|Tekmira Says FDA Modifies Hold On Ebola Application; Cubist Pharma Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN|
|By Staff and Wire Reports|
|Friday, 08 August 2014 19:08|
Tekmira Pharmaceuticals (NASDAQ: TKMR) shares jumped seven percent after-hours Thursday when the company said a Food and Drug Administration action may enable the use of the company's TKM-Ebola drug for individuals infected with Ebola virus.
The FDA modified its full clinical hold on the company's Investigational New Drug Application for the treatment to a partial clinical hold, according to Tekmira, which said it received "verbal confirmation" from the agency.
"We are carefully evaluating options for use of the drug within accepted clinical and regulatory protocols," Tekmira Chief Executive Mark Murray said.
The hold had been placed July 3 when the FDA sought additional data as well as protocol changes to assure the safety of volunteer subjects.
Published preclinical studies looked promising for the treatment, which is being developed under a $140 million contract with the U.S. Department of Defense.
Tekmira changed hands recently in Friday's pre-market session at $16.52, up 15.7 percent.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN® (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.
The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.
CUBICIN is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. CUBICIN is supplied in a single-use vial packaged in a carton (refer to www.cubicin.com). CUBICIN was distributed Nationwide to multiple consignees.
Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.
As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.
Cubist is arranging for return of recalled product. For healthcare professionals and pharmacists with medical questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EDT, Monday through Friday.
Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax.
Complete and submit the report Online: http://www.fda.gov/MedWatch/report.htm
Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced a multi-year partnership agreement with the Scleroderma Research Foundation (SRF) to support the foundation's activities and the further progress of SRF's groundbreaking research programs.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it will report second quarter 2014 financial results on Thursday, August 14, 2014.
Global Holdings, Inc. (PINKSHEETS: GBHD) announces its acquisition of Infusive Technologies, LLC, which developed a proprietary and patented multi-chamber, sequential, dose syringe technology.
GrowBLOX Sciences, Inc. (OTCQB: GBLX) announced today that Chief Science Officer (CSO) Andrea Small-Howard, PhD, MBA, will be interviewed live by host Michael Yorba on Clear Channel Business Talk Radio's The Traders Network Show.
Hemp, Inc. (OTC:HEMP) commended the United States Securities and Exchange Commission (SEC) for charging crooked stock promoters for manipulating the market in an effort to "pump-and-dump" certain OTC stocks.
Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced that Sam Backenroth, Chief Financial Officer, will present a corporate overview and business update at the 2014 Wedbush Life Sciences Management Access Conference, being held at the Le Parker Meridien Hotel in New York City on August 12-13, 2014.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that Faheem Hasnain, its President and Chief Executive Officer, will be presenting at the Wedbush PacGrow Life Sciences Conference at Le Parker Meridien Hotel in New York City.