Healthcare Roundup – Gilead not quite there with remdesivir nod in Europe, Chi-Med’s NDA for savolitinib accepted in China

欧洲监管机构正在审查吉利德瑞德西韦的数据,和黄医药沃利替尼的中国新药上市申请已获受理
Published on: May 30, 2020
Author: Amy Liu

Gilead not quite there with remdesivir nod in Europe

In an update, the European Medicines Agency’s advisory group CHMP states that it has started a rolling review of data on Gilead Sciences’ (NASDAQ:GILD) remdesivir for COVID-19. It finished the first cycle of the rolling review on May 15 and has requested additional data.

The next step in the process is the submission of said data together with an application for conditional approval. The company has yet to file the application but is expected to do so shortly.

CHMP will assess it “under a timeline which will be reduced to the absolute minimum to still allow a thorough evaluation of the benefits and risks.”

Shares down a fraction premarket.

Chi-Med’s NDA for savolitinib accepted in China

Hutchison China MediTech’s (NASDAQ:HCM) New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations has been accepted for review by the China National Medical Products Administration.

An updated analysis with 70 patients will be presented as part of the American Society of Clinical Oncology (“ASCO”) 2020 Meeting, available on May 29, 2020 at 8:00 a.m. ET.

In 2011, Chi-Med entered into a global licensing and joint development agreement with AstraZeneca (NYSE:AZN) for savolitinib.

Moderna advancing mid-stage study of COVID-19 vaccine

Moderna (NASDAQ:MRNA) announces that the first participants in each age cohort have been dosed in its Phase 2 clinical trial of its mRNA SARS-CoV-2 vaccine candidate mRNA-1273.

The study will enroll 600 healthy volunteers across two age cohorts: 18-55 years old and 55+ years old. Each will receive placebo or a 50 μg or a 100 μg dose of mRNA-1273 at both vaccinations and will be followed for 12 months after the second shot. The estimated primary completion date is March 2021.

Shares down 1% after hours.

FDA OKs Menlo minocycline foam for inflammatory skin condition

The FDA approves Menlo Therapeutics’ (MNLO -4.8%) Zilxi (minocycline) topical foam, 1.5% for the treatment of adults with inflammatory lesions associated with rosacea, a skin condition characterized by redness and visible blood vessels on the face.

The company says it is the first minocycline (antibiotic) product of any kind to earn the FDA nod for the indication.

Shares have been volatile during the session with an intraday range of $2.20 (-12.4%) – 2.88 (+14.7%).

Sanofi halts enrollment in studies of malaria drug in COVID-19

Sanofi (SNY -0.2%) has apparently suspended recruitment in its studies testing the use of malaria med hydroxychloroquine in COVID-19 patients.

Developing…

Update: France, Italy and Belgium have paused a large study of the drug following an earlier WHO decision to do the same. The European Medicines Agency (EMA) continues to caution on the drug’s safety profile, reiterating its position that its use should be restricted to clinical trials and emergency use programs while further analyses are done.

U.S. hospitals have backed away also. Orders have dropped 90% from the late-March peak to ~125K pills last week according to drug buyer Vizient.

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