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 The leading web portal for pharmacy resources, news, education and careers July 2, 2015
Pharmacy Choice - News - U.S. Pharmaceutical Industry - July 2, 2015

Pharmacy News

 U.S. Pharmaceutical Industry
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7/2/15 - AB Science: the Data and Safety Monitoring Board recommends continuation of three phase 2 studies
AB Science SA, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors, announces that the external Data and Safety Monitoring Board has recently recommended, based upon updated safety and efficacy data, continuation of three on-going phase 2 studies assessing masitinib, one in second-line treatmen
7/2/15 - Accurexa Appoints William Callahan to Its Board of Directors
NEWARK, DE/ ACCESSWIRE/ July 2, 2015/ Accurexa Inc., a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that William Callahan has been appointed to its Board of Directors, effective July 1, 2015. Throughout his career he has held positions of increasing responsibility in engineering and..
7/2/15 - Achaogen to Present at the Cantor Fitzgerald Inaugural Healthcare Conference [Week, The (Oman)]
-Achaogen, Inc., a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant gram-negative infections, announced today that it will present at the Cantor Fitzgerald Inaugural Healthcare Conference in New York, NY. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of.
7/2/15 - Acucela Hires Roger Girard as Chief Strategy Officer
Acucela Inc., a clinical-stage biotechnology company that specializes in discovering and developing novel drug candidates to potentially treat and slow the progression of sight-threatening ophthalmic diseases, announced today that it has hired Roger Girard as Chief Strategy Officer. Having built 14 successful companies over the past 40 years in...
7/2/15 - Adapt Pharma Acquires Narcan NDA and Obtains License to the Narcan Trademark
Adapt Pharma Limited announced today that it has obtained a license to the Narcan trademark and acquired the related Narcan New Drug Application. Adapt Pharma previously announced that it had commenced a rolling submission of an NDA to the FDA for a nasal spray formulation of naloxone, a drug intended to treat opioid overdose. Use of the Narcan nam
7/2/15 - Adaptimmune Announces FDA Acceptance of Investigational New Drug (IND) Application for MAGE-A10 T in Patients With Non-Small Cell Lung Cancer
The acceptance of this IND allows Adaptimmune to initiate an open label Phase I/II study designed to evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC. Adaptimmune's proprietary technology enables the Company to routinely generate TCRs which address intracellular targets, such as MAGE-A10, that are not accessible to certain other.
7/2/15 - ADDING MULTIMEDIA FDA Approves ORKAMBI? (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI?, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two
7/2/15 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled...
Also include the FDA docket number found in brackets in the heading of this document. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. In the Federal Register of August 27, 2014, FDA announced the availability of a draft guidance for ind
7/2/15 - Agile Therapeutics to Present at the Cantor Fitzgerald Inaugural Healthcare Conference [Moj News Agency (Iran)]
-Agile Therapeutics, Inc. a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced today that Al Altomari, President and Chief Executive Officer will present at the Cantor Fitzgerald Inaugural Healthcare Conference scheduled on Wednesday, July 8, 2015 at
7/2/15 - AGTC to Host Conference Call and Webcast to Discuss Biogen Collaboration
Applied Genetic Technologies Corporation, a clinical stage biotechnology company developing adeno-associated virus- based gene therapies for the treatment of rare eye diseases, today announced that the Company will host a conference call and webcast to discuss its recently announced collaboration with Biogen. The call will take place today at...
7/2/15 - Bharat Book Bureau: Biological Safety Testing Market Research Analysis by Application & Test - Global Forecast to 2019
Between 2001 and 2010, the FDA approved 225 drug applications and Health Canada approved 99. In addition, according to WIPO, Europe accounted for 3,822 of the pharmaceutical and 1,998 of the biotechnology patents granted in 2012. Furthermore, according to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970. Th
7/2/15 - CereSpir Incorporated Submits Special Protocol Assessment Request to FDA for a Phase 3 Clinical Trial to Test the Ability of CSP-1103 to Slow the... [Khaleej Times (United Arab Emirates)]
CereSpir Incorporated Submits Special Protocol Assessment Request to FDA for a Phase 3 Clinical Trial to Test the Ability of CSP-1103 to Slow the Progression of Mild Cognitive Impairment Due to Alzheimer's Disease. The SPA request includes the proposed Phase III study protocol, statistical analysis plans and briefing materials along with specific..
