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Update on Pending Denosumab BPCIA Litigations

There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey before...more

GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement in Trio of Lawsuits

Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more

WHO Prequalifies Bavarian Nordic’s MVA-BN as First Vaccine Against Mpox

On September 13, 2024, the World Health Organization (WHO) announced that it added the first vaccine against monkeypox (mpox) to its prequalification list. The vaccine, MVA-BN, is manufactured by Bavarian Nordic A/S....more

Updates on Aflibercept BPCIA Litigation - January 2024

On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more

FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA.  SCD is a group of inherited...more

Sandoz Invests in New Biosimilar Manufacturing Facility

On July 20, 2023, Sandoz announced that it plans to invest approximately $90 million to build a Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026. The facility will be used to manufacture both drug...more

Janssen Seeks a Preliminary Injunction in BPCIA Ustekinumab Case Against Amgen

On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654,...more

Biogen Seeks a Preliminary Injunction in Natalizumab BPCIA Case Against Sandoz

​​​​​​​Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...more

Denosumab Clinical Trial Updates

​​​​​​​The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies....more

Outlook Therapeutics to Revise Ophthalmic Bevacizumab BLA in Light of FDA Request

Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA. LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection...more

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...more

Biogen and Xbrane Enter into Worldwide Commercialization and License Agreement for Certolizumab Pegol Biosimilar

On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the...more

British Columbia Expands Biosimilar Initiative to Rapid-Acting Insulins

On December 1, 2021 the government of British Columbia announced that it is further expanding its biosimilar initiative. The statement reported that as of November 30, 2021 an estimated 30,000 patients on the rapid-acting...more

Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo. Susvimo is a refillable ocular implant - requiring refills every six months - that continuously delivers...more

FDA Accepts BeiGene’s BLA for Tislelizumab in Esophageal Squamous Cell Carcinoma

On September 13, 2021 BeiGene announced the FDA’s acceptance of its BLA for tislelizumab in esophageal squamous cell carcinoma (ESCC). While tislelizumab is already approved for five indications in China, this marks the first...more

Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two...more

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