Industry News

- Read more about BioMarin announces that FDA will not take action on the Kyndrisa™ NDA by the PDUFA date
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.
- Read more about Faron Pharma recruits first patient in Pan-European phase III INTEREST study to treat ARDS
Faron Pharmaceuticals Ltd (Faron), the clinical stage biopharmaceutical company, has announced the enrollment of the first patient in the phase III INTEREST clinical programme for Traumakine for the treatment of acute respiratory distress syndrome (ARDS). Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs.
- Read more about FDA Grants Rare Pediatric Disease Designation to REGENXBIO's RGX-111 Gene Therapy
REGENXBIO Inc. a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).
- Read more about Amarantus Requests RPDD and ODD from US FDA to treat GCMN with Engineered Skin Substitute
Amarantus Bioscience Holding Inc. , a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.
- Read more about Lupin receive FDA approval for generic Femhrt tablets
Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.
- Read more about Dengvaxia, First dengue vaccine approved in Brazil
Sanofi Pasteur, the vaccines division of Sanofi, announced that Brazil has granted regulatory approval to Dengvaxia®, representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines earlier this month.
- Read more about Exelixis Completes Submission of NDA for Cabozantinib for Advanced Renal Cell Carcinoma Treatment
Exelixis, Inc. announced that it has completed the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.
- Read more about Lupin Receives FDA Approval for Potassium Chloride Extended Release Capsules
Drug major Lupin has received final approval from the US health regulator to market Potassium Chloride extended release capsules, used to treat potassium deficiency in the body, in the American market.
- Read more about Seattle Genetics and Bristol-Myers Squibb Initiate Phase 1/2 Clinical Trial of ADCETRIS®with Opdivo® (Nivolumab)
Seattle Genetics Inc. and Bristol-Myers Squibb announced that the companies have initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). This is the second of two trials being conducted under a previously announced clinical trial collaboration agreement between Bristol-Myers Squibb Company and Seattle Genetics. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Recent preclinical data suggest that ADCETRIS causes immunogenic cell death of tumor cells, providing rationale for combination with Opdivo, a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system.
- Read more about Takeda announce its New Business Venture with Teva in Japan
Takeda Pharmaceutical Company Limited and Teva Pharmaceutical Industries Ltd made the below follow-up announcement regarding the overview of their new business venture in Japan, which was initially disclosed on November 30, 2015 in the press release titled, "Teva and Takeda establish unique partnership to meet the wide-ranging needs of patients and growing importance of generic medicines use in Japan".