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On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema (HAE).

On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, "Janssen") filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma...

Today, the Nobel Assembly at Karolinska Institutet announced that the Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman "for their discoveries...

Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office's statistics portal, as of January 30, 2024...

On September 13, 2022, Lupin Ltd. announced that its RYMTI product, a biosimilar to ENBREL, has been approved in Canada.

On August 12, 2025, Lupin Limited ("Lupin") announced that it has partnered with Sandoz Group AG ("Sandoz") to market and commercialize Lupin's biosimilar ranibizumab across multiple regions.

Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab).

Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter ("CRL") for its aflibercept 8 mg BLA for the treatment of patients with wet age-related...

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.'s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb...

On February 11, 2026, Samsung Bioepis, Co., Ltd ("Samsung") and Regeneron Pharmaceuticals, Inc. ("Regeneron")...

Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to ...

On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech's PERJETA® (pertuzumab).

On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, "the first ustekinumab biosimilar in Europe commercially available in an autoinjector."

On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million.

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC...

During the COVID-19 public health emergency (PHE), many federal telehealth rules were made flexible to accommodate the need for continued access to healthcare, including prescribing controlled...

On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA)...