FDA

Medical Device Consultants names senior regulatory consultant

Wednesday, July 20, 2011 11:55 AM

Medical Device Consultants has named Brian Edwards senior regulatory staff consultant of its regulatory services group. He will be based in Minneapolis, Minn., where he will support clients with U.S. FDA and international medical device submissions.

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Aeterna Zentaris to present phase II AEZS-108 results

Wednesday, July 20, 2011 11:25 AM

Aeterna Zentaris will present the final phase II  results in endometrial cancer on its anticancer compound, AEZS-108, during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological  Oncology ("ESGO"), Sept. 11-14 in Milan, Italy.

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QRxPharma files NDA for MoxDuoR IR

Wednesday, July 20, 2011 11:16 AM

QRxPharma reported the initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the FDA.

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FDA approves LialdaR

Wednesday, July 20, 2011 11:13 AM

Shire, a global biopharmaceutical company, reported the FDA approved LialdaR (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

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Upsher-Smith launches phase III epilepsy study

Wednesday, July 20, 2011 11:08 AM

Upsher-Smith Laboratories initiated a phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted Orphan Drug designation for this use by the FDA.

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FDA pledges to work with medical entrepreneurs

Tuesday, July 19, 2011 01:02 PM

The head of the FDA pledged to work more closely with small medical technology companies, which have spent the last year alleging that the agency is needlessly slowing approvals of new drugs and devices, according to the Associated Press.

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Despite seeing benefits, industry awaits FDA final guidelines before adopting adaptive design trials

Monday, July 18, 2011 08:02 AM

The promise of adaptive design clinical trials exists, with increased ethical treatment of patients, greater likelihood of finding the optimal dose and shortened study duration. But a variety of sponsor and CRO barriers—lack of experienced personnel with the required skills and knowledge, misunderstood benefits and greater complexity of design and trial implementation—have slowed their widespread adoption.

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FDA names new deputy commissioner for medical products and tobacco

Friday, July 15, 2011 10:52 AM

The FDA has named former Dartmouth Medical School Dean Stephen Spielberg to the newly created position of deputy commissioner for medical products and tobacco, according to an internal letter sent to FDA employees obtained by Reuters.

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Inovio releases phase I flu vaccine results

Friday, July 15, 2011 10:27 AM

Inovio Pharmaceuticals, a developer of therapeutic and preventive vaccines against cancers and infectious diseases, announced that significant T cell and antibody responses were generated in its phase I clinical study of VGX-3400X, a SynCon DNA vaccine for the prevention of avian H5N1 influenza delivered using intramuscular (IM) electroporation.

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Chimerix launches AdV HALT trial

Friday, July 15, 2011 10:21 AM

Chimerix, a biotechnology company, has begun patient dosing in the AdV HALT trial.  The FDA has granted CMX001 Fast Track designation status for the development program for this indication.

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