Surprising no one, Jennifer Doudna and Emmanuelle Charpentier won the 2020 Nobel Prize in Chemistry “for the development of a method for genome editing,” that is, the CRISPR/Cas9 system. Read More
LONDON – Enterprise Therapeutics Ltd. has sold its TMEM16A cystic fibrosis portfolio to Roche Holding AG for an up-front payment of £75 million (US$96.9 million), with more to come on achievement of predetermined milestones. Read More
With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555. Read More
With COVID-19 cases once again surging across the globe and several countries considering targeted lockdowns, vaccines remain the best hope of restoring a sense of normalcy amidst the pandemic. For vaccines to work though, people must have enough confidence in the efficacy and safety that they’re willing to get vaccinated when the vaccines become available. That’s why the emergency use authorization (EUA) guidance the FDA released Oct. 6 for COVID-19 vaccines is so important. Read More
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck. Read More
BEIJING – Biologics developer Genor Biopharma Co. Ltd. raised HK$2.69 billion (US$347 million) via a pre-revenue IPO on the Hong Kong Stock Exchange on Oct. 7, with shares (HKEX:6998) trading 16.25% higher to close at HK$27.95. Read More
As expected, weight mitigation and opioid-related risks turned up as the main concerns in briefing documents for the joint advisory panel meeting Oct. 9 to mull the approvability of Alkermes plc’s ALKS-3831. Read More
HONG KONG – Belgium-based Bone Therapeutics SA has inked development and commercialization deals for its bone cell therapy platform in Chinese and Southeast Asian markets. Read More
Janpix Inc., of Cambridge, Mass., has raised a $10 million series B designed to progress its monovalent small-molecule protein degraders of STAT3 and STAT5 into final preclinical studies and eventually into the clinic to treat various hematological and solid tumor cancers. Read More
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: EMA’s new platform for scientific advice; FDA draft guidance for breast cancer trials. Read More
New hires and promotions in the biopharma industry, including: Achilles, Akili, Ashvattha, Carmell, In8bio, Inositec, Kahr, Polyneuron, Radius. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Abfero, Achieve, BMS, Epizyme, Ilya, Immunitybio, Lilly, Nantkwest, Napo, Onconano, Pfizer, Redhill, Stoke, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Arca, Arch, Biomarin, Eton, Lilly, OWP, Pluristem, Polarean, TLC, Y-Mabs. Read More
