Wacker Biotech AG, of Munich, Germany, will produce the drug substance in Spectrila (asparaginase), a drug from its customer, Hamburg, Germany-based Medac Gesellschaft fur klinische Spezialpräparate mbhH, which was recently approved by the European Commission. The medication will be used for treating acute lymphocytic leukemia. Wacker developed the manufacturing process for the drug substance – recombinant L-asparaginase – from the initial cell line to commercial production. Read More
Biolight Life Sciences Ltd., of Tel Aviv, Israel, has filed form F-1 with the SEC to raise up to $10 million. The company is focused on the discovery, development and commercialization of products and product candidates, which address ophthalmic conditions, including glaucoma, dry eye syndrome and age-related macular degeneration. The firm applied to list ordinary shares on the Nasdaq Capital Market, under the symbol BOLT. Read More
Shire plc, of Dublin, reported that for the full year of 2015 its product sales, excluding Intuniv, were up 10 percent, with growth driven by Vyvanse (lisdexamfetamine dimesylate) for the treatment of attention deficit hyperactivity disorder in adults (up 19 percent to $1.722 billion), Cinryze (up 23 percent to $618 million), and Lialda/Mezavant (up 8 percent to $684 million). Total product sales generated $6.1 billion (2014: $5.83 billion); total revenues were up 7 percent to $6.4 billion (2014: $6,022 million). Read More
HYDERABAD, India – Despite reservations private equity players might have about a sector with longer gestation periods and stringent regulations, India's biopharmaceutical industry appears to be in an upbeat mood with new investments on the way and at least one state government announcing a land bonanza to set up biotech parks Read More
Despite pricing well below range, an upsized IPO by cystic fibrosis drug developer Proteostasis Therapeutics Inc. (NASDAQ:PTI) fell 17 percent during its first day of trading Thursday, joining a small but intrepid class of four biotech IPOs this year, all of which have seen shares fall from their initial price. (See chart, below.) Read More
HONG KONG – A protein identified in the dengue virus by Dutch researchers could represent a promising new target for the development of an antiviral drug against dengue fever, a vaccine and effective treatment for which both remain elusive, report researchers from Radboud University Medical Center in Nijmegen, the Netherlands. Read More
Avexis Inc. made it out the door with an upsized IPO, pricing 4.75 million common shares at $20 apiece – the midpoint of its intended range – to raise $95 million. But the company's shares (NASDAQ:AVXS) encountered headwinds as soon as they stepped off the stoop, falling as much as 20 percent early and closing at $18.05 for a loss of $1.95, or 9.8 percent, on another down day in the broader markets that included a 2.4 percent fall-off in the Nasdaq Biotechnology Index, which closed at 2,572.84. Read More
The president's budget – with its sweeping call to tackle cancer, the growing opioid abuse epidemic, drug prices, the Zika virus and other ailments plaguing the U.S. health care system – will not be an easy sell, especially in an election year. Read More
Biofrontera AG, of Leverkusen, Germany, reported data from three pivotal phase III trials in which lead candidate, BF-200 ALA, demonstrated patient clearance rates of 85 percent to 91 percent in the topical treatment of actinic keratosis, a superficial skin cancer caused by sun damage. Read More
