News

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Emergent gives ProMetic long-term access to its Winnipeg facility.

The Critical Path Institute launched a consortium to help develop therapies for newborns.

The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix, two companies focused on asthma.

CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.

SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.

Supply chain consortium establishes a working group to address quality problems in India.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

Pall has agreed to be acquired by Danaher for $127.20 per share.

Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.

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.

A range of packages is available for industry partners to implement charity giving.

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 company voluntarily recalls select lots of Adrucil due to particulate matter.

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

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.