
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Prescription drug usage data on more than one million Marketplace enrollees suggest that costs for specialty drugs are 36% higher for people with Obamacare.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.

Medicago's new production facility will make plant-based vaccines and therapeutics.

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.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

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.