The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo

Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use recommended approval of Xtandi (enzalutamide) for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy

Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus

Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency

Cubist Pharmaceuticals Inc., of Lexington, Mass., and Astellas Pharma Inc., of Tokyo, said they entered an agreement under which Cubist obtains the rights to ceftolozane in certain Asia-Pacific and Middle East territories from Astellas

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency

AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said the FDA's Oncologic Drugs Advisory Committee will review the new drug application for tivozanib for patients with advanced renal cell carcinoma during the morning session of its May 2 meeting

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults

In other news, Evotec said it expanded its collaboration with MedImmune, part of London-based AstraZeneca plc, after hitting a key milestone...Under the agreement, Pepscan will use its CLIPS platform and other protein mimicry technologies to help discover new antibodies

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients