Actavis Inc., of Parsippany, N.J., and Kissei Pharmaceutical Co. Ltd., of Tokyo, said they filed lawsuits against Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG, along with Hetero USA Inc., Hetero Labs Ltd. and Hetero Labs Ltd. Unit III, all part of Hyderabad, India-based Hetero Group, claiming infringement of U.S. Patent No. 5,387,603, covering Rapaflo (silodosin), a treatment for the signs and symptoms of benign prostatic hyperplasia. The lawsuit was filed in response to

Chemocentryx Inc., of Mountain View, Calif., completed target enrollment of 270 patients in a Phase II safety, tolerability and initial efficacy study of lead internal candidate CCX140, a CCR2 antagonist, in diabetic nephropathy. The company expects enrollment in the randomized, double-blind, placebo-controlled trial to exceed 300 when enrollment closes on or before June 30, enabling Chemocentryx to report 12-week data in approximately 200 patients in the third quarter. Full 52-week data

Amarantus Bioscience Holdings Inc., of Sunnyvale, Calif., said positive neuroprotective properties for its MANF therapeutic were reported in a preclinical study conducted at Qilu Hospital of Shandong University in Jinan, China. The findings suggested that MANF shows the potential to alleviate cell damage and inflammation in rat primary astrocytes by suppressing endoplasmic reticulum stress, indicating that MANF plays a role in astrocyte inflammation and functioning and may suggest a promising

Bluebird Bio Inc.'s above-the-range initial public offering (IPO) sold about 5.9 million shares at $17 each to raise $101 million for a gene therapy strategy that deploys stem cells harvested from the patient's bone marrow, and the lead program is slated to kick off a Phase II/III trial late this year in childhood cerebral adrenoleukodystrophy (CCALD), caused by the buildup of fatty acids that damages the myelin sheath. The Cambridge, Mass.-based firm's stock (NASDAQ:BLUE) closed Wednesday at

By combining Namenda (memantine, Forest Laboratories Inc.) with nitroglycerin, researchers have developed a compound that appears capable of repairing damaged synapses in animal models of Alzheimer's disease. Such reversal of synaptic fortune might mean that the new compound, named Nitromemantine by its makers, could be developed into the first disease-modifying treatment for Alzheimer's. The drug "finally is the one that seems to protect the synapses, which is the holy grail," memantine

The potential value of cell therapy in wound care applications grabbed the attention of the biotech world last fall when Smith & Nephew plc, of London, picked up Fort Worth, Texas-based Healthpoint Biotherapeutics for $782 million in cash on the strength of its cell therapy product, HP802-247, in wound care. (See BioWorld Today, Nov. 29, 2012.) Macrocure, of Petach Tikva, Israel, hopes to generate similar success. The company's lead product, Curexcell, uses white blood cells obtained from the

The longer timelines the FDA is proposing for biosimilar meetings and reviews add insult to the injury of expecting sponsors of the follow-on biologics (FOBs) to pay user fees up front, according to several generic drugmakers. Since biosimilars are on an abbreviated path, they should require fewer agency resources and less review time than a new reference drug, Mylan Inc. said in comments on the FDA's latest draft guidance about staff meetings with FOB sponsors. Given that fact, the drugmaker

Eli Lilly and Co.'s decision to stop its Phase II study with LY2886721, a beta secretase (BACE) inhibitor as a potential once-daily treatment for slowing Alzheimer's disease (AD), was "sad news, obviously," said Decision Resources analyst Georgiana Kuhlmann. "But I think, without more information, no one is ready to call this the end of the BACE inhibitor class," which "roared to life around last summer," with a handful of companies jumping aboard the bandwagon, Kuhlmann said. She noted that

SAN DIEGO – At a session at the recent Calbio meeting, biotech executives from multiple companies explained how they got their start-ups off the ground. Be it capital-efficient virtual biotechs, strategic partnerships, venture capital funding or initial public offerings (IPOs), the message was clear: There's more than one way to build a biotech. "It really depends on the profile and the capital requirements," stressed Faheem Hasnain, president and CEO of Receptos Inc. "For a company like ours

The FDA is investigating two unexplained deaths in patients who received an intramuscular injection of Indianapolis-based Eli Lilly and Co.'s antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The agency said the patients died a few days after receiving an appropriate dose, well after the three-hour post-injection monitoring period required under the risk evaluation and mitigation strategy. Very high olanzapine blood levels were found in both patients. The label for the long-acting drug

LONDON – "I really hope to create a building where as you walk round the corridors, at the coffee machine and in the cafeteria, that you hear people talking science, that science becomes the language of the place." That is the vision Menelas Pangalos, executive vice president of innovative medicines at Astrazeneca plc, outlined as he discussed the announcement that the company's new £330 million (US$514 million) global R&D center and corporate headquarters is to be built on the Cambridge

Acadia Pharmaceuticals Inc., of San Diego, presented data at the International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, from its Phase III program testing pimavanserin in Parkinson's disease psychosis (PDP), including data from the pivotal -020 study and related -015 open-label safety extension trial. Interim data from the -015 study suggested that long-term administration of 40 mg of pimavanserin, an inverse agonist of serotonin 5-HT2A, is generally safe and

Biologics are innovative drugs, biosimilars are copies, and never the twain shall meet. That's the underlying message brand drugmakers sent to the FDA as they urged it to maintain the distinctions between the 351(a) and 351(k) approval paths. Opening the 351(a) path – used for new biologics – to follow-on drugs that either implicitly or explicitly rely on data from approved biologics would undermine the legitimacy of the biosimilar route and disrupt the balance Congress established between

Advinus Therapeutics Ltd., of Bangalore, India, entered a partnership with Moffitt Cancer Center in Tampa, Fla. Two promising targeted cancer therapies (a Rb:Raf-1 disruptor and a Rho-associated protein kinase [ROCK] inhibitor) developed by Moffitt scientists are selected as the first set. The Rb:Raf-1 disruptor holds clinical potential because disruption of the Rb:Raf-1 interaction leads to inhibition of cellular signaling pathways involved in cell growth, blood vessel creation and the spread

Polyglutamine stretches in proteins lead to trouble so frequently that there is a whole disease category named after them. The polyglutamine, or polyQ, disorders, of which Huntington's disease is the most famous member, but far from the only one, as "polyglutamine domains have been associated with a lot of pathological conditions," Dartmouth University's Amy Gladfelter told BioWorld Today. The reason such polyglutamine stretches are problematic is that they cause proteins to aggregate. And such

Antibe Therapeutics Inc., of Toronto, closed its initial public offering (IPO) of 3.9 million common shares at 55 cents apiece, generating proceeds of $2.1 million and listing on the TSX Venture Exchange as "ATE." In addition, Antibe completed a private placement to two investors, issuing 282,000 common shares at the IPO's offering price for proceeds of $155,100. The shares issued as part of the private placement are subject to a hold period that expires on Oct. 19. Burgeonvest Bick Securities

News of at least a three quarter delay in seeking regulatory approval for Fabry disease candidate migalastat unsurprisingly sent shares of Amicus Therapeutics Inc. falling 24 percent in Monday morning trading, but reports of the firm's recent meeting with the FDA left room for optimism for the Glaxosmithkline plc-partnered molecular chaperone. The agency was "extremely engaging," Amicus CEO John Crowley told BioWorld Today. "All in, I think it was a very encouraging meeting with the FDA