Top news
* The U.S. Food and Drug Administration granted Roche Holding AG's Avastin full approval for treating patients with glioblastoma, a form of brain cancer, that progressed following prior therapy. The FDA previously granted the drug provisional approval.
* Novo Nordisk A/S secured FDA approval for semaglutide, now known as Ozempic, a diabetes drug meant to improve blood sugar levels as an add-on to diet and exercise.
* GlaxoSmithKline plc is investing £40 million into an expansion of its previously announced genetic research alliance with the UK Biobank, as the British government takes steps to strengthen the appeal of the life sciences sector despite lack of resolution in ongoing Brexit negotiations.
Also part of the U.K.'s Life Sciences Sector Deal, a Johnson & Johnson unit will collaborate with the University of Oxford on novel clinical trial methodologies in the U.K., including platform trials focused on mental health disorders.
On the policy front
* The National Institutes of Health is close to moving a plan of action forward for a proposed partnership with drugmakers to accelerate the development of nonaddictive alternatives to opioids and better overdose-reversal agents, but the initiative lacks government funds and industry has yet to commit any cash, the head of the agency told lawmakers.
* The Institute for Clinical and Economic Review, an independent price advisory group, plans to update last year's review of the plaque psoriasis drug class after new options on the market coming from Valeant Pharmaceuticals International Inc. and Johnson & Johnson.
M&A and capital markets
* Advanced Accelerator Applications SA's board approved Novartis' bid to acquire the company and recommended that shareholders accept the offer. The board said the proposed $3.9 billion deal was in the best interests of the company and its stakeholders.
* Advicenne SA closed its IPO on Euronext's regulated market in Paris, raising a total of €27 million.
Drug and product pipeline
* The FDA granted priority review status for Clovis Oncology Inc.'s supplemental new drug application for its ovarian cancer treatment. The status was granted based on positive data from a phase 3 trial.
* GlaxoSmithKline said its shingles treatment Shingrix met its main goal in a phase 3 trial. The treatment demonstrated an efficacy of 68.17% against shingles in subjects above 18 years of age after receiving an autologous hematopoietic stem cell transplant.
Operational activity
* Johnson & Johnson and Bayer AG were ordered by a Philadelphia court to pay $27.8 million to an Indiana couple over their failure to warn of internal bleeding risks associated with the blood thinner Xarelto, Reuters reported.
* The Australian Competition and Consumer Commission launched proceedings in the Federal Court of Australia against units of GlaxoSmithKline and Novartis AG for allegedly making misleading representations in the marketing of certain pain relief products.
* MacroGenics Inc. closed its collaboration and license agreement with Incyte Corp. Under the deal, Incyte secured rights to develop and commercialize MacroGenics' investigational cancer drug MGA012.
Other features
* Endpoints News carries a feature about the improving clinical trial transparency of drugmakers, including Johnson & Johnson and Sanofi.
* Biogen Inc.'s appointment of Mark Hernon, formerly of Takeda Pharmaceutical Co. Ltd., as chief information officer points to the company's plans to use information technology to aid its development of treatments for neurological diseases, The Wall Street Journal reported.
* GlaxoSmithKline's newly appointed chief digital and technology officer, Karenann Terrell, who previously hailed from Wal-Mart, said the company is looking at whether artificial intelligence can be used to examine why some HIV patients drop out of treatment, the Journal also reported.
* Bloomberg examines the effects of AstraZeneca PLC's antipsychotic drug Seroquel in combination with methadone.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng fell 2.14% to 28,224.80, and the Nikkei 225 was down 1.97% to 22,177.04.
In Europe, as of midday, the FTSE 100 climbed 0.07% to 7,332.69, and the Euronext 100 had fallen 0.63% to 1,035.28.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
