hectare site in Beerse for dedicated facilities, reflecting growing output and the need for scaled production. A pivotal occurred in when Janssen's team synthesized (R 1625), a derivative initially pursued as a potential but discovered to possess potent neuroleptic properties superior to existing antipsychotics like . Preclinical and early clinical trials confirmed its efficacy in treating and agitation, with minimal , establishing it as a breakthrough in psychiatric . By 1960–1961, the lab extended its research, yielding , a synthetic 50–100 times more potent than , developed through modifications of phenoperidine for enhanced analgesia and rapid onset. These advancements, underpinned by Janssen's high-throughput synthesis approach—yielding up to 200–300 new entities yearly—positioned the firm as a leader in CNS therapeutics, with over 100 patents filed by the period's end. The focus on empirical potency testing over theoretical models ensured practical innovations, though commercial scaling remained limited until external partnerships.

Acquisition and Integration into Johnson & Johnson (1961–1990s)

In 1961, acquired Janssen Pharmaceutica N.V., a Belgian research-based pharmaceutical firm founded by in 1953, following several months of negotiations that culminated in a merger agreement. The acquisition, valued at an undisclosed sum but structured to preserve operational continuity, integrated Janssen into 's emerging pharmaceutical portfolio, which already included McNeil Laboratories and acquired in 1959. This move provided Janssen with access to 's global distribution networks and financial resources, enabling scaled commercialization of its innovations, such as (marketed as Haldol), while gained expertise in disorders and synthetic . Dr. Paul Janssen retained leadership as director of research post-acquisition, directing the Beerse, Belgium facility—expanded under funding into a major European R&D hub with over 1,000 scientists by the 1980s. This autonomy fostered continued productivity, with Janssen Pharmaceutica credited for synthesizing dozens of novel compounds, including (Imodium, 1969) for antidiarrheal use and subsequent antipsychotics. Integration emphasized decentralized R&D within 's divisional structure, allowing Janssen to focus on discovery while leveraging the parent company's manufacturing and regulatory capabilities; by the 1970s, Janssen products accounted for a growing share of 's pharmaceutical revenues, reaching significant milestones like the 1980 launch of expanded therapies. Through the 1980s and into the 1990s, Janssen's integration deepened via cross-company collaborations, such as shared infrastructure and international market entry, culminating in the 1993 U.S. approval of (Risperdal), an developed in Janssen's labs that generated billions in sales and solidified its role in Johnson & Johnson's psychiatric portfolio. The subsidiary maintained its Belgian core, avoiding full centralization in U.S. operations, which supported sustained innovation amid Johnson & Johnson's broader diversification; by the late 1990s, Janssen employed thousands globally and contributed to over 40 marketed drugs, underscoring the acquisition's long-term value in building a resilient pharmaceutical arm resistant to single-site vulnerabilities.

Biotech Expansion and Acquisitions (2000s)

During the 2000s, expanded its capabilities within its pharmaceutical division, which encompassed Janssen Pharmaceutica, through targeted acquisitions to integrate advanced platforms, biologic manufacturing, and specialized therapeutic assets. This strategy addressed limitations in internal small-molecule research by incorporating biotech firms' expertise in areas like computational modeling, cardiovascular biologics, and hemostatic products, thereby diversifying the amid growing competition in innovative therapies. In January 2003, acquired 3-Dimensional Pharmaceuticals Inc., a firm specializing in structure-based and discovery, for $88 million in cash, equivalent to $5.74 per share—a premium reflecting the value of its proprietary technologies for accelerating candidate identification. The deal, completed later that year, integrated 3DP's and tools into J&J's R&D framework, enhancing efficiency in early-stage development for Janssen's therapeutic areas. A larger transaction followed in February 2003 with the $2.4 billion all-cash acquisition of Scios Inc., one of the earliest U.S. biotech companies, providing rights to Natrecor (), an FDA-approved biologic for derived from human B-type . The acquisition, finalized in April 2003 after regulatory and shareholder approvals, bolstered J&J's cardiovascular portfolio and biotech infrastructure, though Natrecor later faced scrutiny over efficacy and safety in expanded trials. Further expansion occurred in November 2008 when J&J agreed to purchase Omrix Biopharmaceuticals Ltd., an Israeli biotech developer of human blood-derived biologics, for $438 million via tender offer at $25 per share. Omrix's technologies, including fibrin sealants like Evicel for surgical hemostasis and immune thromboglobulins, were integrated to support biologic production capabilities aligned with Janssen's immunology and surgical applications. These acquisitions collectively added over $3 billion in , yielding proprietary platforms and products that fortified Janssen's transition toward biologics-heavy , though integration challenges and subsequent clinical outcomes varied.

