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April 18, 2014

Vol. 11 No. 77

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BI’s Volasertib Is an Orphan Drug in the U.S. and EU

U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More

ABPI Lauds MHRA’s 2014-2015 Business Plan

MHRA is planning improvements to its assessment and approval times for drugs and clinical trials. Read More

In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

New legislation introduced in the U.S. House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill patients. Read More

CPI Break Ground on Major Drugs Center

The Centre for Process Innovation officially broke ground on its state-of-the-art national biologics center April 16. Read More

Scripps Advance Drug-Discovery Initiative Starts With J&J

U.S.-based non-profit The Scripps Research Institute has engaged the Johnson & Johnson Innovation Center in California as its first collaborator for Advance, a new drug-discovery initiative aimed at translating early-stage biomedical research projects into clinical-development candidates. Read More

Galapagos, GSK Successfully Conclude Phase IIa Study of Skin Disease Drug

Belgian biotech group Galapagos NV said it has successfully concluded the Phase IIa study of a skin disease drug it is developing with Britain’s GlaxoSmithKline. Read More

Boehringer Ingelheim Plans 10 Drug Launches by 2016

Boehringer Ingelheim laid out an ambitious agenda for itself over the next two years, planning more than 10 new launches of drugs in eight disease indications by 2016 for diabetes, COPD, asthma, lung cancer, idiopathic pulmonary fibrosis, a rare form of leukemia, and the treatment and prevention of deep venous thrombosis and pulmonary embolism. Read More

Pill Developed to Fight Measles Passes Key Test in Animals

Scientists have developed an experimental pill that helped protect ferrets from a measles-like virus, raising hope for a treatment to thwart the deadly infection in unvaccinated people who have been exposed to the virus, according to an international study released on April 16. Read More