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Senate to discuss drug costs; J&J, Bayer halt heart drug trial


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Senate to discuss drug costs; J&J, Bayer halt heart drug trial

Top news

* Sen. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, scheduled a hearing for Oct. 17 to examine drug costs. The upcoming hearing is the second in what was supposed to be a series of three sessions.

* Johnson & Johnson and Bayer AG are bringing an early stop to a phase 3 trial of Xarelto as the trial was unable to show a difference in the effectiveness of the heart drug when compared to the standard of care and aspirin.

* The European Medicines Agency issued a £31.8 million tender for temporary workers to better cope up with the challenges of relocating following Brexit. The agency has already warned of the future of EU public health as its staff shies away from relocation plans.

On the policy front

*National Institutes of Health director Francis Collins said becoming an addiction-free nation will require bold efforts and more funding. Collins has been seeking partners from the biopharmaceutical industry for an initiative aimed at addressing the opioid epidemic, but no drugmaker has stepped up to be part of the NIH's initiative.

* Sen. Claire McCaskill, D-Mo., introduced a bill that seeks to prevent tribal sovereign immunity from blocking the U.S. Patent and Trademark Office's review of a patent. The bill was in response to an alleged loophole in a deal that Allergan plc made with St. Regis Mohawk Tribe to shield the patents of its dry eye drug Restasis from review.

* The Association of the British Pharmaceutical Industry agreed to not further pursue a judicial review of the National Institute for Health and Care Excellence's new cost rules for drugs.

Drug and product pipeline

* Teva Pharmaceutical Industries Ltd.'s multiple sclerosis treatment Copaxone faces competition in Europe as Synthon and Alvogen secured European marketing approval for a generic version of the drug.

*A phase 3 trial of Biogen Inc.'s Spinraza demonstrated improved motor function in infants and children with spinal muscle atrophy, or SMA, a rare neuromuscular disorder.

Operational activity

* The U.S. Court of Appeals for the Federal Circuit dismissed a permanent injunction on the sale of Sanofi and Regeneron Pharmaceuticals Inc.'s cholesterol-lowering drug Praluent. Amgen Inc., which markets a rival drug Repatha, previously brought a lawsuit claiming Praluent infringed on two of its patents.

* AbbVie Inc. will pay over $140 million in damages to an AndroGel user on claims that the company misrepresented the risks of the drug, causing the user to suffer a heart attack.

* Novartis AG sold the Indian rights to some of its medicine brands to Mauritius-based private equity firm Samara Capital Inc., a company spokesperson said. The sale includes the rights to Cofvector, Monkezin and Glyred, along with exclusive licenses to Curam, Foristal and Gretacal.

* The U.S. Patent and Trademark Office upheld Eli Lilly and Co.'s patent covering the vitamin regimen for Alimta, a chemotherapy drug. In the proceedings initiated by Neptune Generics LLC and Novartis' Sandoz Inc., the Patent Trial and Appeal board found that the claims of the vitamin regimen patent were valid.

* Endo International plc unit Par Pharmaceutical Inc. said it would not launch a generic version of Omidria until 2032 after reaching a settlement with Omeros Corp. over the eye drug.

* Johnson & Johnson said it will discontinue manufacturing and selling the Animas, Vibe and OneTouch Ping insulin pumps, effectively exiting the insulin pump market.

* New Jersey's attorney general sued Insys Therapeutics Inc., accusing the drugmaker of engaging in consumer fraud and submitting false claims to health insurers to boost sales of its opioid Subsys.

Our features

No evidence that most new cancer drugs extend life, says BMJ study: The majority of cancer treatments approved in Europe between 2009 and 2013 launched without clear evidence that they improved survival or quality of life for patients, a study in the BMJ said.

Other features

* The New York Times features an article on a GlaxoSmithKline plc executive who sparked the research to cure adrenoleukodystrophy, a degenerative brain disease affecting children, using gene therapy and a disabled form of HIV. The study's success inspired the founding of bluebird bio Inc., a biotechnology company focusing on gene therapies for genetic diseases and cancer.

* Companies that sell both prescription medications and over-the-counter drugs — such as GlaxoSmithKline and Johnson & Johnson — are faced with a quandary: whether to stick to offering consumer necessities or direct their focus on traditional pharmaceutical markets, the Financial Times has a feature.

The day ahead

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

In Asia, the Hang Seng increased 0.28% to 28,458.04, and the Nikkei 225 rose 0.30% to 20,690.71.

In Europe, around midday, the FTSE 100 was up 0.21% to 7,524.04, and the Euronext 100 was down 0.15% to 1,046.54.

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