The Pharma Data

JUNE 6, 2025

Drivers of Market Growth: From Precision Medicine to Cost Optimization The shift toward targeted therapies , rare diseases , and personalized medicine is fundamentally altering pharmaceutical commercialization strategies. Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage.

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FDA Law Blog: Drug Discovery

JUNE 18, 2025

As defined by the National Cancer Institute, tumor board meetings convene multidisciplinary specialists to decide on the best treatment plan for new and complex cancer cases. FDA plans to issue a limited number of vouchers, without specifying an exact number as of yet. The vouchers will be issued to “companies aligned with U.S.

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DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

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Drug Patent Watch

AUGUST 15, 2023

A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.

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The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. RIABNI is already approved for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). In the U.S.,

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Biosimilars FDA Approval FDA Pharmacokinetics 52

The Pharma Data

APRIL 18, 2022

. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. “We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options.” Reese, M.D., million people in the United States.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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Quanticate

SEPTEMBER 25, 2024

In rheumatoid arthritis (RA) clinical trials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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Biosimilars FDA Approval Treatment Therapies 52

Conversations in Drug Development Trends

JULY 9, 2024

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. However, the treatment journey does not end with weight reduction, as maintaining weight loss overall is equally crucial.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 58. Complaint ¶ 59.

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The Pharma Data

JANUARY 12, 2021

In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million , as well as pay royalties on sales of resulting therapies. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Vaccine Therapies Immune Response Disease 52

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.

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The Pharma Data

JUNE 25, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

MARCH 22, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

SEPTEMBER 1, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

JULY 8, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

APRIL 9, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website. About Biogen.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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Therapies Production Government Disease 52

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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The Pharma Data

JUNE 7, 2022

AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc.

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Licensing Licensing Small Molecule Disease 40

The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.

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Treatment Clinical Trials Biosimilars Pharmaceutical Companies 40

The Pharma Data

MAY 31, 2022

The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson’s disease.

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Disease Small Molecule Engineering Biosimilars 52

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen. About Aducanumab.

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Licensing Licensing Biosimilars Disease 52

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § Last month bipartisan legislation, S.

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Research Therapies Clinical Trials Treatment 59

The Pharma Data

APRIL 28, 2022

currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. For those already on ADUHELM, this meant a potential halt in their treatment plans. Organization.

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Clinical Trials Treatment Biosimilars Disease 52

The Pharma Data

MARCH 28, 2022

While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies. We remain focused on pioneering new treatments that will positively impact people living with this debilitating disease.”. Biogen Inc.

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RNA Therapies Disease Biosimilars 52

The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). percentage points (-3.6

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Biosimilars Clinical Trials Treatment Marketing 52

The Pharma Data

MAY 2, 2022

Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

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Pharmaceuticals Production Treatment Disease 52

The Pharma Data

MARCH 23, 2022

(NYSE: PFE) today announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2mg once daily.

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Trials Small Molecule Biosimilars Therapies 52

The Pharma Data

MARCH 16, 2022

Food and Drug Administration (FDA) granted accelerated approval for ADUHELM as the first Alzheimer’s disease treatment to address a defining pathology of the disease. ADUHELM is indicated for the treatment of Alzheimer’s disease. SVP, Head of Neurodegeneration Development at Biogen. “We

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The Pharma Data

JUNE 1, 2022

In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. About Zuranolone Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

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Biosimilars Treatment Therapies Disease 52

The Pharma Data

MARCH 16, 2022

These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques. These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.” Biogen Inc. About Biogen.

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Disease Clinical Trials Treatment Trials 52

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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FDA Treatment Trials Biosimilars 52

The Pharma Data

MARCH 5, 2021

Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. We are making 15 drugs that treat key symptoms of COVID-19 available to low-and lower-middle income countries at zero profit until a vaccine or curative treatment is available.

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Vaccine Production Biosimilars Hospitals 52

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan. and a disease control rate (DCR) of 86.2%

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