Pharmaceutical News

RSS

AVI BioPharma receives $11.5M DTRA fund to develop AVI-7012 for treating Junin virus infection

AVI BioPharma, Inc. a developer of RNA-based drugs, announced today that it has received expanded contract funding of approximately $11.5 million from the Defense Threat Reduction Agency's (DTRA) Transformational Medical Technologies Initiative (TMTI) to support development of the Investigational New Drug (IND) data package for its candidate drug, AVI-7012, to treat Junin virus infection.

5 Oct 2009

Bristol-Myers Squibb and AstraZeneca receive marketing authorisation for ONGLYZA in Europe

Bristol-Myers Squibb Company and AstraZeneca announced today that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union.

5 Oct 2009

LA BioMed granted $1.3M for investigating ESAI's KRONOS IV in correcting erectile dysfunction

Las Vegas-based Endogenous Stem Cells Activators Inc. (ESAI) announced today that it will award a $1.3 million grant to Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LABioMed) for pre-clinical studies aimed at activating penile endogenous (adult) stem cells with the company's drug, KRONOS IV.

5 Oct 2009

Phase 3 clinical study results of Ketotransdel topical cream to be presented

Transdel Pharmaceuticals, Inc. today announced that it will host a conference call and audio webcast on Tuesday, October 6, 2009 at 9:00 am, eastern, to announce the top-line results of its Phase 3 clinical study for Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain.

5 Oct 2009

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Baxter International Inc. today announced the commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration at the 2009 American College of Emergency Physicians (ACEP) scientific assembly (Boston). HYLENEX, an enzyme, allows fluids to be administered under the skin (subcutaneously) rather than through a vein.

From Baxter International Inc. 5 Oct 2009

Preclinical study results of AVL-181 protease inhibitor presented

Avila Therapeutics, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, pan-genotype, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181.

5 Oct 2009

FDA grants Impax tentative approval of ANDA for FLOMAX generic version

Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX® for the functional symptoms of benign prostatic hyperplasia.

5 Oct 2009

Sigma-Aldrich and Sangamo Biosciences extend license agreement for ZFP technology

Sigma-Aldrich Corporation and Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced a major expansion of their existing license agreement to include the exclusive rights to develop and distribute zinc finger DNA binding protein (ZFP)-modified cell lines for commercial production of protein pharmaceuticals.

5 Oct 2009

Lupin grants Salix exclusive rights to its bioadhesive drug delivery technology for use with rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of September 30, 2009 Lupin Ltd. granted Salix the exclusive right in the United States to its bioadhesive drug delivery technology for use with rifaximin. Salix and Lupin have entered into a development, commercialization and license agreement under which the two companies will collaborate in the development and commercialization of a product incorporating rifaximin and utilizing Lupin’s proprietary technology.

5 Oct 2009

Allergan files declaratory relief action to allow it to share relavant information on BOTOX

Allergan, Inc. today filed a declaratory relief action in the United States District Court for the District of Columbia seeking a ruling that would allow Allergan to proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of BOTOX (onabotulinumtoxinA) for certain “off-label” therapeutic uses.

5 Oct 2009

Second round of revised quality standards for blood thinner heparin released

Further helping to secure public health, a second round of revised quality standards for the widely used blood thinner heparin became effective today, the U.S. Pharmacopeial (USP) Convention announced. Working closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and other regulatory and scientific bodies, USP started initial revisions in 2008 after adverse reactions and deaths resulted from heparin intentionally adulterated with over-sulfated chondroitin sulfate (OSCS).

5 Oct 2009

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

5 Oct 2009

Pharma and biotech companies to assess new FDA REMS guidance

Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products.

5 Oct 2009

comScore study results of changes in search engine marketing in the pharmaceutical industry

comScore, Inc., a leader in measuring the digital world, today released the results of a study of changes in search engine marketing in the pharmaceutical industry as a result of the FDA warning letters distributed in March 2009.

5 Oct 2009

The Lewin Group issues recommendations to overcome barriers obstructing the lupus drug development

Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years - since the Eisenhower Administration.

From CSL Ltd 5 Oct 2009

Workshop to revise and update Pharmacy Benefit Management and Drug Therapy Management

URAC, the nation's leading health care accreditation and education organization, will introduce new performance measures and reporting standards to its Pharmacy Benefit Management (PBM) and Drug Therapy Management (DTM) Accreditation programs at a workshop focused on the latest revisions and updates to the standards.

5 Oct 2009

Researchers engineer antidotes for blood-thinner aptamers

Imagine a surgical patient on a blood-thinning drug who starts bleeding more than expected, and an antidote that works immediately - because the blood thinner and antidote were designed to work together. Researchers at Duke University Medical Center have engineered a way to do this for an entire, versatile class of drugs called aptamers and published their findings in Nature Medicine.

4 Oct 2009

$APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin$

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), and the leading supplier of heparin sodium to the U.S. market, announced today its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, 2009 implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin.

3 Oct 2009

Caraco closes Asset Purchase Agreement with Forest as part of ANDA patent litigation settlement

Caraco Pharmaceutical Laboratories, Ltd. announced that, as part of the previously announced settlement of the legal proceedings related to Lexapro (escitalopram oxalate) tablets, it closed an Asset Purchase Agreement ("APA") transaction with Forest Laboratories, Inc. ("Forest") to acquire several products from Forest's Inwood line of business.

3 Oct 2009

HSPH's survey on H1N1 vaccines

In a new survey, Harvard School of Public Health (HSPH) researchers found that just 40% of adults are "absolutely certain" they will get the H1N1 vaccine for themselves, and 51% of parents are "absolutely certain" that they will get the vaccine for their children. The survey examined the reasoning among those who said they would not get the vaccine or might not. This is the latest in a series of surveys of public views concerning the H1N1 flu outbreak undertaken by the Harvard Opinion Research Program at HSPH. The polling was done September 14-20, 2009.

3 Oct 2009

Pharmaceutical News

AVI BioPharma receives $11.5M DTRA fund to develop AVI-7012 for treating Junin virus infection

Bristol-Myers Squibb and AstraZeneca receive marketing authorisation for ONGLYZA in Europe

LA BioMed granted $1.3M for investigating ESAI's KRONOS IV in correcting erectile dysfunction

Phase 3 clinical study results of Ketotransdel topical cream to be presented

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Preclinical study results of AVL-181 protease inhibitor presented

FDA grants Impax tentative approval of ANDA for FLOMAX generic version

Sigma-Aldrich and Sangamo Biosciences extend license agreement for ZFP technology

Lupin grants Salix exclusive rights to its bioadhesive drug delivery technology for use with rifaximin

Allergan files declaratory relief action to allow it to share relavant information on BOTOX

Second round of revised quality standards for blood thinner heparin released

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Pharma and biotech companies to assess new FDA REMS guidance

comScore study results of changes in search engine marketing in the pharmaceutical industry

The Lewin Group issues recommendations to overcome barriers obstructing the lupus drug development

Workshop to revise and update Pharmacy Benefit Management and Drug Therapy Management

Researchers engineer antidotes for blood-thinner aptamers

APP Pharmaceutical continues support of FDA's USP standards for unfractionated heparin

Caraco closes Asset Purchase Agreement with Forest as part of ANDA patent litigation settlement

HSPH's survey on H1N1 vaccines

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

Reducing polypharmacy through innovative drug formulation technologies

Latest News