ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in central nervous system disorders, today announced that it will present at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 11, 2016, at 2:20 p.m. Pacific Time
Actelion Pharmaceuticals Ltd/ Actelion's Annual General Meeting of Shareholders held in Basel, Switzerland- All Board proposals approved. ALLSCHWIL/ BASEL, SWITZERLAND- 04 May 2016- At today's Annual General Meeting of Actelion Ltd, held in Basel, Switzerland, shareholders voted in favor of all proposals by the Board of Directors with a significant
Shares of Alembic Pharma closed 1.59% lower at Rs. 593.30 on BSE after the company received USFDA's approval for partial onset seizures drug. The company has received final approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Lacosamide Tablets, SO mg, 100 mg, lSO mg and 200 mg.The approved ANDA is therapeut
Angiochem, a biotechnology company developing ANG1005 for the treatment of Leptomeningeal Carcinomatosis in patients with breast cancer and brain metastases, announced today that the U.S. Food and Drug Administration has scheduled an End-of-Phase 2 meeting to discuss clinical study results of the compound. Angiochem submitted a meeting request to t
Dr. Ruffolo is the retired President of Research and Development at Wyeth Pharmaceuticals, and retired Corporate Senior Vice President of Wyeth. Dr. Ruffolo brings substantial drug discovery and development expertise to Aridis. Prior to Wyeth, Dr. Ruffolo spent 17 years at SmithKline Beecham Pharmaceuticals where he was Senior Vice President and Di
Audentes Therapeutics, Inc., a biotechnology company focused on developing and commercializing gene therapy products for patients suffering from serious, life-threatening rare diseases, today announced a collaboration with the Orphan Disease Center at the Perelman School of Medicine at the University of Pennsylvania to develop AT342, an AAV gene...
-BioMarin Pharmaceutical Inc. today announced that the European Medicines Agency has granted BioMarin's request for accelerated assessment for the planned cerliponase alfa Marketing Authorization Application. The company expects to submit the cerliponase alfa MAA to the EMA and the Biologics License Application to the U.S. Food and Drug...
NESS ZIONA, Israel, May 4, 2016/ PRNewswire/. BiondVax Pharmaceuticals Ltd. announced today that BiondVax's CEO, Dr. Babecoff will be presenting at 10:30am at Pioneers 2016, a conference presented by Joseph Gunner& Co, taking place at the New York Palace Hotel.
Collegium Pharmaceutical, Inc. today announced positive topline results from a comparative clinical trial evaluating the effect of physical manipulation by crushing of Xtampza? ER compared with the abuse-deterrent version of OxyContin . Xtampza ER, Collegium s first FDA approved product utilizing its proprietary DETERx technology platfo
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of
DGAP-News: VAXIMM AG/ Key word: Study VAXIMM initiates Phase 2 a study in advanced colorectal cancer with oral T-cell vaccine VXM01 04.05. 2016/ 09:00 The issuer is solely responsible for the content of this announcement.- VAXIMM initiates Phase 2 a study in advanced colorect
INDIANAPOLIS- Eli Lilly and Company announced the U.S. FDA has granted Priority Review for the biologics license application for olaratumab, a PDGFR? The company has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication. Lilly also submitted olaratumab to the Eu
Elite Pharmaceuticals, Inc. announced today that its Board of Directors has appointed Davis S. Caskey to its board effective April 28, 2016.. From 1990 until 2013, Mr. Caskey was employed by ECR Pharmaceuticals Co., Inc., a venture that was founded in 1990 and acquired by Hi-Tech Pharmacal in March 2009, where he served as the operating officer.
Epizyme, Inc., a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has accepted the company s Investigational New Drug application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function.
DUBLIN- BioMarin Pharmaceutical Inc. expects to submit EU and U.S. Marketing Application for Cerliponase alfa, intended for the treatment of children with CLN2 disease, a form of Batten disease, by mid-2016. In just another two months, Corcept Therapeutics Inc. will be reporting results from a phase 1/ 2 trial of mifepristone in combination with an
-Evoke Pharma, Inc. today announced that it expects to provide top line data results from its pivotal Phase 3 clinical trial of EVK-001 in women with symptoms associated with diabetic gastroparesis early in the third quarter of 2016. Dave Gonyer, R.Ph., President and CEO stated, Having completed enrollment in our pivotal Phase 3 trial of EVK-001, w
Eli Lilly and Company announced today that the U.S. Food and Drug Administration has granted Priority Review for the biologics license application for olaratumab, a PDGFR antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma not amenable to curative treatment with radiotherapy or su
-Foamix Pharmaceuticals Ltd.,, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced the completion of enrollment in a Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. It affects more than 16 million people i
Actelion's Annual General Meeting of Shareholders held in Basel, Switzerland- All Board proposals approved. Actelion Pharmaceuticals Ltd/ Actelion's Annual General Meeting of Shareholders held in Basel, Switzerland- All Board proposals approved. ALLSCHWIL/ BASEL, SWITZERLAND- 04 May 2016- At today's Annual General Meeting of Actelion Ltd, held in B
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that Justin Gover, GW s Chief Executive Officer, will present at the Bank of America Merrill Lynch 2016 Healthcare Conference on Tuesday, May 10, 2016,
EVENT: Health and Human Services Department; Food and Drug Administration holds a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss new drug application 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed...
Horizon Pharma plc, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced it received three additional Notice of Allowances from the United States Patent and Trademark Office for U.S. patent.
Strauss-Levy has 15 years of experience in clinical research and regulatory affairs, and has established an outstanding track record, having supported the advancement of several products through the clinical development and regulatory approval processes in the United States and Europe, including several Phase III clinical trials, "said Zeev Weiss,
Ionis Pharmaceuticals, Inc. today reported its financial results for the first quarter were in line with the company's expectations. We are actively engaged in NDA preparations for all three of these drugs in anticipation of Phase 3 data from each in the first half of next year, "said B. Lynne Parshall, chief operating officer of Ionis Pharmaceut
Juniper Pharmaceuticals, Inc., a women's health therapeutics company, today announced financial results for the three-month period ended March 31, 2016. Phase 2 b trial of COL-1077 10% lidocaine vaginal gel in women undergoing a minimally invasive pipelle-directed endometrial biopsy on track for Q3 2016 data readout; Pre-IND meeting with the U.S.