Theorem Clinical Research

Drug Sponsors

Amarin to eliminate 50% of staff following FDA Advisory Committee vote

Wednesday, October 23, 2013 03:13 PM

Amarin, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, plans to reduce operating expenses by eliminating approximately 50% of its staff worldwide, following the recent recommendation of the FDA Endocrinologic and Metabolic Drugs Advisory Committee against the potential Vascepa (icosapent ethyl) label expansion.

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Amgen acquires Filgrastim franchise rights from Roche in 100 markets

Wednesday, October 23, 2013 02:45 PM

Amgen has entered into a definitive agreement with F. Hoffmann-La Roche (Roche) to acquire Roche's rights to filgrastim and pegfilgrastim in approximately 100 markets, effective January 2014.

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Sideris Pharmaceuticals inks agreement with Novartis

Wednesday, October 23, 2013 02:27 PM

Sideris Pharmaceuticals has entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive right to acquire Sideris and its lead asset, the iron-chelating candidate SP-420. Including upfront, acquisition and milestone payments, the agreement with Novartis could reach up to $300 million.

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MedImmune acquires Spirogen, collaborates with ADC Therapeutics

Monday, October 21, 2013 01:39 PM

MedImmune, the global biologics R&D arm of AstraZeneca, has acquired Spirogen, a privately-held biotech company focused on antibody-drug conjugate technology for use in oncology.

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CFFT grants Savara Pharmaceuticals $1.7 million award

Friday, October 18, 2013 01:56 PM

Savara Pharmaceuticals has received a $1.7 million research award from Cystic Fibrosis Foundation Therapeutics(CFFT), the nonprofit drug discovery and development affiliate of the CF Foundation. The award will advance the development of AeroVanc, the first inhaled antibiotic being developed to treat the increasing number of people with cystic fibrosis (CF) who have persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection.

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Moderna Therapeutics expands headquarters, laboratories

Friday, October 18, 2013 11:11 AM

Moderna Therapeutics, a developer messenger RNA therapeutics, a new treatment modality to enable the in vivo production of therapeutic proteins, has expanded their headquarters to Technology Square in Cambridge, Mass. Moderna will have up to 100 full-time employees at two locations by the end of 2013.

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Clinical Site Services changes name to CSSi

Wednesday, October 16, 2013 10:48 AM

Clinical Site Services (CSS), a provider of clinical trial patient enrollment solutions, has changed its name to CSSi. The name change reflects the evolution of the company from its origins in site performance management to its position as a provider of global patient recruitment, with a focus on delivering on-time enrollment of patients in clinical studies for sponsors and CROs.

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Roche to invest $880 million in global biologic medicine manufacturing network

Monday, October 14, 2013 02:16 PM

Roche plans to invest $880 million within its global manufacturing network to increase production capabilities for its biologic medicines over the next five years. The investment will be spread across sites in Penzberg, Germany; Basel, Switzerland; and Vacaville and Oceanside, Calif., U.S. Approximately 500 new jobs will be created in conjunction with the facility expansions.

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Sorrento acquires Sherrington Pharmaceuticals

Friday, October 11, 2013 01:01 PM

Sorrento Therapeutics, a publicly-traded, development-stage biopharmaceutical company, has acquired Sherrington Pharmaceuticals, a privately-held company focused on the development of a chronic pain treatment for end-stage cancer patients and other severe pain indications.

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Teva accelerates cost reduction program, to cut 5,000 jobs

Friday, October 11, 2013 01:00 PM

Global pharmaceutical company Teva Pharmaceutical Industries has accelerated its worldwide restructuring program, introduced in December 2012, which includes actions to divest non-core assets, increase organization effectiveness, improve manufacturing efficiency and reduce excess capacity.

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Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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