Theorem Clinical Research

Merck

Pfizer, Merck to collaborate on anti-cancer combination regimen

Wednesday, August 27, 2014 10:01 AM

Pfizer and Merck have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a phase Ib clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).  The financial terms of the agreement have not been disclosed. 

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Telik appoints new board of director members

Friday, August 15, 2014 12:19 PM

Telik, a clinical stage oncology drug development company based in California, which recently merged with MabVax Therapeutics in July, has appointed six new members of the board of directors to help guide the company and its management in developing an expanded product development pipeline post-merger.

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FDA approves new sleep drug Belsomra

Friday, August 15, 2014 09:17 AM

The FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

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AWARE for All Clinical Research Education Day returns to Boston

Monday, August 4, 2014 02:53 PM

The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, has announced the return of AWARE for All Boston, a free event designed to promote understanding and dialogue around clinical research participation.

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Covance adds two to clinical development services leadership team

Monday, July 14, 2014 01:04 PM

Covance has announced two key additions to its clinical development services scientific leadership team with the appointments of Robert Wasserman, M.D., as vice president and global therapeutic area head, oncology, and Rogelio Mosqueda-Garcia, M.D., Ph.D., as global vice president, early clinical services within medical and scientific affairs. Both are based in Princeton, N.J.

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Merck's biopharmaceutical division appoints Luciano Rossetti global head of R&D

Monday, July 14, 2014 12:59 PM

Merck's biopharmaceutical division has appointed Luciano Rossetti, M.D., executive vice president and global head of R&D as of July 21.

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Mersana Therapeutics, Merck ink $792 million agreement

Wednesday, June 25, 2014 02:08 PM

Mersana Therapeutics and the biopharmaceutical division of Merckhave agreed to collaboratively develop next-generation antibody-drug conjugates (ADCs). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody specifically targets and delivers the cytotoxic drug to cancer cells, which could lead to higher drug levels at the tumor site.

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Bionomics, Merck enter research collaboration

Wednesday, June 25, 2014 01:47 PM

Bionomics has entered into an exclusive research collaboration and license agreement with Merck for its BNC375 research program targeting cognitive dysfunction associated with Alzheimer's disease and other central nervous system conditions.  

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Merck to acquire Idenix for $3.85 billion

Monday, June 9, 2014 02:01 PM

Merck has agreed to acquire Idenix Pharmaceuticals for $24.50 per share in cash, for a total value of approximately $3.85 billion. The transaction has been approved by the boards of directors of both companies.

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Merck globally enrolling treatment-naïve adults with HIV-1

Friday, June 6, 2014 01:57 PM

Merck has announced that the first patient has been enrolled in the company’s global phase III clinical trial, ONCEMRK. ONCEMRK is assessing a once-daily investigational formulation of ISENTRESS (raltegravir), known as reformulated raltegravir, as part of combination HIV therapy for treatment-naïve HIV-1-infected adults. ISENTRESS film-coated tablets currently are administered twice daily in accordance with the approved prescribing Information.

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CWWeekly

September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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