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Merck wins $2.5B in patent trial vs. Gilead; Sanofi advances in Actelion talks

* Sanofi is reportedly in advanced talks to acquire Swiss drugmaker Actelion Ltd. The parties are said to be discussing a price of about $275 per Actelion share, valuing the company at about $29.6 billion. Johnson & Johnson, which abandoned deal talks with Actelion, presented an initial offer for Actelion of CHF246 per share, valuing the company at $26 billion, which Actelion rejected.

* Novartis AG agreed to acquire Ziarco Group Ltd., a privately held company focused new dermatology treatments, for an undisclosed sum. The acquisition will add ZPL389, an eczema drug in development, to Novartis' dermatology portfolio and pipeline.

* A federal jury in a U.S. District Court in Delaware ordered Gilead Sciences Inc. to pay Merck & Co. Inc. $2.5 billion in damages for infringing the latter's patents for two hepatitis C drugs. The jury decided that Gilead's development of blockbuster drugs Sovaldi and Harvoni violated patents held by Idenix Pharmaceuticals, which was acquired by Merck in 2014.

* The attorneys general of 20 U.S. states jointly filed a federal lawsuit against generic drugmakers for allegations that they conspired to unreasonably restrain trade, artificially inflate and manipulate prices, and reduce competition in the U.S. for an antibiotic and an oral diabetes medication. Teva Pharmaceutical Industries Ltd.'s Teva Pharmaceuticals USA Inc. and Mylan NV's Mylan Pharmaceuticals Inc. are among the defendants in the case.

* Eli Lilly & Co. lowered its EPS outlook range for 2016 to between $2.57 and $2.67 from the previous forecast of between $2.66 and $2.76.

* The U.K. Competition and Markets Authority said it found that Actavis UK, which is now Allergan PLC, broke competition law by hiking the price of its 10-milligram hydrocortisone tablets by more than 12,000%, costing Britain's National Health Service £70 million in 2015, compared to about £522,000 per year before April 2008. The lifesaving hydrocortisone tablets are used as the primary replacement therapy for people with adrenal insufficiency, such as those with Addison's disease.

M&A and capital markets

* Baxter International Inc. agreed to acquire Claris Injectables Ltd., the generic injectables unit of Claris Lifesciences Ltd., for $625 million. The deal is expected to close in the second half of 2017.

* Repligen Corp. acquired TangenX Technology Corp. from Novasep Holding SAS in an all-cash transaction of €37.0 million. Repligen expects sales of TangenX products to achieve double-digit growth and contribute between $7.0 million and $7.5 million in revenue for 2017.

* Medivir AB completed its divestment of BioPhausia AB to Karo Pharma AB (publ). Medivir's board will convene an extraordinary general meeting to transfer the net proceeds from the sale, amounting to about 870 million Swedish kronor, to the company's shareholders via a voluntary share redemption offer.

* Chongqing Lummy Pharmaceutical Co. Ltd. plans to invest 160 million Chinese yuan to take a 16% stake in a newly established health insurance company, the China Securities Journal wrote.

* TiGenix NV's American depository shares debuted at $14.00 apiece, below the IPO price of $15.50 per ADS, Reuters noted.

Drug and product pipeline

* Eli Lilly & Co. and Boehringer Ingelheim Corp. launched their insulin product, Basaglar, in the U.S. market. Basaglar is used to control high blood sugar in patients with type 1 diabetes and adults with type 2 diabetes and is considered an alternative to Sanofi's Lantus, also a long-acting insulin glargine injection.

* Chugai Pharmaceutical Co. Ltd. filed applications with Japan's Ministry of Health, Labour and Welfare for anti-influenza drug Tamiflu for the dosage and administration of treatment of influenza type A or B virus infection to newborns and infants.

* Agios Pharmaceuticals withdrew its investigational new drug application to treat a type of anemia. The company discontinued development of the pyruvate kinase-R activator, AG-519, after a verbal notification of a clinical hold from the U.S. FDA.

* Alembic Pharmaceuticals Ltd. received approval from the U.S. FDA for its abbreviated new drug application for itraconazole 100-milligram capsules, an equivalent of Janssen Pharmaceuticals Inc.'s Sporanox capsules. Itraconazole capsules are indicated for the treatment of certain fungal infections.

* Biopharmaceutical group Cellectis SA will file an investigational new drug application with the U.S. FDA by the end of 2016 for its UCART123 treatment for acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm, after the National Institutes of Health's Recombinant DNA Advisory Committee gave its unanimous approval for two phase 1 study protocols. The company plans to start phase 1 clinical trials in the first half of 2017.

* Cerenis Therapeutics Holding SA received U.S. FDA approval to proceed with clinical trials for its CER-209 potential treatment for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. The company will begin enrollment for a phase 1 trial in the first quarter of next year.

Operational activity

* Roche Holding Ltd.'s F. Hoffman-La Roche Ltd. decided to terminate the development, commercialization and license agreement with Pacific Biosciences of California Inc. for the development and supply of diagnostic products based on the company's genome sequencing SMRT technology.

* Knight Therapeutics Inc. signed a license agreement with AstraZeneca PLC for exclusive rights to Movantik in Canada and Israel. The drug is approved in Canada for the treatment of opioid-induced constipation in adult patients with noncancer pain who have had an inadequate response to laxatives.

* Portola Pharmaceuticals Inc. agreed to purchase CMC ICOS Biologics Inc.'s commercial supply of Andexanet alfa, a recombinant protein specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. As part of the agreement, CMC will provide other services supporting the Portola's regulatory applications in the U.S. and EU.

* Guangdong Zhongsheng Pharmaceutical Co. Ltd. established an ophthalmic investment management subsidiary in Guangzhou, China, with a registered capital of 50 million Chinese yuan, Reuters reported.

* ImmunoCellular Therapeutics Ltd. named Anthony Gringeri CEO after Andrew Gengos resigned.

* Prothena Corp. PLC appointed Carol Karp chief regulatory officer to lead the company's quality, regulatory and safety organizations.

The day ahead

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

In Asia, the Hang Seng slipped 0.18% to 22,020.75, while the Nikkei 225 increased 0.66% to 19,401.15.

In Europe, around midday, the FTSE 100 was up 0.31% to 7,020.64, and the Euronext 100 was up 0.57% to 927.51.

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