In a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee today, members vote 18-3 against approval for privately-held Clarus Therapeutics' oral testosterone Rextoro.
The committees voted yesterday 20-1 in favor of revising who should be prescribe testosterone replacement therapies (TRT) and the need to conduct further studies to assess the cardiovascular risks. The revised population of patients appropriate for TRT will be much smaller as a result.
TriVascular Technologies (TRIV -0.1%) initiates a voluntary field safety corrective action related to certain of its 29 mm Ovation Prime aortic stent grafts. The action pertains to 30 devices, all of which are held by distributors ex. U.S.
In a letter to be sent to international distributors, the company reports an increase in complaints about incomplete polymer fill of the 29 mm stent graft body during the implant procedure. This failure could lead to transient hypotension, prolonged procedure time and/or failure to exclude the aneurysm.
This is no associated risk to patients with existing implanted Ovation Prime stent grafts. The complaint rate is only 0.3% but the company is responding to a trend in complaints pertaining to the devices made within a certain time frame. It has implemented manufacturing process improvements in response to the complaints.
Thinly-traded nano cap Echo Therapeutics (ECTE -26.4%) plummets on a 5x surge in volume albeit on turnover of only 152K shares.
Platinum Management, the firm's largest shareholder, delivered a letter to the BOD disclosing its intention to seek the return of its $5M investment associated with the December 10, 2013 Securities Purchase Agreement. It believes Echo entered into the contract in bad faith with no intention of performing its obligations or using the funds for the intended purposes.
Platinum and its affiliates control ~30% of ECTE shares.
Demonstrating a superb example of recent-IPO volatility, ReWalk Robotics (RWLK -15.3%) retreats on relatively light turnover of 1.6M. The stock debuted on Friday at $12 then exploded to a high of $43.71 on Tuesday before correcting.
Thinly-traded nano cap Liposine (LPCN -25.9%) gyrated wildly after trading resumed this morning. The current price of $6.04 is near the bottom of high - low range of $11.33 - 5.90. Turnover is light at 54.5K shares.
NASDAQ halted trading yesterday pending news from the Ad Comm meeting on testosterone therapy.
The FDA approves Siemens Healthcare's lower-priced Somatom Scope CT scanner. The 16-slice scanner is designed use in private radiology practices, community hospitals and other specialty practices by virtue of its light weight and low (130.2 sq. ft.) space requirement.
Providence Service Corp. (PRSC +2.5%) acquires Matrix Medical Network in a cash-and-stock transaction valued at $400M ($360M in cash plus 946,722 shares of PRSC common stock) from private equity firm Welsh, Carson, Anderson and Stowe.
The Scottsdale, AZ-based Matrix provides in-home health assessment and care management services across 33 states. It posted $187M in revenue in the 12-month period ended June 30, 2014.
The transaction is expected to close in Q4 2014 and will be accretive to earnings in 2015.
Merck Animal Health signs up to market Neogen's (NEOG +1.1%) Igenity Dairy Heifer Program, a panel of genomic tests that help dairy farmers in their breeding and heifer selection. The tests can be performed soon after a calf is born.
The tests enable a dairy farmer to avoid the financial risk that a heifer does not have the genetic merit to produce a superior calf when it reaches breeding age, usually two years.
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.