Abbvie Inc., of North Chicago, initiated a global phase III trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC). Read More
Prosonix Ltd., of Oxford, UK, said it entered a global licensing deal with Mylan Inc., of Pittsburgh, for its inhaled respiratory products, PSX1001 and PSX1050. Read More
Akebia Therapeutics Inc., of Cambridge, Mass., said it completed enrollment in its ongoing 200-patient phase IIb study of AKB-6548, a hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia associated with chronic kidney disease in patients who are not dependent on dialysis. Read More
Mucosis B.V., of Groningen, the Netherlands, entered a long-term collaboration and license agreement with Changchun, China-based Changchun BCHT Biotechnology Co. and raised €5 million (US$6.9 million) in a new financing round. Read More
About 13 years ago, when Amber Salzman's son and two nephews were diagnosed with adrenoleukodystrophy (ALD), a genetic brain disorder, she didn't know much about rare diseases at all. That's changed for the CEO of Paris-based AAVLife, which – with $12 million in series A money – is taking aim at another: Friedreich's ataxia (FA). Read More
Two decades before the TGN1412 disaster that sent six previously healthy volunteers to the emergency room, another clinical trial went badly wrong: that of the experimental hepatitis drug fialuridine [FIAU] in 1993. Read More
SHANGHAI – 2013 was another banner year for biopharmaceutical licensing deals in China, with inbound agreements continuing to grow and outbound transactions showing up noticeably for the first time. Read More
Although the amounts are shrinking, biotechs are still seeking to squeeze through the initial public offering (IPO) window. After three filings last week in the hunt for a combined raise of $174 million, Angion Biomedica Corp. registered Monday with the SEC seeking up to $35 million, including overallotments. Read More
Hoping for a checkmate, generic drugmakers petitioned the Supreme Court Monday to either clear the board for a late May launch of generic versions of Copaxone or force Teva Pharmaceuticals USA Inc. to post a hefty bond to reimburse them for their losses if its final patent on the multiple sclerosis (MS) drug remains struck down on appeal. Read More
Cell therapy developer Txcell SA grossed just €16.2 million (US$22.4 million) in a scaled-back initial public offering (IPO) on the Euronext exchange in Paris, evidence that Europe's big funding freeze may be thawing but only gradually. The IPO was priced at the bottom of the indicative price range of €5.58 to €6.82 per share its underwriters set at the outset of the book-building process. Read More
Merck & Co. Inc. gained an anticipated FDA approval Monday for Grastek, its immunotherapy tablet for grass pollen-induced allergies, adding direct competition for Greer Laboratories Inc.'s recently approved Oralair in a race to expand the reach of disease-modifying allergy treatments. Read More
