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FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA.

7 Jul 2010

Cornerstone reacquires all development, commercial rights to HMGB1 related technology from MedImmune

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that the Company has reacquired all development and commercial rights to its high-mobility group box protein 1 (HMGB1) related technology from MedImmune, LLC.

6 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

BioNeutral, KRP complete manufacturing and distribution agreement

BioNeutral Group Inc., a specialty chemical technology-based life science company, announced today that it completed an agreement with Keystone Research and Pharmaceuticals for its proprietary formulations for use in the Veterinary, Dental and Cosmetic markets. The Terms are being held confidential.

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

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Adeona Pharmaceuticals, Inc., announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.

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

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

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

Bradmer intends to complete private placement of common shares

Bradmer Pharmaceuticals Inc. announced today that it intends to complete a private placement of up to 5,263,157 common shares at a price of $0.095 per share, for aggregate gross proceeds to the Corporation of up to $500,000.00.

5 Jul 2010

Quintiles announces strategic alliance agreement with UMMC as part of Prime Site program

Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today announced a strategic alliance agreement with the University Malaya Medical Centre as part of its unique Prime Site program - an initiative focused on accelerating the development of new and more effective medicines.

5 Jul 2010

PSR launches OrphanIQ website for companies involved in Orphan Drug development

PSR announced today the launch of its new service and dedicated website, OrphanIQ. OrphanIQ is a quick and easy way for companies involved in Orphan Drug development to ask a short question on a variety of topics without the need for setting up time-consuming agreements and contracts. Questions will be handled by the relevant expert, who will first assess whether the question can be answered without obtaining further information, and within a reasonable time-frame, and will subsequently provide a written answer.

5 Jul 2010

PSE launches new gPROMS Solids product at IFPRI annual meeting

Process Systems Enterprise (PSE), providers of the world-leading gPROMS high-fidelity process modelling environment and related ModelCare services, launched its new gPROMS Solids product at this week's annual meeting of the International Fine Particles Research Institute (IFPRI) in Spa, Belgium.

3 Jul 2010

C-SSRS is effective for monitoring suicidality in clinical trials: ERT

ERT , a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces that a recent survey of over 250 respondents reported that all clinicians polled found the Columbia Suicide Severity Rating Scale (C-SSRS) to be an effective method for prospectively monitoring suicidality.

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

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

Endo subsidiary successfully completes tender offer for HealthTronics' outstanding common stock

Endo Pharmaceuticals today announced the successful completion of the tender offer by its wholly owned subsidiary, HT Acquisition Corp., for all of the outstanding shares of common stock of HealthTronics, Inc..

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

Watson Laboratories receives FDA approval for Tacrolimus ANDA

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Tacrolimus 5 mg capsules, the generic equivalent to Astellas' Prograf® capsules.

2 Jul 2010

Pharmaceuticals News and Research

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Cornerstone reacquires all development, commercial rights to HMGB1 related technology from MedImmune

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

BioNeutral, KRP complete manufacturing and distribution agreement

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

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

EUSA grants Ohara Japanese rights to Erwinase oncology therapy

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

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

Bradmer intends to complete private placement of common shares

Quintiles announces strategic alliance agreement with UMMC as part of Prime Site program

PSR launches OrphanIQ website for companies involved in Orphan Drug development

PSE launches new gPROMS Solids product at IFPRI annual meeting

C-SSRS is effective for monitoring suicidality in clinical trials: ERT

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Impax confirms challenge of patent relating to RENVELA

Endo subsidiary successfully completes tender offer for HealthTronics' outstanding common stock

Strativa receives FDA approval for Zuplenz oral soluble film

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

Watson Laboratories receives FDA approval for Tacrolimus ANDA

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