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Roche, X-Chem sign collaborative agreement

X-Chem, Inc. today announced the signing of a multi-year collaborative agreement with Roche to apply X-Chem's proprietary platform to the rapid discovery of drug candidates against several of Roche's high-value therapeutic targets.

2 Jul 2010

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

Caraco Pharmaceutical Laboratories, Ltd. has started shipping rivastigmine tartrate capsules. These products, approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA), are therapeutically equivalent to Exelon® capsules from Novartis.

2 Jul 2010

GSK, Genmab amend ofatumumab agreement

GlaxoSmithKline and Genmab A/S announced today an amendment to the ofatumumab co-development and commercialisation agreement. Under the terms of the amendment, GSK will take responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab in oncology indications.

2 Jul 2010

USPTO awards Furiex method patent for dapoxetine in treatment of premature ejaculation

Furiex Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office issued a patent on May 18, 2010, for the method for treatment of premature ejaculation using dapoxetine. Furiex developed dapoxetine in collaboration with Alza Corporation and its affiliates. U.S. Patent No. 7,718,705 includes claims directed to dosing dapoxetine on an as-needed basis, capturing the advantage dapoxetine has over other compounds in the same class, which require a pre-loading period for efficacy.

2 Jul 2010

United Therapeutics, Lee's Pharmaceutical enter distribution agreement for Remodulin Injection in China

United Therapeutics Corporation and Lee's Pharmaceutical Holdings Ltd. announced today that they have entered into an exclusive agreement for the distribution of Remodulin (treprostinil) Injection in China. Remodulin is a subcutaneously or intravenously administered prostacyclin analogue for the treatment of pulmonary arterial hypertension. Lee's Pharmaceutical is a leading Chinese pharmaceutical company with both a strong cardiovascular focus and extensive commercialization experience.

2 Jul 2010

Patients receiving TMP-SMX antibiotics are more likely to develop hyperkalemia: Study

Older adults taking the antibiotic combination trimethoprim-sulfamethoxazole (TMP-SMX)—widely prescribed for urinary tract infections—are at increased risk of elevated potassium levels, called hyperkalemia, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN).

2 Jul 2010

Lupin's Famotidine for Oral Suspension receives FDA approval

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the US Food and Drug Administration (FDA) for its Famotidine for Oral Suspension (40 mg / 5 mL). Commercial shipments of the product have already commenced.

2 Jul 2010

Wound Care Innovations signs distribution agreement with KOMED for CellerateRx

Wound Management Technologies, Inc. announced an important milestone in its planned growth strategy. Its wholly owned subsidiary Wound Care Innovations signed a distribution agreement with KOMED, LLC of Georgia for direct response advertising on television and niche online marketing of CellerateRx® in the United States.

1 Jul 2010

Watson commences shipment of generic Exelon

Watson Pharmaceuticals, Inc. announced today that, under a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis"), Watson has commenced shipment of a generic version of Exelon® (rivastigmine tartrate) 1.5mg, 3mg, 4.5mg and 6mg capsules. Exelon® is used to treat dementia in people with Alzheimer's disease.

1 Jul 2010

AstraZeneca announces new support program for patients on ARIMIDEX

AstraZeneca today announced a new patient support program for postmenopausal women with hormone receptor-positive early breast cancer who are prescribed ARIMIDEX. The program is designed to provide eligible patients with instant discounts, potentially saving the patient up to $300.

1 Jul 2010

FDA grants Cyclacel's sapacitabine orphan drug designation for AML and MDS

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

1 Jul 2010

Prasco to sell and distribute authorized generic version of ZEGERID capsules

Prasco Laboratories announced today that it is now shipping the authorized generic version of ZEGERID® (omeprazole/sodium bicarbonate) capsules. Authorized generics are generic pharmaceuticals manufactured identically to the brand product and sold under a private label. Under the terms of a distribution and supply agreement with Santarus, Prasco will sell and distribute the capsule form of Omeprazole/Sodium Bicarbonate in 20 mg and 40 mg strengths in the U.S. under the Prasco label.

1 Jul 2010

Survey: 66% of patients with metastatic colorectal cancer are now tested for KRAS

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has revealed new results from a global survey demonstrating that 66% of patients with metastatic colorectal cancer (mCRC) are now tested for KRAS to determine if they could benefit from a personalized therapy, such as Erbitux® (cetuximab). This represents a 50% increase in levels of KRAS testing in just one year.

1 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

ESMT CA study: Cutting pharmaceutical prices will reduce number of new medications

Cutting pharmaceutical prices will severely reduce the number of new medications making it to market, according to a groundbreaking independent study from ESMT Competition Analysis. For the first time, the study on 'Pharmaceutical Innovation and Pricing Regulation' clearly models and quantifies the direct link between strict regulation and low innovation.

1 Jul 2010

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Dartmouth Linguistics Professor Lewis Glinert and Jon Schommer, the associate head of the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, have examined the corporate websites dedicated to the 100 best-selling prescription drugs. They found a startling lack of consistency in an industry where advertising standards are regulated by the Food and Drug Administration.

1 Jul 2010

Researchers uncover potential drug treatment for noise-induced hearing loss

Researchers from the University of Auckland, New Zealand, have discovered that a potent new drug restores hearing after noise-induced hearing loss in rats. The landmark discovery found that injection of an agent called 'ADAC', activates adenosine receptors in cochlear tissues, resulting in recovery of hearing function. The finding paves the way for effective non-surgical therapies to restore hearing loss after noise-induced injury. Dr. Srdjan Vlajkovic and his team's work1 is published in a special edition of Springer's journal Purinergic Signalling, focusing on the inner ear.

1 Jul 2010

Endo responds to FDA Complete Response letter for FORTESTA NDA

Endo Pharmaceuticals has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.

1 Jul 2010

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Arena Pharmaceuticals, Inc. today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. 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.

1 Jul 2010

Eisai signs agreement with Arena Pharmaceuticals GmbH to commercialize lorcaserin

Eisai Inc., the U.S. pharmaceutical operation of Tokyo-based Eisai Co., Ltd., announced today that it has entered into an agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., for exclusive U.S. rights to commercialize lorcaserin, a drug candidate for potential use in the treatment of obesity, including weight loss, for patients who are obese (Body Mass Index or BMI ≥ 30) or overweight (BMI ≥ 27) with at least one weight-related co-morbid condition.

1 Jul 2010

Pharmaceutical News

Roche, X-Chem sign collaborative agreement

Caraco Pharmaceutical Laboratories commences marketing of rivastigmine tartrate capsules

GSK, Genmab amend ofatumumab agreement

USPTO awards Furiex method patent for dapoxetine in treatment of premature ejaculation

United Therapeutics, Lee's Pharmaceutical enter distribution agreement for Remodulin Injection in China

Patients receiving TMP-SMX antibiotics are more likely to develop hyperkalemia: Study

Lupin's Famotidine for Oral Suspension receives FDA approval

Wound Care Innovations signs distribution agreement with KOMED for CellerateRx

Watson commences shipment of generic Exelon

AstraZeneca announces new support program for patients on ARIMIDEX

FDA grants Cyclacel's sapacitabine orphan drug designation for AML and MDS

Prasco to sell and distribute authorized generic version of ZEGERID capsules

Survey: 66% of patients with metastatic colorectal cancer are now tested for KRAS

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

ESMT CA study: Cutting pharmaceutical prices will reduce number of new medications

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Researchers uncover potential drug treatment for noise-induced hearing loss

Endo responds to FDA Complete Response letter for FORTESTA NDA

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Eisai signs agreement with Arena Pharmaceuticals GmbH to commercialize lorcaserin

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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