The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs. Read More
A month after Astrazeneca plc’s $39 billion takeover of Alexion Pharmaceuticals Inc. was finalized, the merged company has hit its first speed bump after the new unit discontinued a phase III rare disease trial. Alexion, of Boston, said it axed the 382-patient CHAMPION-ALS trial of its long-acting C5 complement inhibitor Ultomiris (ravulizumab) in amyotrophic lateral sclerosis (ALS). Read More
The completion of the third largest biopharmaceutical acquisition on record has significantly boosted M&A values in 2021, although the industry still falls more than 38% below the same period last year. Read More
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV. Read More
For most people, neither polyglutamine disorders nor neuromuscular disorders are likely to be among the things they associate with androgen receptor (AR) dysfunction. But the three are indeed linked. And researchers have reported new insights into the nature of those links that could lead to a treatment for spinal and bulbar muscular atrophy, and possibly other disorders linked to AR signaling dysfunction. Read More
Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs. Read More
PERTH, Australia – Imugene Ltd. has closed an AU$90 million (US$64 million) placement and an AU$5 million share repurchase plan that will allow the company to progress its CAR T pipeline through 2025 and pursue a collaboration with Celgene Corp. spin-off Celularity Inc. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Coherus, Compugen, Intrabio, Janssen, Junshi, Nervgen, Nrx, Scioto, Zealand, Zhaoke. Read More
