Tag:
hepatitis B
Latest Headlines
Latest Headlines
Dynavax gains $50M in new research funding
The private equity group Symphony Capital Partners has agreed to invest $50 million into a new research unit with Dynavax Technologies. Emblematic of some of the more creative financing deals to hit biotech recently, Dynavax will grant intellectual property to the entity--Symphony Dynamo--while holding an option to buy some or all of the cancer and hepatitis research it undertakes. "It will enable us to continue to focus critical resources on advancing our lead programs in ragweed allergy …
Valeant to out-license programs in restructuring
Valeant Pharmaceuticals is restructuring, with plans to focus on its late-stage drug prospects and pare back expenses while boosting earnings. The restructuring includes plans to out-license pradefovir for hepatitis B and VRX-840773, its HIV compound. Valeant will concentrate development efforts on Viramidine (taribavirin), retigabine and Infergen. The drug developer will also look to cut costs in sales and reorganize its commercial regions to three from four. "The steps we are …
Novartis inks $525M hep C deal
Novartis has inked a deal to pay Idenix up to $525 million for the rights to an experimental therapy for hepatitis C. The news comes fast on the heels of an announcement from Idenix--which is 56 percent owned by Novartis--that clinical trials of valopicitabine (NM283) had run into trouble. Some analysts see the licensing deal as a way for Novartis to display its confidence in the program at a critical point. Novartis will pay $25 million up front, with $45 million tied to Phase III. …
Anadys reports big response in hep B trial
San Diego-based Anadys announced that a small, mid-stage trial of its experimental hepatitis B therapy cut viral loads by more than 99 percent. The Phase II trial included 59 patients who took a dose of ANA380 over a 12-week period. Those taking the three highest doses achieved a reduction of more than 99.9 percent in their viral load. All patients had been previously treated with lamivudine, a standard hep B therapy. Anadys is developing the drug with South Korea's L.G. Life Sciences. A …
Novartis seeks EU approval for hep B drug
Novartis and its drug development partner Idenix have filed for EU marketing approval for telbivudine as a therapy for hepatitis B. U.S. approval is already being sought and a new submission for Asian markets is expected in the coming weeks. "This MAA submission with the EMEA is another significant step in the development of telbivudine, a drug with the potential to improve the management of chronic hepatitis B, a disease with potentially fatal consequences that affects millions of people …
ALSO NOTED: Human Genome Sciences to spin off CoGenesys; Nuvelo receives SPA from FDA; Voyager withdraws IPO; and much more...
> Human Genome Sciences will spin off CoGenesys, its early-stage drug development division. The independent company will focus on the early development of selected gene-based product opportunities. Report > Nuvelo has received a Special Protocol Assessment (SPA) agreement from the FDA for its second Phase III trial of NAPA-3 for acute peripheral arterial occlusion (PAO), or "leg …
Crucell inks $449M deal to create largest independent vaccine maker
Amsterdam-based Crucell said it has inked a deal to buy Switzerland's Berna Biotech and create one of the world's biggest drug development operations focused on vaccines. The merger is aimed at making the combined operation more competitive with the likes of GlaxoSmithKline, Sanofi-Aventis and Merck. The acquisition will add Berna's vaccines for hepatitis B, respiratory and travel ailments.- read this article from the Financial Times for more information
Idenix, Novartis hepatitis drug meets trial goal
Idenix Pharmaceuticals and Swiss drug maker Novartis said telbivudine, their experimental drug for hepatitis B, met its primary goal in a Phase III trial. The 1,350-patient study showed telbivudine was at least as effective as lamivudine, the standard Hepatitis B treatment, after one year of use. The companies said they plan to ask US regulators for approval by the end of 2005.- read this press release for more
ALSO NOTED: Able Labs files Ch. 11; Vertex wins fast track; Tamiflu works against avian flu; and much more...
> Troubled Able Laboratories has filed for Chapter 11 bankruptcy. Story > The FDA has granted fast-track status to Vertex's experimental HIV drug. Story > US government researchers say they've shown in mice tests that Tamiflu suppresses the avian flu strain now …
Anadys lands big licensing deal for hep C drug
San Diego-based Anadys has signed a licensing deal for its experimental hepatitis C drug with Novartis, earning $20 million up front and as much as $550 million more in milestone payments. A $10 million payment will be triggered if Anadys' upcoming IND application is approved by the FDA. ANA975 is in Phase I trials for hep C but may also be developed for other indications such as hepatitis B infection. "Results of our clinical studies suggest that TLR7 agonists may represent an …
