With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country. Read More
LONDON – The Oxford University team behind the development of Astrazeneca plc’s COVID-19 vaccine have become the first to publish full and complete interim phase III data in a peer-reviewed journal. Read More
No one will be sad to see the back of a horrendous year, with the raging pandemic bringing the world to its knees. However, the potential end to this dire situation is now tantalizingly in sight. The collective sigh of relief was certainly demonstrated by investors. According to Cowen & Co. analysts, “the sector had its strongest rally since the Spring and the biotech indices kept pace with the broader markets." Read More
Rayzebio Inc. has swiftly followed up its recent $45 million series A round with a $105 million series B round that attracted several top-tier crossover investors. Read More
Questions of durability came up regarding Curis Inc.’s latest data with CA-4948, but that didn’t stop shares from soaring to $6.55 by day’s end, an increase of $5.11, or 355%. The ride came after Lexington, Mass.-based Curis rolled out positive preliminary data from the firm’s ongoing open-label, single-arm phase I dose-escalation study with the compound. Read More
Remix Therapeutics Inc., a Cambridge, Mass.-based startup developing small-molecule RNA modulators, said it has raised $65 million in series A financing led by Foresite Capital. Read More
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients. Read More
DUBLIN – Top-line data from a placebo-controlled phase II trial of Vicore Pharma Holding AB’s angiotensin II type two receptor agonist, C21, provide preliminary evidence that the oral drug may provide benefit to patients with severe COVID-19 disease on top of steroid therapy. Read More
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD). Read More
New hires and promotions in the biopharma industry, including: Avid, Candel, Cerevance, Delcath, Kronos, Opiant, Protara, Seranovo, Tufts Center. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Beigene, Cerecor, Cyxone, Henlius, ITM, Ix, Takeda, Turning Point. Read More
