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Phase III clinical study: Vimpat demonstrates fewer partial-onset seizures versus placebo in adults with epilepsy

UCB today announced that the antiepileptic drug (AED) Vimpat® (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia.

12 Mar 2010

VisEn Medical introduces VivoTag 680 XL fluorescent dye for labeling biomolecules

VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced today the commercial launch of its new VivoTag® 680 XL fluorescent dye for labeling biomolecules in a broad range of in vitro and in vivo imaging applications.

12 Mar 2010

Medivir AB announces license agreement with Daewoong Pharmaceutical for MIV-210 drug

Medivir AB (Sweden) today announced a license agreement with Daewoong Pharmaceutical Co. Ltd., (South Korea) for its hepatitis B virus (HBV) polymerase inhibitor drug, lagociclovir valactate (MIV-210).

12 Mar 2010

$ASBMR Task Force studies link between long-term bisphosphonate usage and rare bone fractures$

ASBMR Task Force studies link between long-term bisphosphonate usage and rare bone fractures

Recent reports suggesting a link between long-term bisphosphonate usage and rare bone fractures have sparked rising concern among patients, health care professionals and the public. The American Society of Bone and Mineral Research (ASBMR) is examining this urgent clinical issue and will present its findings later this year.

12 Mar 2010

Ipsen grants Rhythm exclusive global license for melanocortin and ghrelin programs

Ipsen, a global biotechnology specialty care group, and Rhythm Pharmaceuticals, a biotechnology company developing peptide therapeutics for metabolic diseases, announced today that they have concluded a license agreement for Ipsen’s proprietary peptide therapeutics targeting obesity, metabolic diseases, and gastrointestinal disorders.

12 Mar 2010

Generic Focalin XR patent suit: Intellipharmaceutics International announces settlement

Intellipharmaceutics International Inc. today announced that Novartis Pharmaceuticals Corporation and Celgene Corporation have settled their patent suit in the U.S. District Court for the District of New Jersey, and Elan Pharma International Ltd. has settled its patent suit in the U.S. District Court for the District of Delaware, with Intellipharmaceutics Corp., a wholly-owned subsidiary of Intellipharmaceutics International, and its licensee Par Pharmaceutical, Inc. over a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR® (dexmethylphenidate hydrochloride).

12 Mar 2010

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration for ciprofloxacin dry powder inhaler for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients. A similar designation has already been granted by the European Medicines Agency.

12 Mar 2010

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

The Pharmaceutical Research and Manufacturers of America spent $6.3 million lobbying Congress and other government arms on health care in the fourth quarter of 2009, The Associated Press reports. PhRMA "spent just 2 percent more than the $6.17 million it paid out for lobbying in the year-ago period.

12 Mar 2010

WHO welcomes Gates Foundation support in advancing global vaccine efforts

WHO welcomes the Bill & Melinda Gates Foundation pledge of US$ 10 billion over the next ten years to accelerate global vaccine efforts.

12 Mar 2010

HTDS receives Registration Certificate for MEVAC-Vari vaccine in Guatemala

Hard to Treat Diseases and its subsidiary Mellow Hope announce that the company received Registration Certificate for its MEVAC-Vari vaccine in Guatemala.

12 Mar 2010

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Azur Pharma Limited today announced it has signed a definitive agreement with Elan Pharmaceuticals, Inc. (a subsidiary of Elan Corporation, plc) to acquire the analgesic therapy, PRIALT(R) (ziconotide intrathecal infusion).

12 Mar 2010

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

Sigma-Aldrich announces global licensing agreement with CSIRO for RAFT agents

Sigma-Aldrich (Nasdaq: SIAL) announced today that it has entered into a worldwide licensing agreement with Australia's Commonwealth Scientific and Industrial Research Organization (CSIRO) to manufacture and sell Reversible Addition-Fragmentation chain Transfer (RAFT) agents – organic molecules that can be added to polymerization reactions to precisely control molecular weights and structures of polymers.

12 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

FDA warns healthcare professionals about bogus surgical mesh products

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

11 Mar 2010

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2009.

11 Mar 2010

Legalising cannabis: School children debate

Should cannabis be legalised? This thorny political issue will be debated by teams of school children in a national competition designed to challenge the pupil's scientific knowledge. The event is part of the Festival of Social Science organised by the Economic and Social Research Council (ESRC) and will be staged at the Royal Pharmaceutical Society of Great Britain.

11 Mar 2010

Helix BioMedix enters into distribution agreement with RubyDerm Bio

Helix BioMedix, Inc., a developer of bioactive peptides, announced that the Company entered into an agreement with RubyDerm Bio, Inc. under which RubyDerm will assume responsibility, on an exclusive basis, for the distribution of certain of Helix BioMedix’s branded prestige skin care products to spas, beauty stores, hospitals, clinics, physicians, and consumers in South Korea, China and Japan.

11 Mar 2010

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

11 Mar 2010

Pharmaceutical News

Phase III clinical study: Vimpat demonstrates fewer partial-onset seizures versus placebo in adults with epilepsy

VisEn Medical introduces VivoTag 680 XL fluorescent dye for labeling biomolecules

Medivir AB announces license agreement with Daewoong Pharmaceutical for MIV-210 drug

ASBMR Task Force studies link between long-term bisphosphonate usage and rare bone fractures

Ipsen grants Rhythm exclusive global license for melanocortin and ghrelin programs

Generic Focalin XR patent suit: Intellipharmaceutics International announces settlement

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

WHO welcomes Gates Foundation support in advancing global vaccine efforts

HTDS receives Registration Certificate for MEVAC-Vari vaccine in Guatemala

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

Sigma-Aldrich announces global licensing agreement with CSIRO for RAFT agents

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

FDA warns healthcare professionals about bogus surgical mesh products

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Legalising cannabis: School children debate

Helix BioMedix enters into distribution agreement with RubyDerm Bio

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

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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