Search Results for: "Pharma: Other News to Note"
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Pharma: Other News To Note
Without admitting or denying allegations, Lilly consented to pay a civil settlement of $29.4 million and agreed to have an independent compliance consultant conduct a 60-day review of the company's internal controls and compliance program related to the FCPA...As part of the settlement, Sanofi agreed to pay $109 million to the settling parties and expects to enter a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human ServicesBioWorld Today | Friday, December 21, 2012 -
Pharma: Other News To Note
Allergan Inc., of Irvine, Calif., said it completed the acquisition of SkinMedica Inc., of Carlsbad, Calif., for about $350 million.BioWorld Today | Thursday, December 20, 2012 -
Pharma: Other News To Note
Flutemetamol, an investigational positron emission tomography imaging agent, to support Merck's development of MK-8931, an oral, beta-amyloid precursor protein site cleaving enzyme inhibitor in development for Alzheimer's disease...Shire plc, of Dublin, Ireland, reported a positive outcome from the European Decentralised Procedure for Elvanse (to be known as Tyvense in Ireland), indicated as part of a comprehensive treatment program for attention-deficit hyperactivity disorder in children, ages 6BioWorld Today | Wednesday, December 19, 2012 -
Pharma: Other News To Note
Takeda acquired URL Pharma earlier this year for gout therapy Colcrys...and Canada to Probuphine, a subdermal implant and a long-acting product designed to deliver six months of buprenorphine hydrochloride following a single treatmentBioWorld Today | Tuesday, December 18, 2012 -
Pharma: Other News To Note
The cornerstone of the initiative is the MMRF CoMMpass study, which is designed to follow 1,000 newly diagnosed multiple myeloma patients over five years to understand the molecular changes underpinning the progress of the disease...Vanda said it intends to appeal the opinion and request a re-examination of the CHMP decisionBioWorld Today | Monday, December 17, 2012 -
Pharma: Other News To Note
The alliance will involve researchers from both organizations working together to investigate new ways of treating neurological diseases such as Alzheimer's, Parkinson's and other related disorders...The goal will be to identify and validate drug targets, develop new therapeutics and evaluate them in proof-of-concept trialsBioWorld Today | Friday, December 14, 2012 -
Pharma: Other News To Note
Eisai has a pending new drug application for Aciphex delayed-release sprinkle capsules 5 mg and 10 mg for the proposed indication of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children, ages 1 to 11BioWorld Today | Wednesday, December 12, 2012 -
Pharma: Other News To Note
GlaxoSmithKline plc, of London, and the Fred Hutchinson Cancer Research Center entered a partnership to develop therapeutics to treat an inherited form of muscular dystrophy...The goal of the agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the diseaseBioWorld Today | Tuesday, December 11, 2012 -
Pharma: Other News To Note
Reddy's Laboratories Ltd., of Hyderabad, India, acquired exclusive marketing and sales rights to Pamorelin LA (triptorelin) Depot, by Debiopharm Group, of Lausanne, Switzerland, in India for locally advanced or metastatic, hormone-dependent prostate cancerBioWorld Today | Monday, December 10, 2012 -
Pharma: Other News To Note
Janssen Biotech Inc., of Horsham, Pa., and Janssen Biologics B.V., of Leiden, Netherlands, both part of Johnson & Johnson, submitted a supplemental biologics license application (sBLA) to the FDA and a Type II Variation to the European Medicines Agency (EMA) requesting approval of Stelara (ustekinumab) to treat adult patients with active psoriatic arthritis...The FDA gave guidance and permission to Lipocine Inc., of Salt Lake City, for its Phase III study of oral testosterone replacement therapyBioWorld Today | Friday, December 7, 2012 -
Pharma: Other News To Note
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 recipientsBioWorld Today | Thursday, December 6, 2012 -
Pharma: Other News To Note
Ipsen SA, of Paris, and Galderma Pharma SA, of Lausanne, Switzerland, said they extended their collaboration for the promotion and distribution of Dysport, Ipsen's botulinum toxin Type A in aesthetic indications, renewing the deal in Brazil and Argentina and adding Australia where Galderma has the exclusive promotion and distribution rights for Dysport in the glabellar lines indicationBioWorld Today | Tuesday, December 4, 2012 -
Pharma: Other News To Note
Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for priority review Eisai's NDA for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of gastroesophageal reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of ageBioWorld Today | Monday, December 3, 2012 -
Pharma: Other News To Note
Forest Laboratories Inc., of New York, and Gedeon Richter plc, of Budapest, Hungary, said Forest submitted a new drug application for cariprazine, a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, for use in schizophrenia and bipolar mania...Pfizer Inc., of New York, said it completed its acquisition of Cupertino, Calif.-based NextWave Pharmaceuticals Inc., a privately held specialty pharma firm developing products for attention deficit hyperactivity disorderBioWorld Today | Thursday, November 29, 2012 -
Pharma: Other News To Note
Abbott, of Abbott Park, Ill., said the European Commission approved Humira (adalimumab) for the treatment of pediatric patients, ages 6 to 17, with severe active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapyBioWorld Today | Wednesday, November 28, 2012 -
Pharma: Other News To Note
The product is licensed from Cipher Pharmaceuticals Inc., of Mississauga, Ontario, and was formulated in such a way that it does not need to be given with a high-fat meal, as is usually the case with isotretinoinBioWorld Today | Tuesday, November 27, 2012 -
Pharma: Other News To Note
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.BioWorld Today | Monday, November 26, 2012 -
Pharma: Other News To Note
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 royaltiesBioWorld Today | Wednesday, November 21, 2012 -
Pharma: Other News To Note
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 clinicallyBioWorld Today | Tuesday, November 20, 2012 -
Pharma: Other News To Note
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 businessBioWorld Today | Monday, November 19, 2012
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