Top news
* Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told S&P Global Market Intelligence that the time is ripe now for a "full-court press" in investment and resources from all stakeholders to accelerate developing a universal influenza vaccine.
* Mylan NV reported a year-over-year decline in both profit and total revenue for the fourth quarter of 2017 after sales fell 17% in North America. Sales of Mylan's EpiPen auto-injector for severe allergic reactions dropped by $131.9 million in the fourth quarter due to the launch of an authorized generic, higher governmental rebates and increased competition.
* Susan Gibson, deputy assistant attorney at the U.S. Drug Enforcement Administration's Diversion Control Division, told lawmakers that illicit synthetic forms of legitimately marketed prescription opioids, such as fentanyl, and new psychoactive substances have been proliferating — fueling the increase in U.S. overdose deaths.
Rogue chemists creating synthetic opioids, cannabinoids and cathinone products with unknown pharmacological effects are able to stay one step ahead of law enforcement by making small tweaks in the molecular structures of their products, Gibson told members of the House Energy and Commerce Health Subcommittee at a Feb. 28 hearing.
* Meanwhile, more U.S. states are actively considering restricting the initial supply of opioid painkillers that patients can receive, according to a National Conference of State Legislatures database.
U.K.-based pharmaceutical company Mallinckrodt Plc has received subpoenas from a number of states related to the distribution, marketing and sale of its opioid products.
* Attorney General Jeff Sessions said the U.S. government will hold accountable companies that allegedly contributed to the opioid epidemic, including Johnson & Johnson and Purdue Pharma, by seeking reimbursement from them for taxpayer money spent in fighting the crisis, Bloomberg News reported.
On the policy front
* The European Medicines Agency adopted revised guidelines on clinical studies for medicines that target Alzheimer's disease, in a bid to encourage the testing of new drugs before the disease's symptoms start appearing, as well as the potential use of biomarkers.
* Canadian Finance Minister Bill Morneau signaled that he does not intend to introduce a universal healthcare coverage plan that would throw out the country's current system, Bloomberg noted.
M&A and capital markets
* Paris-based Sanofi secured U.S. and German antitrust clearance for its deal to acquire Belgian biotech Ablynx NV.
* Stockholm-based Karo Pharma AB (publ) acquired a drug portfolio — comprising medicines that address the therapeutic areas of infectious, cardiovascular and dermatological diseases — from Danish drugmaker LEO Pharma A/S for €260 million in a pure asset deal, effective April 4.
* Israeli generic-drug manufacturer Teva Pharmaceutical Industries Ltd. is looking to issue a total of €1 billion and $2.25 billion worth of senior notes in separate transactions through its units, in order to refinance debt.
* Grail Inc., a Menlo Park, Calif.-based cancer detection startup, is planning an IPO in Hong Kong, Bloomberg News reported, citing people with knowledge of the matter.
Drug and product pipeline
* Heat Biologics Inc.'s HS-110 in combination with Bristol-Myers Squibb Co.'s Opdivo showed positive results in a phase 2 study to treat advanced non-small cell lung cancer.
* The U.S. Food and Drug Administration granted approval to Sorrento Therapeutics, Inc. and its majority-owned unit SCILEX Pharmaceuticals Inc. for non-opioid painkiller ZTlido 1.8%, used to treat post-herpetic neuralgia or post-shingles pain.
* The U.S. FDA extended the review of Irish drugmaker Allergan plc's new drug application for ulipristal acetate for abnormal bleeding in the uterus due to fibroids.
Operational activity
* Swiss drugmaker Novartis AG and San Francisco-based Pear Therapeutics, Inc. are partnering to develop software applications designed to treat patients with schizophrenia and multiple sclerosis.
* Daiichi Sankyo Co. Ltd. intends to reduce its workforce by about 280 employees from various locations in the U.S. as part of a restructuring plan.
* Mylan and Revance Therapeutics Inc. agreed to develop and market Revance's copycat version of Allergan's blockbuster drug Botox, which is used to fill wrinkles and treat migraine headaches.
Our features
Bayer sets Monsanto acquisition closing date for Q2: Bayer AG said it expects to close its $62.5 billion deal to acquire Monsanto in the second quarter of 2018, later than originally anticipated.
Express Scripts CEO says deals make company ready for influx of biosimilars: The U.S. pharmacy benefit manager is primed for the incoming wave of cheaper biological drugs, according to executive comments on the company's fourth-quarter and full-year 2017 earnings calls.
Other features
* Drugmakers around the world are racing to get a grip on medical information available in patient health records and via partnerships with technology firms as these data prove to be useful in developing more personalized treatments, especially for cancer, heart disease and respiratory disorders, Reuters noted.
* In a renewed push into the healthcare space, Microsoft Corp. unveiled its Azure cloud platform for gene analysis and is also offering a blueprint that will aid companies hoping to move health data to the cloud while adhering to privacy rules, Bloomberg wrote. The move comes as rival Amazon.com Inc. gets a foothold in the healthcare field.
* Bloomberg highlighted researchers' inclination to revamp the way they develop the flu vaccine to make it more effective against the ever-mutating virus.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng was up 0.65% to 31,044.25, and the Nikkei 225 fell 1.56% to 21,724.47.
In Europe as of midday, the FTSE 100 dropped 0.68% to 7,182.46, and the Euronext 100 slid 0.85% to 1,019.63.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
