Go-live of Werum’s PAS-X MES at Takeda’s API production site in Grange Castle, Ireland / Successful transformation to paperless factory / Huge benefits in quality, regulatory compliance, operations and data availability / PAS-X SAP interfaces for seamless data exchange Lüneb … Read More »

Award-winning Science and Medicine Team expands its expertise PHILADELPHIA, PA – August 20, 2019:  Signant Health, formerly CRF Health and Bracket, has appointed Anthony Todd Everhart, MD, FACP to the Signant Health Science and Medicine Team as Clinical Vice President, Inter … Read More »

Topic : The Roles And Responsibilities of a HIPAA Privacy & Security Officer Overview Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regul … Read More »

ACG Engineering – Designed in Europe, Made in India ACG Engineering (ACGE) – part of ACG Group, the only supplier in the world offering end-to-end manufacturing solutions for the pharmaceutical industry – has acquired Germany-based pharma processing equipment company, Xertec … Read More »

New facet to Contract Packager’s growing Cold Storage capabilities helps expand service offerings into biopharma sector   WAYNE, NJ – Reed-Lane, a New Jersey-based contract packaging provider serving leading pharmaceutical manufacturers, has added a dedicated room for vial a … Read More »

Pricing of $57.5 Million Public Offering of Preferred Stock and Warrants and Entry into Concurrent Private Placement of up to $70.0 Million of Preferred Stock and Warrants and $12.1 Million Upfront Option Fee In a release issued earlier today by Bellicum Pharmaceuticals, Inc … Read More »

Chicago, Aug. 16, 2019 – For the first time in its 38-year history, Chicago-based AbelsonTaylor, one of the world’s premier health and wellness advertising agencies, has a new president. Founder Dale Taylor announced today that Jeff Berg, formerly executive vice president an … Read More »

Knopp Biosciences LLC today announced the start of Phase 2 dose-ranging clinical trial in moderate-to-severe eosinophilic asthma. Recruitment in the trial is underway and the first patient has been enrolled. The Company anticipates reporting top-line data from this trial in … Read More »

Blauvelt, NY, August 13, 2019 – Schreiner MediPharm, a Germany-based global provider of specialty pharmaceutical labeling solutions, now offers a new forensic authentication feature for pharmaceutical labels in cooperation with Applied DNA Sciences. SigNature® DNA is a high- … Read More »

SILVER SPRING, Md., Aug. 15, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine re … Read More »

This research, which investigates the risk of drug-induced folate deficiency with HIV integrase inhibitors, was published in Drug Metabolism and Disposition (DMD) BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced … Read More »

NEW YORK (Reuters) – Novartis AG said on Wednesday it replaced the two top research and development executives at its Avexis unit after some data was manipulated from early testing of a gene therapy for infants that costs more than $2 million. Avexis’ Chief Scientific Office … Read More »

ZURICH (Reuters) – Swiss drugmaker Novartis (NOVN.S) has named company veteran Victor Bulto as head of its U.S. pharmaceuticals business, effective on Sept. 1. He replaces Fabrice Chouraqui, who will step down at the end of August, Novartis said in a statement. It gave no re … Read More »

Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections The U.S. Food and Drug Administrati … Read More »

SILVER SPRING, Md., Aug. 14, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. U.S. Foo … Read More »

John O’Brien, a former insurance industry executive, will step down less than one year after his appointment as senior advisory to HHS Secretary Alex Azar on drug-pricing reform. He had worked for HHS since March 2017 and also previously worked for CMS. By Alaric Dearment A … Read More »

By Alex Keown Eli Lilly is standing tall this morning after announcing that its psoriasis drug Taltz overcame Johnson & Johnson’s Tremfya in a head-to-head study. In a Phase IV post-marketing study, Indianapolis-based Eli Lilly said Taltz (ixekizumab) met the primary and … Read More »

CAMPBELL, CA and REDWOOD CITY, CA – (August 13, 2019) – Saama Technologies, Inc.(“Saama”) announced today that it has signed a definitive agreement to acquire Comprehend Systems, Inc.(“Comprehend”). This agreement combines Saama and Comprehend’s respective industry positions … Read More »

By George Underwood GlaxoSmithKline has poached Merck KGaA’s Maya Martinez-Davis to head up its US Pharmaceuticals division as it announces current president Jack Bailey will be stepping down at the end of the year. Martinez-Davis is currently regional president, Latin Ameri … Read More »

GSK today announced that Jack Bailey, President US Pharmaceuticals has decided to step down from his role at the end of the year. Bailey will be succeeded by Maya Martinez-Davis, currently Regional President, Latin America Region at EMD Serono, the biopharmaceutical business … Read More »