DUBLIN – Mina Therapeutics Ltd. continues to make progress in its long-term ambition to establish small activating RNA (saRNA) as a new therapeutic modality. The biotech has now entered a multitarget research collaboration with Eli Lilly and Co., in which it is receiving $25 million up front and up to $245 million in development and commercial milestones per product. Read More
Little more than a year ago, when COVID-19 lockdowns began, turned out to be a prime time for finding the right funding and partners. That’s when privately held Capsigen Inc. was on a search that ended with a Biogen Inc. deal that could add up to $1.3 billion. Read More
About 13 years after four MIT graduate students and a computer science professor launched Ginkgo Bioworks Inc., the Boston-based synthetic biology platform business is merging with a special purpose acquisition company (SPAC) in the largest life sciences deal of its kind to date. Read More
Appia Bio Inc. raised $52 million in a series A funding round to bring forward a novel take on allogeneic cell therapy for cancer, based on a rare lymphocyte population, invariant natural killer T (iNKT) cells, which exhibit aspects of both NK cell and T-cell biology. Read More
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic." Read More
LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10. Read More
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S. Read More
In an open letter to Pfizer Inc. employees, the company’s CEO, Albert Bourla, provided some insight about why some countries don’t have COVID-19 vaccines and others have a surplus. It has nothing to do with intellectual property (IP), or even price, Bourla said. Read More
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread. Read More
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Gene & Cell Therapy annual meeting, including: Adaptimmune, Akouos, Beam, Catamaran, Codiak, Dyno, Freeline, M6P, Neurogene, Passage, Phio, Poseida, Precision, Senti, Verve. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Alnylam, Arcturus, Arthrosi, Ascendis, Axcella, Biosight, Bioxcel, Brooklyn Immunotherapeutics, Day One, Harbour, Larimar, MAPS, Noxopharm, Noxxon, Oculis, Orchard, Tetra. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Bold, Cerecor, Foghorn, Organicell Regenerative Medicine, Pfizer, Rocket, Samus. Read More
