Roche Holding AG is walking away from a deal with Atea Pharmaceuticals Inc. to co-develop the COVID-19 oral antiviral treatment AT-527 after the mid-October failure of a global phase II study testing the medicine in non-hospitalized adults with mild or moderate disease missed its primary endpoint. Roche’s decision tosses the rights and licenses back to Atea so it can continue its development and commercialization efforts. Read More
After Moderna Inc. lowered its revenue expectations earlier this month, the company’s swollen stock price plunged over the next two weeks by more than 32%, signifying that BioWorld’s Drug Developers Index can no longer rely solely on one company to keep industry stocks in positive territory. Read More
A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic. Read More
Chroma Medicine Inc. emerged from stealth with $125 million in series A financing and high ambitions to rewrite the rules of genomic medicine by modulating the epigenetic status of target genes in order to switch expression on or off and thereby achieve therapeutic outcomes. Read More
PERTH, Australia – Radiopharm Theranostics Ltd. raised AU$50 million (US$36.4 million) in an oversubscribed IPO to advance its platform of radiopharmaceutical products for both diagnostic and therapeutic uses. Read More
NHS England has struck new pricing agreements that expands access in the U.K. to blood thinning direct oral anticoagulants (DOACs) to tackle strokes in patients with atrial fibrillation. Though still available to NHS clinicians, Boehringer Ingelheim GmbH’s blockbuster DOAC Pradaxa (dabigatran) is notably not involved. Read More
Bristol Myers Squibb Co. has completed a $20 million equity investment in Compugen Ltd., part of an ongoing expansion a collaboration between the companies to combine their medicines for the potential benefit of patients with solid tumors. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Biogen, Crispr, Coya, Cyclo, Cytodyn, Diurnal, Icure, Moderna, Mymd, Siga, Viacyte. Read More
