Regulatory

Biohaven Receives Agreement From FDA on Initial Pediatric Study Plan for Rimegepant, a Second Generation Oral CGRP-Receptor Antagonist for the Acute Treatment of Migraine

November 20, 2017

NEW HAVEN, Conn., Nov. 20, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that the Company has received agreement from the U.S. Food and Drug Administration (FDA) on the initial pediatric study plan (iPSP) for orally-dosed rimegepant. Rimegepant is a second-generation, small molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed […]

United Therapeutics Announces Additional Six Months Of Regulatory Exclusivity For Adcirca®

November 20, 2017

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Nov. 20, 2017 /PRNewswire/ — United Therapeutics Corporation (NASDAQ: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Adcirca® (tadalafil) tablets through May 21, 2018, based on study results submitted by Eli Lilly and Company (Lilly) in response to a […]

FDA Grants Breakthrough Therapy Designation and Orphan Drug Designation to PellePharm for Topical Patidegib in Gorlin Syndrome

November 20, 2017

MENLO PARK, Calif.–(BUSINESS WIRE)–PellePharm, a clinical-stage biopharmaceutical company committed to targeting rare genetic dermatological conditions at the source, today announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy Designation and Orphan Drug Designation to topical patidegib for reduction of the life-long serious clinical morbidity and disease burden of persistently developing […]

U.S. Food and Drug Administration (FDA) Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy

November 20, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis (hATTR amyloidosis) with polyneuropathy. BTD is intended to expedite […]

Intra-Cellular Therapies Receives FDA Fast Track Designation for Lumateperone for the Treatment of Schizophrenia

November 20, 2017

NEW YORK, Nov. 20, 2017 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lumateperone for the treatment of schizophrenia. The Company requested Fast Track designation […]

Quanticate launches statistical monitoring services following the ICH GCP E6(R2) addendum

November 20, 2017

LONDON (UK) – Quanticate, a data-focused clinical research organisation (CRO), has launched its centralised statistical monitoring service (https://www.quanticate.com/centralized-statistical-monitoring) as an extension of its statistical consultancy offering in response to recent amendments to the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guidelines. The new service will offer Quanticate’s customers statistical consultancy that incorporates […]

Comprehend Systems Appoints New CEO in Response to Surging Demand for Clinical Intelligence Solutions; Enterprise Growth Expert to Scale Company and Expand Partner Ecosystem

November 20, 2017

Redwood City, Calif., November 13, 2017—Comprehend Systems, Inc., the leader in Clinical Intelligence solutions, has named Terry Cunningham CEO.  Cunningham will focus on scaling Comprehend in response to explosive customer demand for solutions that reduce time and risk in clinical trials. Cunningham will also drive expanded partner programs to help sponsors achieve faster, better clinical […]

Eftilagimod Alpha (LAG-3Ig Or IMP321) Pre-IND Meeting With the FDA

November 15, 2017

SYDNEY, Australia, Nov. 15, 2017 (GLOBE NEWSWIRE) — Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima”) is pleased to announce that it held a Pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in November to discuss the regulatory pathway for the development of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the […]

Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS

November 15, 2017

CAMBRIDGE, Mass., Nov. 15, 2017 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that all of its marketing applications for volanesorsen have been accepted for review in the U.S., EU […]

FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

November 14, 2017

Increased Use of Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation (M&S) is a Priority in Both the Prescription Drug User Fee Act and Generic Drug User Fee Amendments Certara®, the global leader in model-informed drug development and regulatory science, today announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s […]

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