After receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the New Drug Application for tenapanor for control of serum phosphorus in adults with chronic kidney disease on dialysis, Waltham, Mass.-based Ardelyx is restructuring to save money.
Second-quarter 2021 sales of AstraZeneca’s Covid-19 vaccine more than tripled to $894 million from the first quarter, but the drugmaker on July 29 again delayed the U.S. application for approval as the company gathers more data for submissions.
The first half of 2021 saw a flurry of IPOs as multiple companies make the move to become publicly traded.
Vectura Group announced that the company would be undergoing a $1.36 billion takeover by global investment firm The Carlyle Group.
Thermo Fisher Scientific Inc. is acquiring contract researcher PPD Inc. for $17.4 billion as the medical device maker adds more muscle to the company’s pharmaceutical services business.
Cidara Therapeutics inked a deal worth up to $780 million with Johnson & Johnson to develop and commercialize Cidara’s candidate CD388 for the prevention and treatment of seasonal and pandemic influenza.
Novavax Inc.’s Covid-19 vaccine was 96 percent effective in preventing cases caused by the original version of the coronavirus in a late-stage trial conducted in the United Kingdom, the company said on March 11, moving it a step closer to regulatory approval.
The U.S. Food and Drug Administration approved Aveo Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma in people who have had two or more previous systemic therapies.
Denmark’s Novo Nordisk is acquiring New Jersey-based Emisphere Technologies in a deal worth about $1.8 billion.
Shares of Satsuma Pharmaceuticals plunged in trading after the company revealed the migraine treatment STS101 failed to hit co-primary endpoints in a late-stage study.
