Novartis AG, of Basel, Switzerland, gained FDA approval of Flucelvax, described as the first cell culture-derived seasonal flu vaccine cleared for marketing in the U.S. The vaccine was approved for adults 18 years old and older.
LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated...Following completion of those programs, the pharma firm will have an exclusive option to license rights in exchange for development and commercial milestones payments and royalties
Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, said the European Committee for Medicinal Products for Human Use granted a positive opinion recommending approval of Zytiga (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically
The acquisition is set to close later this year and is expected to complement Allergan's existing facial aesthetics business, which includes Botox Cosmetic, Juvederm and Latisse...Allergan said it expects to operate SkinMedica as a separate global business
Forxiga is the first SGLT2 inhibitor to gain approval in diabetes and is intended for use as an adjunct to diet and exercise in combination with other glucose-lowering products such as insulin or as a monotherapy in metformin-intolerant patients
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and BaroFold Inc., of Aurora, Colo., said they entered a nonexclusive technology and commercial license option agreement, in which Boehringer will acquire a laboratory-scale reactor of BaroFold's Pressure Enabled Manufacturing Technology (PreEMT) that can also be qualified for GMP use. PreEMT will be available for development of biopharmaceutical production processes. Financial terms were not disclosed.
Foundation Medicine Inc., of Cambridge, Mass., and AstraZeneca plc, of London, signed a multi-year collaboration to identify alterations found in cancer-related tumor genes that may predict a person's response or resistance to targeted medicines...Foundation Medicine also was granted right of first negotiation to develop potential diagnostic products from the collaboration...Janssen plans to discontinue the Prezista 400-mg tablet
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75 mg due to a potential packaging defect that may compromise the bottle integrity...A damaged bottle could allow moisture to get into the bottle, which may impair the quality of Pradaxa
Bristol-Myers Squibb Co., of New York, said the National Institute of Health and Clinical Excellence decided to recommend Yervoy (ipilimumab), which is approved in Europe for treating advanced metastatic melanoma, within the final appraisal determination...That decision will enable eligible patients in England and Wales to routinely access treatment with Yervoy through the National Health Services
The firm anticipates peak annual sales to exceed $200 million...The 80,000-square-foot expansion is expected to be completed in March 2014 and is intended to manufacture insulin cartridges to meet the growing diabetes demand in the U.S...Health Canada had asked Novartis to suspend distribution of Agriflu and Fluad late last month as a precautionary step
Cialis for once-daily use was approved to treat erectile dysfunction (ED) in Europe in 2007...The FDA also approved Cialis 5 mg for once-daily use to treat men who have both ED and BPH...Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA accepted for review two supplemental new drug applications for use of atypical antipsychotic Latuda (lurasidone) as monotherapy and as adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with
The alliance will facilitate research on 13 undisclosed rare disease indications and has the potential to add candidates to Shire's early stage pipeline
Forest Laboratories Inc., of New York, said it inked a deal with moksha8, of Sao Paolo, Brazil, providing Forest with a commercial footprint in Latin America and giving moksha8 access to antidepressant drug Viibryd (vilazodone) and potentially other Forest products for the Latin American market...Terms call for Forest to provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals
Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome...Sanofi Pasteur MSD, of Lyon, France, a unit of Sanofi SA, said it plans to license and commercialize a 6-in-1 pediatric vaccine in its European territories...The hexavalent
Eli Lilly and Co., of Indianapolis, said the FDA approved the label inclusion for Alimta (pemetrexed) with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting for patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer following first-line Alimta plus cisplatin. Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said it filed a supplemental biologics license application
A.P. Pharma Inc., of Redwood City, Calif., said the FDA accepted the company's resubmission of a new drug application for APF530, a long-acting formulation of granisetron in development for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting...Watson Pharmaceuticals Inc., of Parsippany, N.J., and Actavis Group, of Zug, Switzerland, are being required by the Federal Trade Commission to sell the rights and assets to 18 drugs to Sandoz International GmbH, a unit of
Biostar Pharmaceuticals Inc., of Xianyang, China, said it signed a one-year agreement valued at about $3 million to manufacture and supply Xijing Hospital with five additional drugs...Watson Pharmaceuticals Inc., of Parsippany, N.J., said it received approval for its abbreviated new drug application for Trospium Chloride Extended-release Capsules, the generic equivalent to Irvine, Calif.-based Allergan Inc.'s Sanctura XR...Watson said it intends to begin immediately shipping the product, which is
Roche AG, of Basel, Switzerland, lost its appeal in the federal circuit to get a preliminary injunction against generic formulations of its bisophosphonate Boniva (ibandronate) for the treatment of osteoporosis
The grant will award up to €1 million (US$1.3 million) annually to fund innovative academic research in MS...and Canada and by Merck Serono to those based elsewhere
Novartis AG, of Basel, Switzerland, gained FDA approval of Flucelvax, described as the first cell culture-derived seasonal flu vaccine cleared for marketing in the U.S. The vaccine was approved for adults 18 years old and older.