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Bayer receives FDA priority review for copanlisib to treat follicular lymphomaGerman drug manufacturer Bayer has received priority review designation for the new drug application (NDA) for copanlisib from the US Food and Drug Administration (FDA). The experimental drug is indi2017/6/1
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Eli Lilly Scores Phase III Migraine Success with GalcanezumabOn May 12, 2017, Eli Lilly announced the successful Phase III results for its calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, for the prophylactic treatment of episodic and c2017/6/1
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EU nations urge funding to research new drugs and vaccines for tuberculosisLeaders representing the French and Netherlands governmentshave urged for funding to develop new treatment and prevention tools against drug-resistant tuberculosis (TB) at a meeting held in Brussels.2017/5/31
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US FDA issues CRL to Hikma’s generic version of GSK’s Advair DiskusHikma Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) of its generic version of GlaxoSmithK2017/5/31
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Good Distribution Practices for Pharmaceutical ExcipientsIPEC Europe is pleased to announce that this important webinar will be held on 22 June 2017, at 14:30 CEST. The IPEC Federation very recently revisedits Good Distribution Practices for Pharmaceutic2017/5/26
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EU officials question 'unjustified' cancer drug pricing from AspenUpon receiving information thatAspen Pharmacare has taken steep price increases on lifesaving cancer meds in Europe and threatened to pull its products in order to get the hikes through, EUantitrust r2017/5/26
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Novartis, slammed by Korean scandal, tweaks its ethics, compliance policiesRocked by a corruption scandal in Korea and facing a kickbacks probe in Greece, Novartis says it's strengthening and simplifying its global ethics and compliance approach. The Swiss drug giant is aim2017/5/25
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Rheumatoid Arthritis Biosimilars: Regulatory and Clinical ConsiderationsPosted by Alicia M. Baker, Director, Global Regulatory Affairs Strategy, Covance Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in th2017/5/25
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J&J strikes settlement in ‘phantom’ Motrin recall suitJohnson & Johnsonhas finally gotten a consumer health care fiasco behind it when it agreed this week to pay Oregon $400,000 to settle a suit stemming from its efforts years ago to retrieve faulty2017/5/24
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Johnson & Johnson appeal of $72M talc verdict could hinge on Bristol-Myers Squibb's SCOTUS caseReeling from multiple court defeats over claims the company’s talcum powders caused ovarian cancer, Johnson & Johnson attorneys are taking their arguments to appeals court, hoping to turn back lia2017/5/24