|US FDA Staff Shoot Down Pfizer Rare Disease Drug; Repros Updates Special Protocol Assessment Studies for Androxal|
|By Staff and Wire Reports|
|Tuesday, 22 May 2012 21:03|
U.S. drug reviewers recommended on Tuesday rejecting a Pfizer Inc (NYSE:PFE) drug because the data did not prove it worked well in treating a rare neurodegenerative disease.
The U.S. FDA staff reviewed the drug, tafamidis, ahead of an advisory panel of outside experts, which will vote on whether to recommend it for approval on Thursday. The FDA will make a final decision later, taking into account the panel's recommendation.
Tafamidis, which is already approved in Europe under the name Vyndaqel, is meant to treat familial amyloid polyneuropathy, a fatal condition that affects about 8,000 people worldwide, according to Pfizer.
Repros Therapeutics Inc.® (Nasdaq: RPRX) announced it has modified the pivotal protocol following additional FDA input post the May 9th meeting. The revision included additional secondary endpoints specifying the number of men in the study that exhibit a single time point of testosterone concentration greater than 1500, 1800 and 2500 ng/dL. It is common to experience such high excursions for approved topical products. No subject in an Androxal® study has ever exhibited a concentration greater than 1500 ng/dL and the maximum levels achieved are approximately 1100 ng/dL.
This level occurs rarely and only in men administered the higher (25 mg) dose. The pivotal studies are designed to titrate men to greater than 450 ng/dL by first starting on the 12.5 mg dose. The Company believes 60% of men will achieve the 450 ng/dL up-titration threshold on the 12.5 mg dose resulting in 40% of men up-titrating to the 25 mg dose.
BioTime, Inc. (NYSE MKT: BTX) today announced that its subsidiary LifeMap Sciences, Inc. has entered into a license agreement with Yeda Research and Development Company Ltd, the technology transfer arm of the Weizmann Institute of Science, to market a new database called MalaCards.
Celgene Corporation (NASDAQ: CELG) today announced its presentation at Sanford C. Bernstein’s 28th Annual Strategic Decisions Conference on Wednesday, May 30, 2012 at 3:00p.m. EST will be webcast live and will be available in the investor relations section of the Company’s Web site at www.celgene.com.
Codexis, Inc. (NASDAQ:CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals and pharmaceuticals, today announced a three-year extension of its catalyst and process development collaboration with Merck to develop enzymes for use in pharmaceutical manufacturing.
Covidien plc (NYSE: COV) today announced that its wholly-owned subsidiary, Covidien International Finance S.A. (CIFSA), priced an underwritten offering of $600 million aggregate principal amount of 1.350% senior notes due 2015 and $650 million aggregate principal amount of 3.200% senior notes due 2022.
Deltagen, Inc. (Pink Sheets:DGEN), a leading provider of drug discovery tools and services to the biopharmaceutical industry, today reported unaudited consolidated financial results for the three months ended March 31, 2012.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that the company will be webcasting its presentation at the Jefferies 2012 Global Healthcare Conference in New York on Tuesday, June 5, 2012 at 10:30 AM Eastern.
FLIR Systems, Inc.(NASDAQ: FLIR) announced today that it has been awarded an indefinite delivery, indefinite quantity contract from the U.S. Army to support the MEDEVAC program.
Galectin Therapeutics (NASDAQ: GALT) will host a conference call at 10:00 A.M. Eastern Time on Thursday, May 24, 2012, to provide an update following the Company’s Annual Meeting of Shareholders.
Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) is pleased to provide an update on BREVAGen™ sales and the "credentialing" process with the top ten U.S. Preferred Provider Organizations ("PPOs").
GeoVax Labs, Inc. (otcqb/otcbb:GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced that the NIH-funded HIV Vaccine Trials Network (HVTN) has opened enrollment for a Phase 1 trial for the company's second-generation HIV vaccine.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced several new studies using PillCam® COLON 2, including data evaluating its viability as an out-of-clinic procedure.
Impax Laboratories, Inc. (NASDAQ: IPXL) held its 2012 Annual Meeting of Stockholders today in San Mateo, California. Impax stockholders elected to a one-year term each of the seven nominees for director named in the Company’s proxy statement, approved, on an advisory basis, the compensation of the Company’s named executive officers as described in the proxy statement (“say-on-pay” vote) and ratified the appointment of KPMG LLP as independent auditors for the fiscal year ending December 31, 2012.
Medtronic, Inc. (NYSE:MDT) today announced financial results for its fourth quarter and fiscal year ended April 27, 2012.
Pegasystems Inc. (NASDAQ: PEGA), the leader in Business Process Management (BPM) and software for customer centricity, today announced that Amerigroup Corporation has significantly increased its claims first-pass rate within just three months of deploying Pega Claims Repair, and is on track for even higher efficiencies in the near future.
Pfizer Inc. (NYSE: PFE) and EatingWellMedia Group, publisher of EatingWell Magazine and part of Meredith Corporation (NYSE: MDP), today announced the launch of Pfizer's Lipitor For You"Recipes 2 Go"mobileapplication ("app"), marking the first time Pfizer has released a consumer mobile app for a prescription product in the U.S.
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, will present at the Jefferies 2012 Global Healthcare Conference on Tuesday, June 5, 2012 at 10:30 a.m. (ET), in New York City.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that its annual meeting of shareholders will be held on Thursday, May 24, 2012 at 8am EDT at the Radnor Hotel in St. Davids, PA.
Sunshine Biopharma Inc. (OTCBB: SBFM) a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed the pharmacokinetics studies in live rats for its lead anti-tumor compound, Adva-27a.