Top news
* Regeneron Pharmaceuticals Inc. said its fourth-quarter 2017 non-GAAP net income came in at $607.3 million, or $5.23 per share, up 72% from $352.5 million, or $3.04 per share, in the year-ago period. Total revenues for the quarter were $1.58 billion, up 29% year over year.
* Alexion Pharmaceuticals Inc. booked fourth-quarter 2017 non-GAAP net income of $337.6 million, or $1.48 a share, up from $287.7 million, or $1.26 a share, in the year-ago period. The company expects non-GAAP EPS to come in at $6.60 to $6.80 for full year 2018.
* Teva Pharmaceutical Industries Ltd. said its fourth-quarter 2017 non-GAAP net income attributable to the company totaled $1.01 billion, or 93 cents per share, down from $1.48 billion, or $1.38 per share, in 2016. Revenues for the quarter were $5.5 billion, down 16% year over year.
* A bipartisan two-year spending agreement reached by Senate Republican and Democratic leaders would direct billions of dollars in new funds toward addressing the U.S. opioid crisis, advancing biomedical research and ensuring healthcare coverage for poor children.
Under the bill, the Children's Health Insurance Program would be extended for an additional four years in addition to the six-year extension lawmakers passed in January. The budget deal would also direct almost $90 billion toward disaster relief for states that were devastated by hurricanes and wildfires.
M&A and capital markets
* Sanofi launched a tender offer to buy all of the outstanding common shares of Bioverativ Inc. for $105 per share in cash. The French drugmaker agreed to acquire Bioverativ in an $11.6 billion deal in January.
* Brazil's antitrust agency, The Administrative Council for Economic Defense, approved Germany-based Bayer AG's proposed $63.5 billion deal to acquire Monsanto Co., Reuters reported.
* Aviragen Therapeutics Inc. and Vaxart Inc. agreed to amend the terms of their merger to increase value for Aviragen stockholders. Under the revised terms, Aviragen stockholders would own 49% of the combined company, up from 40% in the previous deal.
Drug and product pipeline
* The U.S. Food and Drug Administration approved Gilead Sciences Inc.'s new drug application for Biktarvy, a triple-therapy for adults with HIV-1 infection who have not had any antiretroviral treatment. Biktarvy will compete with Juluca, a similar therapy from GlaxoSmithKline plc's HIV unit ViiV Healthcare.
Meanwhile, ViiV Healthcare filed lawsuits in U.S. and Canada claiming that Gilead's Biktarvy infringes patents on its HIV treatment Tivicay and other compounds with the drug's "unique chemical scaffold."
* Takeda Pharmaceutical Co. Ltd.'s Ninlaro has been recommended for inclusion under the Cancer Drugs Fund by the National Institute for Health and Care Excellence, or NICE, allowing the treatment to be used in blood cancer patients while more data is collected to assess its value.
* Sanofi removed the investigational cancer treatment SAR428926 from its clinical pipeline. The French drugmaker obtained the therapy from ImmunoGen Inc. last May 2017.
* Verastem Inc. submitted a new drug application to the U.S. FDA for duvelisib as a treatment for certain lymphomas, which are cancers that begin in the cells of the immune system.
* Novartis AG secured U.S. FDA approval for a label update for Cosentyx to include moderate to severe scalp psoriasis, an autoimmune condition affecting the skin.
* Japan's Astellas Pharma Inc. said its rheumatoid arthritis drug peficitinib worked better at treating patients compared to placebo in two phase 3 trials.
* Exelixis Inc.'s kidney cancer treatment Cabometyx, in combination with Bristol-Myers Squibb Co.'s Opdivo, either alone or with Yervoy, reduced the tumor size of patients with treatment-resistant tumors.
Operational activity
* Indivior PLC filed patent lawsuits against Dr. Reddy's Laboratories Ltd., Alvogen Inc. and Teva Pharmaceutical Industries Ltd.
* During surprise inspections carried out in 2017 on 55 drug distributors in China, about one in three did not meet quality requirements, the China Food and Drug Administration said. Of the total, 18 were found to be in severe violation of drug quality management practices.
* Kyowa Hakko Kirin Co. Ltd. said its profit attributable to owners jumped to about ¥42.90 billion for 2017, up from ¥30.45 billion in 2016. The company attributed the overall growth to an increase in licensing revenue and lower research and development expenses which offset the impact of a cut in drug prices and other factors.
* GlaxoSmithKline CEO Emma Walmsley said there is no immediate need for the company to pursue a large-scale deal, including an acquisition of Pfizer Inc.'s consumer assets, as her first priority is to strengthen the pharmaceutical pipeline organically.
Separately, the U.K. Serious Fraud Office has asked GlaxoSmithKline to provide additional information on third-party advisers engaged by the company in the course of a bribery investigation in China. The investigation came after China's Ministry of Public Security launched an investigation in 2013, which found that GSK China Investment Co. Ltd. had offered money or property to nongovernment personnel for improper commercial gains.
Our features
Hospitals to gain in Senate budget deal: Delays in Medicaid cuts and an extension in Medicare funding for hospitals were included in a Senate budget deal.
Other features
* Billionaire Patrick Soon-Shiong, who achieved fame for inventing cancer medication Abraxane, recently bought the Los Angeles Times and the San Diego Union-Tribune for $500 million. The Washington Post has a feature about investigations and criticism surrounding Soon-Shiong, including allegations that the billionaire was using his NantHealth Foundation to boost the bottom lines of his for-profit businesses.
* Blood pressure drug prasozin, which is widely prescribed to treat patients with post-traumatic stress disorder, failed to demonstrate that it can improve sleep and reduce nightmares in 304 military veterans under a trial, Reuters reported.
* An antibody that neutralizes an appetite-regulating hormone has been developed by scientists, with the potential of being designed into a viable anti-obesity drug, CNBC said in a feature.
* The supply of rheumatologists in the U.S. are shrinking amid a growing number of sufferers seeking care for health problems such as arthritis, back pain and osteoporosis, Reuters reported.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng rose 0.42% to 30,451.27, while the Nikkei 225 climbed 1.13% to 21,890.86.
In Europe, around midday, the FTSE 100 fell 0.87% to 7,215.73, and the Euronext 100 was down 1.21% to 1,009.32.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
