Pharmaceutical News

RSS

Europe's pharma sector faces increasing challenges

The Wall Street Journal: "After a healthy second quarter, Europe's pharmaceutical sector may find itself in trouble in the months ahead as companies face patent expiries, tougher regulation and burdensome health care reforms.

26 Aug 2010

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec and Elan Corporation, plc today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma

26 Aug 2010

FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy

Actelion Pharmaceuticals US, Inc., today announced that the U.S. Food and Drug Administration has approved the brand name VELETRI® for the company's epoprostenol for injection therapy. VELETRI has been commercially available since April 2010 as Epoprostenol for Injection for the treatment of moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease. Actelion plans to release VELETRI-labeled product by early fourth quarter of 2010.

26 Aug 2010

New syndicated report highlights medical management of noninfectious uveitis

BioTrends Research Group, Inc. is pleased to announce the publication of a new syndicated report, TreatmentTrends: Noninfectious Uveitis. This report, based on feedback gathered in an on-line survey completed by 72 retinal specialists in June/July 2010, addresses the medical management of noninfectious uveitis (anterior, intermediate, posterior and panuveitis) and referral/co-management patterns between retinal specialists and other specialties.

25 Aug 2010

Somaxon Pharmaceuticals, Procter & Gamble to co-promote Silenor

Somaxon Pharmaceuticals, Inc. today announced that Somaxon and Procter & Gamble have entered into a co-promotion agreement for Silenor (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.

25 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Perrigo obtains FDA clearance to manufacture infant formula products

Perrigo Company announced it received FDA clearance on August 23, 2010 to manufacture infant formula liquid concentrate and ready-to-use products through its partner Kerry Proteins and Nutritionals located in Sainte Claire, Quebec.

25 Aug 2010

Shire receives FDA ruling on Pentasa Citizen's Petition

Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa.

25 Aug 2010

Inspire Pharmaceuticals, Allergan sign amended agreement for ophthalmic formulations

Inspire Pharmaceuticals, Inc. announced today it has entered into an Amended and Restated License, Development and Marketing Agreement with Allergan, Inc., which revises terms related to the PROLACRIA (diquafosol tetrasodium ophthalmic solution) 2% development program and Inspire's right to receive revenues from Allergan based on net sales of RESTASIS (cyclosporine ophthalmic emulsion) 0.05% and any other human ophthalmic formulations of cyclosporine owned or controlled by Allergan.

25 Aug 2010

Warner Chilcott receives FDA response to citizen petition for ASACOL and ASACOL HD products

Warner Chilcott plc today announced that it has received the Food and Drug Administration's response to a citizen petition it had filed regarding its ASACOL and ASACOL HD products.

25 Aug 2010

WHO grants prequalification status to pneumococcal vaccine, paving way for U.N. procurement

The WHO "has granted prequalification status to Pfizer Inc.'s children's pneumococcal vaccine, Prevenar 13, paving the way for United Nations agencies and governments to start ordering the product," the Associated Press reports (8/23).

25 Aug 2010

OXIS International to introduce new ergothioneine-based products for joint health and healthy aging

OXIS INTERNATIONAL, INC. is proud to announce that it will introduce the benefits of Ergothioneine to the consumer market in September 2010 via breakthrough products for joint health and healthy aging. The first products, ErgoFlex® and ErgoPlex®, will initially be marketed via a direct mail offering being developed in partnership with Creative Direct Marketing Group, the leading service provider in the direct mail sector of the direct to consumer channel.

25 Aug 2010

Physicians decrease LABA/ICS combination therapy for asthma treatment: Survey

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that some surveyed physicians indicate that they will decrease their overall prescribing of long-acting beta2 agonists (LABA)/inhaled corticosteroids (ICS) combination therapies over the next 12 months for the treatment of asthma in response to the U.S. Food and Drug Administration's new safety controls for LABA-containing medications.

