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ERT updates executive management team

Thursday, July 2, 2015 09:36 AM

ERT, a global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, has appointed Steve Nuckols executive vice president and chief commercial officer. As chief commercial officer, Nuckols will be responsible for all global business development activities within ERT, with primary focus on ensuring ERT’s products and services best meet the needs of its global pharmaceutical customers.

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Quest Diagnostics

NIH begins clinical trial of new medication for alcohol use disorder

Thursday, July 2, 2015 09:28 AM

A clinical trial investigating a potential treatment for alcohol use disorder (AUD) was announced by the National Institute of Alcohol Abuse and Alcoholism (NIAAA). The study will assess the safety and efficacy of gabapentin enacarbil (HORIZANT) in extended-release tablets for treating moderate to severe AUD. NIAAA is part of the NIH.

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FDA extends PDUFA date for Genentech’s cobimetinib NDA

Thursday, July 2, 2015 09:17 AM

Exelixis has been informed by partner Genentech, a member of the Roche Group, that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech's NDA for cobimetinib by the standard extension period of three months, from Aug. 11 to Nov. 11.

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Great Basin wins NIH grant to develop test for CRE superbug

Thursday, July 2, 2015 09:01 AM

The National Institute of Allergy and Infectious Diseases, part of the NIH, has awarded a research grant to Great Basin Scientific and Brigham Young University (BYU), to develop a rapid molecular diagnostic test direct from whole blood for carbapenem-resistant Enterobacteriaceae (CRE). The NIH research grant will play a key role in meeting the goals of President Obama's recent National Action Plan for Combating Antibiotic-Resistant Bacteria.

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Baxalta launches focused on orphan diseases and underserved conditions

Thursday, July 2, 2015 08:53 AM

Baxalta has launched as a global biopharmaceutical company dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions. The company continues to advance in hematology and immunology and seeks to expand its oncology portfolio for patients with limited treatment options. Baxalta plans to launch 20 new products by 2020, leveraging the company’s existing global capabilities and footprint in more than 100 countries.

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Entasis launches with a drug-resistant bacterial infections portfolio

Thursday, July 2, 2015 08:47 AM

Entasis Therapeutics, a Waltham, Mass.-based company, has launched with a portfolio of diverse, innovative investigational drugs for the treatment of serious drug-resistant bacterial infections.

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PPD creates pediatric investigator network to enhance global trials capabilities

Wednesday, July 1, 2015 10:56 AM

Global CRO Pharmaceutical Product Development (PPD) has formalized relationships with eight investigator sites as part of a pediatric investigator network (PIN) the company has established to further enhance its pediatric clinical development capabilities.

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Actelion creates Vaxxilon together with the Max Planck Society

Wednesday, July 1, 2015 10:38 AM

Actelion, a biopharmaceutical company based in Switzerland, has created a start-up, together with the Max Planck Society, in synthetic carbohydrate vaccines. The new company, Vaxxilon, aims to discover, develop, and commercialize synthetic carbohydrate vaccines.

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Transgene plans restructuring to focus on R&D, cuts 120 jobs

Wednesday, July 1, 2015 10:21 AM

Transgene, a France-based biotechnology company specializing in immunotherapies for cancer and infectious diseases, plans to modify its vertical integration model and to implement a restructuring in order to maintain its competitiveness and to ensure a sustainable future.

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AMAG Pharmaceuticals acquires Lumara Health's Maternal Health Business

Wednesday, July 1, 2015 10:20 AM

AMAG Pharmaceuticals, a Massachusetts-based specialty pharmaceutical company, has completed the acquisition of Lumara Health, a St. Louis, Mo.-based specialty pharmaceutical company with a particular focus on maternal health. The transaction was announced on September 29, 2014 and included upfront consideration of $600 million in cash and 3,209,971 shares of AMAG common stock, and additional contingent consideration of up to $350 million based on the achievement of sales milestones. 

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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