|Pfizer Wins FDA Approval for Use of Prevnar 13; FDA Approves OXYTROL for Women|
|By Staff and Wire Reports|
|Friday, 25 January 2013 20:03|
Pfizer Inc. (NYSE: PFE) announced the U.S. FDA has granted approval for the expansion of the company's pneumococcal conjugate vaccine, Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13.
“As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide,” said Susan Silbermann, president, vaccines, Pfizer. “We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease.”
The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma. The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children aged 6 years through 17 years consistent with the safety profile established in previous trials in infants and young children.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the U.S. FDA has approved OXYTROL FOR WOMEN (oxybutynin transdermal system, 3.9 mg/day), the first and only over-the-counter (OTC) treatment for overactive bladder in women. OXYTROL FOR WOMEN addresses an important unmet need for overactive bladder, or OAB, a condition that affects more than 20 million American women. Despite the fact that OAB is a treatable medical condition, more than 80 percent of women with OAB do not seek treatment.
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) will host a live webcast of its fiscal 2013 second-quarter conference call on Wednesday, Jan. 30, 2013, at 3:45 p.m. CT (4:45 p.m. ET).
Covidien plc (NYSE: COV) today reported results for the first quarter of fiscal 2013 (October - December 2012). First-quarter net sales of $3.06 billion were 5% above the $2.90 billion reported in the comparable period a year ago.
DelMar Pharmaceuticals, Inc. (OTCQB: BRRY) ("DelMar") today announced the successful acquisition (the "Acquisition"), through a share exchange agreement, of all of the outstanding shares of Del Mar Pharmaceuticals (BC) Ltd., a clinical and commercial stage drug development company with a focus on the treatment of cancer.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Desloratadine ODT (2.5 mg & 5 mg), a bioequivalent generic version of Clarinex® Reditabs® (desloratadine) in the US market on January 24, 2013.
Health, Inc. (NYSE: OPK) today announced the pricing of its offering of $175.0 million aggregate amount of 3.00% convertible senior notes due 2033 (the “Notes”) in a private offering.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today reported financial results for the three-month period ended December 31, 2012 – the second quarter of the Company’s 2013 fiscal year – and provided an update on the Company.
LipoScience, Inc.(NASDAQ: LPDX) today announced the pricing of its initial public offering of 5,000,000 shares of common stock at a price to the public of $9.00 per share.
Provectus Pharmaceuticals, Inc. (OTCQB: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that its shares are now trading on the OTCQB marketplace through the OTC Markets Group's OTC Link® quotation system, and are no longer trading on the OTCBB.
Seattle Genetics, Inc. (Nasdaq: SGEN) today presented interim results from a phase I clinical trial evaluating ASG-5ME for the treatment of metastatic pancreatic ductal adenocarcinoma (PDA) at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium being held January 24-26, 2013 in San Francisco, CA.
Transgenomic, Inc. (OTCBB: TBIO) announced today that it has entered into definitive agreements with a syndicate of institutional and other accredited investors to raise gross proceeds of $8.3 million in a private placement financing.