Recent Milestones and (2010s–2025)

In 2010, 's disparate pharmaceutical operating companies unified under a single brand identity as the Janssen Pharmaceutical Companies of , streamlining global research, development, and commercialization efforts while invoking the innovative legacy of . That same year, the acquisition of biotech firm Crucell for approximately $2.4 billion enhanced Janssen's vaccine portfolio, establishing and accelerating development in infectious diseases. The 2010s and early 2020s featured regulatory successes in , , and infectious diseases, including FDA approval in for the first continuous manufacturing process for darunavir-based therapy, which shortened product release testing from 30 days to a target of 10 days and improved efficiency. In February 2021, the FDA issued for the single-dose Ad26.COV2.S , which was administered to over 18 million people in the U.S. before its EUA revocation in June 2023 due to evolving data and lower uptake compared to mRNA alternatives. Later in 2021, FDA approval of paliperidone palmitate (INVEGA HAFYERA) marked the introduction of the first and only six-month treatment for in adults, extending dosing intervals from prior monthly or three-month options. In August 2023, the FDA approved niraparib and abiraterone acetate (Akeega) as the first-and-only combining a with next-generation for BRCA-positive metastatic castration-sensitive , based on phase 3 trial data showing improved radiographic . September 2023 brought a major corporate following 's spin-off of its consumer health unit into earlier that year, with the Janssen Pharmaceutical Companies renamed Johnson & Johnson Innovative Medicine to foster closer alignment between the pharmaceutical segment and the parent company's 137-year heritage, while emphasizing innovation in areas like and . This shift included phasing out standalone Janssen branding on product labels over time and adopting J&J's refreshed visual identity across its innovative medicine and medtech divisions, aiming to enhance global recognition without altering underlying operations or R&D focus. By 2025, the rebranded entity continued pipeline advancements, including FDA approval on September 19, 2025, for a subcutaneous induction regimen in an undisclosed Janssen therapy, underscoring ongoing commitments to novel delivery methods.

Organizational Structure

Subsidiaries and Divisions

Janssen Pharmaceuticals operates as the pharmaceutical division of , structured through numerous wholly-owned subsidiaries that handle , , , and regional activities across therapeutic areas including , , infectious diseases, and . These entities facilitate localized operations while integrating into 's broader ecosystem, with a focus on biologics, small molecules, and vaccines. Key U.S.-based subsidiaries include Janssen Biotech, Inc., headquartered in , which specializes in biologics and products; Janssen Research & Development, LLC, in , responsible for advancement; and Janssen Oncology, Inc., in , targeting cancer therapies. Janssen Products, LP, in , oversees certain product lines, including through its Janssen Therapeutics division, which focuses on and treatments following the 2011 rebranding of Tibotec Therapeutics. Internationally, prominent subsidiaries encompass Janssen Pharmaceutica NV in , the original founding entity from 1953 serving as a European hub for innovation; Janssen Biologics B.V. in the , emphasizing biologics production; and & Prevention B.V., also in the , dedicated to development. Regional manufacturing and sales arms include Janssen Pharmaceutical Ltd. in , established in 1985 as one of the first Western healthcare ventures there, and Janssen-Cilag entities across , , and for localized distribution. In 2023, initiated a rebranding of its pharmaceutical operations, transitioning the Janssen name to Johnson & Johnson Innovative Medicine to unify branding under the parent company while retaining underlying subsidiary structures for operational efficiency. This shift does not alter the functional roles of core subsidiaries but aligns them more closely with 's global strategy as of fiscal year 2023. Earlier divestitures, such as the 2011 sale of the Ortho Dermatologics division to Companies, streamlined focus away from toward high-priority areas like and infectious diseases.

