In the randomized controlled IN.PACT SFA trial, the 12-month clinically-driven target lesion revascularization (CD-TLR) rate was 2.4% for the IN.PACT Admiral DCB compared to 20.6% for standard PTA. In other words, only 2.4% required another procedure within one year compared to one in five PTA patients.
In the IN.PACT Global post-market study, the follow-up target limb-related medical care costs from discharge to one year were $750/patient lower in the DCB group versus the PTA group, despite higher initial hospital costs. This translates into an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which is similar to other cardiovascular therapies, including coronary drug-eluting stents.
Regenerative medicine firm Avita Medical (OTCQX:AVMXY +1.6%) secures FDA clearance for the expanded use of ReCell Spray-On Skin and broadened eligibility criteria for its clinical trial. The changes will make the trial more accessible and resolve the delays with patient recruitment.
The revised eligibility criteria will now allow for more extensive and severe (deeper) burn injuries and include participants as young as five years of age.
The trial will evaluate ReCell as a complementary treatment to expanded meshed skin grafting in a cohort of 25 patients. The company expects to begin enrolling the new cohort in early 2015 and complete enrollment by the end of 2015. Each patient will be followed for 12 months.
On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
The FDA approves NxStage Medical's (NXTM +0.7%) OneSite single needle technology. OneSite employs a dual lumen needle design that allows a dialysis patient to have only one needle inserted per treatment instead of two.
Thinly-traded nano cap MediciNova (MNOV -10.9%) is off on 5x higher volume as traders take some money off the table from the sharp run-up that began on August 26 when the firm announced the impending start of a clinical trial evaluating MN-166 as a treatment for patients with ALS.
Shares peaked yesterday at $3.38 which represented a 62.5% jump from August 25's close of $2.08.
Oculus Innovative Sciences (OCLS +0.7%) is awarded four new patents related to Microcyn, one in the U.S. for second- and third-degree burns; on in the U.S. and Canada for the treatment of peritonitis and one in China for the Microcyn solution and its method of use.
The company's IP estate now includes 41 issued and allowed patents with 92 pending applications.
PharmAthene (PIP -13.2%) goes south on increased volume albeit on turnover of only 550K. Investors appear to perceive that its potential award from (SIGA -22.2%) may be at risk or at least substantially delayed due to its Chapter 11 filing and appeal.
In a stunningly quick reversal, Opexa Therapeutics (NASDAQ:OPXA) terminates its public offering of stock announced yesterday. Management apparently assessed the situation after the close (its PR went out at 4:21 pm EDT) and determined that market conditions do not favor proceeding.
Avanir Pharmaceuticals (NASDAQ:AVNR) is off 6% premarket on robust volume as traders begin to take profits from yesterday's ultra-bullish 85% jump on turnover of ~89M shares in response to positive Phase 2 trial results for AVP-923.
Northwest Biotherapeutics (NASDAQ:NWBO) is up 10% premarket on good volume in response to its announcement that U.K. authorities have designated DCVax-L as a Promising Innovative Medicine (PIM) under its new Early Access to Medicines Scheme. The program, launched in April of this year, provides for accelerated approval for promising new therapies that address a serious disease or condition with high unmet medical need. It is akin to the U.S. FDA's Breakthrough Therapy Designation (BTD).
PIM approval is a two-step process. Step one is an evaluation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to determine if the product meets three criteria: 1. it addresses the aforementioned serious disease or condition with high unmet medical need; 2. the product is likely to offer a major advantage of available treatments; 3. the potential benefits outweigh the potential adverse effects. Step two is an evaluation of the clinical data to assess the product's benefits and risks. If MHRA's opinion is positive, the product may then be prescribed by physicians before it is formally licensed and while it is still in clinical development.
Brainstorm Cell Therapeutics (OTCQB:BCLI) completes a 1:15 reverse split of its common stock as it continues its path to an uplisting on NASDAQ Capital Market. At today's open of the OTCBB, shares will trade under the symbol (BCLID). After 20 trading days, the symbol will revert back to (OTCQB:BCLI).
In response to receiving a subpoena from the Connecticut Attorney General's Office over potential violations of the state's antitrust law pertaining to its marketing of digoxin, Lannett Company (NYSE:LCI) voluntarily engaged outside counsel and other experts to review its pricing practices. The company says the internal review has been completed and that it acted within applicable laws and regulations.
The company will continue to cooperate fully with CT AG as necessary to resolve the matter.
Siga Technologies (NASDAQ:SIGA) files for voluntary relief under Chapter 11 of the U.S. Bankruptcy Code. It takes the action in order to assure that it can satisfy its commitment to supply the antiviral smallpox drug Tecovirimat to the U.S. Strategic National Stockpile under the BioShield Act of 2004 and fulfill its contract with the Biomedical Advanced Research and Development Authority (BARDA).
Chapter 11 protection will enable Siga to operate as a going concern and pursue what it believes as a valid appeal of a pending Delaware Chancery Court proceeding involving litigation with PharmAthene (NYSEMKT:PIP). In an August 8, 2014 opinion, the Court found that PharmAthene is entitled to an as-yet-unspecified lump sum damages award plus interest and fees based on the U.S. Government's purchases of Siga's smallpox drug allegedly anticipated from December 2006. The size of the award will probably be substantial and would jeopardize Siga's viability and ability to produce and deliver Tecovirimat.
The USPTO issues patent No. 8,835,501 to Spectrum Pharmaceuticals (NASDAQ:SPPI) covering the formulation of Beleodaq (belinostat) with an adjusted term to October 2027 from May 2026. Spectrum owns another Beleodaq patent that covers the chemical entity.
Drugs tagged as Breakthrough Therapies must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies or over placebo if no therapies are available. It was created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. BTD-labelled drugs are Fast Track'd but have the additional benefit of more-intensive agency guidance and discussion.
Eylea is currently approved for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
The company expects to submit a supplemental BLA (sBLA) in the U.S. for diabetic retinopathy this year.