AcelRx and Grunenthal Announce Collaboration for EU Commercialization of ZALVISO™

- FDA establishes the PDUFA action date of July 27, 2014 for Zalviso -

AcelRx Pharmaceuticals, Inc. (ACRX) and Grunenthal GmbH announced today that they have entered into a commercial collaboration, covering the territory of the European Union, certain other European countries and Australia for ZALVISO™ (previously known as ARX-01) for potential use in pain treatment within or dispensed by a hospital, hospice, nursing home or other medically supervised setting.  ZALVISO, a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device is AcelRx's lead program.  AcelRx retains all rights in remaining countries, including the U.S. and Asia.

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CytRx Reports Highly Statistically Significant Positive Results from its Global Phase 2b Clinical Trial

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial. The trial investigated the efficacy and safety of aldoxorubicin compared with doxorubicin in subjects with first-line metastatic, locally advanced or unresectable soft tissue sarcomas (STS). Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without the major dose-limiting toxicities seen with administration of doxorubicin alone.

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The Medicines Company Acquires Rempex Pharmaceuticals

Novel Portfolio of Gram-Negative Antibiotics in Development Added to The Medicines Company's Infectious Disease Hospital Care Franchise

The Medicines Company (NASDAQ: MDCO) today announced that it has acquired Rempex Pharmaceuticals, Inc., a company with multiple potential new therapies focused on multi-drug resistant gram-negative bacteria. 

Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company, said, "Acute and intensive care hospitals around the world face rapid and increasing antibacterial resistance, especially to gram-negative pathogens. The assets of Rempex, particularly Carbavance™, will allow us to intensify our efforts to save lives, alleviate suffering and contribute to the economics of healthcare by serving leading hospitals."

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Ampio Receives FDA Confirmation that The Spring Study is Pivotal and Will Initiate the Final Pivotal Trial for Ampion™ Biological License Application (BLA)

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting.  The FDA letter includes the following statements:

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ARIAD Announces Positive Opinion by the European Medicines Agency on the Continued Availability of Iclusig in Patients with Leukaemias

Recommendations made to minimize risk of occlusive vascular events

ARIAD Pharmaceuticals, Inc. (ARIA) today announced adoption of a positive opinion by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) on the continued availability of Iclusig® (ponatinib) in the EU for use in patients in its authorized indications. Following its review of updated clinical-trial data on Iclusig, the CHMP made a series of recommendations on measures to help minimize the risk of occlusive vascular events in patients taking Iclusig. The authorized indications of Iclusig, as approved in July 2013, are as follows:

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