Global Operations and Regional Focus

Janssen Pharmaceuticals, operating as part of Johnson & Johnson's Innovative Medicine division, maintains manufacturing, research, and commercial operations across , , , and , with key hubs supporting global supply chains and regional innovation. Its European headquarters and primary R&D center are in Beerse, , which functions as a central node for pharmaceutical production and distribution serving and beyond, including a consolidated facility in that streamlined operations from 15 prior European centers as of 2013. In , core facilities are concentrated in , including administrative and development sites in Raritan and Titusville, alongside expanded R&D in , to foster biotech partnerships. Manufacturing expansions include a new 500,000-square-foot biologics plant in , with groundbreaking in March 2025 as part of a $55 billion U.S. investment commitment. Europe features additional production in Latina, Italy, bolstered by a €125 million upgrade in 2024 within a €580 million regional initiative, and ten sites across five Irish counties (Cork, , Limerick, Galway, Mayo) dedicated to R&D and manufacturing since at least 2024. Asia-Pacific operations emphasize growth in emerging markets, with facilities like the Xian plant in integrating into J&J's global network, and regional leadership targeting , , , and retinal therapies through early-stage collaborations. In EMEA, a innovation center coordinates partnerships across , , and , prioritizing public health challenges in , , and cardiopulmonary areas. Latin America maintains regional coordination for commercial activities, supporting broader access to Janssen's portfolio amid J&J's multinational structure spanning over 60 countries.

Research and Development

Therapeutic Areas of Emphasis

Janssen Pharmaceuticals, operating as part of Innovative Medicine, directs its research and development toward six primary therapeutic areas: , , , cardiovascular and metabolism, , and . These foci aim to address unmet medical needs through novel biologics, small molecules, and vaccines, with an emphasis on precision medicine and transformative therapies. In , Janssen invests heavily in treatments for solid tumors, hematologic cancers, and , leveraging technologies such as bispecific antibodies and radioligand therapies to improve patient outcomes. Key efforts include advancing CAR-T cell therapies like Carvykti, approved by the FDA in 2022 for , which demonstrated a 98% overall response rate in clinical trials. The portfolio targets autoimmune and inflammatory conditions, including , , and , with biologics like Stelara () inhibiting IL-12 and IL-23 pathways to achieve sustained remission in patients. Research emphasizes JAK inhibitors and next-generation monoclonal antibodies to modulate immune responses more selectively. Neuroscience initiatives focus on , depression, and , developing antipsychotics such as Invega Sustenna and antidepressants targeting novel mechanisms beyond traditional serotonin pathways. Pipeline efforts include Alzheimer's immunotherapies aimed at amyloid-beta clearance, informed by phase 3 trial data showing slowed cognitive decline. For infectious diseases and vaccines, Janssen develops solutions for , , and emerging pathogens, including the single-shot authorized in 2021, which reported 66% efficacy against moderate to severe disease in global trials involving over 44,000 participants. Emphasis is placed on long-acting antiretrovirals and broadly neutralizing antibodies for prevention. Cardiovascular and metabolism research addresses conditions like pulmonary arterial hypertension and metabolic disorders, with drugs such as Uptravi () reducing morbidity and mortality risks by 40% in long-term studies. Innovations target and pathways to improve vascular function. and retina areas round out the emphases, with therapies for rare retinal diseases and advanced pulmonary conditions, integrating gene therapies and sustained-release formulations to enhance efficacy and patient adherence. These efforts align with Janssen's strategy of prioritizing high-burden diseases amenable to breakthrough science.

Pipeline Innovations and Technologies

Janssen Pharmaceuticals, as part of Innovative Medicine, maintains a robust research pipeline comprising over 100 indications across , , , and other areas, with a strong emphasis on novel modalities to address unmet medical needs. Key innovations include bispecific antibodies, such as (RYBREVANT), which simultaneously targets EGFR and MET receptors to enhance antitumor activity in non-small cell and expanding indications like . The company also advances chimeric antigen receptor T-cell (CAR-T) therapies, including a dual-targeting / construct in phase 1b trials for relapsed or large B-cell , demonstrating early safety and efficacy signals that could broaden access beyond single-target approaches. Gene therapy represents another pillar of Janssen's technological innovation, particularly in rare genetic disorders. For instance, an RPGR candidate is in phase 3 development (LUMEOS trial) for , aiming to restore function through targeted genetic correction. In addition, advanced drug delivery platforms like the TARIS system enable localized intravesical administration of (INLEXZO) for non-muscle invasive , reducing systemic exposure while improving therapeutic precision in phase 2/3 studies. These technologies are supported by multi-modality combinations, including co-antibody therapies like JNJ-4804 for , reflecting Janssen's strategy of integrating small molecules, biologics, and delivery innovations to optimize clinical outcomes. Looking ahead to 2025, Janssen anticipates several milestones, including potential regulatory submissions and data readouts for these modalities, such as phase 3 results for RYBREVANT in new settings and expansions of CAR-T applications, underscoring a commitment to scalable, high-impact therapies. This approach prioritizes assets with significant potential, as identified in novel therapies projected to exceed $5 billion in peak-year sales, driven by platforms that address resistance mechanisms and improve patient tolerability.

