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Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

US WorldMeds launches Revonto for malignant hyperthermia

US WorldMeds is proud to announce the launch of Revonto™ (dantrolene sodium for injection), the first patented scientific advancement in the treatment of malignant hyperthermia (MH). The time to reconstitute dantrolene sodium for injection has been dramatically reduced to approximately 20 seconds or until the solution is clear. Revonto™ retains the cost-savings of the original dantrolene sodium for injection product while offering a significant improvement in pharmacotherapy.

7 Jul 2010

Pfizer's new chewable Lipitor for children receives European Commission approval

Pfizer Inc. announced it has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.

7 Jul 2010

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment.

6 Jul 2010

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

Hard to Treat Diseases, Inc. and Shenzhen Mellow Hope are excited to announce that the company has secured a new business partner in Ethiopia through which Mellow Hope will distribute biomedical vaccines.

6 Jul 2010

EMA completes validation process for Dyax's ecallantide MAA

Dyax Corp. announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU).

6 Jul 2010

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

Columbia Laboratories, Inc. announced today that it has closed the sale of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc.. Columbia's business now consists of its royalty and manufacturing revenues, potential milestone payments, its collaboration with Watson on the development of next-generation progesterone products, and its novel bioadhesive drug delivery technologies and other products.

6 Jul 2010

EUSA grants Ohara Japanese rights to Erwinase oncology therapy

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has granted the Japanese development and commercialization rights to its oncology therapy Erwinase(R) to Ohara Pharmaceutical Company Limited. The agreement represents the first product partnership EUSA has established in Japan.

6 Jul 2010

$CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL$

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. announced today that it has submitted an expanded Pediatric Investigation Plan to the European Medicines Agency, as part of the process for its submission for a Marketing Authorization Application for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

6 Jul 2010

APP receives FDA marketing clearance for preservative-free Heparin Lock Flush Solution

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market preservative-free Heparin Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL and 100 USP Units/1 mL, and will soon launch these single dose vial presentations.

6 Jul 2010

Antioxidant supplements increase artery elasticity in patients with multiple cardiovascular risk factors

Long-term supplementation with dietary antioxidants has beneficial effects on sugar and fat metabolism, blood pressure and arterial flexibility in patients with multiple cardiovascular risk factors. Researchers writing in BioMed Central's open access journal Nutrition and Metabolism report these positive results in a randomized controlled trial of combined vitamin C, vitamin E, coenzyme Q10 and selenium capsules.

6 Jul 2010

Novel therapy slows tumor growth in 85% of advanced breast cancer patients: Study

A novel therapy designed to attack tumors in patients with a genetic mutation in either BRCA1 or BRCA2, slowed tumor growth in 85 percent of advanced breast cancer patients treated in a small study, researchers report in the July 6 issue of The Lancet.

6 Jul 2010

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Neurim Pharmaceuticals confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

6 Jul 2010

Neogenix Oncology files patent application with USPTO for 16C3 antigen

Neogenix Oncology announced today that the company has filed a patent application with the U.S. Patent and Trade Office (USPTO) for the 16C3 antigen. The Company believes that this antigen is tumor specific for pancreatic and colorectal tumors; and, based on preliminary clinical data, may also have diagnostic utility as a biomarker for these cancers.

3 Jul 2010

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Fera Pharmaceuticals is pleased to announce the launch of Neptazane (Methazolamide) 25 mg and 50 mg tablets. Both strengths are available in 90 count bottles.

3 Jul 2010

Intellipharmaceutics provides update on generic version of Effexor XR

Intellipharmaceutics International Inc., today announced the following with regard to its generic drug commercialization activities.

3 Jul 2010

Impax confirms challenge of patent relating to RENVELA

Impax Laboratories, Inc. today confirms that it has initiated a challenge of a patent listed by Genzyme Corporation in connection with RENVELA® (sevelamer carbonate for suspension), 2.4 g and 0.8 g.

3 Jul 2010

Strativa receives FDA approval for Zuplenz oral soluble film

Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

3 Jul 2010

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

Watson Pharmaceuticals, Inc. today completed the acquisition of the U.S. rights to Columbia Laboratories' CRINONE® and PROCHIEVE® progesterone gel product line and 11,200,000 shares of Columbia common stock.

3 Jul 2010

Today's OpEds: Insurance premium caps; Doc shortage; High-risk pool

The insurer's proposed premium hikes are staggering, but the problem is that medical costs have been growing considerably faster than inflation. AB 2578 would help put a check on unjustified hikes ... The Assembly passed the bill last month, and we urge the Senate to follow suit (7/2).

3 Jul 2010

Pharmaceutical News

Shire receives FDA approval of Daytrana for ADHD in adolescents

US WorldMeds launches Revonto for malignant hyperthermia

Pfizer's new chewable Lipitor for children receives European Commission approval

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

EMA completes validation process for Dyax's ecallantide MAA

Columbia closes sale of progesterone related assets and 11.2M shares to Watson

EUSA grants Ohara Japanese rights to Erwinase oncology therapy

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

APP receives FDA marketing clearance for preservative-free Heparin Lock Flush Solution

Antioxidant supplements increase artery elasticity in patients with multiple cardiovascular risk factors

Novel therapy slows tumor growth in 85% of advanced breast cancer patients: Study

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Neogenix Oncology files patent application with USPTO for 16C3 antigen

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Intellipharmaceutics provides update on generic version of Effexor XR

Impax confirms challenge of patent relating to RENVELA

Strativa receives FDA approval for Zuplenz oral soluble film

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

Today's OpEds: Insurance premium caps; Doc shortage; High-risk pool

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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