Drug Development
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
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Novartis and Antares Therapeutics are shooting for the stars, launching a joint mission to develop small molecule oncology therapies.
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO; and Jef Akst and Annalee Armstrong report back from San Diego.
As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
Given its intravenous route of administration, Merck’s tulisokibart will likely “need to be meaningfully improved” over Roche’s afimkibart, which can be given subcutaneously, BMO Capital Markets analysts said. Both assets are being tested for ulcerative colitis.
While existing antibody-drug conjugates have been incredible advancements in cancer care, patients are ready for a better experience. At the BIO International Convention in San Diego on Thursday, BioSpace will lead a discussion on the next generation of ADCs.
Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
Among the health department’s efforts is an expedited investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.
Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
Formed by Sofinnova Partners and former Sanofi executive Frédéric Marrache, Bionyra Pharma emerged from stealth Monday with an initial focus in inflammatory bowel disease and atopic dermatitis.