Major Pharmaceutical Products

Essential Medicines and Core Portfolio

Janssen Pharmaceuticals has developed multiple medications included on the World Health Organization's Model List of , emphasizing treatments for prevalent global health issues such as infectious diseases, mental health disorders, and parasitic infections. Key examples include (Imodium), an agonist introduced in 1976 for controlling acute nonspecific diarrhea by slowing intestinal motility; haloperidol (Haldol), a first-generation launched in 1958 for managing and acute psychotic states through D2 receptor blockade; (Vermox), an agent approved in 1971 that inhibits formation in parasitic worms, effective against soil-transmitted helminths; and miconazole (Daktarin), a broad-spectrum released in the 1970s for topical treatment of infections and . These drugs, many originating from founder Paul Janssen's research, are valued for their cost-effectiveness and broad applicability in low-resource settings. More recent additions to the WHO list from Janssen's portfolio include (Imbruvica), a inhibitor approved by the FDA in 2013 for relapsed and , added to the list in October 2021 for its role in treating certain B-cell malignancies; and bedaquiline (Sirturo), a diarylquinoline antimycobacterial introduced in 2012 as part of multidrug regimens for , addressing a critical gap in treatment options. These inclusions underscore Janssen's ongoing contributions to essential therapies amid evolving global health priorities. The core portfolio of Janssen centers on innovative biologics and small-molecule drugs in and , which form the backbone of its commercial revenue and therapeutic impact. standouts include (Darzalex), a CD38-directed approved in 2015 for , often used in combination regimens to induce ; and (Erleada), a launched in 2018 for non-metastatic castration-resistant by competitively binding the . In , (Stelara), an IL-12/23 inhibitor approved in 2009, treats moderate-to-severe plaque , , , and by modulating cytokine-driven inflammation; while (Tremfya), a selective IL-23 inhibitor introduced in 2017, targets similar autoimmune conditions with improved specificity. These products, alongside co-developed with , represent Janssen's emphasis on targeted mechanisms yielding durable clinical responses.

Oncology and Immunology Advances

Janssen has developed several targeted therapies transforming treatment for hematologic malignancies, particularly multiple myeloma and lymphomas. DARZALEX (daratumumab), a CD38-directed monoclonal antibody, received initial U.S. FDA approval on November 16, 2015, for patients with multiple myeloma who had received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who were double refractory to such treatments. Subsequent approvals expanded its use to frontline settings and combinations, such as with bortezomib, melphalan, and prednisone for newly diagnosed transplant-ineligible patients in June 2019. IMBRUVICA (ibrutinib), a Bruton's tyrosine kinase (BTK) inhibitor, was first approved by the FDA on November 13, 2013, for relapsed mantle cell lymphoma, with later expansions to chronic lymphocytic leukemia (CLL) and other B-cell malignancies, establishing it as a cornerstone for oral targeted therapy in these cancers. In , CARVYKTI (), a BCMA-directed CAR-T therapy developed in collaboration with Legend Biotech, gained FDA approval on February 28, 2022, for adults with relapsed or refractory after at least four prior lines of therapy, including a , immunomodulatory agent, and anti-CD38 . This approval marked Janssen's entry into autologous CAR-T for , with phase 3 data from CARTITUDE-4 showing improved versus standard regimens in earlier lines, leading to expanded approval in April 2024 for patients after one prior line. Recent efforts include advancing bispecific antibodies and combinations for solid tumors, with data presented at ESMO 2025 demonstrating promising efficacy in , , and cancers through precision approaches like EGFR-targeted therapies. In , Janssen targets immune-mediated inflammatory diseases with biologics modulating key cytokines. STELARA (), an IL-12/23 p40 subunit inhibitor, was initially approved by the FDA in 2009 for moderate-to-severe plaque , with expansions to in 2013, Crohn's in 2016, and ulcerative in 2019, demonstrating sustained remission in clinical trials across these indications. TREMFYA (), a selective IL-23 p19 inhibitor, received FDA approval on July 13, 2017, for moderate-to-severe plaque , followed by in 2020 and expanded uses including pediatric in 2025, supported by phase 3 data showing superior skin clearance and joint response rates compared to TNF inhibitors. These agents reflect Janssen's focus on cytokine-specific inhibition to achieve disease modification in , , and , with ongoing pipeline efforts in and broader inflammatory pathways.

