Pharmaceutical News

RSS

Antibiotic protects against noise-induced hearing loss in young mice

A type of antibiotic that can cause hearing loss in people has been found to paradoxically protect the ears when given in extended low doses in very young mice.

28 Jan 2010

Sepracor's STEDESA NDA: FDA extends PDUFA action date

Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the STEDESA™ (eslicarbazepine acetate) New Drug Application (NDA) on April 30, 2010, which is a three-month extension to the original Prescription Drug User Fee Act (PDUFA) date of January 30, 2010.

28 Jan 2010

Good bacteria may help counteract negative effects of antibiotics in humans

Scientists have long pondered the seeming contradiction that taking broad-spectrum antibiotics over a long period of time can lead to severe secondary bacterial infections. Now researchers from the University of Pennsylvania School of Medicine may have figured out why.

27 Jan 2010

Vitamin D supplements can counter the effects of Crohn's disease

A new study has found that Vitamin D, readily available in supplements or cod liver oil, can counter the effects of Crohn's disease. John White, an endocrinologist at the Research Institute of the McGill University Health Centre, led a team of scientists from McGill University and the Universit- de Montr-al who present their findings about the inflammatory bowel disease in the latest Journal of Biological Chemistry.

27 Jan 2010

Large research gap exists in effectiveness, mechanism and safety of drugs in children

Only a few anti-spasticity medications used for children with cerebral palsy are backed by sufficient research to justify their use, according to a new review of scientific literature headed by a UT Southwestern Medical Center neurologist and conducted by a national panel of interdisciplinary experts nationwide.

27 Jan 2010

Gilead Sciences reviewing Notice Letter regarding Teva Pharmaceuticals' generic Viread ANDA

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate).

27 Jan 2010

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).

27 Jan 2010

WHO addresses handling of H1N1 at Council of Europe meeting

During a Council of Europe meeting on Tuesday to address the WHO's handling of the H1N1 virus, the WHO said it had not "fallen under the sway of drugs firms and exaggerated the dangers of the H1N1 flu virus, but said it might have handled the crisis better," Reuters reports.

27 Jan 2010

WellWorld Science officially launches Livea in the U.S.

After more than 30 years of research and an extensive open-label weight loss study, WellWorld Science® announces the official U.S. launch of Livea®, a doctor-developed, non-prescription, patent-pending appetite-control supplement that is unlike any other dietary supplement on the market.

27 Jan 2010

NIST researchers determine best practices for storing and monitoring refrigerated vaccines

Every year, billions of dollars worth of vaccines are shipped to thousands of medical providers across the country, and every year doctors must dispose of tens of millions of dollars worth of those vaccines because they became too warm or too cold while in storage.

27 Jan 2010

Spectrum Pharmaceuticals discontinues the development of ozarelix in BPH

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it is discontinuing development of ozarelix in benign prostatic hypertrophy (BPH).

27 Jan 2010

Acyclovir reduces occurrence of HSV-2 genital ulcers but does not affect HIV transmission

Research from a five-year international clinical study shows that acyclovir, a commonly prescribed drug used to suppress symptoms of the herpes virus, does not affect HIV transmission by people with both viruses.

27 Jan 2010

MU researcher develops EFdA compound that is more potent than current HIV therapies

With the help of effective drug therapies, HIV patients are living longer, healthier lives. Now, researchers want to improve these drug therapies and develop alternative preventative strategies, such as vaginal gels and creams that contain the same or related compounds used in treatments for people infected with HIV.

27 Jan 2010

Researchers identify new drugs to protect brain cells from neurological disease

Researchers have identified a compound that mimics one of the brain's own growth factors and can protect brain cells against damage in several animal models of neurological disease.

27 Jan 2010

USAN approves generic name "ulimorelin" for Tranzyme Pharma's TZP-101

Tranzyme Pharma today announced that the United States Adopted Name Council (USAN) has approved the generic name “ulimorelin” for Tranzyme’s novel, late-stage, prokinetic agent TZP-101. Ulimorelin, if approved, is expected to be a first-in-class drug for the treatment of gastrointestinal (GI) dysmotility indications in acute care (hospital-based) settings.

27 Jan 2010

Jubilant Biosys, Endo Pharmaceuticals expand their drug discovery partnership in oncology

Jubilant Biosys Ltd., a subsidiary of Jubilant Organosys Ltd., and Endo Pharmaceuticals ( ENDP)., of Chadds Ford, Pa., U.S.A., announced today that they have expanded their drug discovery partnership in oncology, following the successful delivery of an early stage milestone.

27 Jan 2010

Counterfeit version of Alli sold over the Internet: FDA warns

FDA is alerting consumers to an unsafe, counterfeit version of the weight-loss drug Alli sold over the Internet.

27 Jan 2010

USPTO grants Cenestra Health patent relating to high-purity omega-3 fatty acid formulations

Cenestra Health announced today that the U.S. Patent and Trademark Office has issued a key patent related to the company's high-purity omega-3 fatty acid formulations and their methods of use. U.S. Patent No. 7652068, entitled "Omega-3 Fatty Acid Formulations," covers a unique, high-purity formulation of the omega-3 fatty acids EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid).

27 Jan 2010

Potential risk factors in skipping insulin injections

More than half of people with diabetes who take insulin injections to control their diabetes say they have intentionally skipped an injection, with one-fifth of them reporting that they do so "sometimes" or "often," according to a study being published this month in Diabetes Care.

27 Jan 2010

Study: PROSTVAC-VF vaccine effective in treating patients with metastatic prostate cancer

In a newly published clinical trial, patients with metastatic prostate cancer who received a vaccine of harmless poxviruses engineered to spur an immune system attack on prostate tumor cells lived substantially longer than patients who received a placebo vaccine, report researchers at Dana-Farber Cancer Institute and affiliated organizations.

27 Jan 2010

Pharmaceutical News

Antibiotic protects against noise-induced hearing loss in young mice

Sepracor's STEDESA NDA: FDA extends PDUFA action date

Good bacteria may help counteract negative effects of antibiotics in humans

Vitamin D supplements can counter the effects of Crohn's disease

Large research gap exists in effectiveness, mechanism and safety of drugs in children

Gilead Sciences reviewing Notice Letter regarding Teva Pharmaceuticals' generic Viread ANDA

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

WHO addresses handling of H1N1 at Council of Europe meeting

WellWorld Science officially launches Livea in the U.S.

NIST researchers determine best practices for storing and monitoring refrigerated vaccines

Spectrum Pharmaceuticals discontinues the development of ozarelix in BPH

Acyclovir reduces occurrence of HSV-2 genital ulcers but does not affect HIV transmission

MU researcher develops EFdA compound that is more potent than current HIV therapies

Researchers identify new drugs to protect brain cells from neurological disease

USAN approves generic name "ulimorelin" for Tranzyme Pharma's TZP-101

Jubilant Biosys, Endo Pharmaceuticals expand their drug discovery partnership in oncology

Counterfeit version of Alli sold over the Internet: FDA warns

USPTO grants Cenestra Health patent relating to high-purity omega-3 fatty acid formulations

Potential risk factors in skipping insulin injections

Study: PROSTVAC-VF vaccine effective in treating patients with metastatic prostate cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Latest News