* New York Attorney General Eric Schneiderman is alleging that AstraZeneca PLC unit MedImmune LLC engaged in a kickback scheme to increase profits from one of its pediatric medications in a lawsuit that seeks to recover millions of dollars in damages for the state's Medicaid program.
* The U.S. Court of Appeals for the Federal Circuit handed a victory to Mylan NV, ruling that the EpiPen manufacturer could produce a generic version of The Medicines Co.'s blood clot inhibitor. The ruling reverses a decision by an Illinois federal judge who upheld The Medicines Co.'s patents for Angiomax.
* As part of efforts to revive the failed bill to repeal and replace the Affordable Care Act, House Republicans yesterday added a new amendment to the American Health Care Act. The measure, which was introduced by Reps. Gary Palmer of Alabama and David Schweikert of Arizona and adopted in a 9-2 vote by the House Rules Committee, would create an "invisible risk-sharing program" aimed at helping states reduce premiums by reimbursing health insurers for high-cost individuals.
M&A and capital markets
* Allergan PLC's $2.47 billion purchase of ZELTIQ Aesthetics Inc. was cleared under U.S. antitrust laws. The deal's waiting period under the Hart-Scott-Rodino Act expired, bringing the companies closer to completion.
* Yamo Deniz left Sanofi unit Sanofi Genzyme to join Flexion Therapeutics as its chief medical officer, the Boston Business Journal reported. The move comes amid rumors that the companies are in talks about a potential merger. Deniz most recently served as Sanofi Genzyme's head of global medical affairs for rare diseases.
* Stada-Arzneimittel AG is in talks to sell its 50% stake in Stada Vietnam, the Frankfurter Allgemeine Zeitung reported. The German pharmaceutical is the takeover target of two competing private equity consortia which are offering €58 per share for the drugmaker, valuing it at €4.7 billion, including debt.
* Galenica Santé made a strong debut on the Swiss bourse, rising 10% above its IPO price of CHF39 per share, Neue Zürcher Zeitung wrote. Galenica Ltd. priced the IPO at the top of its indicative range following strong investor demand for the offer, which raised CHF1.9 billion, the biggest Swiss IPO since 2015.
Drug and product pipeline
* Alembic Pharmaceuticals Ltd. secured U.S. FDA approval to market a generic version of Eli Lilly & Co.'s depression treatment Prozac. The Indian pharmaceutical will sell fluoxetine hydrochloride tablets in 10- and- 20-milligram doses with an estimated market size of $120 million as of December 2015, according to QuintilesIMS data.
* The FDA also approved Supernus Pharmaceuticals Inc.'s request for a label expansion for Trokendi XR to include the treatment of migraine headaches in adults and adolescents aged 12 years and up. Trokendi XR is a novel once-daily extended release formulation of topiramate for the treatment of epilepsy.
* Medivir AB reported positive data in its phase 2 study of remetinostat, a skin-directed histone deacetylase inhibitor, in patients with early-stage cutaneous T-cell lymphoma, a chronic, orphan hematologic cancer that presents in the skin. The company will launch a phase 3 trial later this year.
* Ultragenyx Pharmaceutical Inc. and Kyowa Hakko Kirin Co. Ltd. unit Kyowa Kirin International PLC reported positive data from the phase 2 clinical trial of KRN23, or burosumab, to treat X-linked hypophosphatemia and tumor-induced osteomalacia in children aged five to 12.
* Novartis AG unit Novartis International AG exercised its option to in-license ECF843 from Lubris LLC for ophthalmic indications in all regions outside Europe. ECF843 is being developed as a potential treatment for dry eye, which is caused by chronic lack of moisture on the eye's surface.
* Cipla Ltd. unit Cipla USA Inc. signed a worldwide licensing agreement, barring East Asia, with MedRx Co. Ltd. to develop and commercialize MRX-4TZT, a Tizanidine patch for the management of spasticity. MEDRx will receive up to $30 million in upfront, developmental, regulatory and commercial milestone payments.
* Takeda Pharmaceutical Co. Ltd. announced a joint venture with Pharm Research Associates (UK) Ltd., transferring part of Takeda Development Center Japan to PRA. The expansion of Takeda's existing alliance with PRA is intended to help Takeda in its strategic R&D shift to oncology, gastroenterology and central nervous system.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng slipped 0.03% to 24,267.30, while the Nikkei 225 increased 0.36% to 18,664.63.
In Europe, around midday, the FTSE 100 was up 0.17% to 7,315.33, and the Euronext 100 was down 0.07% to 985.75.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.