The FDA approves Intuitive Surgical's (NASDAQ:ISRG) da Vinci S and da Vinci Si Surgical Systems for use in benign base of tongue resection procedures. The systems were previously approved for use in transoral otolaryngology procedures for the resection of early-stage benign or malignant tumors classified as T1 and T2.
The da Vinci Xi System is not approved for transoral otolaryngologic surgical procedures.
Oncothyreon (NASDAQ:ONTY) prices its public offering of 10M shares of common stock at $2 per share and a concurrent offering of 10K shares of Series A Convertible Preferred Stock at $2,000 per share for total expected gross proceeds of $40M.
Underwriters over-allotment is 1.5M shares of common stock. Closing date is September 23, 2014.
In a Phase 3b clinical trial, Novo Nordisk's (NYSE:NVO) Ryzodeg (insulin degludec/insulin aspart) administered twice daily provided successful glycemic control with fewer injections than a basal-bolus regimen and reduced rates of hypoglycemia. The study failed to achieve its primary endpoint of non-inferiority, however.
Ryzodeg is a combination of two distinct insulin analogs (70% insulin degludec and 30% insulin aspart). It is the first combination of a basal insulin with an ultra-long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes.
Milestone Scientific (OTCQB:MLSS) subsidiary Milestone Medical receives CE Mark clearance for its CompuFlo Epidural Computer Controlled Anesthesia System (CompuFlo Epidural Model 6000). The device verifies the needle tip placement in the lumbar epidural space in patients at least 18 years of age and the delivery of medication and other fluids in a controlled manner in the lumbar epidural space in either an in-patient or out-patient setting.
The system's core technology is called Dynamic Pressure Sensing (DPS). It measures the density of body tissue in order to assist the clinician in locating a hypodermic needle during an injection.
In a joint meeting between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members vote 20-1 in favor of drug developers' need to further assess the cardiovascular risks of testosterone products. Sixteen voted that it should be studied only in certain situations.
Members also voted 20-1 in favor of a revision of who should be prescribed the drugs. The panel says there is little evidence that testosterone replacement therapies (TRT) are effective for treating low levels of hormone caused by aging.
Prescriptions for TRT products almost doubled from 2010 to 2013. About 20% of TRT patients do not have laboratory evidence that they need the therapy.
Eli Lilly (NYSE:LLY) says that current evidence does not support a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients.
The FDA approves a label expansion for Vivus' (NASDAQ:VVUS) erectile dysfunction (ED) drug Stendra (avanafil) that reduces the time it can be taken before sexual activity from 30 minutes down to 15 minutes. It is the only ED drug approved for this indication.
Auxilium Pharmaceuticals (NASDAQ:AUXL) has exclusive marketing rights to Stendra in the U.S. and Canada.
The 15-minute approval triggers a $15M milestone payment from Auxilium to Vivus.
Rosetta Genomics (ROSG +9.5%) 1H results: Revenues: $0.6M (+187.0%); Operating Expenses: $7.0M (+9.3%); Net Loss: ($7.2M) (-14.2%); Loss Per Share: ($0.66) (+7.0%); Quick Assets: $19.7M (-19.3%).
Cash guidance: cash required to fund operations through 2014: $14M - 15M (includes $7.5M consumed in 1H). The company believes its existing cash and projected revenues will be sufficient to fund operations into 2016.
CareDx (CDNA -4.6%) settles its arbitration case with Roche (OTCQX:RHHBY -0.3%) over unpaid PCR-related royalties on AlloMap revenue. CareDx agrees to pay Roche $2,827,220 to settle past royalties and agrees to pay future royalties on a quarterly basis until September 30, 2017.
The FDA PDUFA date for Alimera Sciences' (ALIM -0.8%) NDA for Iluvien (190 mcg fluocinolone acetonide intravitreal implant in applicator) is September 26, 2014. The company resubmitted its application in April after addressing the issues cited in the FDA's October 2013 CRL that questioned Iluvien's benefit-to-risk and safety profiles.
The company licensed Iluvien from pSivida (PSDV +0.5%) for the U.S. Regulatory clearance will trigger a $25M milestone payment from Alimera to pSivida.
NASDAQ halts trading in nano cap Lipocine (LPCN) citing pending news. A joint meeting is being held today between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the appropriate treatment population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes.
Lipocine's product candidate LPCN 1021 is an oral formulation of testosterone undecanoate.
Motivated by feedback from U.S. and European regulators, ImmunoCellular Therapeutics (IMUC +7.8%) plans to advance ICT-107 to two Phase 3 clinical trials in patients with newly-diagnosed glioblastoma (GBM). Patients will be selected based on their HLA-A2 status. Positives will be in one trial and negatives in the other. The two populations of GBM patients are evenly distributed.
The company hopes to initial the trials in mid-2015.
Complicating matters is the FDA's position that Overall Survival (OS) is the appropriate primary endpoint. ICT-107 failed to achieve this endpoint in Phase 2.