Compassionate use and the impact on clinical research

Monday, April 11, 2016

The Pulse on Global Trials by Matthew Howes

Requests for compassionate use of drugs not yet approved by the FDA have been making headlines, and experts predict this trend will continue. Last year, the FDA received 1,262 expanded access requests from drug companies, on behalf of patients, to use unapproved drugs outside of clinical trial programs.

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Shire and Baxalta to combine, with a rare disease focus

Tuesday, January 12, 2016

Shire and Baxalta have reached an agreement to combine. Baxalta shareholders will receive $18 in cash and 0.1482 Shire ADS per Baxalta share. Based on Shire’s closing ADS price on January 8, 2016, this implies a total current value of $45.57 per Baxalta share, representing an aggregate consideration of approximately $32 billion. The exchange ratio is based on Shire’s 30-day trading day volume weighted average ADS price of $199.03 as of Jan. 8, which implies a total value of $47.50 per Baxalta share.

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Shire to acquire Dyax for $5.9B

Monday, November 2, 2015

Dublin-based Shire has announced it will acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of about $5.9 billion. Dyax shareholders may receive additional value through a non-tradable contingent value right (CVR) that will pay $4 in cash per Dyax share upon approval of DX-2930 in HAE, representing a potential additional $646 million in aggregate contingent consideration.

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Shire acquires Foresight Biotherapeutics for $300M

Wednesday, August 5, 2015

Shire has acquired New York-based, privately held Foresight Biotherapeutics for $300 million. With the acquisition, Shire acquires the global rights to FST-100 (topical ophthalmic drops combining 0.6% povidone iodine (PVP-I) and 0.1% dexamethasone), a therapy in late-stage development for the treatment of infectious conjunctivitis, an ocular surface condition commonly referred to as pink eye. This acquisition further strengthens Shire’s late-stage pipeline, has a clear strategic fit with lifitegrast, which is in late-stage development for treatment of dry-eye disease, and further demonstrates Shire’s commitment to building a leadership position in ophthalmics.

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FDA sued by advocacy groups seeking hepatitis C trials data

Monday, July 6, 2015

Seeking to force faster disclosure of clinical trial data that helped Gilead Sciences win approval for two blockbuster hepatitis C drugs, two public health advocacy organizations filed a lawsuit against the FDA last month—the latest legal action where researchers and patient advocates have scuffled with drug makers and regulators over access to such information.

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Halozyme names Laurie Stelzer CFO

Monday, June 8, 2015

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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