Pharma News

Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

Mersana Therapeutics and Takeda Pharmaceutical Company Limited  announced that they have entered a new strategic partnership granting Takeda rights to Mersana’s lead product candidate, XMT-1522, outside the United States and Canada. The deal also expands an existing collaboration between the companies to provide Takeda with additional access to Mersana’s Fleximer® antibody-drug conjugate (ADC) platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of these programs in the United States. In addition, the companies will co-develop new payloads for use with ADCs.

XMT-1522 is an investigational, Fleximer-based ADC therapy that targets HER2-expressing tumors, including breast, gastric and non-small cell lung cancers. Preclinical data suggest that XMT-1522 may have anti-tumor activity in patients with HER2 low-expressing cancers as well as in patients with HER2 high-expressing cancers that do not respond to currently available HER2-targeting therapies. Mersana anticipates filing an Investigational New Drug application (IND) for XMT-1522 with the U.S. Food and Drug Administration (FDA) in mid-2016.

AstraZeneca  announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced the U.S. Food and Drug Administration (FDA) approved E-Z-HD for use in double-contrast radiographic examinations of the esophagus, stomach.

ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for AP32788, a tyrosine kinase inhibitor (TKI) designed as a targeted therapy for patients with non-small cell lung cancer (NSCLC) with specific mutations in EGFR or HER2. ARIAD anticipates initiation of its Phase 1/2 clinical trial of AP32788 in patients with NSCLC in the second quarter of 2016.

LivaNova PLC, announced it has been granted approval from the United States Food and Drug Administration (FDA) for its innovative stented aortic bioprosthesis CROWN PRT for the treatment of aortic valve disease.  This is the second valve to be approved in the U.S. this year and is expected to be launched in the coming months.  LivaNova’s Perceval valve, the sutureless biological valve on the market for aortic valve replacement procedures, was approved on January 8, 2016.

Proteostasis Therapeutics, Inc., announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PTI-428, an investigational oral treatment for cystic fibrosis (CF).

The widespread belief that radiations from X-rays and CT scans can cause cancer has flaws and is based on an unproven theoretical model, suggests a study.

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Parkinson's patients are prone to a higher risk of injurious falls and hip fractures, a study reveals.The disease, which breaks down specific nerve cells and is usually diagnosed at around the age of 70, has an insidious onset affecting mobility and balance at first that can be traced to at least two decades back, the study said.

Researchers have found that depriving cancer cells of an essential nutrient could offer a promising new approach for the treatment of an aggressive form of kidney cancer.