Infectious Disease Contributions

Janssen Pharmaceuticals has made substantial contributions to the treatment of human immunodeficiency virus () infection through the development of inhibitors and non-nucleoside inhibitors. , marketed as Prezista, received accelerated FDA approval on June 23, 2006, for use in with other antiretrovirals in treatment-experienced adults with HIV-1 infection resistant to multiple inhibitors. Rilpivirine, marketed as Edurant, was approved in 2011 as part of regimens for treatment-naïve adults with HIV-1, offering once-daily dosing and demonstrating noninferior to efavirenz-based in clinical trials. These agents have bolstered long-term viral suppression, with maintaining in regimens over 192 weeks in pivotal studies. In vaccine development, Janssen pioneered the AdVac® adenoviral vector platform, applied to prophylactic against emerging infectious threats. The company's regimen, comprising Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), received marketing authorization on July 1, 2020, for preventive use in individuals aged 1 year and older at risk of virus disease outbreaks. This two-dose prime-boost approach elicited robust, durable immune responses in phase 3 trials involving over 3,000 participants across age groups, with WHO prequalification granted in April 2021 to facilitate deployment in endemic regions. Janssen's Ad26.COV2.S vaccine, utilizing the same AdVac® technology encoding the spike protein, demonstrated 66.9% efficacy against symptomatic and near-complete protection (85.4% to 100%) against severe-to-critical disease in the phase 3 trial of over 44,000 participants. Granted emergency use authorization by the FDA in February 2021 and full approval in select populations thereafter, the single-dose regimen proved particularly valuable for rapid deployment and in resource-limited settings, though real-world effectiveness varied with variants and waned over time without boosters. Ongoing extends to other pathogens, including and respiratory syncytial virus (RSV), though some adult RSV programs were discontinued in 2023 to prioritize high-impact areas like curative approaches.

Risperdal Marketing Practices and Litigation

Risperdal (), an manufactured by Janssen Pharmaceuticals, received FDA approval on December 29, 1993, initially for treating in adults. Despite this limited indication, Janssen engaged in off-label promotion targeting unapproved populations, including elderly patients with dementia-related and pediatric patients for behavioral disorders. Such practices included disseminating misleading sales materials and incentivizing healthcare providers through speaker fees and kickbacks to prescribe Risperdal for these uses, even as clinical data indicated heightened risks, such as increased mortality in elderly patients—prompting an FDA black-box warning in April 2005. These marketing tactics drew scrutiny from the U.S. Department of Justice, culminating in a November 4, 2013, global settlement where , Janssen's parent, agreed to pay $2.2 billion to resolve criminal and civil allegations under the False Claims Act for off-label promotion of Risperdal and related drug Invega. The agreement included a $485 million criminal fine and forfeiture—Janssen pleading guilty to misbranding—and $1.72 billion in civil recoveries shared among federal and state governments for reimbursements under and other programs. States like received $52.7 million, while joined for its portion of the $1.2 billion state-federal civil settlement. Parallel to marketing probes, Janssen faced extensive product liability litigation over Risperdal's side effects, particularly gynecomastia—abnormal breast growth in males—linked to the drug's elevation of prolactin levels, disproportionately affecting adolescent boys prescribed it off-label for conditions like ADHD or autism. By 2021, Johnson & Johnson had resolved "substantially all" of thousands of such claims through settlements, incurring $800 million in expenses separate from the 2013 marketing accord. Notable verdicts included a 2016 jury award of $70 million to a Georgia family for a boy's gynecomastia and a $2.5 million compensatory award to plaintiff Austin Pledger that year; however, many cases settled pre-trial, such as a $5.9 million resolution in Montana and confidential agreements in others. Additional suits alleged failure to warn of risks like and , though dominated multidistrict litigation in , where over 8,000 cases were consolidated by 2016. In October 2012, Janssen settled five Philadelphia gynecomastia cases pre-trial, and further resolutions followed, reflecting empirical evidence from post-marketing studies confirming prolactin-related adverse events despite Janssen's initial downplaying in promotional materials. These outcomes underscored causal links between off-label pediatric use and irreversible harm, with total litigation costs exceeding $3 billion when combined with marketing penalties.

