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FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

9 Aug 2010

Dr Reddy’s launches first generic darbepoetin alfa

Dr. Reddy's Laboratories Ltd. announced today the launch of Cresp® - the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Cresp® has been approved in India for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy.

9 Aug 2010

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Roche announced today that after priority review, Health Canada has approved HERCEPTIN(R) (trastuzumab), in combination with XELODA(R) (capecitabine) or intravenous 5-fluorouracil and cisplatin, for the first-line treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach (gastric cancer) or gastro-esophageal cancer.

9 Aug 2010

Clinical Data first-quarter gross revenue increases 52% to $6.2 million

Clinical Data, Inc. today announced operational and financial results for the first quarter ended June 30, 2010, noting key accomplishments including the acceptance of the Company's new drug application (NDA) for vilazodone by the U.S. Food and Drug Administration (FDA) and the successful completion of a public offering .

9 Aug 2010

AOBO to launch Yin Yang balancing medication Pai Du Qing Zhi Tablet

American Oriental Bioengineering, Inc., a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter products, today announced that its Boke brand Pai Du Qing Zhi Tablet, a prescription medicine aimed at achieving the balance of Yin Yang by regulating metabolism, in order to cleanse the blood and detoxify, dispose of hemorrhoids, fight obesity and lower hyperlipemia, will be commercially launched in the third quarter of 2010.

9 Aug 2010

AOBO announces commercial launch of osteoporosis drug Yi Shen Jian Gu Gel

American Oriental Bioengineering, Inc., a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter ("OTC") products, today announced the commercial launch of Boke brand Yi Shen Jian Gu Gel ("YSJG" Gel) after successful test marketing in the second quarter of 2010.

9 Aug 2010

Repros Therapeutics receives positive feedback from FDA for Androxal

Repros Therapeutics Inc. today announced that the Company has received positive written feedback from the FDA (the "Agency") regarding the Company's drug candidate Androxal. The Agency concurred with Repros' indication statement for the use of Androxal in the treatment of secondary hypogonadism in men wishing to preserve fertility.

9 Aug 2010

An overview of SRVP annual meeting

Islamic countries have acknowledged the importance of self-reliance in vaccine production and are committed to establishing closer cooperation towards achieving it, as they ended their 6th Annual Meeting of Self-Reliance in Vaccine Production (SRVP), in Bandung, Indonesia.

9 Aug 2010

AstraZeneca reaches agreements in principle on monetary terms for SEROQUEL product liability

AstraZeneca announced today that, as of August 9, it had reached agreements in principle on monetary terms with attorneys representing approximately 17,500 SEROQUEL product liability claimants in the United States for approximately $198 million. The agreements in principle are subject to agreement on non-monetary terms.

9 Aug 2010

Anti-viral drug addition to standard treatment regimen increases cure rate for hepatitis C

Adding a direct acting anti-viral drug to the standard treatment regimen for hepatitis C significantly increases the cure rate in the most difficult to treat patients, according to a research report published Monday in the online edition of the journal The Lancet.The research team, led by Paul Kwo, M.D., of Indiana University School of Medicine, reported that adding the drug nearly doubled the treatment's effectiveness when given for 48 weeks in one treatment arm of the study.

9 Aug 2010

Study finds selective serotonin reuptake inhibitors not beneficial for autistic children

Antidepressants commonly prescribed to people with autistic spectrum disorders cannot be recommended based on current evidence, a new study by Cochrane Researchers concludes. Despite some evidence of benefits in adults diagnosed with autism, they say there is no evidence for any benefits associated with selective serotonin reuptake inhibitors (SSRIs) in children, who may suffer serious adverse effects as a result of taking the drugs.

9 Aug 2010

45-year-old Hummelstown patient takes on FDA over Johnson & Johnson’s antibiotic Levaquin

Suffering from injuries to his brain, nerves, and tendons for over four years, 45-year-old John Fratti of Hummelstown, PA, has taken on the Food and Drug Administration with good results. Since taking Johnson & Johnson’s antibiotic Levaquin for an infection he has had many diagnostic studies on his brain and body that show considerable damage. Healthy and athletic at 41 years of age, he now takes multiple prescription pain medications for his injuries.

7 Aug 2010

Ironwood provides investor update for second-quarter 2010

Ironwood Pharmaceuticals, Inc. today provided an update on its business activities for the second quarter of 2010.

7 Aug 2010

EpiCept second-quarter net loss decreases to $4.9 million

EpiCept Corporation today announced operating and financial results for the three and six months ended June 30, 2010, and provided an update with respect to the Company's key business initiatives.

7 Aug 2010

Opexa Therapeutics aims to complete planned experiments, develop clinical study protocols

Opexa Therapeutics, Inc., a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended June 30, 2010 and provided an update on its corporate developments.

7 Aug 2010

BMS to join ranks of AIDS drug companies to offer price concessions

Bristol-Myers Squibb will soon announce an agreement that will provide additional cost savings to cash-strapped ADAPs nationwide. The agreement, with the ADAP Crisis Task Force (ACTF) of the National Alliance of State & Territorial AIDS Directors, is expected to be announced any day. BMS has been the target of a sustained advocacy campaign led by AHF over its pricing of its key AIDS drug Reyataz.

7 Aug 2010

Bloomberg Businessweek explores growing trend in pharma to license, donate HIV drugs

"Pharmaceutical companies, once blasted as uncaring or downright greedy for charging thousands of dollars for a year's worth of AIDS medicines … in poor countries, lately have been slashing prices and licensing their drugs for free or nominal cost to nonprofits or local manufacturers in the developing world," Bloomberg BusinessWeek writes in an analysis piece that examines how this trend, combined with a growing capability among aid agencies to distribute drugs, has the potential to increase access to HIV/AIDS drugs worldwide.

7 Aug 2010

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

7 Aug 2010

FDA seeks ban on Regenerative Sciences for violating cGMP

The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the "Rx only" symbol.

7 Aug 2010

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Alkermes, Inc. today reported financial results for its first quarter of fiscal 2011, which ended on June 30, 2010.

7 Aug 2010

Pharmaceutical News

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Dr Reddy’s launches first generic darbepoetin alfa

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Clinical Data first-quarter gross revenue increases 52% to $6.2 million

AOBO to launch Yin Yang balancing medication Pai Du Qing Zhi Tablet

AOBO announces commercial launch of osteoporosis drug Yi Shen Jian Gu Gel

Repros Therapeutics receives positive feedback from FDA for Androxal

An overview of SRVP annual meeting

AstraZeneca reaches agreements in principle on monetary terms for SEROQUEL product liability

Anti-viral drug addition to standard treatment regimen increases cure rate for hepatitis C

Study finds selective serotonin reuptake inhibitors not beneficial for autistic children

45-year-old Hummelstown patient takes on FDA over Johnson & Johnson’s antibiotic Levaquin

Ironwood provides investor update for second-quarter 2010

EpiCept second-quarter net loss decreases to $4.9 million

Opexa Therapeutics aims to complete planned experiments, develop clinical study protocols

BMS to join ranks of AIDS drug companies to offer price concessions

Bloomberg Businessweek explores growing trend in pharma to license, donate HIV drugs

FDA confirms Advisory Committee meeting date for lorcaserin NDA review

FDA seeks ban on Regenerative Sciences for violating cGMP

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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