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US lawmakers scrutinize pharma industry practices; tax bill in jeopardy

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US lawmakers scrutinize pharma industry practices; tax bill in jeopardy

Top News

* The relevance of Sen. Susan Collins' support for her party's tax reform package may once more be in play after it was revealed that at least one of the Maine lawmaker's Republican colleagues would not be in Washington to vote on the bill, while another's endorsement may again be in jeopardy.

* The Philippines is conducting a congressional hearing into why Sanofi's dengue vaccine, Dengvaxia, was still introduced in a national immunization program despite safety concerns raised by the country's Department of Health, as well as a warning from the World Health Organization, The Wall Street Journal wrote.

* Lawmakers from both Republican and Democratic parties are looking at pharma industry practices that keep drug prices soaring which could result in a bipartisan agreement to ban such actions, Bloomberg News noted.

On the policy front

* Centers for Disease Control and Prevention Director Brenda Fitzgerald insisted her agency has not banned the use of certain terms, such as vulnerable and diversity, in response to criticism of her agency after the Washington Post reported that government policy analysts were directed not to use seven specific terms — "vulnerable," "entitlement," "diversity," "transgender," "fetus," "evidence-based" and "science-based — in preparing budgetary documents and related materials and communications.

* On the same day that Amicus Therapeutics Inc. said it had submitted an application seeking U.S. approval of its Fabry disease drug migalastat, nonprofit watchdog Project on Government Oversight revealed personal correspondences from the company's chief to the head of the Food and Drug Administration, raising questions about the agency's decision to permit the medicine's speedier path to a review.

* Indian drug manufacturing facilities are expected to undergo more frequent regulatory inspections following an agreement between the U.S. FDA and eight EU member states to recognize each other's inspection outcomes, The Economic Times of India reported.

M&A and capital markets

* Aurobindo Pharma Ltd. denied a report published in India's The Economic Times that said the company was looking to buy Orchid Pharma Ltd. According to the Economic Times report, Orchid received interests for buy-outs from seven to eight companies including Aurobindo and Dr. Reddy's Laboratories Ltd.

* Mereo BioPharma Group PLC plans to conduct a registered IPO in the U.S. The offering is expected to commence in the first half of 2018.

Drug and product pipeline

* The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of seven new therapies this month, including Novo Nordisk A/S's type 2 diabetes treatment Ozempic. The panel issued a negative recommendation for Spanish drugmaker Pharma Mar SA's Aplidin, a potential treatment for multiple myeloma.

* The U.S. FDA accepted and granted priority review to AstraZeneca PLC's supplemental new drug application for Tagrisso as a first-line treatment of patients with metastatic non-small cell lung cancer.

* Repros Therapeutics Inc. said its marketing application for enclomiphene in secondary hypogonadism is likely to receive a negative opinion in January 2018 from the European Medicines Agency's Committee for Medicinal Products for Human Use.

* The U.S. FDA lifted the hold on clinical studies of Sanofi and Alnylam Pharmaceuticals Inc.'s hemophilia treatment fitusiran. Studies of the drug were paused due to safety concerns following a patient death.

Operational activity

* Doctors say the U.S. government's Medicare reimbursement system is partly to blame for the slow uptake of Gilead Sciences Inc.'s CAR-T treatment Yescarta, intended for blood cancer patients, Bloomberg News wrote.

* Shire plc filed a new preliminary injunction motion against Roche Holding AG's hemophilia drug Hemlibra in the U.S. district court of Delaware, alleging that it infringed on one of its patents.

* Recordati SpA acquired three of Bayer AG's consumer health brands in the French market: Transipeg and TransipegLib, laxatives for treating symptomatic constipation in adults, and Colopeg, a large volume bowel cleanser indicated in preparation for endoscopic exploration.

Our features

Teva CEO: 'It's going to look good' after 2-year, $3B cost-cutting plan: After Teva Pharmaceutical Industries slashes a quarter of its workforce and suspends dividend, it plans to use the cash flow from improved operating performance, as well as from divestments, to pay down debt, CEO Kare Schultz said on a special call.

Hong Kong bourse expanding listing rules to attract biotech, tech firms: The stock exchange said the decision to expand the listing regime was made after drawing on feedback received in response to a consultation and discussions with the Securities and Futures Commission of Hong Kong.

Other features

* Bloomberg News, Reuters and the Financial Times carry reports on Teva Pharmaceutical Industries Ltd.'s $3 billion restructuring plan that would result in the termination of some 14,000 employees.

* Bloomberg also carries a report on Revance Therapeutics Inc. which is developing a new form of botulinum toxin that could challenge Allergan plc's Botox in reducing wrinkles.

The day ahead

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

In Asia, the Hang Seng was up 0.70% to 29050.41. The Nikkei 225 added 1.55% to 22,901.77.

In Europe as of midday, the FTSE 100 was up 0.45% to 7,524.25, and the Euronext 100 improved 1.11% to 1,049.76.

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