COVID-19 Vaccine Challenges

The , developed by Janssen Pharmaceuticals (a of ), received (EUA) from the U.S. (FDA) on February 27, 2021, as a single-dose adenovirus vector targeting the . Despite demonstrating efficacy against severe in phase 3 trials, the faced significant challenges related to rare but serious adverse events, comparative efficacy limitations, and eventual market discontinuation. A primary safety concern emerged with reports of with (TTS), a rare condition involving blood clots and low platelet counts, predominantly in women under 50 years old. On April 13, 2021, the FDA and Centers for Disease Control and Prevention (CDC) recommended a pause in administration after identifying six confirmed TTS cases among approximately 6.8 million doses administered, including one death. The pause was lifted on April 23, 2021, following review, with updated warnings added to the EUA fact sheet emphasizing the risk for younger women and recommending alternative vaccines where possible. The (EMA) similarly concluded a possible link to very rare unusual blood clots with low platelets, estimating an incidence of about 1 in 100,000 doses overall, though higher in certain demographics. CDC surveillance data later indicated TTS occurred in approximately 4 cases per million doses administered, with nine deaths associated among 60 confirmed U.S. cases as of mid-2023. Additional signals included Guillain-Barré (GBS), with higher-than-expected rates reported to the (VAERS), prompting further monitoring. Efficacy data from the phase 3 showed 66.9% effectiveness against moderate to severe/critical 28 days post-vaccination, rising to 85.4% against severe/critical disease, but waning over time and performing less robustly against variants like compared to mRNA-based vaccines. confirmed against hospitalization and but highlighted lower overall uptake and , contributing to preferences for multi-dose alternatives amid evolving viral threats. These issues culminated in regulatory and commercial setbacks. The vaccine's single-dose profile offered logistical advantages, but pauses and comparisons eroded public confidence, leading to reduced demand. Janssen did not pursue full FDA approval, and on , 2023, requested voluntary withdrawal of the EUA, citing expired U.S. government-purchased lots, lack of demand for future manufacturing, and no plans for additional clinical studies. The FDA revoked the EUA effective June 1, 2023, while allowing use of existing doses until expiry, marking the end of its availability in the U.S. Similar withdrawals occurred in under the Jcovden brand.

Other Regulatory Settlements

In 2013, Janssen Pharmaceuticals Inc., along with subsidiaries Scios Inc. and Janssen Pharmaceutica Inc., resolved civil False Claims Act allegations involving off-label promotion and kickbacks for (nesiritide), a for acute decompensated congestive . The settlement required payment of approximately $214 million specifically tied to Natrecor claims, as part of a broader $2.2 billion resolution with the U.S. Department of Justice and participating states, addressing promotions for unapproved inpatient uses and incentives to healthcare providers that induced false reimbursement submissions. Janssen also faced regulatory scrutiny over its opioid product Duragesic (fentanyl transdermal system). In July 2021, Janssen entered a nationwide settlement agreement committing up to $5 billion over nine years to resolve claims of deceptive marketing that downplayed addiction risks and promoted the drug for unapproved chronic non-cancer pain, contributing to the and improper reimbursements across states. Funds are allocated for abatement programs, with states receiving payments contingent on participation and non-litigation status. In a 2024-2025 False Claims Act whistleblower case, a federal jury found Janssen liable for causing 159,574 false reimbursement claims to federal healthcare programs through off-label promotion of antiretrovirals Prezista () and Intelence (etravirine) from 2006 to 2014, including unsubstantiated claims of lipid neutrality and pediatric efficacy. On March 28, 2025, U.S. District Judge imposed $1.64 billion in ($360 million) and statutory penalties ($1.28 billion at $8,000 per violation), though Janssen has appealed, arguing constitutional challenges to penalty multipliers and evidentiary issues.

