Industry News

- Read more about Mersana Therapeutics and Takeda Expand Partnership
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.
- Read more about TAGRISSO™ approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive NSCLC
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).
- Read more about Bracco diagnostics inc. Get first u.s. Fda approval for barium-based product
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.
- Read more about ARIAD Announces FDA Clearance to Begin Clinical Development of AP32788
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.
- Read more about LivaNova PLC announces FDA approval of stented heart valve CROWN PRT™ for Aortic Valve Disease
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.
- Read more about Proteostasis Therapeutics Receives FDA Fast Track Designation for PTI-428
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).
- Read more about Dr. Reddy's Receives FDA Tentative Approval For Zenavod
Dr. Reddy's Lab (DRL) has received tentative approval from the US health regulator for anti-biotic Zenavod indicated for the treatment of a type of chronic skin disease in adult patients.

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- Read more about Allergan's Rapastinel Receives FDA Breakthrough Therapy Designation
Allergan plc. , a leading global pharmaceutical company announced that its Phase III ready investigational medication rapastinel (GLYX-13) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Major Depressive Disorder (MDD). This follows the Fast Track Designation for rapastinel granted by the FDA in 2014.
- Read more about MabVax Therapeutics Receives FDA Authorization for Phase I Clinical Trial with 89Zr-HuMab-5B1
MabVax Therapeutics Holdings, Inc., announces receipt of notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with 89Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer. The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015. MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.
- Read more about Matinas BioPharma Get FDA Clearance to Initiate Phase 1 Clinical Study of MAT2501
Matinas BioPharma Holdings, Inc., announced that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is authorized to initiate a Phase 1 clinical study for investigational drug, MAT2501 (encochleated amikacin), for the treatment of non-tuberculous mycobacterium (NTM) infections, its lead chronic indication.