GlaxoSmithKline

Regulatory update on GSK-Novartis three-part transaction

Thursday, January 29, 2015 12:25 PM

GlaxoSmithKline has received clearance from the European Commission (E.C.) of its proposed three-part transaction with Novartis, which includes the acquisition of Novartis’s vaccines business (excluding influenza vaccines), the creation of a consumer healthcare joint venture between GSK and Novartis and the divestment to Novartis of GSK’s marketed oncology portfolio, related R&D activities and rights to two pipeline AKT inhibitors.

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Array to acquire Novartis BRAF inhibitor encorafenib (LGX818)

Friday, January 23, 2015 11:40 AM

Array BioPharma, based in Boulder, Colo., has reached a definitive agreement with Novartis Pharma to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.

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FDA approves record 41 new drugs in 2014, over 40% for rare diseases

Friday, January 16, 2015 02:52 PM

Pharmaceutical innovation had a banner year in 2014, as the FDA approved 41 novel drugs and biologics—the largest number in 18 years and a 52% increase from the 27 approved in 2013.

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New Model for Clinical Trial Conduct

Monday, January 12, 2015 08:00 AM

New and somewhat futuristic models for clinical trial conduct are on our doorstep.

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Heptares expands board of directors

Thursday, January 8, 2015 12:41 PM

Heptares Therapeutics, a clinical-stage GPCR structure-guided drug discovery and development company, has appointed Atul Pande and Roberto Solari to its board of directors. Pande and Solari bring significant industry experience in the discovery and validation of drug targets and the subsequent development of novel medicines.

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U.S. immunity against legal claims given to developers of Ebola treatments

Monday, January 5, 2015 12:52 PM

Health and Human Services Secretary Sylvia M. Burwell has announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines. This declaration is intended to assist in the global community's effort to help combat the current epidemic in West Africa and help prevent future outbreaks there.

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As GSK restructuring cuts 900 jobs in RTP, Parexel absorbs 450 of them in new business unit

Monday, December 8, 2014 01:30 PM

GlaxoSmithKline’s global restructuring was felt sharply in North Carolina this week as it announced plans to cut 900 jobs in Research Triangle Park (RTP), where it has 2,500 employees and contractors working in research and development.

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Merck, NewLink Genetics collaborate on investigational Ebola vaccine

Wednesday, November 26, 2014 11:54 AM

Merck and Ames, Iowa-based NewLink Genetics have entered into an exclusive worldwide license agreement to research, develop, manufacture and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.

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Clinverse names John Musante chief commercial officer

Monday, November 24, 2014 02:34 PM

Clinverse, a provider of automated financial management technology solutions for clinical trials, has added John Musante as chief commercial officer. Musante brings more than 25 years of experience across industry sectors including health care, technology, and life sciences.

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Report: Pharma is improving medicines access, but progress is uneven

Monday, November 17, 2014 02:30 PM

The world’s leading pharmaceutical companies are doing more to improve access to medicine in developing countries, with a raft of new initiatives, scale-ups and innovations over the last two years. However, the industry struggles to perform well in some practices that matter, according to the 2014 Access to Medicine Index, published by the Access to Medicine Foundation, a nonprofit organization based in the Netherlands that aims to advance access to medicine by encouraging the pharmaceutical industry to play a greater role in improving access to medicine in less developed countries.

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CenterWatch Data Library
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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