|Pfizer Receives European Approval to Extend Use of Prevenar 13; Positive Results From Halozyme's Enzyme-Augmented Insulin Pump Trial|
|By Staff and Wire Reports|
|Thursday, 27 October 2011 19:19|
Pfizer Inc. (NYSE:PFE) announced the European Commission has approved the Companys pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
Prevenar 13, the first and only pneumococcal conjugate vaccine approved by the European Commission for use in adults, has the potential to prevent invasive pneumococcal disease in adults aged 50 and older a time of life when the risk for contracting the disease begins to increase, said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. It is important that older adults talk to their health care provider about pneumococcal disease prevention and Prevenar 13 as part of a plan for healthy aging.
The European Commissions decision to authorize this new indication for Prevenar 13 followed a review of clinical immunogenicity and safety data involving more than 6,000 adults aged 50 years and older.
Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced positive results from a study in patients with type 1 diabetes that receive their insulin therapy via pumps.
The Phase 1b study was conducted as a randomized, double-blind, crossover design, to determine insulin pharmacokinetics, glucodynamics, safety and tolerability of rHuPH20 (recombinant human hyaluronidase) as a single injection prior to the start of three days of NovoLog insulin aspart pump infusion therapy. The data demonstrated that pre-administration of 150 units of rHuPH20 (approximately 1.3 micrograms of enzyme) led to consistent insulin exposure over the infusion set life and superior glucose control following meals.
The study compared pharmacokinetic (PK) and glucodynamic (GD) responses during euglycemic glucose clamp studies and responses to standardized mixed meal challenges administered in conjunction with individualized doses of insulin aspart, throughout the infusion set use with and without a single injection of rHuPH20 through the catheter set. The study also evaluated safety and local tolerability of rHuPH20 over the course of 72 hours of inpatient pump delivery, following pre-administration of rHuPH20 through subcutaneous infusion.
Compared to insulin aspart alone, pre-administration with rHuPH20 reduced the variability in insulin exposure and action profiles observed with continuous insulin infusion and provided a consistent ultrafast profile over 3 days of use.
Arrowhead Research Corporation (NASDAQ: ARWR) today announced that it has appointed Bruce Given, M.D. to the position of Chief Operating Officer of the Company effective October 26, 2011.
Biogen Idec (NASDAQ: BIIB) and Portola Pharmaceuticals, Inc. today announced that they have entered into an exclusive, worldwide collaboration and license agreement under which both companies will develop and commercialize highly selective, novel oral Syk inhibitors for the treatment of various autoimmune and inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
Bristol-Myers Squibb Company (NYSE: BMY) today announced double-digit net sales growth in a quarter highlighted by important new data on ELIQUIS® for stroke prevention in patients with atrial fibrillation and continued investment in external innovation with several strategic transactions.
Bruker Corporation (NASDAQ: BRKR) today reported financial results for the third quarter ended September 30, 2011.
Celgene Corporation (NASDAQ: CELG) reported Non-GAAP net product sales of $1,218 million for the third quarter of 2011, a 38 percent increase from the same period in 2010.
China Kanghui Holdings (NYSE: KH) ("Kanghui" or the "Company"), a leading domestic developer, manufacturer and marketer of orthopedic implants in China, today announced that the Company plans to release third quarter 2011 financial results on November 9, 2011, after the market closes.
CONMED Corporation(NASDAQ: CNMD) today announced financial results for the third quarter of 2011.
Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the third quarter ended September 30, 2011.
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the company has unblinded its Phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease and that the data achieved statistical significance demonstrating both the superiority and non-inferiority of HEPLISAV as compared to Engerix-B.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will host a conference call on Tuesday, November 8, 2011 at 4:30 p.m. ET. During the call, management will provide an update on Infinity’s business and discuss the company’s third quarter 2011 financial results.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced they will be presenting additional linaclotide results from four pivotal Phase 3 trials and one Phase 2b study in patients with either irritable bowel syndrome with constipation (IBS-C) or chronic constipation (CC) at the American College of Gastroenterology (ACG) 2011 Annual Scientific Meeting being held in Washington, DC from October 29, 2011 to November 2, 2011.
InterMune, Inc. (NASDAQ: ITMN) today announced that it will release its third quarter 2011 financial results at the close of the U.S. markets on Thursday, November 3, 2011.
Marijuana, Inc. (PINKSHEETS: HEMP) announced today the roll-out of their new KushClear™ line of private labeled wellness products.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the generic version of Purdue Pharma's MS Contin®, an opioid analgesic for moderate to severe pain management.
Nu Skin Enterprises, Inc. (NYSE: NUS) is pleased to announce that it has executed a letter of intent to acquire LifeGen Technologies, LLC, a genomics company based in Madison, Wisconsin for $11,662,500.
Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced it will report third quarter 2011 financial results after the NASDAQ Global Market closes on November 3.
PDI, Inc. (Nasdaq: PDII) today announced that it will release its third quarter 2011 financial results on Wednesday, November 9, 2011 after the market close and host a conference call on Thursday, November 10, at 8:30 am Eastern time to discuss the results.
The board of directors of Pfizer Inc. (NYSE: PFE) today declared a 20-cent fourth-quarter 2011 dividend on the company’s common stock, payable December 6, 2011, to shareholders of record at the close of business on November 11, 2011.
Senomyx, Inc. (NASDAQ: SNMX), a company focused on using proprietary taste receptor-based technologies to discover novel flavor ingredients for the food, beverage, and ingredient supply industries, today provided a corporate update and reported financial results for the third quarter ended September 30, 2011.
Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC® (www.safcglobal.com), is introducing a novel CHOZN® GS-/- Zinc Finger Nuclease (ZFN)-modified Chinese Hamster Ovary (CHO) cell line.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it will host a webcast and teleconference with senior management to discuss its financial results as well as provide a general business overview on Thursday, Nov. 3, 2011 at 5:00 pm Eastern.
Synergy Pharmaceuticals, Inc. (OTC QB:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced the presentation of three posters on plecanatide and SP-333 to be given at the 2011 annual scientific meeting of the American College of Gastroenterology which is being held in Washington, DC from October 28 to November 2, 2011.
United Therapeutics Corporation (NASDAQ: UTHR) today announced its financial results for the third quarter ended September 30, 2011.
University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS), a diversified, integrated multi-specialty health delivery system, today announced that it expects to report revenues of approximately $21.0 million and EBITDA of approximately $3.7 million for the quarter ended September 30, 2011.
ViroPharma Incorporated (NASDAQ: VPHM) today announced that it has signed a definitive agreement to acquire DuoCort Pharma AB, a private company based in Helsingborg, Sweden focused on improving glucocorticoid replacement therapy.