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Former Lilly exec Azar may lead HHS; Senate healthcare deal may be in trouble


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Former Lilly exec Azar may lead HHS; Senate healthcare deal may be in trouble

* Former Eli Lilly & Co. executive Alex Azar has emerged as a possible leading contender to be U.S. President Donald Trump's next secretary of Health and Human Services following the resignation of Tom Price in September.

* Rep. Tom Marino, R-Pa., withdrew his name from consideration as the director of the National Office of Drug Control Policy, the White House drug czar. Marino came under fire after a probe revealed that he had pushed a bill through Congress that weakened the Drug Enforcement Administration's ability to rein in distributors selling opioids to rogue pharmacies.

* A bipartisan Senate deal to temporarily restore subsidies cut off by U.S. President Donald Trump may already be in trouble on Capitol Hill, with some House members declaring they would not support it and others giving it a lukewarm response. Trump has also sent mixed signals about his support for the agreement by Sens. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, or HELP, and Patty Murray, D-Wash., the panel's ranking member.

* Sen. Alexander was also on a mission yesterday to find out if rebates in the prescription drug delivery system are really necessary. Other senators at the committee's hearing — the second in a series of three examining prescription drug prices — also wanted to know if biopharmaceutical makers were following the rules of a market-based system of competition or were finding loopholes to hold onto their monopolies, ultimately stifling rivals from selling lower-cost products.

* AstraZeneca, Johnson & Johnson, Pfizer Inc., Roche Holding AG and GE Healthcare are facing a civil lawsuit from several American veterans and relatives of soldiers in Iraq for allegedly routinely bribing Iraqi Ministry of Health officials during the 2003 invasion of Iraq to win drug contracts, the Financial Times reported.

M&A and capital markets

* Mitsubishi Tanabe Pharma Corp. completed the $1.12 billion acquisition of Israel-based pharmaceutical company NeuroDerm Ltd.

* As expected, Impax Laboratories Inc. and Amneal Pharmaceuticals LLC agreed to merge via an all-stock transaction.

* Valeant Pharmaceuticals International Inc. completed Valeant Pharmaceuticals International Inc.a $1 billion offering of 5.50% senior secured notes due Nov. 1, 2025.

* Ablynx NV plans to sell 8,353,221 ordinary shares as part of a global offering, with expected net proceeds of up to $183.5 million.

* Privately held Evofem Biosciences entered into a reverse stock merger agreement with Neothetics Inc. to list on the Nasdaq Stock Market.

* OptiNose Inc. closed its IPO of 8,625,000 common shares priced at $16 apiece to raise about $138 million in gross proceeds.

Drug and product pipeline

* Merck & Co. Inc. said Keytruda more than doubled the median overall survival of metastatic non-small cell lung cancer patients with high levels of PD-L1 when compared to chemotherapy.

* The U.S. Food and Drug Administration accepted and granted priority review to AstraZeneca PLC's Lynparza tablets in patients with a type of metastatic breast cancer. AstraZeneca is developing Lynparza in collaboration with Merck & Co.

* Aduro BioTech Inc. and Johnson & Johnson's investigational drug JNJ-64041757 was well-tolerated in a phase 1 trial for treating advanced non-small cell lung cancer.

* Ignyta Inc.'s investigational protein inhibitor entrectinib showed "compelling durability" in a phase 2 study in patients with ROS1 fusion-positive advanced non-small cell lung cancer.

* Novartis AG's Promacta can be used as a long-term treatment option for adults with chronic/persistent immune thrombocytopenia, a rare and potentially serious blood disorder, long-term study results showed. Promacta is known as Revolade outside the U.S.

* Teva Pharmaceutical Industries Ltd. filed a biologics license application, seeking approval for its migraine treatment fremanezumab from the U.S. FDA.

Operational activity

* India's Central Drugs Standard Control Organization said Sun Pharmaceutical Industries Ltd's Pantocid and Pantocid DSR, intended for treating certain stomach and esophagus problems, failed quality tests last month, The Economic Times of India reported. The drugmaker, however, claimed that the tested medicines were counterfeit products.

* Eli Lilly and CureVac AG are collaborating to develop and commercialize up to five potential cancer vaccine products based on CureVac's proprietary RNActive technology. Under the deal, CureVac will receive an upfront payment of $50 million and an equity investment of €45 million.

* A Missouri appeals court reversed a $72 million verdict against Johnson & Johnson regarding the death of a woman from ovarian cancer after using the company's talc-based products, Reuters reported.

* Novartis is closing its Sandoz generic-drug manufacturing division in Broomfield, Colo., The Denver Post reported, citing company spokeswoman Sofina Mirza-Reid. The closure, which will affect about 450 jobs, is expected to be completed in the fourth quarter of 2019.

* Silence Therapeutics plc filed Silence Therapeutics plca claim against Alnylam Pharmaceuticals Inc. and The Medicines Co. in the U.K. High Court to enforce its intellectual property rights on certain Alnylam products, including drugs Patisiran, Fitusiran, Givosiran and Inclisiran.

* The Commercial Court of Paris ruled against Onxeo SA in its dispute with SpePharm and their joint venture SpeBio BV in relation to alleged contractual breaches.

* Orexigen Therapeutics Inc. is evaluating whether it can continue as a "going concern" as it might not be able to meet its debt obligations due 2018. As part of steps the biotech company may take to meet "possible liquidity requirements," it is looking at getting additional funds, negotiating with note holders and trying to pursue talks for a sale or merger.

Our features

Johnson & Johnson excludes US tax reform plans from upped FY'17 guidance: Johnson & Johnson remains optimistic on the White House's tax reform plan but is not assuming reform in its full-year 2017 outlook, CFO Dominic Caruso said during the company's Oct. 17 earnings conference call.

Other features

* Bloomberg News talks about how drug supply players reacted to Trump's renewed attack on soaring drug prices, with pharmacy benefit managers, drugmakers, insurers and hospitals putting the blame on each other.

The day ahead

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

In Asia, the Hang Seng rose 0.05% to 28,711.76, and the Nikkei 225 was up 0.13% to 21,363.05.

In Europe, as of midday, the FTSE 100 climbed 0.32% to 7,540.50, and the Euronext 100 had grown 0.48% to 1,054.99.

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