la rubrica delle biotech

Aeiou · 4 Giugno 2010

Adolor Corporation to Present at the Ninth Annual Needham Healthcare Conference

Aeiou · 11 Giugno 2010

Bionovo

Bionovo Announces Publication Describing the Discovery of Distinct Classes of Genes Regulated By Estrogen Receptor Beta

Netzach · 4 Agosto 2010

Mi permetto di segnalare questa Pharma che penso possa essere degna di un' occhiata ...

Isis

magolibero · 5 Agosto 2010

QLTI

Development | QLT Inc.

Axial Capital Buys More QLT -- Seeking Alpha

Eliav Assouline and Marc Andersen's hedge fund Axial Capital Management just filed a Form 4 with the SEC regarding shares of QLT Inc (QLTI). Per the filing, Axial purchased 37,226 shares of QLTI at $5.72 per share. This brings their cumulative position in the name to 6,341,812 shares. As we've detailed a few times prior, Axial has been accumulating QLTI shares with purchases in early June and early July as well.

Axial was seeded by legendary hedgie Julian Robertson back in 2005 and the hedge fund resides in the same offices as Tiger Management at 101 Park Avenue. You can view the proverbial 'Tiger Family Tree' of managers that Robertson has seeded/spawned there. Axial was recently mentioned as one of Institutional Investor's 'Hedge Fund Rising Stars.'

Sheppy · 6 Agosto 2010

Salve
anch'io mi permetto di postare queste news a titolo informativo (ma DYOR... fatevi le dovute ricerche)

Late August/Early September
Vivus (VVUS) is expected to announce data from its two-year Sequel clinical trial. The 650-patient study included three treatment arms -- two that were taking doses of Vivus' obesity drug Qnexa and one that was a placebo. The patients were originally enrolled in Vivus Conquer study and then continued for an extra year. The biotech claims that the study will enhance the safety and efficacy data of the drug, but it doesn't include data on teratogenicity or cardiovascular risks.

September 16
Arena Pharmaceuticals (ARNA) will face the Endocrinologic and Metabolic Drugs Advisory Committee where a panel of experts to the FDA will scrutinize the company's obesity drug lorcaserin. Analysts and investors believe that lorcaserin will have better luck than Vivus -- the safety profile has been shown to be far better than Qnexa. Yet, some people worry that the committee will get hung up on the efficacy of the drug.

October 3
Javelin Pharmaceuticals' (JAV) Dyloject for the treatment of moderate to severe pain, mostly used after operations, will face approval by the FDA. It will be the first non-steroidal anti-inflammatory approved for this purpose in 20 years.

October 11
Alexza Pharmaceuticals (ALXA) is awaiting approval of it schizophrenia drug AZ-004. The drug is an inhaled formulation of the drug loxapine. The Canadian biotech Biovail (BVF) acquired the right to the drug in February and will market it in North America if it gets approved. Analysts believe the drug could have a market of $500 million.

Jazz Pharmaceuticals (JAZZ) will also face an FDA decision on this day for its fibromyalgia drug JZP-6. The drug will be scrutinized by the Arthritis and Drug Safety and Risk Management Advisory Committees on August 20. The drug is already approved for the treatment of narcolepsy. The drug is highly susceptible to abuse; this could become an issue at the committee meeting.

October 12
Alkermes (ALKS) expects an approval decision for its opioid addiction treatment Vivitrol on this date. The drug is already approved as an injectible treatment for alcohol dependence. In November, the biotech announced positive results of a phase 3 study that showed Vivitrol helped patients stay off opioids.

October 22
Later in the month, Alkermes will face the FDA again, along with Eli Lilly (LLY) and Amylin Pharmaceuticals (AMLN). The companies will be looking for the approval of Bydureon -- the long-acting formulation of their diabetes drug Byetta. The once-weekly injectible was passed over once by the regulatory agency, which wanted more information on the risks of the drug. It will face stiff competition from Novo Nordisk's (NVO) Victoza if it finally gets to market. Victoza has gained 27% of the GLP-1 market since it was approved in January.

Arena's obesity drug will face approval on this day as well. The approval of the drug will be contingent on how well the advisory committee meeting goes in September. While the FDA isn't required to follow the decisions of its advisory committees, it often does.

October 28
The FDA will make its decision on Vivus' Qnexa. An advisory panel to the FDA voted against approval in July. The panel thought that risks surrounding pregnancy and cardiovascular issues were too great to allow the drug to reach the market without more testing.