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Republicans regroup to accelerate ACA repeal; Sanofi, Mallinckrodt pay up


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Republicans regroup to accelerate ACA repeal; Sanofi, Mallinckrodt pay up

* Vice President Mike Pence went to Capitol Hill Monday night to try and work out a new deal to repeal and replace the Affordable Care Act, Reuters and The Washington Post reported. The chairman of the House of Representatives Freedom Caucus, Rep. Mark Meadows, R-N.C., said he was expecting to see a revamped version of the bill "within the next 24 hours," Reuters noted.

* Meanwhile, five Democrats on the Senate's health committee wrote a letter to President Donald Trump saying that a collaboration with his administration is not possible unless the efforts to undermine the ACA are put on hold, The Wall Street Journal reported.

* President Trump's March 16 proposal to cut the National Institutes of Health's fiscal year 2018 spending by nearly $6 billion, or about 18%, and take another $1.2 billion from the current year would be a draconian measure that would set the agency's budget back 15 years, said former Vice President Joe Biden. "This is no time to undercut progress, for God's sake," Biden told an audience April 3 in Washington at the annual meeting of the American Association for Cancer Research.

* The U.S. government agreed to a 0.45% increase in the final payment rate for 2018 to health insurers offering Medicare Advantage plans for the elderly and the disabled, Reuters noted. Medicare Advantage plans are an alternative to the standard fee-for-service Medicare health plans.

* Kansas House of Representatives fell three votes short of overriding the Republican Governor Sam Brownback's veto on a bill to expand the state's Medicaid program on April 3, Reuters reported.

M&A and capital markets

* GlaxoSmithKline PLC filed a shelf registration statement to raise up to $10 billion via debt securities to refinance debt and for general corporate purposes. The securities will be issued by the company or through one of its finance subsidiaries, GlaxoSmithKline Capital Inc. or GlaxoSmithKline Capital plc.

* Verona Pharma PLC filed for an IPO with the U.S. Securities and Exchange Commission to raise up to $86.3 million in American depositary shares. The U.K.-based biopharmaceutical company applied to list the shares on the Nasdaq Global Market under the symbol VRNA.

Drug and product pipeline

* Bristol-Myers Squibb Co.'s combination of Opdivo and Yervoy showed improved survival rates in a phase 3 trial of patients with previously untreated advanced melanoma, a type of skin cancer. The trial evaluated the overall survival rates after using the combination therapy or Opdivo monotherapy, as compared to Yervoy monotherapy.

* Bristol-Myers and Incyte Corp. agreed to advance a combination of their cancer treatments in phase 3 trials involving patients with first-line non-small cell lung cancer and first-line head and neck cancer. The trials will evaluate Bristol-Myers' Opdivo with Incyte's investigational epacadostat treatment.

* The U.S. FDA approved Teva Pharmaceutical Industries Ltd.'s Austedo tablets for the treatment of chorea, an abnormal involuntary movement disorder associated with Huntington's disease. The decision was based on the safety and efficacy results from a phase 3 study.

* Japan's Ministry of Health, Labor and Welfare approved BioCryst Pharmaceuticals Inc.'s Mundesine for the treatment of relapsed or refractory peripheral T-cell lymphoma, a blood cancer. The drug will be marketed by Mundipharma AG in Japan.

* Paratek Pharmaceuticals Inc.'s Omadacycline met the primary endpoint in a phase 3 trial to the treatment of patients with community-acquired bacterial pneumonia. The company intends to file a new drug application with the U.S. FDA as early as the first quarter of 2018, followed by a European regulatory submission later in 2018.

Operational activity

* Sanofi-Pasteur, Sanofi's vaccines division, will pay about $19.9 million to resolve claims that it incorrectly calculated drug prices and overcharged the U.S. Department of Veterans Affairs for drugs under two contracts between 2002 and 2011. According to the U.S. Department of Justice, the company also agreed not to pursue claims for reimbursement where it contends its error in calculating the federal ceiling price led to a lower price to the VA.

* Mallinckrodt Public Ltd. Co. agreed to pay $35 million to settle U.S. investigations regarding the company's reporting and monitoring related to the manufacturing and distribution of controlled substances. Mallinckrodt reached the agreement with the U.S. Drug Enforcement Administration and the U.S. Attorney's Offices for the Eastern District of Michigan and the Northern District of New York.

* A group of EpiPen buyers filed a national class-action lawsuit in the U.S. District Court for Western District of Washington against Mylan NV regarding the dramatic price increase of its emergency allergy injector EpiPen. The lawsuit accuses Mylan of engaging in a "behind-the-scenes quid pro quo arrangement" to exploit the drug-pricing system for higher profits for the company and pharmacy benefit managers.

* France's Ipsen acquired Merrimack Pharmaceuticals Inc.'s oncology assets, including its pancreatic cancer drug Onivyde.

* Belgium's UCB SA agreed to collaborate with Q-State Biosciences to use its Optopatch technology to develop treatments for epilepsy. The financial details of the deal were not disclosed.

* AstraZeneca PLC's Japan unit AstraZeneca K.K. is transferring marketing rights of five anesthetic brands to Aspen Japan K.K. from July 1, according to a press release. The brands are Anapeine, Xylocaine, Marcaine, Carbocaine and Diprivan.

* Forward Pharma A/S intends to appeal the U.S. Patent Trial and Appeal Board's decision to validate Biogen Inc.'s patent for the multiple sclerosis drug Tecfidera. Biogen has already paid $1.25 billion to license the Danish drugmaker's treatment method for multiple sclerosis.

The day ahead

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

In Asia, the Nikkei 225 fell 0.91% to 18,810.25.

In Europe, around midday, the FTSE 100 climbed 0.43% to 7,314.34, and the Euronext 100 lifted 0.03% to 980.99.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.