News
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Breast cancer came in as the most studied disease in 2022, according to the patient data analytics firm Phesi.
The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.
Horizon Therapeutics’ dazodalibep met the primary endpoint in a second straight Phase II trial for Sjögren’s syndrome.
The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
A pre-specified interim analysis of Junshi Biosciences’ Phase III Neotorch trial showed its anti-PD-1 monoclonal antibody, toripalimab, met its primary endpoint in non-small cell lung cancer (NSCLC).
Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.
Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
Edesa Biotech’s EBO1, a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), showed mixed results compared to placebo in Phase II, the company announced Tuesday.
TC BioPharm and MD Anderson signed a three-year collaboration to better understand the role of gamma delta T cells in cancer treatment.
Massachusetts-based biotech Leap Therapeutics announced Tuesday that it had entered into a merger deal with the privately-held Flame Biosciences, Inc.