Novartis AG has forged even stronger links with Beigene Ltd., taking an option on the latter’s late-stage TIGIT inhibitor cancer immunotherapy ociperlimab in a deal worth up to $1 billion. Basel, Switzerland-based Novartis will pay the Beijing-based pharma $300 million up front in the option, collaboration and license agreement plus up to $700 million if it exercises its option before late 2023. Read More
The FDA has approved Astrazeneca plc and Amgen Inc.’s first-in-class biologic, tezepelumab, for the add-on maintenance treatment of adults and children ages 12 and older with severe asthma, adding further competition to a hotly contested market. An injection marketed under the brand name Tezspire, tezepelumab inhibits the action of thymic stromal lymphopoietin (anti-TLSP). This is a signaling molecule at the top of several cascades influencing allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness. Read More
Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call. Read More
Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002). Read More
What one analyst called “fantastic external validation but, even more importantly, great for the cell therapy and regenerative medicine space” arrived in the form of Lineage Cell Therapeutics Inc.’s potential $670 million deal with Roche Holding AG. With its subsidiary, Cell Cure Neurosciences Ltd., Lineage signed an exclusive worldwide collaboration and license pact with Roche and its Genentech arm. Read More
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Read More
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial. Read More
Brain disorders have not yet profited from advances in precision medicine to the same extent that other disorders have. With the advent of magnetic resonance imaging and other technologies, watching the brain at work has made great strides in recent decades. But those data have often been shoehorned into the categories of the Diagnostic and Statistical Manual of Mental Disorders. Researchers are working to bring diagnostic categories in line with a modern understanding the brain. Read More
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England. Read More
Following extensive discussions with their British counterparts, the European Commission (EC) advanced proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K. Read More
A lead clinical trial investigator for Five Prime Therapeutics Inc.’s flagship cancer drug, bemarituzumab, is facing SEC and criminal charges related to insider trading. Read More
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18. Read More
New hires and promotions in the biopharma industry, including: CB, Centogene, Checkmate, Finch, I-Mab, Intellia, Kriya, Lidds, Provention, Sensorion, Todos, Versantis, XNK. Read More
Biopharmas raising money in public or private financings, including: Armgo, Bellus, Beroni, Cincor, Dynamics Special Purpose, Genenta, Immunity, IMV, Pulmatrix, Senti. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzamend, Bellerophon, Glycomine, Merck, Mindmed, Navidea, Passage, Ridgeback, Taysha, UCB, Vincerx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Basilea, Biogen, Eisai, Erasca, Glaxosmithkline, Global Blood, Karyopharm, Lyell, Medicago, Medicenna, Merck & Co., Miromatrix, Obseva, Paratek, Pfizer, Seagen, Senhwa, Vir, Xalud, Zai. Read More