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Biostar receives Shaanxi SFDA approval to market Xin Aoxing Oleanolic Acid Capsules

Biostar Pharmaceuticals, Inc., the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule, and other pharmaceutical products, announced today it has received new advertising approval from Shaanxi State Food and Drug Administration for marketing Xin Aoxing Oleanolic Acid Capsules.

27 Apr 2010

Rib-X Pharmaceuticals to demonstrate three presentations at Antibacterial Drug Development Conference

Rib-X Pharmaceuticals, Inc., a development-stage antibiotics company with a broad product pipeline based on its innovative discovery platform, today announced that it will be presenting three separate presentations at the Cambridge Healthtech Institute's 4th Annual Antibacterial Drug Development Conference, Resistance is Futile: The Challenge of Antibacterial Drug Development, April 27 - 28, in San Diego, CA.

27 Apr 2010

Nuvo Research's PENNSAID now available in U.S. pharmacies

Nuvo Research Inc., a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.

27 Apr 2010

Pharmacological suppression of nonsense mutations effective in treating genetic defects

Genetic mutation can disrupt the way human cells make proteins, which in turn leads to inherited disease. David Bedwell, a professor in the University of Alabama at Birmingham (UAB) Department of Microbiology, says scientists are closer than ever to producing drugs that fix this disrupted-protein pathway and drastically improving treatment of genetic disease.

27 Apr 2010

Protalix BioTherapeutics submits validation data for taliglucerase alfa manufacturing process to the FDA

Protalix BioTherapeutics, Inc., announced today it has submitted validation data regarding the Company's manufacturing process for taliglucerase alfa to the U.S. Food and Drug Administration (FDA). The Company made the submission in response to a request from the FDA for validation data from the Company's upgraded manufacturing facility. The FDA is currently reviewing the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease.

27 Apr 2010

Scientists now closer to produce drugs to fix disease-causing mutations, spare healthy genes

Inherited diseases such as cystic fibrosis can be caused by genetic "nonsense mutations" that disrupt the way human cells make proteins. David Bedwell, Ph.D., a professor in the University of Alabama at Birmingham Department of Microbiology, says scientists are now closer to producing drugs that will fix this disruption and drastically improve treatment of genetic disease.

27 Apr 2010

CocE exhibits potential for clinical treatment of cocaine toxicity

Cocaine toxicity due to drug overdose results in more than half a million emergency room visits annually. Despite these alarming statistics, there is no Food and Drug Administration-approved pharmacotherapy specifically designed to treat cocaine toxicity. Emergency medical personnel are limited to treating only the immediate life-threatening symptoms of patients, while toxic levels of cocaine and its metabolic break-down products persist and continue to damage the cardiovascular system, liver and brain.

27 Apr 2010

Advair to remain favored fixed-dose LABA/ICS combination therapy through 2013 for asthma and COPD

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite increased competition from several emerging agents, GlaxoSmithKline's Advair will remain surveyed pulmonologists' and primary care physicians' (PCPs) favored fixed-dose long-acting beta2 agonist (LABA)/inhaled corticosteroid (ICS) combination inhaler through 2013 for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

27 Apr 2010

Invida to distribute and promote Ipsen's Diphereline, Somatuline Autogel and Increlex in South-East Asia

Ipsen, a global biopharmaceutical group, and Invida Group, the leading healthcare commercialization solutions partner in the Asia Pacific region, announced today an agreement for the exclusive distribution and promotion by Invida of Ipsen's drugs Diphereline® 3.75mg & 11.25mg, Somatuline® Autogel® and Increlex® in selected countries in South-East Asia.

27 Apr 2010

PPD confirms Japanese approval for Takeda's NESINA NDA

PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited's new drug application for NESINA® (alogliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare on April 16. PPD's compound partnering division collaborated with Takeda to develop this product.

27 Apr 2010

Patients can reduce frequency of Botox- Cosmetic injections and still receive same benefits: Research

Patients can decrease the frequency of Botox- Cosmetic injections after approximately two years and still receive most of the same wrinkle-smoothing cosmetic benefits, according to new research at Oregon Health & Science University.

