* AstraZeneca PLC's head of oncology is joining Innate Pharma SA. The company appointed Mondher Mahjoubi as chairman of the executive board, replacing Hervé Brailly who has been appointed the chairman of the Innate Pharma supervisory board. Mahjoubi is the senior vice president of therapeutic area head-oncology and global product and portfolio strategy at AstraZeneca.
* Eli Lilly & Co. said it will end development of an experimental Alzheimer's treatment that is similar to failed drug candidate solanezumab, though the company is exploring other potential medicines for the disease.
* Japan is planning an annual review of drug prices to counter rising healthcare costs. The government plans to announce measures that would include monitoring all drug prescription prices as opposed to only those that are perceived to be expensive when compared to their foreign counterparts, insiders told Reuters.
Drug and product pipeline
* Mylan NV launched an authorized generic for its lifesaving EpiPen auto-injector at $300 for a pack of two injections. The generic product has the same drug formulation and device functionality as the controversial EpiPen, which is used to treat severe allergic reactions.
* The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Novartis AG's Ilaris for the treatment of three rare periodic fever syndromes. The committee also approved Novartis' Votubia as an adjunctive treatment for patients aged two years and older with refractory partial-onset seizures related to tuberous sclerosis complex.
* Meanwhile, the committee recommended Merck & Co. Inc.'s Keytruda as first-line treatment of metastatic non-small cell lung cancer in adults and lowered the weight and age limit of GlaxoSmithKline PLC's Tivicay for children and adolescents with HIV. Amgen Inc. also received a positive opinion for the extension of Repatha's market authorization to include a new 420 mg injection to treat high cholesterol.
* Japan's Ministry of Health, Labour and Welfare approved Gilead Sciences Inc.'s Vemlidy 25 mg for patients with chronic hepatitis B. The Gilead drug will compete with GlaxoSmithkline Pharmaceuticals Ltd.'s tenofovir disoproxil fumarate in Japan.
* The European Medicines Agency's Committee for Medicinal Products for Human Use made a recommendation in favor of Pfizer Inc.'s Lifmior to treat rheumatoid arthritis and other forms of arthritis, as well as plaque psoriasis. Meanwhile, the U.S. FDA authorized label revisions to Pfizer's Chantix. Specifically, the company is no longer required to make boxed warnings regarding serious neuropsychiatric events that lead to anxiety and depression.
* The European Commission extended the marketing authorization of Zebinix to treat partial-onset seizures in children above the age of six. The drug is already authorized for use in adults over the age of 18. It is marketed in Europe and Russia by Bial and by Bial's licensee, Eisai Co. Ltd.
* Additionally, Eisai said its anticancer agent Treakisym was approved in Japan as first-line treatment of low-grade B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
* India's Lupin Ltd. announced the U.S. launch of Voriconazole to treat fungal infections in 12-year old patients and above. The U.S.-FDA approved generic was launched in 50-mg and 200-mg tablets and 40-mg/ml oral suspension to compete with PF Prism CV's Vfend tablets and oral suspension.
* Richter Gedeon Vegyészeti Gyár Nyilvánosan Muködo Rt. is no longer seeking European Medicines Agency approval for one of its biosimilar drugs after the regulator's Committee for Medicinal Products for Human Use indicated it might not be approved. The Hungarian pharmaceutical company withdrew its marketing application for pegfilgrastim but will continue clinical development in hopes of addressing regulatory concerns.
* The Fujifilm Corp. board recently approved the ¥154.7 billion purchase of Takeda Pharmaceutical Co. Ltd.'s reagent manufacturing business under the Wako Pure Chemical Industries Ltd. name. According to the Nikkei Asian Review, Fujifilm is increasingly turning toward regenerative medicine as profits from its core camera and imaging business sags.
* A U.S. federal judge allowed Takeda Pharmaceutical to refile a patent infringement lawsuit against U.K.-based Hikma Pharmaceuticals PLC, Reuters reported. Takeda says Hikma's Mitigare violates its patents by using the same active ingredient as its Colcrys drug but for different approved uses.
* Shanghai Kinetic Medical Co. Ltd. CFO Wang Yuangen stepped down due to personal reasons, Reuters reported. Meanwhile, Zhejiang Hisun Pharmaceutical Co. Ltd. named Guan Xuhua as its CFO, succeeding Hu Liangbin, and Polynovo Ltd. appointed Gavin Smith as its interim CFO, Reuters noted.
* CRISPR Therapeutics signed a global cross-consent and invention management agreement with Intellia Therapeutics Inc., Caribou Biosciences and ERS Genomics for the foundational intellectual property covering CRISPR/Cas9 gene editing technology.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng slipped 1.03 % to 21,832.68, while the Nikkei 225 fell 0.05% to 19,391.60.
In Europe, around midday, the FTSE 100 was up 0.07% to 7,016.55 and the Euronext 100 was down by 0.11% to 924.82.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.