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.
A futility analysis of Molecular Partners AG’s ensovibep for treating hospitalized COVID-19 adults prompted an independent data safety monitoring board to recommend discontinuing recruitment of patients in the phase III ACTIV-3 study.
Catalyst Biosciences Inc. decided to stop developing marzeptacog alfa (MarzAA), a recombinant human coagulation factor VIIa variant for treating factor VII deficiency, and sell its hemophilia assets to focus on its complement therapeutics and protease medicines platform.
The U.S. NIH said it will go to court if necessary to defend its role in developing Moderna Inc.’s COVID-19 vaccine. NIH spokeswoman Renate Myles told BioWorld that the agency “is not giving up on our claim that NIH is a co-inventor on the mRNA technology used in the Moderna’s COVID-19 vaccine but defers to legal authorities on how this might be resolved.”
Novome Biotechnologies Inc. wasn’t out shaking the trees looking for a partner in its drive to develop cellular therapies for the gut to treat chronic diseases but it found one in Genentech Inc., which was familiar with Novome’s founding work at Stanford University. Now the two have struck a multiyear collaboration to discover, engineer and develop bacterial strains expressing and delivering molecules to targets in the intestinal tract to treat diseases such as inflammatory bowel disease.
In the Biohaven Pharmaceutical Holding Co. Ltd. and Pfizer Inc. collaboration to commercialize Nurtec ODT (rimegepant) outside the U.S., Biohaven will receive tiered double-digit royalties on ex-U.S. net sales as well as milestone payments of up to $1.24 billion. The target: more than 1 billion migraine sufferers worldwide with lots of clinical competition.
New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.
Calithera Biosciences Inc.’s stock took a severe beating Nov. 5 as shares closed 54.5% downward due to the company’s phase II stumble of telaglenastat in treating non-small-cell lung cancer. It was the therapy’s second clinical failure in the past 12 months.
A more than 20-year uneasy biopharma romance between two Swiss giants will be ending as Novartis AG plans to sell its stake in Roche Holding AG back to Roche for about $20.7 billion. Roche described it as a “disentanglement of the two competitors” that will allow it to regain “full strategic flexibility.” Basel, Switzerland-based Novartis currently owns about one-third of Roche, whose shareholders get the final say-so when they vote yea or nay at the company’s Nov. 26 extraordinary general meeting. Novartis was very clear about how it views its stake in Roche, as the company said it “does not consider the financial investment in Roche as part of its core business and therefore not a strategic asset” and that it’s time to “monetize our investment.”
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
