Industry News

- Read more about U.S. FDA approved Expanded Indication on Edwards SAPIEN 3 Transcatheter Heart Valve
Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.
- Read more about Innovus Pharma’s Partner Khandelwal Laboratories receive Approval of Product Licenses by the Indian FDA
Innovus Pharmaceuticals, Inc. announced that its partner Khandelwal Laboratories received the approval of the product licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products in India.
- Read more about FDA grant Tentative Approval to Supernus pharma for Expanded Label of Trokendi XR
Supernus Pharmaceuticals, Inc. announced that the Food and Drug Administration (FDA) has granted tentative approval to the Company's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults.
- Read more about US FDA grants orphan drug status to Pulmatrix's inhaled drug
The US Food & Drug Administration (FDA) has granted orphan drug status for Pulmatrix Inc's inhaled drug for treating pulmonary fungal infections in cystic fibrosis (CF) patients, named PUR1900.
- Read more about Portola Pharma MAA for IndexXa accepted for review by EMA
Portola Pharmaceuticals Inc.announced that the MAA for IndexXa™ (andexanet alfa; trade name in the United States is AndexXa™), a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review. IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery.
22 August 2016

Cerulean present phase 2 study top line results of CRLX101 & Avastin combo in relapsed RCC

Cerulean Pharma Inc, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), announced top-line results from the company's phase 2, randomized, multi-center clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in the treatment of patients with advanced renal cell carcinoma (RCC).
- Read more about AMERIGEN generic version of Temodar approved by FDA
Amerigen Pharmaceuticals Limited announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg).
- Read more about Zymeworks’ ZW25 and ZW33 Granted Orphan Drug Designation by U.S. FDA
Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer. Orphan drug designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.

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- Read more about Quidel’s Solana(R) Trichomonas Assay Receives FDA Clearance
Quidel Corporation announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its Solana® Trichomonas assay for the detection of nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection from the Trichomonas vaginalis parasite. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.
- Read more about Portola Pharmaceuticals Receives CRL from FDA for BLA for AndexXa
Portola Pharmaceuticals Inc. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor Xa inhibitors.