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Rentschler Biopharma SE appoints Dr. Christian Hunzinger as Senior Vice President Project Management
Rentschler Biopharma SE announced the appointment of Dr. Christian Hunzinger (48) as the new Senior Vice President Project Management, effective from January 15, 2019.
Robert Jacks, co-founder and former chief financial officer of Symbiomix Therapeutics, has taken over the reins of Cambridge, Mass.-based Indalo Therapeutics and will help guide the company in the development of therapies for patients suffering from serious fibrotic diseases such as NASH and idiopathic pulmonary fibrosis (IPF).
The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices.
The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
Since taking over the helm of GlaxoSmithKline in 2017, Chief Executive Officer Emma Walmsley has made some significant moves to redefine the company as one focused on the development of pharmaceuticals.
The former executives have been charged with initiating kickback schemes, as well as falsifying data, to increase sales of its powerful opioid Subsys.
Taiwan Liposome Company, Ltd. announced the appointment of George Spencer-Green, MD, MS, as TLC’s new Chief Medical Officer.
As the chief executive officer of Ovid Therapeutics, Jeremy Levin has a lot on his plate. But, there is one thing always in the forefront of Levin’s mind – the patients his company can serve.
Once the user fees run out, the employees paid by them will be furloughed if the government doesn’t get back to work. There are numerous companies with PDUFA dates later than the dates that have been noted.
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