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AbbVie Coughs Up $595 Million+ for BI’s Psoriasis, Crohn’s Drugs

North Chicago, Ill.-based AbbVie (ABBV) and Germany-based Boehringer Ingelheim today announced that they have inked a global collaboration deal to develop and market BI 655066 for psoriasis. AbbVie is paying Boehringer Ingelheim $595 million upfront with additional development and regulatory milestones and royalties if the product makes it to market. BI 655066 is an anti-IL-23 […]

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FDA Green Lights CSL Behring’s Idelvion for Hemophilia B

U.S. FDA Approves CSL Behring’s IDELVION® — The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals KING OF PRUSSIA, Pa. — 04 March 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, […]

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Europe launches new fast approval scheme for promising drugs

European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials.   The European Medicines Agency’s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on […]

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Bristol-Myers Squibb Inks Deal to Annually Launch Two Life Science Startups in Kendall Square

March 7, 2016By Alex Keown, BioSpace.com Breaking News Staff   CAMBRIDGE, Mass. – Bristol-Myers Squibb (BMY) signed a deal with LabCentral to support the launch of two new life sciences and biotech companies in Kendall Square, the hub of the Boston-area pharmaceutical industry, through a “golden ticket” method, the company announced this morning. Under the […]

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Pharma crusader takes India’s drug regulators to court

One of India’s best-known whistleblowers, who exposed dangerous practices in the generic drug industry in 2013, is taking the country’s drugs regulators to court, accusing them of failing to enforce rules on drug safety in the $15 billion industry. Three years ago, Dinesh Thakur exposed how India’s then largest drugmaker and his former employer, Ranbaxy […]

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GSK asthma drug Nucala’s long-term study supports safety profile

GlaxoSmithKline Plc said on Saturday its asthma drug, Nucala, which is already approved in the United States and Europe, showed a similar safety profile in a long-term study compared with previous studies. GSK said Nucala, which is administered once every four weeks by injection, maintained its risk/benefit profile over an extended 52-week period. The drug […]

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Why Core Lab Research Is Superior in Drug Approval Trials

People with chronic health conditions and diseases rely on physicians and their local medical teams to perform clinical assessments and provide the medicine they need.

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UCLA sells royalty rights connected with cancer drug to Royalty Pharma for $1.14 billion

LOS ANGELES and NEW YORK, March 4, 2016 /PRNewswire/ — UCLA and Royalty Pharma announced today that UCLA has sold its royalty interest connected with a leading prostate cancer medication, Xtandi, whose development was based on discoveries by campus researchers. Royalty Pharma has acquired rights to a portion of the future Xtandi royalties co-owned by UCLA, […]

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WHO convenes experts amid ‘accumulating evidence’ of Zika link to disorders

There is “accumulating evidence” of a link between the Zika virus and two neurological disorders, microcephaly and Guillain-Barre syndrome, the World Health Organization said on Friday. The WHO’s Emergency Committee will meet next week to review “evolving information” and its recommendations on travel and trade in what is thought to be high season for transmission […]

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Baxalta Kills Cancer Drug Development Deal With Onconova

Newtown, Pa.-based Onconova Therapeutics, Inc. (ONTX) announced yesterday that it had been informed by Bannockburn, Ill.-based Baxalta (BXLT)that Baxalta was terminating its development and licensing agreement for rigosertib. In 2012, the two companies inked a deal to develop rigosertib for the treatment of higher-risk myelodysplastic syndromes (HR-MDS). All rights to commercialize the drug will revert […]

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