The FDA’s Oncologic Drugs Advisory Committee voted 6-2 April 29 to recommend withdrawing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a third-line treatment for a subgroup of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer. The vote was based on FDA assurances that, if it withdrew the approval, it would work with Merck to delay the withdrawal or set up an access program to ensure the estimated 1,000 patients who are beyond first-line treatment could still get Keytruda. Read More
Capsida Biotherapeutics Inc., a gene therapy startup focused on advanced capsid engineering to generate tissue-selective vectors, emerged from stealth with $50 million in series A funding and another $90 million in cash from a strategic collaboration and option agreement in neurodegenerative disease with Abbvie Inc. Read More
Despite stock-denting phase II data with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis (AD), Cara Therapeutics Inc. CEO Derek Chalmers said the outcome “prioritizes moving forward. We got what we needed from the phase II trial,” which identified the patients most sensitive to the drug, nailed down a dose spectrum, and equipped the company to power a registrational effort, he said. Read More
Cross-border startup Adcentrx Therapeutics Inc., with operations in San Diego and soon in Shanghai, secured $50 million in a series A financing round led by CBC Group to establish its presence in the antibody-drug conjugate (ADC) space. Read More
Just four months after Blue Water Acquisition Corp. raised $50 million in an IPO, it set out on April 27 to merge with Clarus Therapeutics Inc., the developer of testosterone replacement therapy Jatenzo, valuing the Northbrook, Ill.-based firm at $379 million. Earlier in April, BCTG Acquisition Corp. announced plans to buy Cambridge, Mass.-based targeted precision cancer company Tango Therapeutics Inc. for $353 million, about seven months after completing its $167 million IPO. Both Clarus and Tango are seeking the public markets by merging with a special purpose acquisition company, or SPAC, a method that is becoming increasingly popular and an alternative to the traditional IPO. Read More
Urgency to meet the world's worsening load of COVID-19 cases appeared unflagging Thursday, with four new trials kicking off to evaluate treatments aimed at keeping people from progressing to worsened disease and reports on two new variant-focused efforts yielding signs of preclinical promise. Read More
In the final part of its three-day meeting on accelerated approvals granted to anti-PD-1/PD-L1 antibodies, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to continue the accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a therapy for patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer AG). Read More
HONG KONG – Shionogi & Co. Ltd. has inked a multitarget drug discovery collaboration for Inveniai LLC’s artificial intelligence and machine learning platform Alphameld. Inveniai is eligible to receive up to $200 million per program through a combination of up-front payments, development and commercial milestones, and royalties. Read More
Researchers have gained new insights into what makes for transplantable livers – and what doesn’t. In a clinical trial of 12 livers, a team from Massachusetts General Hospital showed that both livers with high fat content and those without could be viable for transplantation. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aft, Alcon, Annovis, Asklepios, Brooklyn Immunotherapeutics, Canbridge, Capricor, Delix, Hikma, Inozyme, Mindset, Mirum, Moderna, Novartis, Park, Repertoire, Selecta, Sirnaomics, Tris, Walvax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, CSL, Genentech, Lipac, Novartis. Read More
