United States

Cempra receives complete response letter from FDA for solithromycin NDAs

Tuesday, January 3, 2017

Cempra, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, has announced that the company has received a Complete Response Letter (CRL) from the FDA relating to the company’s new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

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HHS/NIH finalize requirements for clinical trial reporting

Sunday, January 1, 2017

Faced with noncompliance of required reporting of clinical trial information, the U.S. Department of Health and Human Services (HSS) issued a final rule last September that gave more specifics about registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule also expanded the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological, and device products. National Institutes of Health (NIH)-funded trials fell under reporting requirements, as well, as the NIH issued a complementary policy at the same time. NIH-funded trials must register and submit summary results information to ClinicalTrials.gov even if the trials are not subject to the final rule. Although the enhancements add measures to improve the amount of clinical trial information on ClinicalTrials.gov, some researchers in favor of total transparency say that enforcement action and penalties still fall short.

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FDA accepts for review sNDA for Pfizer’s IBRANCE metastatic breast cancer

Friday, December 23, 2016

Pfizer has announced that the FDA accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE (palbociclib). The sNDA supports the conversion of the accelerated approval of IBRANCE in combination with letrozole to regular approval and includes data from the phase III PALOMA-2 trial, which evaluated IBRANCE as initial therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. This is the same patient population as the randomized phase II PALOMA-1 trial upon which the accelerated approval of IBRANCE plus letrozole was granted in February 2015. 

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Janssen Biotech submits stelara approval application for plaque psoriasis

Monday, December 19, 2016

Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.

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FDA accepts Bayer’s sBLA for myBETAapp and BETACONNECT Navigator

Thursday, December 15, 2016

Bayer has announced that the FDA has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECTNavigator. MyBETAapp is intended for patients taking BETASERON (interferon beta-1b), to help them record their treatment information such as drug injections and injection sites. The BETACONNECT Navigator is a tool that enables healthcare professionals the ability to review injection history for their patients.

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GSK opens new global vaccines R&D center in Rockville, Maryland

Tuesday, December 13, 2016

GlaxoSmithKline will inaugurate its newest global vaccines research and development (R&D) center in Rockville, Maryland, further strengthening and expanding its vaccines presence in the USA. Up to 200 new jobs will be created at the Rockville facility, with GSK investing over $50 million in the next two years to continue to develop the site with latest state-of-the-art scientific research technology and equipment.

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