Research Note on Synta Pharma Print E-mail
Friday, 13 March 2009 17:13
The News: Synta Pharma (SNTA) announced today a 42% reduction in its workforce, laying off 90 employees, in an effort to preserve its cash balance, following the failure of the Phase III melanoma trial with Elescomol, the company's only late stage program. Price: $1.97; Market Cap (MM): $66.8 Market Perform; Simos Simeonidis, Ph.D., Senior Biotechnology Analyst Synta cuts 42% of workforce; waiting for strategic alternatives guidance
Opinion: Pathway for FOBs Should Balance Need for Competition and Need for Innovation Print E-mail
Thursday, 12 March 2009 18:35
This story was written by James Bianco, M.D., prinicipal founder, CEO, and director of Cell Therapeutics (CTIC), which is a member of the ETF Innovators Emerging Bio-Pharma Index. Related Article on Momenta Pharma (MNTA) by Mike Havrilla.President Obama's first budget calls for the creation of a regulatory pathway for the creation of follow-on, or biosmiliar, biologics. This is obviously now the most high-profile call yet to move forward with a system that will provide the benefit of biotech drugs to patients who need them the most.
Full Array of Reasons to Buy CombiMatrix Print E-mail
Thursday, 12 March 2009 17:58
CombiMatrix (CBMX) is an ETF Innovators Emerging Diagnostics Index component and spin-off company from Acacia Research (ACTG) which has operated independently since August 2007 as a developer of DNA MicroArrays for lab-based personalized medicine applications to improve treatment outcomes, which are exempt from the more time-consuming and costly route of FDA approval as in vitro diagnostic products. The tests are also affordable, with a target price of $250-$300 on average. Today, CBMX announced a four-year contract with NASA's Ames Research Center that includes $214,051 in funding for the first year with three additional option years at the same level of funding. The Company will provide NASA with a molecular diagnostics package that will be used to study genetic changes in bacteria as they orbit around the earth. CBMX has developed a diagnostic array reader which is the size of a mobile phone and an expected launch during 3Q09.
Three Oversold Healthcare Catalyst Stocks Print E-mail
Wednesday, 11 March 2009 19:51
With the S&P 500 SPDR ETF (SPY) trading about 8% below its 50-day moving average (DMA), I went in search of oversold healthcare stocks trading at least 16% below their 50 DMA which have potential catalysts within the next six months that may provide some very nice returns.The Healthcare Sector SPDR (XLV) is trading about 12% below its 50 DMA amidst concerns of sweeping healthcare reform that would threaten the profits of health insurers, managed care companies, big pharma, and biotechs - although such concerns may be overblown given the failed attempts at large scale healthcare reform in the past.Momenta Pharma (MNTA) is trading about 29% below its 50 DMA and the Company is uniquely positioned to benefit from legislation that was introduced today to bring safe and affordable generic biologics to the market. The Promoting Innovation and Access to Life Saving Medicines Act in the House of Representatives is expected to establish a regulatory pathway for biogenerics at the FDA.
Trading FDA Decisions: 14 Extreme Trades Print E-mail
Wednesday, 11 March 2009 09:17
Below is a summary of companies from the FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.  Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved). 
Stem Cell Index Soars on Lift of Funding Ban Print E-mail
Monday, 09 March 2009 19:45
The accompanying table includes statistics for the 40 companies in the ETF Innovators Global Stem Cell and Regenerative Medicine Index, which is down 14.2% at a value of 3,387 from a 2/22/09 inception date value of 3,928. Most of the stocks got a major boost today from the widely anticipated executive order from President Obama to eliminate the restrictions on federal funding of stem cell research enacted in 2001 under President George W. Bush. The move allows federally funded researchers to use hundreds of new embryonic stem cell lines for what remains long-term but very promising research which has the potential to cure a wide variety of conditions, including diabetes, paralysis, Parkinson's disease, and many others.
Upcoming FDA Advisory Panel Meetings Print E-mail
Monday, 09 March 2009 14:39
A trio of diabetes drug candidates are affected by a tougher stance at the FDA for this class of drugs, which is focused on cardiovascular risks such as heart attack and stroke. Two of the drugs will be reviewed at early April FDA advisory panel meeting while a third will likely require additional clinical trials. FDA and Clinical Trial Calendars   In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks. In a change that was effective immediately, the agency said studies should "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies."   The agency is calling for extended diabetes clinical studies to include older and sicker patients at higher risk of having a heart attack or stroke and a longer follow-up period lasting up as long as two years (versus 3-6 months).
Momenta Pharma's Three-Part Strategy Print E-mail
Thursday, 05 March 2009 18:59
Momenta Pharma (MNTA) is pursuing a three-part business model which includes complex generic equivalents in partnership with the Sandoz division of Novartis (NVS), proprietary compounds, and follow-on- biologics (FOB).   Momenta is partnered with Sandoz to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company is set to expire on 4/1/09 for Amphastar + partner Watson Pharma (WPI). The other company with a pending ANDA for Lovenox is Teva Pharma (TEVA). In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA regarding the potential for immunogenicity of their products. Sandoz submitted an amendment on 9/26/08 for the M-Enoxaparin ANDA to address these concerns, but is the Generic Drug Division of the FDA does not issue decision date deadlines.
BioDelivery Sciences: A Bet on FDA Approval of Onsolis Print E-mail
Thursday, 05 March 2009 14:17
 While pending FDA new product decisions are never a sure thing, BioDelivery Sciences (BDSI) appears to have the odds stacked in its favor for approval of cancer breakthrough pain drug candidate Onsolis. BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis (BEMA fentanyl) based on the feedback it received from a complete response ruling by the FDA last August. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission. The FDA issued a statement last month directed at drug makers which market the strongest types of painkillers - classified as opiates which are highly regulated as DEA Class 2 Controlled Substances. The FDA wants pain drug makers to play a larger role in stemming abuse and diversion issues amidst concern about the rising incidence of overdose deaths, abuse, misuse, and diversion associated with opiates such as Duragesic (fentanyl patches), OxyContin, and similar drugs.
FDA Panel Will Review Seroquel XR Print E-mail
Wednesday, 04 March 2009 08:06
WASHINGTON, March 3 (Reuters) - U.S. regulators will ask outside advisers for input on safety concerns surrounding expanded use of AstraZeneca Plc's (AZN.L) schizophrenia drug Seroquel XR, the Food and Drug Administration said on Tuesday.The issues for discussion at the April 8 advisory panel meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA notice said.Tardive dyskinesia causes involuntary, repetitive movement of the limbs and lip smacking, grimacing and other symptoms that can be permanent.Seroquel is AstraZeneca's second-best-selling drug, with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formulation.
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