Top news
* A study involving Advaxis, Inc.'s investigational cancer theray in combination with AstraZeneca PLC's Imfinzi was halted after a patient died of respiratory failure during the trial. The U.S. Food and Drug Administration placed a clinical hold on the investigational new drug application for axalimogene filolisbac, which is being tested on patients with a type of cervical cancer associated with human papillomavirus.
* Teva Pharmaceutical Industries Ltd. is giving up its rights to develop a migraine candidate and potentially related drugs as part of its recent restructuring. Japan's Sosei Group Corp. regained the rights to develop and sell HTL0022562 following the termination of a drug discovery deal between Teva and Sosei unit Heptares Therapeutics.
On the policy front
* The U.S. FDA is undertaking new social science research, including a study examining if low- to non-internet users are being adequately informed about the risks and benefits of prescription medicines. The research is part of an effort to better understand if patients and doctors are benefiting from the regulator's policies for drug companies' promotions of their products.
* The Medicare Payment Advisory Commission, which advises Congress on Medicare, is planning to explore ways to spur more urgent care clinics in the nation as a cheaper alternative. Members of the commission are concerned too many people are going to emergency rooms for relatively minor cases that could be handled more cheaply in urgent care centers and doctors' offices.
However, Rita Redberg, a University of California, San Francisco cardiologist and a member of the commission, said creating more urgent care centers would be missing the point, and she believes the key is to bolster more physicians' offices.
* Republican leaders of the U.S. House Energy & Commerce committee, including the committee's chairman, Rep. Greg Walden, R-Ore., wrote to the Centers for Medicare and Medicaid Services yesterday to say they were concerned about the agency's ability to assure that some hospitals were meeting standards.
Drug and product pipeline
* Portola Pharmaceuticals Inc. said a study found that AndexXa reversed blood-thinning activity in patients experiencing acute major bleeding while taking a class of anti-clotting agents known as Factor Xa inhibitors. AndexXa is under review by the U.S. FDA, with an assigned action date of May 4.
* Anthera Pharmaceuticals Inc. will discontinue further development of its pancreas drug Sollpura after it failed to show that it worked as well as existing treatments in the market. The drugmaker was studying the therapy in patients with exocrine pancreatic insufficiency due to cystic fibrosis, a rare genetic disorder.
* Sarepta Therapeutics Inc. will seek U.S. FDA approval for a second drug to treat Duchenne muscular dystrophy, a muscle-wasting genetic disorder.
* Sanofi decided against exercising an option to develop Alnylam Pharmaceuticals Inc.'s investigational medicine lumasiran, which is being studied to address primary hyperoxaluria type 1, a rare kidney condition.
* Gout patients with pre-existing heart conditions risk a higher chance of death when treated with febuxostat, sold by Takeda Pharmaceutical Co. Ltd. as Uloric, compared to those treated with allopurinol, also known as Zyloprim, according to a study published by the New England Journal of Medicine.
Operational activity
* Arena Pharmaceuticals Inc. is selling its drug manufacturing facility in Zofingen, Switzerland, to Siegfried Holding AG for CHF 4 million in cash.
* Gilead Sciences Inc. said Norbert Bischofberger is stepping down as the company's chief scientific officer and executive vice president of research and development, effective at the end of April. John McHutchison, who is serving as Gilead's executive vice president of clinical research, will replace Bischofberger as chief scientific officer.
* Coherus Biosciences Inc. said its petitions to invalidate Amgen Inc.'s patents covering etanercept were rejected by the U.S. Patent Trial and Appeal Board. Etanercept is the main component of Amgen's rheumatoid arthritis therapy.
* Orexigen Therapeutics Inc. filed for Chapter 11 bankruptcy protection and will look to sell the company.
* Myriad Genetics Inc. received a subpoena from the U.S. Department of Health and Human Services as part of an investigation into possible submission of false or improper claims under Medicare and Medicaid.
* Nektar Therapeutics is replacing Chesapeake Energy Corp. on the S&P 500 after the latter's market value dipped below the minimum required for listing on the large-cap index.
Our features
With HIV trends shifting, drugmakers look to boost diversity in research: Diversity was the key theme at an annual meeting of HIV researchers in Boston, where participants presented trials for the latest medicines alongside studies showing race- and gender-related infection and treatment trends.
Other features
* The New York Times has a feature on the debate about the effectiveness of antidepressants.
* The Wall Street Journal writes about the difficulties drugmakers face marketing weight-loss therapies after Orexigen Therapeutics filed for bankruptcy.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng rose 0.02% to 31,601.45, while the Nikkei 225 climbed 0.66% to 21,968.10.
In Europe, around midday, the FTSE 100 dropped 0.02% to 7,213.59 and the Euronext 100 rose 0.21% to 1,034.61.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
S&P Global Ratings, S&P Dow Jones Indices and S&P Global Market Intelligence are owned by S&P Global Inc.