25 Aug 2010

Study: No association between first-trimester exposure to antiherpetic antiviral drugs and major birth defects

An analysis of data from Denmark finds no associated increased risk of major birth defects for mothers who were exposed during the first trimester of pregnancy to the antiviral drugs acyclovir, valacyclovir, and famciclovir, often used to treat herpes simplex and herpes zoster infections, according to a study in the August 25 issue of JAMA.

25 Aug 2010

Cedarlane to distribute Pfenex's high value reagent proteins in Canada, U.S.

Pfenex Inc. and Cedarlane today announced that they have entered into a non-exclusive distribution agreement. Cedarlane will market and distribute high value reagent proteins produced by Pfenex to researchers in Canada and the United States.

25 Aug 2010

CAS researchers confirm Gleevec’s first generation drug targets chronic myelogenous leukemia

Today, leukemia patients who have struggled with cancer therapy resistance and intolerance will now have more options thanks to targeted drug therapy. Such new treatment options are due, in part, to a rapid increase in journal and patent publications following the discovery of Gleevec, as reported by Chemical Abstracts Service (CAS), the world's authority for chemical information.

25 Aug 2010

Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

Simulations Plus, Inc.,a leading provider of simulation and modeling software for pharmaceutical discovery and development, has announced the launch of Version 7.0 of GastroPlus, the industry's gold standard software for the simulation of drug absorption, pharmacokinetics, and pharmacodynamics.

25 Aug 2010

Study finds measurable immunity to pandemic H1N1 virus in Norway population

By autumn 2009, almost half of the population of Norway had been vaccinated against the pandemic influenza A (H1N1) virus. Many had also been infected by the virus during the summer and autumn outbreaks. The majority of those who were vaccinated or were infected are expected to have developed immunity to the virus.

25 Aug 2010

Two diabetes medications increase risk of heart attack, failure: Study

In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same about 4 percent for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

25 Aug 2010

Kamada, Baxter enter distribution and manufacturing agreement for Glassia Alpha-1 Antitrypsin Product

Kamada, Ltd., a biopharmaceutical company engaged in development, production and marketing of specialty life-saving therapeutics and Baxter International Inc., a global, diversified healthcare company announced today that they have entered into an exclusive distribution and manufacturing agreement for Kamada's liquid, ready to use, intravenous Alpha-1 Antitrypsin Product for the treatment of hereditary Alpha-1 Antitrypsin Deficiency approved by the USFDA on July 1st, 2010 for marketing under the trade name "Glassia™".

From Baxter International Inc. 25 Aug 2010

Pharmaceutical News

Europe's pharma sector faces increasing challenges

Biogen to publish data on two-step assay for anti-JC virus antibody detection

FDA approves brand name VELETRI for Actelion's epoprostenol for injection therapy

New syndicated report highlights medical management of noninfectious uveitis

Somaxon Pharmaceuticals, Procter & Gamble to co-promote Silenor

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Perrigo obtains FDA clearance to manufacture infant formula products

Shire receives FDA ruling on Pentasa Citizen's Petition

Inspire Pharmaceuticals, Allergan sign amended agreement for ophthalmic formulations

Warner Chilcott receives FDA response to citizen petition for ASACOL and ASACOL HD products

WHO grants prequalification status to pneumococcal vaccine, paving way for U.N. procurement

OXIS International to introduce new ergothioneine-based products for joint health and healthy aging

Physicians decrease LABA/ICS combination therapy for asthma treatment: Survey

Study: No association between first-trimester exposure to antiherpetic antiviral drugs and major birth defects

Cedarlane to distribute Pfenex's high value reagent proteins in Canada, U.S.

CAS researchers confirm Gleevec’s first generation drug targets chronic myelogenous leukemia

Simulations Plus launches Version 7.0 of GastroPlus software for pharmaceutical industry

Study finds measurable immunity to pandemic H1N1 virus in Norway population

Two diabetes medications increase risk of heart attack, failure: Study

Kamada, Baxter enter distribution and manufacturing agreement for Glassia Alpha-1 Antitrypsin Product

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

Latest News