Top News

Court Blocks First FDA-Approved Biosimilar, for the Time Being

May 07, 2015

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Alexion Acquires Synageva for $8.4 Billion

May 06, 2015

Alexion announces it will expand its rare disease pipeline with a definitive agreement to acquire Synageva.

Biosimilar Giants Launch Biosimilars Forum

May 06, 2015

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

The Acquisition Battle Continues with Another Perrigo Rejection

April 30, 2015

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Takeda Faces Cancer Lawsuits with $2.4 Billion in Settlements

April 30, 2015

Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.

Mylan Rejects Teva’s $40 Billion Offer

April 29, 2015

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

Mylan Ups Offer to Perrigo to More than $32 Billion

April 29, 2015

After rejecting Teva’s unsolicited $40 billion purchase offer, Mylan has increased its own offer to purchase Perrigo from $29 billion to over $32 billion in cash in stocks.

FDA Releases Final Biosimilar Guidance

April 28, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

April 23, 2015

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

A Franchise Approach to the Modular Industry

April 23, 2015

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.