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Home » Newsletters » BioWorld

BioWorld

April 15, 2014

View Archived Issues

Cytos Biotechnology hits the skids as CYT003 misses phase IIb endpoint

Cytos Biotechnology AG passed the point of no return Monday, following the failure in a phase IIb trial of its CYT003 therapeutic vaccine for allergic asthma. The Swiss immunotherapy pioneer is considering either a liquidation of the company or bankruptcy. Read More

Lexicon's phase II data: tipping point in partner talks on diabetes drug?

Lexicon Pharmaceuticals Inc.'s phase II data with oral LX4211 in type 1 diabetes could be just enough to "transport" the company into the sweet deal that investors have been waiting for. Read More

Medcity formed to help London become a leading biotech cluster

LONDON – London is looking to capitalize on its large concentration of universities, medical research institutions and teaching hospitals, to shape itself as a leading biotech cluster. Read More

Federal Circuit ruling weakens drugmakers' life cycle strategy

In striking down Roche AG's method of osteoporosis treatment claims for once-monthly Boniva, the Federal Circuit may have raised the bar for using a life cycle approach to protect blockbuster drugs from generic and biosimilar competition. Read More

Neostem adds 'neo' pipeline with CSC acquisition

Neostem Inc. set its sights on the hot cancer immunotherapy market with an agreement to acquire California Stem Cell Inc. (CSC) through a stock transaction. The New York-based cell therapy company, whose most advanced program, AMR-001, is a chemotactic hematopoetic stem cell product to treat damaged heart muscle following heart attack, moves melapuldencel-T, an autologous stem cell immune-based therapy, to the head of the class and takes on the challenge of a phase III trial with the CSC buy. Read More

Portola shares gain as company details betrixaban trial design

Portola Pharmaceuticals Inc.'s shares (NASDAQ:PTLA) rose 6.4 percent Monday as the company advanced its global pivotal trial of betrixaban, testing how well the drug prevents blood clots when patients are hospitalized for critical cardiovascular conditions and following their release. Read More

Japan eyes biotech, innovation in efforts to bolster jobs, economy

TOKYO – Japan's Prime Minister Shinzo Abe is counting on a program of "three arrows" to continue revitalizing his country's economy. The first two arrows in his quiver are massive monetary easing and targeted fiscal support. The third, and possibly the most important arrow in the long term, is a series of structural reforms. High up on the list of the reforms is a somewhat radical shift in the way Japan approaches medical and biotechnology research. Read More

Financings roundup

Elite Pharmaceuticals Inc., of Northvale, N.J., said it entered a common stock purchase agreement with Lincoln Park Capital Fund LLC for up to $40 million. Read More

Stock movers

Read More

Other news to note

Biomarin Pharmaceutical Inc., of San Rafael, Calif., said the FDA granted Kuvan (sapropterin dihydrochloride) powder for oral solution and tablets a six-month pediatric exclusivity extension. The action extends the product's market exclusivity to June 2015 and is based on studies submitted in response to a written request by the FDA to investigate the use of Kuvan in pediatric patients from birth to age 6. Read More

Clinic roundup

Intercept Pharmaceuticals Inc., of New York, presented results from the phase III POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) at the International Liver Congress of the European Association of the Study of the Liver meeting in London. Read More

Pharma: Other news to note

Ipsen SA, of Paris, reported initial results on phase III study of Dysport in the treatment of adults suffering from upper limb spasticity at the 8th World Congress for Neurorehabilitation in Istanbul. Four weeks after Dysport injection, results demonstrated a statistically significantly higher proportion of responders in muscle tone improvement vs. placebo. Read More

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