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The top business, scientific and regulatory news from the pharmaceutical and biotechnology industries.

First Biosimilar Application Kicks Off Legal Battle

October 31, 2014

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

EMA: Extrapolation Across Indications for Biosimilars a Possibility

October 30, 2014

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Sanofi Board Votes to Remove CEO Christopher A. Viehbacher

October 29, 2014

The board of directors at Sanofi unanimously agree to remove Sanofi's CEO.

Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment

October 29, 2014

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

Yale and Gilead Extend Sequencing Initiative

October 28, 2014

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

FUJIFILM Announces Agreement to Acquire Kalon Biotherapeutics

October 27, 2014

FUJIFILM announced an agreement to acquire Kalon Biotherapeutics, a biopharmaceutical contract manufacturing organization specializing in vaccine manufacturing.

Despite AbbVie Snub, Shire Says it Will Double Sales by 2020

October 24, 2014

Shire announces it will expand its orphan drug portfolio and is ready for future M&A discussions.

J&J Speeds Ebola Vaccine Development and Expands Production

October 24, 2014

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.

Unum Raises $12 million in Funding for ACTR-Based Cancer Treatment

October 24, 2014

Unum Therapeutics raised $12 million in Series A funding for its development of antibody-coupled T cell receptors (ACTRs) for the treatment of nonspecific tumor cells.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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