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FDA, Biovista to collaborate in analysis of drug side effects

Biovista Inc. today announced that the U.S. Food and Drug Administration (FDA) has licensed its technology platform to help analyze, identify, and better understand the way certain drugs can cause harmful side effects.

13 Jan 2010

Jiangbo Pharmaceuticals obtains renewal of Good Manufacturing Practices Certificate for Pharmaceutical Products

Jiangbo Pharmaceuticals, Inc. (the "Company" or "Jiangbo"), a pharmaceutical company with its principal operations in China, today announced that one of its factories in China obtained a renewal of its Good Manufacturing Practices Certificate for Pharmaceutical Products ("GMP Certificate") from the State Food and Drug Administration (SFDA) for its tablets and granules.

13 Jan 2010

BDSI to discuss planned BEMA Granisetron IND with the FDA

BioDelivery Sciences International, Inc. announced that the company has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned Investigational New Drug (IND) application for BDSI’s antiemetic (anti-nausea and vomiting) product candidate, BEMA Granisetron. The meeting will take place on March 17, 2010. The company will discuss with the FDA clinical development and regulatory plans for BEMA Granisetron, which is anticipated to enter Phase 1 studies in the second quarter of 2010.

13 Jan 2010

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Phase II study results of the agent ASA404 showed promise in patients with either squamous or non-squamous non-small cell lung cancer (NSCLC).

13 Jan 2010

Scientists identify fast-acting compound to improve cognitive function impairments

A fast-acting compound that appears to improve cognitive function impairments in mice similar to those found in patients with progressive Alzheimer's disease has been identified by scientists at Wake Forest University School of Medicine and the Vanderbilt University Medical Center Program in Drug Discovery.

13 Jan 2010

AARDA pleased with FDA's approval of RA drug ACTEMRA

Friday, January 8, 2010, the Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab), a new biologic response modifier for adult patients with moderately to severely active rheumatoid arthritis (RA).

13 Jan 2010

Media outlets examine U.S. plans for leftover H1N1 vaccine, efforts to keep flu vaccine production on track

After working to ensure the U.S. had access to enough H1N1 (swine flu) vaccine, health officials may now face a new dilemma - a vaccine surplus, the Associated Press reports.

12 Jan 2010

TD2 and COTI work together to obtain approval of clinical trials for COTI-2

TGen Drug Development (TD2) and Critical Outcome Technologies Inc. (COTI) (TSXV:COT) announced today that they will work together to obtain approval of clinical trials for a promising new anti-cancer drug called COTI-2.

12 Jan 2010

VaxInnate grants license to Biological E. to develop and commercialize recombinant H1N1 vaccine in India

VaxInnate Corporation today announced that it has granted Indian biopharmaceutical company Biological E. Limited a license to its recombinant H1N1 pandemic swine flu vaccine and is collaborating to facilitate the manufacture, clinical development and commercialization of the vaccine in India.

12 Jan 2010

GAO: Some meds had 'extraordinary' price hikes over past eight years

A report from the Government Accountability Office (GAO) issued Monday finds that "[p]rices on a growing number of prescription medications have ballooned in recent years as consolidation in the drug industry leaves fewer companies manufacturing niche medications," The Associated Press reports.

12 Jan 2010

Ibutilide Fumarate Injection launched

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals announced today the launch of Ibutilide Fumarate Injection, the generic equivalent of Corvert® from Pfizer Inc.

12 Jan 2010

Older patients with acute myeloid leukemia may benefit from decitabine drug

Older patients with acute myeloid leukemia (AML) might benefit from a drug that reactivates genes that cancer cells turn off, according to research at Washington University School of Medicine in St. Louis and collaborating institutions.

12 Jan 2010

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

Although erlotinib is an approved second-line therapy for lung cancer, its management is complicated by side effects that get worse as the dose increases.

12 Jan 2010

NanoViricides outlines its technology and current drug programs at Biotech Showcase conference

NanoViricides, Inc. (the "Company"), reports that the Company has been invited to present on January 12th at the Biotech Showcase™, a conference designed to showcase promising companies and technologies for partnering and investment purposes.

12 Jan 2010

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the U.S. and Europe, a drug that resolves tophi in less than one year would become the patient share leader in the chronic tophaceous gout patient subpopulation and would be used in the vast majority of patients who suffer severe tophaceous gout, according to surveyed U.S. and European rheumatologists.

12 Jan 2010

New GAO report shows price increase for brand-name drugs doubles from 2000 to 2008

A new report from the Government Accountability Office (GAO) that finds “extraordinary price increases” for brand-name drug products from 2000 – 2008 was largely fueled by the “lack of therapeutically equivalent drugs” and “limited competition,” underscores the need for policymakers to promote policies in health reform which increase competition and lower costs, the Pharmaceutical Care Management Association (PCMA) said today.

12 Jan 2010

BioTrends Research Group releases Wave One LaunchTrends: EXTAVIA report

BioTrends Research Group, Inc. announces the release of the Wave One LaunchTrends(®): EXTAVIA report. The survey was completed by U.S. Neurologists Extavia (Interferon beta 1b).

12 Jan 2010

Reducing DA dosage causes acute withdrawal symptoms in Parkinson's patients

New research has shown that reducing the dosage of dopamine agonist (DA) drugs, a mainstay treatment for Parkinson's disease (PD), sometimes causes acute withdrawal symptoms similar to those reported by cocaine addicts -- including anxiety, panic attacks, depression, sweating, nausea, generalized pain, fatigue, dizziness and drug cravings. These symptoms can be severe, and are not alleviated by other PD medications.

12 Jan 2010

Prescribing culture of antipsychotic medications in nursing homes examined

Older adults newly admitted to nursing homes with high rates of antipsychotic prescribing in the previous year are more likely to receive antipsychotic agents, according to a report in the January 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Of these treated patients, some had no identified clinical indication for this therapy.

12 Jan 2010

Department of Health vaccinates 49,078 Pennsylvanians at 33 H1N1 flu clinics

The Department of Health vaccinated 49,078 Pennsylvanians at 33 H1N1 flu clinics held across the state on Jan. 8 and 9. The department urges anyone who has not yet been vaccinated to get immunized.

12 Jan 2010

Pharmaceutical News

FDA, Biovista to collaborate in analysis of drug side effects

Jiangbo Pharmaceuticals obtains renewal of Good Manufacturing Practices Certificate for Pharmaceutical Products

BDSI to discuss planned BEMA Granisetron IND with the FDA

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Scientists identify fast-acting compound to improve cognitive function impairments

AARDA pleased with FDA's approval of RA drug ACTEMRA

Media outlets examine U.S. plans for leftover H1N1 vaccine, efforts to keep flu vaccine production on track

TD2 and COTI work together to obtain approval of clinical trials for COTI-2

VaxInnate grants license to Biological E. to develop and commercialize recombinant H1N1 vaccine in India

GAO: Some meds had 'extraordinary' price hikes over past eight years

Ibutilide Fumarate Injection launched

Older patients with acute myeloid leukemia may benefit from decitabine drug

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

NanoViricides outlines its technology and current drug programs at Biotech Showcase conference

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

New GAO report shows price increase for brand-name drugs doubles from 2000 to 2008

BioTrends Research Group releases Wave One LaunchTrends: EXTAVIA report

Reducing DA dosage causes acute withdrawal symptoms in Parkinson's patients

Prescribing culture of antipsychotic medications in nursing homes examined

Department of Health vaccinates 49,078 Pennsylvanians at 33 H1N1 flu clinics

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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