Shire

Halozyme names Laurie Stelzer CFO

Monday, June 8, 2015 01:16 PM

Halozyme Therapeutics, an oncology biotech company headquartered in San Diego, has announced its chief financial officer David Ramsay will retire this summer, and named biotech veteran Laurie Stelzer as his successor. Stelzer will assume chief financial officer  duties on June 15 and will work with Ramsay through a transition period.

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Shire, Foundation Fighting Blindness ink research agreement for rare pediatric eye disease

Monday, May 4, 2015 01:01 PM

Shire and the Foundation Fighting Blindness, a national nonprofit organization focused on the entire spectrum of retinal diseases, have formed a new agreement to further research for a novel treatment for autosomal dominant retinitis pigmentosa (adRP), a rare genetic disease that usually first occurs in late childhood or adolescence and is followed by the progressive loss of peripheral vision. There currently are no approved treatment options for adRP.

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WCG encourages its global research network to use ACTA as clinical trial contract solution

Monday, April 20, 2015 06:00 AM

Global IRB WIRB-Copernicus Group (WCG) today said it will encourage the 1,200 members of its global research network to accept and use the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multicenter clinical trials.

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FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Thursday, April 9, 2015 02:20 PM

The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.

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Shire, Cincinnati Children's establish rare disease research collaboration

Thursday, March 26, 2015 02:37 PM

Shire and Cincinnati Children's Hospital Medical Center have announced a three-year, broad research collaboration for rare diseases. The goal of the collaboration is to discover and develop novel therapies to treat rare diseases with high unmet medical need combining Shire's development and commercialization capabilities with Cincinnati Children's research experience.

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Shire acquires Meritage Pharma

Wednesday, February 25, 2015 11:27 AM

Shire has acquired Meritage Pharma, a global, privately held company, for $70 million upfront and additional contingent payments based on development and regulatory milestones.

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Pharming appoints Dr. Perry Calias chief scientific officer

Thursday, February 19, 2015 02:17 PM

Pharming Group has appointed Dr. Perry Calias chief scientific officer. Calias will have overall responsibility for the company's new enzyme replacement therapy (ERT) programs, achieving the scientific milestones set in the business plan, enhancing the IP portfolio, overseeing new product development and contributing to the overall strategic direction of the company.

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PharmaTimes clinical research awards to be presented Feb. 26

Thursday, February 12, 2015 03:33 PM

The 2015’s PharmaTimes Clinical Researcher of the Year—The Americas awards will be presented Feb. 26 in North Carolina.

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Vyvanse is FDA-approved for moderate to severe binge eating disorder

Thursday, February 5, 2015 01:29 PM

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

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Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

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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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