Merck

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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Moderna, Merck to develop messenger RNA-based antiviral vaccines

Wednesday, January 14, 2015 12:41 PM

Moderna Therapeutics has announced a license and collaboration agreement with Merck, through a subsidiary, for the discovery and development of vaccines and passive immunity treatments against viral diseases using modified messenger RNA (mRNA). Moderna’s work in the collaboration will be led by Valera, its venture focused on the development of mRNA vaccines and therapeutics to fight infectious disease. Moderna is privately held, Cambridge, Mass.-based company founded by Flagship VentureLabs.

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Eli Lilly inks agreements with Merck, Bristol-Myers Squibb

Wednesday, January 14, 2015 12:21 PM

Eli Lilly has formed two separate collaboration agreements. The first agreement with Merck is an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials. The second, with Bristol-Myers Squibb, is a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of BMS' immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299).

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Merck acquires OncoEthix, a privately-held oncology company

Friday, December 19, 2014 12:06 PM

Merck has acquired, through a subsidiary, OncoEthix, a Swiss-based, privately held biotechnology company specializing in oncology drug development. Merck has gained an investigational, novel oral BET (bromodomain) inhibitor, OTX015, currently in phase Ib studies for the treatment of hematological malignancies and advanced solid tumors.

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Report: Top 30 pharma companies spent $112B on R&D in 2013

Thursday, December 18, 2014 11:19 AM

The world’s leading 30 pharmaceutical companies spent a combined $112 billion on R&D in 2013, an increase of $723 million over the previous year, according to London-based research and consulting firm GlobalData.

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Amgen initiates trial of Talimogene Laherparepvec and Merck's Keytruda

Thursday, December 11, 2014 01:46 PM

Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck's FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.

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FDA expands Gardasil 9 approval

Thursday, December 11, 2014 01:07 PM

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

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EFPIA hires Joe Jimenez, CEO of Novartis, as new president

Thursday, December 11, 2014 12:06 PM

EFPIA has appointed Joe Jimenez, CEO of Novartis, as its new president. He will work alongside Dr. Stefan Oschmann, CEO Pharma of Merck, and Marc de Garidel, chairman and CEO of Ipsen, who have been appointed as vice presidents by the board.

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Merck to acquire Cubist Pharmaceuticals for $9.5B to expand hospital acute care pipeline

Monday, December 8, 2014 03:29 PM

Shying away from mega-mergers to instead focus on mid-sized drug makers that complement its product pipeline, Merck said this morning it will acquire Cubist Pharmaceuticals for $9.5 billion, including $1.1 billion in debt.

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Merck’s EngageZone receives IDG’s CSO Security Award

Thursday, December 4, 2014 02:22 PM

EngageZone has been named an honoree of a 2015 CSO50 Award from IDG's CSO. This prestigious honor is awarded to a select group of organizations with security projects that have created outstanding business value and thought leadership for their companies.

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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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