Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot. Read More
In its first big pharma deal since it was founded around a cell programming technology in 2009, Immusoft Corp. signed Takeda Pharmaceutical Co. Ltd. to a research collaboration and license option targeting rare inherited metabolic disorders. The agreement brings an undisclosed up-front fee and research funding to Immusoft, which is also eligible to earn more than $900 million if all options are exercised and all milestones hit. Read More
LONDON – Intellia Therapeutics Inc. is to receive 10% of the equity in Sparingvision SAS as part of a deal giving the French ophthalmology specialist certain exclusive rights to in vivo CRISPR/Cas9 technologies in the treatment of ocular diseases. Read More
Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response to COVID-19 vaccination. Read More
In a deal that could be worth more than $450 million, Olix Pharmaceuticals Inc. and Hansoh Pharmaceutical Group Co. Ltd. have agreed to discover, develop, and commercialize siRNA therapeutics for various liver-based targets implicated in cardiovascular, metabolic, and other indications. Read More
Mitochondrial disease, where the tiny energy factories in cells aren’t functioning properly, can have devastating and sometimes fatal consequences. As there are no approved treatments, patients rely on strategies such as strict diets and conserving energy to try and control symptoms that can affect organs including the brain, kidneys, muscles, pancreas and heart. Netherlands-based biotech Khondrion BV is one of a group of companies that is making progress against this group of rare inherited conditions that affects around one in every 4,000 people. Read More
Aum Biosciences Pte. Ltd., a company developing targeted cancer therapies, has closed a $27 million series A funding round. The Singapore-based company plans to use the proceeds to advance clinical development of its portfolio with immediate initiation of two phase II programs for MNK and tropomyosin receptor kinase inhibitors. Read More
New hires and promotions in the biopharma industry, including: Adicet, Ampio, Cytovia, I2O, J&J, Lianbio, Pepgen, Poseida, Prime Medicine, Reform, Satsuma, Tracon, Travere, Verismo. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics, including: Basilea, Black Diamond, Catalym, Compass, Immuneering, Repare. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaccine, Aerie, Agenus, Apeiron, Arcturus, Ascletis, Astellas, BMS, Inflarx, Inhibrx, Inovio, Istari, Otonomy, Vtv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corium, Curevac, Deciphera, Gensight, Hoth, Intelgenx, Nrx, Ocular, Protara, Sofie, Viiv. Read More
