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

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee

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...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is set to close with Weston, Mass.-based Biogen Idec Inc

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...Eisai Inc., of Woodcliff Lake, N.J., reported that the German Federal Joint Committee said it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments

Araxes Pharma LLC, of San Diego, said it inked an exclusive arrangement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop first-in-class therapeutics against a certain cancer target...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...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI

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...In other news, Evotec said a compound identified and optimized in a research collaboration with Osaka, Japan-based Ono Pharmaceutical Co

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults...In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes 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...Noxxon Pharma AG, of Berlin, said it treated the first patients in a Phase IIa trial of its anti-hepcidin Spiegelmer NOX-H94 to treat anemia associated with chronic disease

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

Ildong gained exclusive rights to commercialize temanogrel in South Korea for myocardial infarction, acute coronary syndrome, stroke, peripheral artery disease and other cardiovascular diseases...Arena also is eligible to receive a royalty on net sales of temanogrel in South Korea, while Ildong is eligible to receive a share of future payments to Arena for licensing transactions and sales of temanogrel in other countries...AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo