* Pfizer Inc. is said to be considering options to off-load a group of cardiology, urology and primary care drugs that generate more than $700 million in sales. The New York-based drugmaker is reportedly considering selling the treatments as a package, and a potential sale could fetch the pharma giant more than $2 billion.
* A bill aimed at stopping drug price gouging yesterday got the backing of Rep. Greg Walden, R-Ore., chairman of the U.S. House Committee on Energy and Commerce. The legislation calls on the FDA to prioritize and expedite the review of generic-drug applications for medicines in shortage or where there are few, if any, competitors.
* David Meeker, executive vice president and head of Sanofi Genzyme, the Cambridge, Mass.-based subsidiary of Sanofi, said it would be better for the pharma sector to engage in "self-regulation" as opposed to cost-control legislation that could kill innovation in the industry, the Boston Business Journal wrote.
* The Trump administration is proposing a new federal rule on the Affordable Care Act program that would toughen regulation and limit the number of so-called special enrollment periods for individual health plans, CNBC reported. The rule could also require Americans, whose insurance premiums are in arrears, to settle their existing debts before signing up for a new health plan.
* While drugmakers prepare for the U.K.'s departure from the European Medicines Agency, pharma officials hope that a scheme allowing an independent British drug regulator to work with the agency would ease regulatory burden, Reuters reports.
M&A and capital markets
* Braeburn Pharmaceuticals Inc. withdrew plans for an IPO as a result of uncertainty in the U.S. healthcare industry. The Princeton, N.J.-based company was looking to offer 7.7 million shares at a range of between $18 and $21 per share, but will consider such a move at a later date.
* Arix Bioscience is planning to raise up to £100 million in its IPO of 48,309,179 shares priced at £2.07 apiece. Following the offer's completion, Arix will have a free float of at least 25% of its issued ordinary share capital.
* Cytokinetics Inc. agreed to sell Royalty Pharma a portion of the royalty on worldwide sales of omecamtiv mecarbil, a cardiac muscle activator it is co-developing with Amgen Inc. Cytokinetics will receive an upfront cash payment of $90 million in exchange for the sale of a 4.5% royalty rate on potential worldwide sales, which may increase for up to an additional 1% under certain circumstances.
Drug and product pipeline
* Amgen's phase 3 drug trial for Repatha met its primary composite endpoint and the key secondary composite endpoint. The trial evaluated whether the drug reduced the risk of cardiovascular events in patients with atherosclerotic cardiovascular disease, the buildup of plaque in arteries.
* The U.S. FDA approved Bristol-Myers Squibb Co.'s Opdivo as an intravenous treatment for a type of bladder cancer.
* Meanwhile, England's National Institute for Health and Care Excellence said it will not recommend Pfizer's breast cancer drug Ibrance as it is too costly for routine funding from the National Health Service.
* Teva Pharmaceutical Industries Ltd. submitted an abbreviated new drug application with the U.S. FDA to market a generic version of Novo Nordisk A/S' Victoza diabetes drug in the U.S. The Victoza injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
* AstraZeneca PLC discontinued a late-stage trial of a combo treatment of PD-L1 candidate durvalumab and CTLA-4 med tremelimumab in first-line metastatic pancreatic ductal carcinoma, according to FierceBiotech. The drugmaker said it will continue to develop durvalumab both on its own and in combination with tremelimumab for patients with recurrent metastatic squamous cell head and neck cancers.
* AMAG Pharmaceuticals Inc. said the definitive pharmacokinetic study of Makena in healthy post-menopausal women met its primary objective. The company plans to submit a supplemental new drug application to the FDA for the Makena subcutaneous auto-injector in the second quarter.
Operational activity
* Amgen saw an 8% year-over-year increase in fourth-quarter 2016 GAAP net income to $1.94 billion, or $2.59 per share, from $1.80 billion, or $2.37 per share. For full year 2016, net income totaled $7.72 billion, or $10.24 per share, up from $6.94 billion, or $9.06 per share, in 2015.
* The Japan IP High Court upheld Eli Lilly & Co.'s patents for the Alimta vitamin regimen in a dispute involving the company and Sawai Pharmaceutical Co. Ltd.
* Eisai Co. Ltd. plans to seek approvals globally in the first quarter of fiscal 2017 for its anti-cancer agent Lenvima as a first-line treatment of advanced hepatocellular carcinoma, the most common form of liver cancer.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng slipped 0.24% to 23,129.21, while the Nikkei 225 increased 0.02% to 18,918.20.
In Europe, around midday, the FTSE 100 was up 0.56% to 7,181.04, and the Euronext 100 was up 0.76% to 933.38.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.