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
By Randy Osborne | BioWorld Today | Wednesday, June 19, 2013
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
By Nuala Moran | BioWorld Today | Wednesday, June 19, 2013
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
By Mari Serebrov | BioWorld Today | Wednesday, June 19, 2013
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
By Anette Breindl | BioWorld Today | Wednesday, June 19, 2013
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
LONDON – Scientists have teased out a molecular mechanism that allows synapses to respond as quickly or as slowly as required for all neurological functions ranging from simple movements to cognitive function. The finding provides a key to how neurons can provide a constant stockpile of neurotransmitter-filled synaptic vesicles, ready to be released at the synapse when needed. Nils Brose, director of the department of molecular neurobiology at the Max Planck Institute for Experimental Medicine
By Sharon Kingman | BioWorld International | Wednesday, June 19, 2013
SHANGHAI, China – A licensing agreement may help troubled Israeli firm Biolinerx Ltd. get a toehold in China with its hepatitis C virus (HCV) treatment BL-8030. In a deal worth as much as $30 million in initial and milestone payments, Biolinerx, of Jerusalem, entered an agreement for the development, manufacture and commercialization of BL-8030 with liver therapy specialist Jiangsu Chia-tai Tianqing Pharmaceutical Co. Ltd. (CTTQ), of Jiangsu, China. CTTQ is a subsidiary of Hong Kong-based Sino
By Shannon Ellis | BioWorld International | Wednesday, June 19, 2013
Valneva SE priced its previously flagged and fully underwritten €40 million (US$53.3 million) rights issue at €2.65 per share, a steep discount on the company's prevailing share price of €4.61 immediately prior to the final pricing decision. The move will give the Lyon, France-based company enough fuel to achieve its main strategic objective, to become financially self-sustaining by 2015. The strategy also depends on the company rolling over an existing €20 million debt facility to an
By Cormac Sheridan | BioWorld International | Wednesday, June 19, 2013
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
By Nuala Moran | BioWorld International | Wednesday, June 19, 2013
By Anette Breindl Science Editor Predicting protein folding has made strides in recent years, mainly through unconventional approaches. Computer games like foldit have been able to apply crowdsourcing to proteins, and solve structures that had evaded traditional computing power. (See BioWorld Today, Aug. 13, 2010.) But George Rose, who is at Johns Hopkins University, said he thinks that the problem can, and perhaps should, be solved in a more fundamental way. Current methods for predicting a
By Marie Powers Staff Writer Although the official start of summer is still a few days away, the biotech world already is producing a bumper crop of initial public offerings (IPO). As a trio of companies – Bluebird Bio Inc., PTC Therapeutics Inc. and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013
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
By Jennifer Boggs | BioWorld Today | Tuesday, June 18, 2013
Tacking toward the middle, the Supreme Court gave the FTC some berth Monday in challenging pay-for-delay settlements between generic and brand drugmakers, but it closed the hatch on a "quick look" approach that would presume all such agreements are unlawful. While the ruling doesn't toss the settlements overboard, it clears the way for more antitrust challenges, both by the FTC and third parties. It also could churn up some rough seas for existing settlements that may now face potential class
By Mari Serebrov | BioWorld Today | Tuesday, June 18, 2013
Abbvie Inc., of Chicago, reported preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL). The open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the
Eisai Inc., of Woodcliff Lake, N.J., expanded its Hatfield, UK-based EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre with a additional global packaging capability. The new facility will primarily handle the blister packaging of Eisai's investigational treatment lenvatinib which is used to treat thyroid cancer as well as other types of solid tumors. The Hatfield site is the company's EMEA headquarters and is growing in significance to Eisai's worldwide business as it
Although the official start of summer is still a few days away, the biotech world already is producing a bumper crop of initial public offerings (IPO). As a trio of companies – Bluebird Bio Inc., PTC Therapeutics Inc. and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013.) Onconova filed its S-1 Friday
By Marie Powers | BioWorld Today | Tuesday, June 18, 2013
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