Sage Therapeutics ended two late-stage studies of the depression drug zuranolone after discussions with the U.S. Food and Drug Administration led the company to believe they were unnecessary for potential regulatory approval.
Bristol Myers Squibb is withdrawing the biopharmaceutical giant’s Istodax from the market after recent trials showed that the peripheral T-cell lymphoma drug did not achieve primary efficacy endpoint.
Novartis will launch a new phase three study to expand the use of Zolgensma – the world’s most expensive one-time therapy at $2.1 million per patient treatment – after the U.S. regulator lifted its restrictions.
Ipsen, a global biopharmaceutical firm that specializes in neuroscience, oncology and rare diseases, partnered with Exicure, a clinical-stage biotech company that develops treatments for neurological, inflammatory and genetic disorders, to create new therapies for Angelman syndrome (AS) and Huntington’s disease (HD).
AbbVie’s Rinvoq continues to demonstrate the medicine’s clinical potential to become the heir-apparent to the company’s blockbuster drug Humira, which will lose patent protection in 2023. In the company’s second-quarter 2021 report, AbbVie touted advances Rinvoq made throughout the three months, including positive Phase III data in ulcerative colitis.
Combining AstraZeneca’s Covid-19 vaccine with a second dose from either Pfizer-BioNTech or Moderna’s jab provides “good protection”, Denmark’s State Serum Institute said on Aug. 2.
The U.S. Food and Drug Administration rejected Ardelyx Inc.’s chronic kidney disease drug tenapanor by issuing a Complete Response Letter.
Trials mixing a first dose of the Russian-made Sputnik V vaccine with AstraZeneca’s shot revealed no serious side effects and no subsequent cases of coronavirus among volunteers, the Russian Direct Investment Fund (RDIF) said on July 30.
Three pharmaceutical and biotechnology companies announced the recent success of their respective funding rounds to support future efforts.
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.