Impact and Legacy

Scientific and Health Outcomes

Janssen Pharmaceuticals' drug portfolio has yielded measurable improvements in patient survival and disease management across oncology and hematology, particularly through ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor approved for chronic lymphocytic leukemia (CLL). In the phase 3 RESONATE-2 trial with up to 10 years of follow-up, first-line ibrutinib treatment achieved a 9-year overall survival rate of 68% (95% CI, 64-72%), compared to 57% (95% CI, 51-62%) with chlorambucil, demonstrating sustained progression-free survival benefits irrespective of high-risk genetic features. Real-world data corroborate these findings, showing ibrutinib-treated CLL patients attaining 9-year overall survival rates comparable to age-matched general populations, with reduced infection risks linked to restored immune competence via decreased disease burden. In and , (Remicade), a TNF-alpha inhibitor, has advanced treatment of autoimmune conditions like and , with over 20 years of clinical use revealing mechanisms of blockade that reduce inflammation and joint damage, informing subsequent biologic therapies. (Stelara), targeting IL-12/23, exhibited efficacy in (PsA) phase 3 trials (PSUMMIT-1 and PSUMMIT-2), achieving American College of Rheumatology 20 response rates of 42-50% at week 24 versus 22-25% , alongside improvements in clearance and physical function sustained through one year, though long-term data indicate comparable persistence to TNF inhibitors with lower adverse event rates. For infectious diseases, (Prezista), a inhibitor, has enhanced virologic control, particularly in treatment-experienced patients; observational studies report 48-week suppression rates superior to other inhibitors, with meta-analyses confirming tolerability and efficacy in both naive and resistant cases due to its high genetic barrier to resistance. The Janssen Ad26.COV2.S showed 85% efficacy against severe-critical disease and hospitalization in phase 3 trial data (median 2 months post-dose), with real-world evidence indicating 94% boosted protection against hospitalization in the U.S., though rare adverse events including with syndrome (approximately 3-4 cases per million doses) and Guillain-Barré syndrome prompted preferential use of alternatives in some populations. In disorders, (Risperdal) reduces symptoms such as hallucinations, delusions, and affective disturbances, with clinical trials demonstrating symptom alleviation at doses of 1-6 mg/day; however, it elevates levels, potentially causing , , and fertility issues, alongside and risks in up to 20% of users on long-term atypical antipsychotics. Systematic reviews highlight these trade-offs, noting benefits in acute management but requiring monitoring for metabolic and endocrine effects. Overall, Janssen's contributions emphasize targeted therapies improving quality-adjusted life years, tempered by profiles necessitating individualized .

Economic and Industry Influence

Janssen Pharmaceuticals, operating as the core of Johnson & Johnson's Innovative Medicine segment, generated $57.0 billion in sales in 2024, marking a 4.0% increase from 2023 and comprising approximately 64% of Johnson & Johnson's of $88.8 billion for the year. This segment's performance underscores Janssen's pivotal role in sustaining Johnson & Johnson's amid diversification into medical technology, with key drivers including biologics like Stelara and Darzalex, which together exceeded $20 billion in global sales. Janssen's economic footprint extends through substantial investments, with allocating over $17 billion to R&D in 2024, predominantly directed toward pharmaceutical innovation under Janssen's purview. These expenditures, representing about 19% of segment sales, support a pipeline of over 90 investigational compounds and fuel advancements in , , and infectious diseases, thereby contributing to job creation in high-skill sectors and stimulating ancillary economic activity in clusters worldwide. Janssen's global manufacturing operations, including facilities in , , and , , enhance local economies by exporting high-value pharmaceuticals and integrating into international supply chains. In the broader , Janssen exerts influence through pioneering therapies originating from founder Paul Janssen's work, which introduced over 40 novel compounds and set benchmarks for efficacy in areas like antipsychotics and antivirals, influencing subsequent paradigms across competitors. The company's market leadership in and —holding significant shares in biologic treatments—drives pricing dynamics and regulatory standards, while strategic acquisitions and partnerships amplify its role in shaping industry consolidation and pipelines. This positions Janssen as a for sector growth, with its operational expansions correlating to broader economic multipliers in healthcare-related GDP contributions.

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