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First Edition: November 13, 2013

Today's headlines include not-so-positive predictions about whether healthcare.gov will be fully functional by the end of November.

13 Nov 2013

Results announced for Phase 3B/4 study of RAPAMUNE in kidney transplant patients

Pfizer Inc. (NYSE:PFE) announced today top-line results from a Phase 3B/4 study of RAPAMUNE® (sirolimus) evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to RAPAMUNE® 3 to 5 months after transplant.

12 Nov 2013

FDA approves Prior Approval Supplement for EMBEDA Extended Release Capsules CII

Pfizer Inc. announced today that the U.S. Food and Drug Administration has approved a Prior Approval Supplement for EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

4 Nov 2013

Pfizer to continue development of Remoxy Extended-Release Capsules CII

Pfizer Inc. announced today that, having achieved technical milestones related to manufacturing, it will continue the development program for Remoxy (oxycodone) Extended-Release Capsules CII.

22 Oct 2013

Pfizer announces top-line results from phase 3b studies with Lyrica Capsules

Pfizer Inc. (NYSE:PFE) announced top-line results from two phase 3b, placebo-controlled studies with Lyrica® (pregabalin) Capsules CV in patients with fibromyalgia (FM) and painful diabetic peripheral neuropathy (DPN), respectively.

19 Oct 2013

European Commission approves updated label of Prevenar 13 for high risk pneumococcal disease

Pfizer Inc. (NYSE:PFE) announced today that the European Commission approved updates to the Summary of Product Characteristics (SmPC) for the company's pneumococcal conjugate vaccine Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), regarding its use in certain populations at high risk of pneumococcal disease.

18 Oct 2013

Sanofi's Nasacort Allergy 24HR nasal spray receives FDA approval for over-the-counter use

Sanofi announced today that the U.S. Food and Drug Administration approved Nasacort Allergy 24HR nasal spray as an over-the-counter treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older.

12 Oct 2013

Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis

Pfizer Inc. announced today top-line results from two Phase 3 clinical trials of tofacitinib, a novel, oral Janus kinase inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis: OPT Compare (A3921080) and OPT Retreatment (A3921111).

10 Oct 2013

Research roundup: Health law's effects on consumer spending; Mass. experience finds increased use of laparoscopic surgery

The authors find that average out-of-pocket spending is expected to decrease for all groups considered in the analysis, although decreases in out-of-pocket spending will be largest for those who would otherwise be uninsured.

5 Oct 2013

Out-of-pocket medical expenses to decline for most consumers under federal Affordable Care Act

Out-of-pocket medical expenses will decline for most consumers who become newly insured or change their source of health insurance under the federal Affordable Care Act, according to a new RAND Corporation study.

2 Oct 2013

Innovative packaging design aids convergence in the pharmaceutical industry

PCI, a global supplier of pharmaceutical commercial packaging solutions and clinical trials services, announces the availability of a white paper detailing how it’s innovative packaging design aids convergence in the pharmaceutical industry.

30 Sep 2013

Colorado continues preparing for exchange 'snafus'; abortion coverage questions persist for Washington's marketplace

Meanwhile, researchers say that if Connecticut's streamlined enrollment process works well, it could mean a significant jump in the number of people who gain insurance for the first time.

30 Aug 2013

Viewpoints: GOP trapped between angry base and reality of health law; small businesses 'scrambling;' competing views of Medicaid expansion in Va.

Recent political reporting suggests that Republican leaders are in a state of high anxiety, trapped between an angry base that still views Obamacare as the moral equivalent of slavery and the reality that health reform is the law of the land and is going to happen (Paul Krugman, 8/18).

20 Aug 2013

Moberg Pharma granted exclusive rights to market Kerasal Nail in China

Moberg Pharma AB today announced that Menarini Asia-Pacific, a member of the Menarini Group - a top 40 global pharmaceutical company - has been granted the exclusive rights to market and sell Kerasal Nail in China. The companies now intend to seek marketing authorization for the product in the Chinese market.

22 Jul 2013

Pfizer announces approval of tofacitinib for treatment of rheumatoid arthritis

Pfizer Inc. announced today that tofacitinib has been approved for the treatment of rheumatoid arthritis in patients who had an inadequate response to existing therapies in several additional countries around the world, including Switzerland, which is the first European country to receive approval.

15 Jul 2013

Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration has accepted for review a Supplemental New Drug Application for Eliquis (apixaban), for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in adult patients who have undergone hip or knee replacement surgery.

11 Jul 2013

Pfizer's Prevenar 13 receives European approval to include adults for prevention of invasive disease

Pfizer Inc. announced today the company's pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), received European approval for an expanded indication to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).

10 Jul 2013

Elcelyx's study shows NewMet has better glucose-lowering effects than metformin in type2 diabetic patients

Elcelyx Therapeutics announced today that clinical study results confirm that the primary site of action of Type 2 diabetes medicine metformin is in the lower bowel rather than in the circulation.

24 Jun 2013

Calif. regulator seeks to bar Anthem from small business health exchange

Meanwhile, Minnesota officials announce the opening of a call center Sept. 3 to answer consumer questions about the state's online insurance marketplace, which will begin enrolling people a month later.

15 Jun 2013

Elcelyx Therapeutics' posters related to NewMet to be presented at ADA's 73rd Scientific Sessions

Elcelyx Therapeutics today announced that the company and principal investigator Ralph A. DeFronzo, M.D. will present posters related to NewMet, a delayed-release formulation of generic metformin, at the 73rd Scientific Sessions of the American Diabetes Association in Chicago, IL.