Regulatory Index News w/c 4 February 2019

Here is a selection of this week's news from around the world


Roche submits FDA supplemental biologics license application for Kadcyla

Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla (trastuzumab emtansine) to include the adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.

To read more follow this PharmaTimes link 


Pharma CEOs to testify in Senate drug pricing hearing

Chief executives of Pfizer, Merck & Co., Bristol-Myers Squibb, AbbVie and Sanofi all plan to attend an upcoming hearing in front of the Senate Finance Committee, the companies confirmed to BioPharma Dive, setting the stage for a high-profile confrontation between lawmakers and the pharmaceutical industry over prescription drug pricing.

To read more follow this BioPharmaDive link


Mylan takes step toward knocking down key patent for Biogen's top seller

The key patent protecting Biogen's top-selling drug in the U.S. is now under review by trademark officials. Should they strike down the patent, about half of the big biotech's stateside revenue could be at risk.

To read more follow this BioPharmaDive link


Mundipharma launches Pelmeg biosimilar in Europe

Mundipharma has announced the launch of Pelmeg (pegfilgrastim), a biosimilar of Neulasta, following its European Commission (EC) approval in November 2018.

To read more follow this PharmaTimes link


Merck and GSK join forces for difficult to treat cancers

Merck and GlaxoSmithKline (GSK) have announced a global alliance to jointly develop and commercialise M7824 (bintrafusp alfa), a novel immunotherapy with potential in multiple difficult to treat cancers.

To read more follow this PharmaTimes link


Sanofi turns R&D focus inward amid cuts to drug pipeline

French pharma Sanofi aims to source more of its drug pipeline internally, betting on its own research labs to deliver as the company reprioritizes how it will allocate the roughly 6 billion euros it plans to spend on R&D each year through 2021.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

07th February 2019

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