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US pricing probe targets big pharma; US FDA shutdown delays Aimmune's therapy

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US pricing probe targets big pharma; US FDA shutdown delays Aimmune's therapy

Top news

* Rep. Elijah Cummings, D-Md., chairman of the House Oversight Committee, opened an investigation into the pricing practices of a dozen drugmakers involving medicines from multiple classes. The companies targeted in the probe are AbbVie Inc., Amgen Inc., AstraZeneca PLC, Celgene Corp., Eli Lilly and Co., Johnson & Johnson, Mallinckrodt Public Ltd. Co., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi and Teva Pharmaceutical Industries Ltd.

* Biotech Aimmune Therapeutics Inc.'s peanut allergy drug became one of the early casualties of the U.S. Food and Drug Administration's ongoing partial shutdown, which hit its 25th day Jan. 15. The drugmaker said that the FDA told the company the regulatory work on its marketing application for its experimental oral immunotherapy to treat peanut allergy in pediatric patients was on hold until the shutdown ends — a timeline that is uncertain.

* The Democratic Republic of the Congo's Ebola epidemic could become worse as the questionable election process increases public's mistrust of government agencies, Reuters wrote.

On the policy front

* In 2019, China's National Medical Products Administration is set to make available 48 new drugs developed overseas, including 12 cancer drugs, out of which eight are already being sold in the country, according to National Health Commission.

* Following a similar California judgment spanning several states, a Pennsylvania judge issued a nationwide injunction against the Trump administration's rule that exempts businesses from providing insurance coverage for birth control under the Affordable Care Act, Reuters reported.

* The U.K.'s National Health Service is launching a breast cancer screening test on a pilot basis to identify women at high risk of developing the disease, The Times reported. The test, expected to be in routine NHS use within two years, will use the women's DNA, family history and lifestyle information to provide results.

M&A and capital markets

* GlaxoSmithKline PLC said it has extended its cash tender offer to buy breast cancer drug maker Tesaro Inc. to Jan. 18 from Jan. 14. The U.K.-based pharmaceutical giant said about 77.2% of Tesaro's outstanding shares had been tendered as of Jan. 14.

* Lexington, Mass.-based Kaleido BioSciences Inc. is planning to raise up to $100 million in an IPO. The company plans to list its shares on the Nasdaq Global Select Market under the symbol KLDO. Kaleido is developing therapies that can treat diseases by changing the composition of microbes in various organs.

* Ascendis Health Ltd. said it is in negotiations relating to an unsolicited offer for its Cyprus-based business unit Remedica Ltd. Ascendis, which is listed on the Johannesburg Stock Exchange, saw its shares rise 12.52% to 6.2 South African rand per share at market close Jan. 14.

* Canada's ICC International Cannabis Corp. plans to buy 49.9% of Wayland Group Corp.'s global assets and license portfolio. Ontario-based Wayland, a medical cannabis producer, will receive 300 million ICC shares at a deemed price of 43 cents each, valuing Wayland's international business at about $258 million.

Drug and product pipeline

* The European Commission approved a combination of Bristol-Myers Squibb Co.'s cancer medicines Opdivo and Yervoy to treat a certain kind of kidney cancer. The New York-based biopharmaceutical giant said that the approval was given as an initial treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

* Merck & Co. Inc.'s blockbuster medicine Keytruda reduced the risk of death for patients with esophageal cancer by 31% when compared to chemotherapy during a phase 3 clinical trial. The Kenilworth, N.J.-based company released topline results from the late-stage study called Keynote-181 in November 2018, which showed that the study met one of its main goals of improving overall survival in patients treated with Keytruda over chemotherapy.

* Scientists from the U.S. FDA raised concerns about the cardiovascular risks of Amgen's experimental osteoporosis medicine romosozumab, saying those issues cannot be ignored. Amgen and its partner UCB SA are seeking to market the medicine in the U.S. under the brand name Evenity to treat osteoporosis.

* The FDA approved Exelixis Inc.'s Cabometyx to treat patients with hepatocellular carcinoma — the most common form of liver cancer — who have been previously treated with sorafenib, which is sold by Bayer AG as Nexavar.

* The U.S. FDA approved the expanded use of French drugmaker Sanofi's Adacel to include repeat vaccination for tetanus, diphtheria and pertussis.

Operational activity

* Israel-based Teva Pharmaceutical Industries will pay $135 million to Illinois as settlement for resolving allegations that it inflated the wholesale prices used in setting the rates for Medicaid reimbursements.

* Pfizer cut 150 jobs at Lake Forest, Ill. and Chennai, India, as well as shut down the development of five preclinical programs, Endpoints News reported, citing a company spokesperson. The layoffs come after the company announced plans to close two manufacturing facilities in India affecting about 1,700 employees.

Our features

Pharma dealmakers seeking long-term growth balance pipeline diversity and focus: At 2019's J.P. Morgan Healthcare Conference in San Francisco, executives from the industry's largest players spoke often about this balancing act, reflecting a trend toward portfolio and pipeline diversification within core therapeutic areas.

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US FDA approves fewer innovative medical devices in 2018: The U.S. Food and Drug Administration's approval of innovative medical devices fell from a record high of last year, though the regulator made efforts to ease regulations for other types of products.

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Other features

* After exiting neuroscience research in 2018, Pfizer has set aside $150 million to invest in brain-disease-focused startups through its venture capital arm Pfizer Venture Investments, Business Insider wrote.

* Laboratory tests showed that a rare brain-infection-causing amoeba can be killed with a combination of tiny silver particles and anti-seizure drugs, though the therapy is yet to be tested in animals models, The New York Times reported, citing a study published in the journal Chemical Neuroscience.

* Lung cancer screening tests with low-dose computed tomography could lead to higher healthcare costs and more complications, Reuters reported, citing a study published in the journal JAMA Internal Medicine.

The day ahead

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

In Asia, the Hang Seng increased 2.02% to 26,830.289, while the Nikkei 225 rose 0.96% to 20,555.29.

In Europe, around midday, the FTSE 100 increased 0.022% to 6,856.51 and the Euronext 100 was up 0.42% to 933.19.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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