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BioDelivery Sciences International files NDS for BEMA Fentanyl

BioDelivery Sciences International, Inc.today announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined.

3 Oct 2009

EMEA grants positive opinion for Baxter's CELVAPAN H1N1 pandemic vaccine

Baxter International Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its “positive opinion” for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion confirms the acceptability of Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product.

From Baxter International Inc. 3 Oct 2009

Americans are not getting correct drug information, says study

Do consumers truly understand how to take their medications and the possible side effects and interactions that can occur as a result? Though the vast majority of study respondents who have recently picked up a prescription drug say they understand how to take their medication (90%), only 60% are aware of the potential interactions with other prescribed medication, and only 58% are aware of interactions with OTC medication they are taking, according to the latest ‘Under the Skin’ survey by ORC Guideline, an infoGROUP company.

3 Oct 2009

First U.S. patients could receive H1N1 vaccine next week

U.S. health officials announced Thursday the first batches of the H1N1 (swine flu) vaccine the government ordered will begin arriving in designated locations across the country on Tuesday and may be administered in the first patients by the end of next week, Reuters reports (Fox, 10/1).

3 Oct 2009

Update from BioCryst Pharmaceuticals regarding antiviral peramivir

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Office of the Secretary, Department of Health & Human Services (HHS) has issued "HHS Secretary's Declaration for the Use of the Public Readiness and Emergency Preparedness Act for the Influenza Antiviral Peramivir."

3 Oct 2009

Nutra Pharma manufactures first commercial batch of Cobroxin

Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has completed manufacturing the first commercial batch of Cobroxin and has successfully released it for final distribution.

3 Oct 2009

FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

3 Oct 2009

CNN, TIME examine increasing antibiotic resistance

CNN examines a recent report by researchers that warns of increasing antibiotic resistance and appeals for governments to take action to develop new antibiotics to avert a health crisis.

3 Oct 2009

ALL initiative three-year clinical observational study results published

A program that bundled two generic, low-cost drugs - a cholesterol-lowering statin and a blood pressure-lowering drug - and gave daily doses to 68,560 people with diabetes or heart disease for two years is estimated to have prevented 1,271 heart attacks and strokes in the first year following the study period, according to a Kaiser Permanente study published online in the American Journal of Managed Care.

3 Oct 2009

New study underscores lack of appropriate government action to ensure safety of vaccines

A new study in the leading scientific journal NeuroToxicology lends further credence to parents and scientists concerned about an increasingly aggressive childhood vaccine schedule and toxic vaccine components.

2 Oct 2009

Array BioPharma to present poster on ARRY-403 glucokinase activator

Array BioPharma Inc. today announced that a poster on ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented at the European Association for the Study of Diabetes annual meeting, on October 2, 2009, in Vienna, Austria.

2 Oct 2009

Molecular mechanisms of BN108 and timosaponin AIII described in a journal

Bionovo, Inc. today announced the publication in the peer-reviewed, open-access journal Public Library of Science One (PLoS ONE) of a paper describing the molecular mechanisms underlying the selective cytotoxic activity of its drug candidate BN108 and its active compound, timosaponin AIII.

2 Oct 2009

sNDA for Clonicel submitted to the FDA

Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

2 Oct 2009

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

AFRESA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

2 Oct 2009

Change in Heparin manufacturing - expected to decrease the potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

1 Oct 2009

Actavis' clients launch generic Atorvastatin in Spain

Actavis Group, the international generic pharmaceuticals company, today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market.

1 Oct 2009

Mayo study reveals infliximab reduces the need for colectomy

A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology.

1 Oct 2009

HRA Pharma launches its new generation emergency contraceptive in Europe

HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate, 30mg), its new generation emergency contraceptive, has been launched in France, Germany and the United Kingdom via local HRA teams. HRA Pharma will progressively launch ellaOne in all European countries over the coming months.

1 Oct 2009

GSK allowed access to DiscoveRx' PathHunter ß-Arrestin parental cell lines and reagents

DiscoveRx Corp. announced today the signing of a global agreement with GSK, a leading pharmaceutical company, to provide access to its PathHunter™ ß-Arrestin parental cell lines, clones and associated reagents for use in GSK’s internal GPCR Screening and Profiling efforts.

1 Oct 2009

Advaxis announces Phase I trial results of its ADXS11-001 therapeutic cancer vaccine

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc. (OTCBB: ADXS), the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in three (3) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection.

1 Oct 2009