United States

Catalent, Biota Pharmaceuticals expand alliance

Tuesday, July 16, 2013 09:30 AM

Catalent Pharma Solutions, a global development solutions and advanced drug delivery technologies company, and Biota Pharmaceuticals have allied to develop and provide filling and packaging capabilities to supply clinical trial materials of laninamivir octanoate, a first-in-class, inhaled, long-acting neuraminidase inhibitor being developed by Biota to treat influenza A and B viruses.

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BNA, JPNI among 30 sites in ACADIA clinical trial

Monday, July 15, 2013 01:35 PM

Boulder Neurosurgical & Spine Associates (BNA) and the Justin Parker Neurological Institute (JPNI) are among approximately 30 sites in the U.S. participating in the ACADIA clinical trial. The trial seeks to evaluate the safety and efficacy of the ACADIA Facet Replacement System, an investigational device for treatment of lumbar spinal stenosis (LSS).

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FTC seeks information on proposed Actavis acquisition of Warner Chilcott

Monday, July 15, 2013 01:17 PM

Actavis, a globally integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products, and Warner Chilcott, a supplier of inhalation drug development, delivery and supply capabilities, have both received a request for additional information from the Federal Trade Commission (FTC) in connection with Actavis' pending acquisition of Warner Chilcott. The information request was issued under notification requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act").

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Forte launches Overture electronic data capture system

Friday, July 12, 2013 03:14 PM

Forte Research Systems, a developer of clinical research management software, has launched its electronic data capture (EDC) system. Overture EDC is for researchers in the academic setting that need a system to handle complex clinical research protocols.

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FDA, EMA approve C-Path’s simulation tool for Alzheimer’s trials

Friday, July 12, 2013 02:16 PM

Both the FDA and the EMA have independently reached favorable decisions on the value of independent nonprofit Critical Path Institute’s (C-Path) new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease (AD).

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Michael J. Fox Foundation announces research partners

Friday, July 12, 2013 01:50 PM

Research projects from five biopharmaceutical companies in the U.S., Canada and Israel comprise the 2013 first half of The Michael J. Fox Foundation for Parkinson's Research (MJFF) Partnering Program. Participants' research projects are presented directly to industry groups that may wish to invest in further development. By connecting industry leaders with those studies ripe for investment, the Foundation aims to drive forward promising research in Parkinson's disease (PD) through the pipeline of drug development and eventually into patients' hands.

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Whole genome sequencing of Alzheimer’s patients to be made available to researchers

Friday, July 12, 2013 01:28 PM

The Alzheimer's Association and the Brin Wojcicki Foundation have announced new data has been generated by the "Big Data" project for Alzheimer's disease. The data will be made freely available to researchers worldwide to advance Alzheimer's science.

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Acorda Therapeutics acquires neuropathic pain assets

Thursday, July 11, 2013 12:30 PM

Acorda Therapeutics, a biotechnology company focused on developing therapies that restore function and improve the lives of people with MS, spinal cord injury and other neurological conditions, has acquired two neuropathic pain management assets from NeurogesX. Qutenza is approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia. The company also acquired NP-1998 (previously NGX-1998), a phase III ready, prescription strength capsaicin topical solution.

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Asubio broadens inclusion criteria for spinal cord injury trial

Thursday, July 11, 2013 10:00 AM

Asubio Pharmaceuticals has expanded enrollment for its ASCENT-ASCI (Asubio Spinal Cord Early Neuro-recovery Treatment for Acute Spinal Cord Injury) trial to include AIS A, B and C injury to the cervical spine. ASCENT-ASCI is a phase II clinical trial evaluating SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.

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Azaya Therapeutics launches Parexo Labs

Wednesday, July 10, 2013 12:14 PM

Azaya Therapeutics, an oncology company focused on developing cancer treatments through its nanotechnology platform, has launched a new division, Parexo Labs, a contract development and manufacturing organization (CDMO) providing chemical testing and liposomal manufacturing services to outside organizations.

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