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Trump keeps Collins as NIH head; Supreme Court to hear Bristol-Myers Squibb case


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Trump keeps Collins as NIH head; Supreme Court to hear Bristol-Myers Squibb case

* Francis Collins, the director of the National Institutes of Health, will stay in his post as part of the Donald Trump administration, Renate Myles, chief of the NIH's news media branch, told S&P Global Market Intelligence. Trump is not keeping Obama's chiefs at the FDA and the Centers for Disease Control and Prevention, Robert Califf and Tom Frieden, respectively.

* The U.S. Supreme Court will review a California Supreme Court ruling allowing state courts to hear claims over Bristol-Myers Squibb Co.'s blood-thinning drug Plavix despite the residences of the plaintiffs and the location of the company's headquarters, Reuters wrote. Bristol-Myers Squibb is defending itself against allegations that the drug increased the risk of internal bleeding, heart attack and stroke.

* Bristol-Myers Squibb is no longer seeking accelerated approval in the U.S. for its Opdivo-Yervoy combination in first-line lung cancer. The company said it based the decision on a "review of data available at this time."

In other Bristol-Myers Opdivo news, the company said its cancer drug achieved the desired efficacy and safety benchmarks in a phase 3 clinical trial involving patients with advanced gastric cancer who become intolerant to chemotherapy. The drug significantly reduced the risk of death by 37% in patients suffering from the cancer when compared to placebo.

* Merck & Co. Inc. CEO Ken Frazier told Reuters that non-small cell lung cancer drug Keytruda, which recently obtained priority review status from the U.S. FDA, would potentially lead the competitive cancer race for combination treatments. He also believes that Keytruda in combination therapy would cost less compared to some rival approaches, adding that Merck never had double-digit price increases on its drug offerings.

* The U.S. FDA formally launched the Oncology Center of Excellence and named Richard Pazdur its director, effective Jan. 19, advancing the Obama administration's Cancer Moonshot Initiative. The OCE is supposed to leverage the FDA across its centers for devices, drugs and biologics to accelerate the development of oncology-related medical products and promote a coordinated approach to clinical evaluation.

* Sanofi is still seeking to grow through acquisitions despite the "competitive" M&A scene, although it will only do so "if it makes sense strategically," CEO Olivier Brandicourt said at the World Economic Forum in Davos, Switzerland. Brandicourt noted that Sanofi does not want to spend too much on expensive assets and that there are limited potential merger targets, Reuters reported.

* Mylan NV has not yet reached a settlement with the U.S. government for overcharging for the company's anti-allergy EpiPen, the outgoing head of the Centers for Medicare and Medicaid Services, Andy Slavitt, told Sen. Charles Grassley, R-Iowa. Mylan said in October 2016 that it would pay $465 million as a settlement to resolve allegations that it had incorrectly classified EpiPen for the Medicaid program as a generic drug rather than a brand-name medicine, which resulted in the company underpaying rebates and overcharging states for the drug, Reuters noted.

Meanwhile, Kaléo Pharma CEO Spencer Williamson told CNBC that Auvi-Q, the main competitor to EpiPen, will be back on the market Feb. 14. Auvi-Q will cost $360 for two auto-injectors for patients paying in cash, while those with household income of less than $100,000 who do not have insurance will get the product for free. Kaléo said it will charge insurance companies $4,500 for two auto-injectors and expects many insurers to cover the product.

M&A and capital markets

* Takeda Pharmaceutical Co. Ltd. commenced the cash tender offer by unit Kiku Merger Co., Inc. for all outstanding shares of ARIAD Pharmaceuticals's common stock at $24 per share, in connection with Takeda and ARIAD's merger agreement. Following the purchase of shares in the tender offer, ARIAD will become an indirect wholly owned subsidiary of Takeda.

* Altimmune Inc. is going public in a reverse merger transaction with PharmAthene Inc. The companies plan to merge in an all-stock transaction, with the resulting entity operating under the Altimmune name.

* Cytori Therapeutics Inc. is acquiring certain assets from privately held Azaya Therapeutics to boost its position in regenerative medicine. Cytori will have access to Azaya's proprietary nanoparticle development platform after issuing $2 million worth of its stock and extinguishing $2 million of the company's trade payables.

Drug and product pipeline

* The U.S. FDA approved Imbruvica for the treatment of relapsed or refractory marginal zone lymphoma, a rare form of blood cancer. The drug is jointly developed and commercialized by AbbVie Inc.'s Pharmacyclics LLC and Johnson & Johnson's Janssen Biotech Inc.

* The FDA also approved Roche Holding Ltd.'s Elecsys troponin T blood test to diagnose patients with a suspected heart attack.

* Allergan PLC's Rhofade cream received FDA approval for the treatment of persistent facial redness in adults with rosacea, a chronic skin disorder.

* The FDA approved Synergy Pharmaceuticals Inc.'s once-daily 3 mg Trulance for adults with constipation. The company also completed two phase 3 trials for the drug to treat irritable bowel syndrome with constipation.

* UCB SA filed a supplemental new drug application to the FDA for Briviact CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.

* The Japanese Ministry of Health, Labour and Welfare granted priority review to Bayer AG unit Bayer Yakuhin Ltd. for regorafenib in the second-line treatment of patients with unresectable hepatocellular carcinoma, the most common form of liver cancer.

* Shire PLC said the U.S. FDA acknowledged receipt of the class 2 resubmission of a new drug application for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation which is being evaluated as a potential once-daily treatment for attention deficit hyperactivity disorder.

* Novavax Inc. initiated a phase 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate in patients 60 years of age and older.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng slipped 0.71% to 22,885.91, while the Nikkei 225 increased 0.34% to 19,137.91.

In Europe, around midday, the FTSE 100 increased 0.03% to 7,210.73, and the Euronext 100 was up 0.42% to 937.37.

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