FDA

Alexion to acquire Synageva

Wednesday, May 6, 2015 02:56 PM

Cheshire, Conn.-based Alexion Pharmaceuticals will acquire Synageva, a biopharmaceutical company based in Lexington, Mass., for $115 in cash and 0.6581 Alexion shares for each share of Synageva, implying a total per share value of $230 based on the nine-day volume-weighted average closing price of Alexion stock through May 5.

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Quest Diagnostics

OPKO Health acquires EirGen Pharma

Wednesday, May 6, 2015 02:46 PM

OPKO Health, a multinational biopharmaceutical and diagnostics company, has acquired EirGen Pharma, a specialty pharmaceutical company focused on the development and commercial supply of high-potency, high-barrier-to-entry pharmaceutical products for sale in the U.S., Canada, Japan, Australia, most European countries and more than 40 others around the world.

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Teva completes acquisition of Auspex Pharmaceuticals

Wednesday, May 6, 2015 02:39 PM

Teva Pharmaceutical Industries has completed the acquisition of Auspex Pharmaceuticals through the successful tender offer for all of the outstanding shares of common stock of Auspex at $101 per share in cash, representing total consideration of approximately $3.2 billion in enterprise value and approximately $3.5 billion in equity value. The acquisition is expected to enhance Teva’s revenue and earnings growth profile and strengthen its core central nervous system franchise. Auspex now is a wholly owned subsidiary of Teva.

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FPWR, NORD launch Global Prader-Willi Syndrome Registry

Monday, May 4, 2015 01:23 PM

The Foundation for Prader-Willi Research (FPWR), a nonprofit charitable organization, and National Organization for Rare Disorders (NORD), a nonprofit organization representing all patients and families affected by rare diseases in the U.S., have launched the Global Prader-Willi Syndrome Registry, a new database to accelerate research and cures for the rare disease Prader-Willi Syndrome (PWS).

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FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs

Monday, May 4, 2015 08:00 AM

The FDA, which has successfully reduced the review times for new medications, wants to help biopharmaceutical companies lower the rising costs of clinical trials by streamlining some of its processes and working more closely with industry.

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FDA approves first generic Abilify to treat mental illnesses

Thursday, April 30, 2015 11:07 AM

Alembic Pharmaceuticals, Hetero LabsTeva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic Abilify (aripiprazole) in multiple strengths and dosage forms. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. 

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CRI and Cancer Immunology

Monday, April 27, 2015 08:00 AM

Since being named “Breakthrough of the Year” by Science magazine less than two years ago, cancer immunology has been taken from the fringe to the forefront. 

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Mitotech releases positive phase II data of SkQ1 for dry eye

Friday, April 24, 2015 02:11 PM

Mitotech, a Luxembourg-based clinical-stage biotechnology company developing novel antioxidant molecules targeting mitochondria, has achieved significant positive results in its U.S. phase II clinical trial of SkQ1 compound in patients with moderate to severe dry eye syndrome. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria, which proved to be effective in a topical ophthalmic formulation for treatment of dry eye syndrome.

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Biohaven to begin phase I study in 3Q2015, readying for phase III study start by 1Q2016

Friday, April 24, 2015 01:58 PM

Biohaven Pharmaceutical Holding is on schedule to initiate a phase I pharmacokinetic and biomarker study with its lead drug development candidate BHV-0223. Biohaven plans to initiate the trial no later than 3Q2015. After confirming projected drug exposure levels in the phase I study, Biohaven will move directly into a phase III registrational trial in affective disorders.

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Juniper Pharmaceuticals formation scientific advisory board

Friday, April 24, 2015 01:52 PM

Juniper Pharmaceuticals, a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health, has created a scientific advisory board (SAB) comprised of international physicians and scientists whose mission will be to provide scientific and clinical advice on the identification and advancement of product candidates for Juniper's women's health portfolio.

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CWWeekly

May 4

Walgreens leverages its 100 million customer database in patient recruitment deal with five big pharma companies

Synchrogenix partners with CISCRP on transparency, developing lay language trial summaries for participants

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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