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American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Goodwin

FDA Approves BLA for Novavax’s COVID-19 Vaccine

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On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

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While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Goodwin

Recent Biologics Deals - December 2024

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Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on...more

Goodwin

Teva and mAbxience Add Additional Oncology Biosimilar Candidate, Expanding Strategic Partnership

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​​​​​​​On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Recent Biosimilar Commercialization Developments

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​​​​​​​Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Goodwin

Similis Bio and Blau Farmaceutica Enter into Development and License Agreement for Biosimilars

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On October 25, 2022, JSR Life Sciences and Blau Farmaceutica announced that Similis Bio, JSR Life Sciences’s business unit focused on biosimilar development, has signed its first development and license agreement with Blau...more

Goodwin

Henlius and Eurofarma Entered into a License Agreement for Henlius’ 3 Products in Latin America

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Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company,...more

Goodwin

FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for...

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Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes...more

Goodwin

Deal news: Bio-Thera Solutions and Intract Pharma

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Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal...more

Goodwin

Biogen/Samsung Approval of BYOOVIZ™

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Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA.  BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of...more

Goodwin

Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement

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Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According...more

Proskauer - The Patent Playbook

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2021

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more

Goodwin

Biogen and Bio-Thera Solutions Announce Collaboration on Proposed Actemra® (Tocilizumab) Biosimilar

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This month, Biogen and Bio-Thera announced a commercialization and license agreement for their proposed tocilizumab biosimilar, currently in Phase 3 trials for the treatment of moderate to severe rheumatoid arthritis....more

Haug Partners LLP

Takeda Defeats Motion to Dismiss Patent and Contract Claims

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On September 9, 2020, Judge Richard G. Andrews of the United States District Court for the District of Delaware ruled in favor of Takeda Pharmaceuticals U.S.A., Inc. in the case Takeda Pharmaceuticals U.S.A., Inc. v. Mylan...more

Goodwin

Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

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We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab...more

Goodwin

Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

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Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more

Patterson Belknap Webb & Tyler LLP

PTAB Holds Indian Tribes Don’t Offer an Out from IPR

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs. The PTAB’s decision also...more

Troutman Pepper Locke

Allergan’s Mohawk Gambit May Be Doomed – PTAB Rethinks the Scope of Sovereign Immunity

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A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to...more

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