27 Apr 2010

Watson Laboratories sued by Teva Women's Health over generic Cenestin ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, has been sued by Teva Women's Health, Inc., in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for synthetic conjugated estrogens, A, in the 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablet strengths. Watson's ANDA is for the generic equivalent of Teva's Cenestin®. The suit was filed on April 23, 2010, in the United States District Court for the District of New Jersey.

27 Apr 2010

Court of Appeals denies McNeil Pediatrics' CONCERTA patent appeal

The Court of Appeals for the Federal Circuit has denied an appeal by McNeil Pediatrics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., to overturn a 2009 decision by the U.S. District Court of Delaware that the patent for CONCERTA (methylphenidate HCl) Extended-Release Tablets CII is invalid and not infringed by Andrx Corporation.

27 Apr 2010

MorphoSys AG reports Q1 results for 2010

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results for the three months ending March 31, 2010 according to International Financial Reporting Standards (IFRS).

27 Apr 2010

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.

27 Apr 2010

Stinging FDA review for Acurox – the implications

The US FDA’s advisory panel’s decision to recommend against approval of Acura Pharmaceuticals/King Pharmaceuticals’ Acurox (oxycodone plus niacin) was based upon the view that data were lacking that niacin-induced flushing could potentially reduce misuse of Acurox with single-ingredient oxycodone. The panel also contended that clinical studies were not conducted in populations that might be likely to benefit from the drug’s purported abuse-deterrent properties, such as those with chronic pain and adolescents who are experimenting with drug use.

27 Apr 2010

Popular antidepressants may have beneficial side effects for cardiovascular health: Study

A class of antidepressants known as selective serotonin reuptake inhibitors may provide a boost to cardiovascular health by affecting the way platelets, small cells in the blood involved in clotting, clump together, say researchers at the Loyola University Medical Center in Maywood, Ill.

26 Apr 2010

Researchers show how analgesia should be carried out for children and adolescents

Properly performed analgesia protects children from pain and traumatization. In the current issue of Deutsches Ärzteblatt International, Christoph Neuhäuser and his colleagues show how analgesia for children and adolescents should be carried out.

26 Apr 2010

New syndicated report covers the use of DMAs for treatment of MS published

BioTrends is pleased to announce the publication of a new syndicated report, TreatmentTrends: Multiple Sclerosis. This report covers the use of disease-modifying agents for the treatment of multiple sclerosis, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth and expected future use.

26 Apr 2010

Aton Pharma acquires the U.S. marketing rights to LODOSYN tablets from BMS

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has acquired the U.S. marketing rights to LODOSYN (carbidopa) tablets from Bristol-Myers Squibb Company.

26 Apr 2010

Pharmaceutical News

Biostar receives Shaanxi SFDA approval to market Xin Aoxing Oleanolic Acid Capsules

Rib-X Pharmaceuticals to demonstrate three presentations at Antibacterial Drug Development Conference

Nuvo Research's PENNSAID now available in U.S. pharmacies

Pharmacological suppression of nonsense mutations effective in treating genetic defects

Protalix BioTherapeutics submits validation data for taliglucerase alfa manufacturing process to the FDA

Scientists now closer to produce drugs to fix disease-causing mutations, spare healthy genes

CocE exhibits potential for clinical treatment of cocaine toxicity

Advair to remain favored fixed-dose LABA/ICS combination therapy through 2013 for asthma and COPD

Invida to distribute and promote Ipsen's Diphereline, Somatuline Autogel and Increlex in South-East Asia

PPD confirms Japanese approval for Takeda's NESINA NDA

Patients can reduce frequency of Botox- Cosmetic injections and still receive same benefits: Research

Watson Laboratories sued by Teva Women's Health over generic Cenestin ANDA

Court of Appeals denies McNeil Pediatrics' CONCERTA patent appeal

MorphoSys AG reports Q1 results for 2010

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

Stinging FDA review for Acurox – the implications

Popular antidepressants may have beneficial side effects for cardiovascular health: Study

Researchers show how analgesia should be carried out for children and adolescents

New syndicated report covers the use of DMAs for treatment of MS published

Aton Pharma acquires the U.S. marketing rights to LODOSYN tablets from BMS

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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