7/2/15 - Cystic Fibrosis Foundation Celebrates FDA Approval of Orkambi as an Important Advance for the Cystic Fibrosis Community
The Cystic Fibrosis Foundation celebrates the FDA s approval today of the lumacaftor/ivacaftor combination drug as an important advance for the cystic fibrosis community. Orkambi was developed by Vertex Pharmaceuticals Inc. with significant clinical, scientific and funding support from the CF Foundation. We applaud the FDA for its swift appro
7/2/15 - Dr. Pierre-Andr Wicker joins Pharmaleads' Board of Directors
Pierre-Andr Wicker is joining the Company's Board of Directors. Pierre-Andr Wicker has spent most of his career in the pharmaceutical industry in the United States. Pierre-Andr Wicker, a renowned specialist in international therapeutic molecule development strategies.
7/2/15 - Dr. Pierre-Andre Wicker joins Pharmaleads' Board of Directors
Pierre-Andr Wicker is joining the Company's Board of Directors.. Pierre-Andr Wicker has spent most of his career in the pharmaceutical industry in the United States. Pierre-Andr Wicker, a renowned specialist in international therapeutic molecule development strategies.
7/2/15 - Endocyte to Present at the Cantor Fitzgerald Healthcare Conference [Palestine Chronicle, The]
-Endocyte, Inc., a biopharmaceutical company and leader in developing targeted small molecule drug conjugates and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that the company's management team will present at the Cantor Fitzgerald Healthcare Conference on Wednesday, July 8, at 4:15 p.m. ED
7/2/15 - Evoke Pharma to Present at Cantor Fitzgerald Inaugural Healthcare Conference [Kurdish Globe, The (Iran)]
-Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, will host an investor presentation on Wednesday, July 8, 2015 at 10:15 AM ET at the Cantor Fitzgerald Inaugural Healthcare Conference. The conference is being held on July 8, 2015 at Le Parker Meridien Hotel in New York City. Metoclopramide
7/2/15 - FDA approves new combination pill for cystic fibrosis from Vertex Pharmaceuticals
WASHINGTON Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death.
7/2/15 - FDA Approves ORKAMBI? (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI?, the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two
7/2/15 - FDA clears drug for leading form of cystic fibrosis
But it will come at a steep price more than $250,000 for a year's treatment. The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals Inc. for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older. Vertex said Orkambi will cost $259,000 per year.
7/2/15 - FDA Issues Notice on Unapproved, Misbranded Otic Prescription Drug Products
WASHINGTON, July 2 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. A Notice by the Food and Drug Administration on 07/02/2015. Dates: This notice is effective July 2, 2015.
7/2/15 - Fidia Farmaceutici S.p.a. Enters the Italian Pediatric Market Segment
Signed partnership agreement with APR Applied Pharma Research s.a. for the promotion and marketing of the HALYKOO Line in Italy. ABANO TERME, Italy& BALERNA, Switzerland Fidia Farmaceutici S.p.a. enters the Italian pediatric healthcare market with the acquisition of the HALYKOO Line developed by the Swiss-based company APR Applied Pharma Resear
7/2/15 - First Medical Device Cleared by FDA With Adherence Claim
Proteus Digital Health, Inc. today announced that the FDA has expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence. To the Company s knowledge, this is the only device with an FDA- sanctioned claim for measurin
7/2/15 - First Patient Dosed in IST of CDK Inhibitor Seliciclib in Cushing's Disease, a Serious Endocrine Disorder
Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today announced that the first patient has been dosed in an investigator sponsored trial of the Company's oral cyclin dependent kinase inhibitor selicicl
7/2/15 - Gilead Submits NDA to FDA for Single Tablet Regimen for HIV; CEL-SCI Reports June Patient Enrollment
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 1, 2015.{ nfg} Gilead Sciences, Inc. announced it has submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen that combines Gilead's emtricitabine 200 mg and tenofovir alaf
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