BioSpace News Archive

With no well-controlled data to support its efficacy, the FDA rejected Aldeyra’s methotrexate injection for primary vitreoretinal lymphoma.

Shares of Sarepta dropped 11% a day after securing accelerated approval for the first gene therapy to treat Duchenne muscular dystrophy over concerns about the potential for label expansion.

The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.

The government asked a federal judge to overturn a verdict in which a Delaware jury ruled in favor of Gilead, deciding that its preventative HIV drugs Truvada and Descovy did not infringe on its patents.

Under the merger announced Thursday, Tourmaline shareholders will own nearly 80% of the new company, which will retain its name and continue to focus on developing its anti-IL 6 antibody.

The biotech is leveraging the potential of antibody-drug conjugates for non-internalizing targets in solid tumors through its proprietary Click-to-Release platform.

Tagworks Pharmaceuticals BV announced a $65 million Series A financing led by Ysios Capital and Gilde Healthcare with participation from Novartis Venture Fund, New Enterprise Associates, and Lightstone Ventures.

Sanofi announced that its Q2 2023 Memorandum for modelling purposes is available on the “Investors” page of the company’s website:.

Ferring Pharmaceuticals announced that Jean-Frédéric Paulsen has been appointed Executive Chairman of the Ferring Group, as it enters a new phase of growth following the approval of two innovative medicines by the US Food and Drug Administration.

Memo Therapeutics AG, a late-stage biotech company developing best-in-class therapeutic antibodies, announced that the first patient has been enrolled in a pivotal, multicenter U.S. Phase II/III trial of AntiBKV, MTx’s antibody therapeutic that targets BK polyomavirus infection in renal transplant patients.