Industry News

Mylan notifies Perrigo of HSR filing regarding proposed acquisition

Centerwatch - Mon, 2015-04-13 08:20
Mylan, a global generics and specialty pharmaceutical company, has provided Perrigo, an Irish international manufacturer of over-the-counter pharmaceuticals, with notice of its filing of the pre-merger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) with the U.S. Federal Trade Commission and the U.S. Department of Justice Antitrust Division regarding its proposed acquisition of Perrigo, as required by the HSR Act. Mylan proposed to acquire Perrigo for $205 per share in a cash-and-stock transaction on April 6.
Categories: Industry News

Roche acquires CAPP Medical, strengthens oncology translational research pipeline

Centerwatch - Mon, 2015-04-13 08:18
Roche has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and located in Palo Alto, Calif., to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA (ctDNA) in blood.
Categories: Industry News

Medivir, Cancer Research Technology collaborate to develop new class of cancer drugs

Centerwatch - Mon, 2015-04-13 08:15
Medivir, a research-based pharmaceutical company based in Sweden, and Cancer Research Technology (CRT), Cancer Research U.K.’s commercialization and development arm, have partnered to develop a new class of drugs that has shown promise for treating a range of different cancers, including pancreatic cancer.
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How to restart a clinical trials program

Centerwatch - Mon, 2015-04-13 04:00
The circumstances of a recent pre-study assessment visit were unexpectedly touching, and productive, considering the absence of a Study Coordinator (SC).
Categories: Industry News

FDA Drug Info Rounds Video

FDA News - Fri, 2015-04-10 16:37
A new series of training videos for practicing clinical and community pharmacists
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Parexel adds three programs to Parexel Academy

Centerwatch - Fri, 2015-04-10 09:47
Parexel International, a global biopharmaceutical services provider, has announced three new academic programs at the Parexel Academy. The offerings span the globe and are designed to prepare students for careers in the biopharmaceutical industry. They include:
Categories: Industry News

BioXcel, Takeda partner to repurpose assets for orphan diseases

Centerwatch - Fri, 2015-04-10 09:45
BioXcel, a Branford, Conn.-based provider of cloud-based pharma big data solutions for discovering novel products, has partnered with Takeda Development Center Americas for the repurposing of assets across the gamut of rare diseases.
Categories: Industry News

NIH funds nine antimicrobial resistance diagnostics projects

Centerwatch - Fri, 2015-04-10 09:31
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has awarded more than $11 million in first-year funding for nine research projects supporting enhanced diagnostics to rapidly detect antimicrobial-resistant bacteria. The awardee institutions will develop tools to identify certain pathogens that frequently cause infections in health care settings and, specifically, those that are resistant to most antimicrobials. Advancing the development of rapid and innovative diagnostic tests for identifying and characterizing resistant bacteria is a key goal of the President’s recent National Action Plan for Combating Antibiotic-Resistant Bacteria.
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Pfizer launches competitive grants program for cardiovascular disease research

Centerwatch - Fri, 2015-04-10 09:21
Pfizer has launched a new competitive grants program to support research projects investigating the role of Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) in health and cardiovascular disease. This competitive grants program, which is an extension of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Cardiovascular program, is part of Pfizer's ongoing commitment to translate scientific discoveries into innovative medicines for patients with cardiovascular disease.
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Eisai to restructure U.S. operations, cut workforce 25%

Centerwatch - Fri, 2015-04-10 09:19
Eisai Inc., a U.S. subsidiary of Eisai Co., a global R&D-based pharmaceutical company headquartered in Japan, plans to restructure its operations in the U.S., including a reduction of its workforce by approximately 25% across various U.S. functions. This realignment supports Eisai's desire to create a more efficient and focused organization.
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Relmada Therapeutics appoints Lisa Nolan SVP of business development

Centerwatch - Fri, 2015-04-10 07:54
Relmada Therapeutics, a clinical-stage company developing novel therapies for the treatment of chronic pain, has appointed Lisa Nolan, Ph.D., as senior vice president of business development. Nolan will be responsible for overseeing alliance and business development activities across the company.
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Margaret A. Hamburg appointed Institute of Medicine foreign secretary

Centerwatch - Fri, 2015-04-10 07:29
Margaret A. Hamburg, former commissioner of the FDA, has been appointed as the next foreign secretary of the Institute of Medicine, the health arm of the National Academy of Sciences. In this part-time position, Hamburg will work as a senior adviser on international matters to the IOM president and council and as liaison to foreign academies of medicine and science.
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Pediatric Exclusivity Granted

FDA News - Thu, 2015-04-09 10:33
Updated statistics and exclusivity determinations list.
Categories: Industry News

FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Centerwatch - Thu, 2015-04-09 10:20
The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.
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EnteroMedics appoints Scott A. Shikora EVP of medical affairs, CMO

Centerwatch - Thu, 2015-04-09 10:09
EnteroMedics, a developer of medical devices using neuroblocking therapy to treat obesity, metabolic diseases and other gastrointestinal disorders, has named Scott A. Shikora, M.D., FACS, executive vice president of medical affairs and chief medical officer of EnteroMedics, effective June 1. He will lead the company's medical affairs, clinical and regulatory functions.
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Greenphire opens new global headquarters

Centerwatch - Thu, 2015-04-09 09:49
Greenphire, a provider of payment technology for the clinical trials industry, has moved its operations to new headquarters in King of Prussia, Pa. The move quadruples the company's office space in the region and supports Greenphire's ongoing growth strategy that will see the business rapidly scale its operational infrastructure to support its growing global client base.
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Sanford-Burnham, Daiichi Sankyo ink agreement

Centerwatch - Thu, 2015-04-09 09:48
Sanford-Burnham Medical Research Institute, a nonprofit, independent institute that employs more than 1,000 scientists and staff in San Diego, Calif., and Orlando, Fla., has signed a licensing agreement to further develop a first-in-class small molecule with Daiichi Sankyo for the treatment of cardiovascular-metabolic disease.
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DARPA awards Inovio $45M Ebola program grant

Centerwatch - Thu, 2015-04-09 09:43
Inovio Pharmaceuticals, based in Plymouth Meeting, Pa., has been awarded a $45 million grant from the Defense Advanced Research Projects Agency (DARPA) to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola.
Categories: Industry News

Roche becomes majority shareholder in Foundation Medicine

Centerwatch - Thu, 2015-04-09 09:41
Roche has become a majority shareholder of Foundation Medicine, a molecular information company based in Cambridge, Mass. Roche purchased approximately 15.6 million shares of common stock through a tender offer from Foundation Medicine stockholders at a price of $50 per share.
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