Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of pseudobulbar affect, irrespective of neurologic cause. The CHMP also recommended approval of two dose strengths of Nuedexta: 20/10 mg and 30/10 mg capsules. Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a
CHICAGO – For Avaxia Biologics Inc., the decision to attend BIO 2013 was a no-brainer. The Lexington, Mass.-based company is in the middle of a Phase Ib study of lead compound AVX-470, an orally administered anti-TNF polyclonal antibody, in ulcerative colitis (UC). Results are expected in November, and if all goes well the company plans to report data in January 2014 at the J.P. Morgan Healthcare Conference in San Francisco. Based on preclinical safety and efficacy findings, founder and CEO
By Marie Powers | BioWorld Today | Monday, April 29, 2013
Listeria monocytogenes' main medical claim to fame is that it causes food poisoning. But by combining a weakened strain of the bacterium with a radioactive payload, scientists have used Listeria to kill metastases from pancreatic cancer. The bacteria were less effective at taking out the primary tumors. But, corresponding author Claudia Gravekamp told BioWorld Today, "we are quite successful" at dealing with the primary tumors – "primary tumors can be removed by surgery or radiation." The
By Anette Breindl | BioWorld Today | Monday, April 29, 2013
Intolerant Hosts Can Damage Themselves One of the major reasons that influenza is dangerous is that it softens the body up for pneumonia, which can deliver a fatal blow to weakened individuals and is, in fact, responsible for the majority of the deaths that start with a flu infection. But why the flu should predispose to pneumonia to the extent that it does has remained unclear. Infected individuals cope in two different ways: by controlling infections via resistance, and via adapting to the
TAIPEI, Taiwan – When Taiwan and China signed the Economic Cooperation Framework Agreement (ECFA) in June 2010, the two politically opposed sides pledged to remove some of the barriers that have kept them separated since the end of the Chinese civil war of 1949; economically, if not politically. That agreement has implications that go beyond regional economics. Because of the ECFA, Taiwan may be slowly positioning itself to become an important gateway into the immense market of China for
By Dave Silver | BioWorld Today | Monday, April 29, 2013
WASHINGTON – While the intrinsic value of using companion diagnostics to target the right drugs to the right patients is recognized by all components of the health care system, including drugmakers, diagnostic developers, clinician and patient interest groups and payers, more cohesion is needed among all those parties – and at earlier stages in development – for personalized medicine to reach its potential value. A conference last week organized by the Personalized Medicine Coalition (PMC) and
By Jonathan Goldstein | BioWorld Today | Monday, April 29, 2013
Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis. The CHMP said it is of the opinion that the drug does not demonstrate a favorable risk-benefit profile and recommended against marketing authorization. Pfizer intends to appeal the opinion and seek a re-examination by CHMP. Xeljanz, a JAK inhibitor, gained
"I think every client I've ever had has tried to think of ways to extend the monopoly they've enjoyed." – Edmund Pitcher, patent attorney "There is no reason, I think, [for biotechs] to feel threatened as assets tend to spend the 'internship' years with biotechs. Great things graduate from academic institutions, but new graduates are seldom ready for real life." – Jeff Stewart, director of Raleigh, N.C.-based biopharma consultant Campbell Alliance, discussing the trend toward partnering
CHICAGO – It was certainly an interesting week for Canada's biotechnology industry, with two big pharmas using the BIO 2013 International Convention to make announcements about their investments in the nation's research and development. Merck Canada Inc., of Kirkland, Quebec, revealed that it will be providing C$4 million (US$3.9 million) through two collaborative partnerships. Thomas Cannell, president and managing director of Merck Canada, said the first is an investment in a public-private
By Peter Winter | BioWorld Insight | Monday, April 29, 2013
Financing Anterios Inc. closed an $8.5 million corporate financing. Esperion Therapeutics Inc. pulled down $33 million in a preferred stock financing. Genticel SA raised $23.6 million in a Series C round led by Wellington Partners. GW Pharmaceuticals plc set the terms for its proposed U.S. IPO aiming to raise about $40 million. iBio Inc. priced a public offering of 8.925 million units at 48 cents each, raising $4.28 million. Insys Therapeutics Inc. plans to raise $68 million in an IPO of 4
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date FEBRUARY Exelixis Inc. (South San Francisco) Swedish Orphan Biovitrum AB (Stockholm, Sweden) ND Partnership to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European Union and potentially other countries The agreement will last for three years, with Exelixis maintaining full commercial rights outside the covered territory and for all other indications 2/25
Company Company Deal Value Biogen Idec Inc. Elan Corp. plc $3.25B MacroGenics Inc. Gilead Sciences Inc. $1B bluebird bio Celgene Corp. $225M The Medicines Co. Alnylam Pharmaceuticals Inc. $205M Afraxis Inc. Genentech Inc. $187.5M BIND Biosciences Inc. Amgen Inc. $180.5M Concert Pharmaceuticals Inc. Jazz Pharmaceuticals plc $120M Genentech Inc. RQx Pharmaceuticals Inc. $111M
To spur innovation in biopharma and other industries, Congress must make it a national priority, according to the Congressional Budget Office (CBO). In a review of the nation's commitment to innovation over the past three decades, CBO Director Douglas Elmendorf noted the decrease in federal spending on R&D, relative to GDP, and the decline of innovation as a priority in regulatory policy. The FDA is building its arsenal against counterfeit antimalarial drugs through a public-private partnership
Total Value in 2013: $5,960.77M* Number of Deals in 2013: 93 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date FEBRUARY Ablynx NV (Ghent, Belgium) Spirogen Ltd. (London) ND Research collaboration to evaluate the potential of a cancer drug conjugate combining Spirogen's cytotoxic drugs, pyrrolobenzodiazepines and associated linker technology, with Nanobodies generated Ablynx will provide access to Nanobodies against an undisclosed target, and Spirogen will
In the current fiscal environment, everything in the U.S. budget is open to scrutiny. Fortunately for the biodefense industry, protecting the nation from bioterrorism tends to have bipartisan support, especially when potential threats get extensive news coverage. This month alone, there have been ricin-laced letters sent to President Barack Obama, Sen. Roger Wicker and Mississippi judge Sadie Holland, and claims that the chemical weapon sarin was used during the Syrian civil war. Funding for
By Brian Orelli | BioWorld Insight | Monday, April 29, 2013
Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., said the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of pseudobulbar affect, irrespective of neurologic cause. The CHMP also recommended approval of two dose strengths of Nuedexta: 20/10 mg and 30/10 mg capsules. Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a