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Inviragen, SingVax merge their complementary vaccine pipelines

Inviragen and SingVax have merged their complementary vaccine pipelines and their international product development capabilities to create a company that is developing a wide range of vaccines for infectious diseases prevalent in emerging economies.

6 Oct 2009

Fresenius Medical Care to offer seasonal influenza and H1N1 flu vaccines

As the Centers for Disease Control and Prevention (CDC) predicts a more severe flu season this year, people with chronic health conditions are especially at risk and can develop a more severe illness from any influenza infection, including the H1N1 virus.

6 Oct 2009

Vaccine to treat cocaine dependence reduces use of the drug, according to study

A vaccine to treat cocaine dependence appears to reduce use of the drug in a subgroup of individuals who attain high anticocaine antibody levels in response, according to a report in the October issue of Archives of General Psychiatry, one of the JAMA/Archives journals. However, only 38 percent of vaccinated individuals produced high enough antibody levels and those who did maintained them for only two months.

6 Oct 2009

Sequella receives ARRA funds to manufacture SQ109 for treating tuberculosis

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing novel antibiotics to treat life-threatening infectious diseases, today announced that it received a $694,000 grant supplement as part of the American Recovery and Reinvestment Act (ARRA) of 2009.

6 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

FDA's Oncologic Drugs Advisory Committee recommends approval of GlaxoSmithKline's VOTRIENT

GlaxoSmithKline today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of VOTRIENT(TM) (pazopanib). Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC). Pazopanib is an investigational, oral treatment for patients with advanced RCC.

6 Oct 2009

U.N. officials highlight need for vaccine assistance to poor countries

U.N. officials on Sunday said that the H1N1 (swine flu) virus had arrived in poorer countries, highlighting a growing need for financial assistance and H1N1 vaccines for such regions, SAPA/News24.com reports.

6 Oct 2009

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

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

Pharmaceutical News

Inviragen, SingVax merge their complementary vaccine pipelines

Fresenius Medical Care to offer seasonal influenza and H1N1 flu vaccines

Vaccine to treat cocaine dependence reduces use of the drug, according to study

Sequella receives ARRA funds to manufacture SQ109 for treating tuberculosis

Schering-Plough receives FDA recommendation approval for PEGINTRON

FDA's Oncologic Drugs Advisory Committee recommends approval of GlaxoSmithKline's VOTRIENT

U.N. officials highlight need for vaccine assistance to poor countries

FOLOTYN available for commercial sale in the United States

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

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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