This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Policy revisions on individual liability for corporate misconduct, noncompliance with agency guidance documents and dismissal of False Claims Act cases suggest a greater willingness by DoJ leadership to reconsider arguments often raised by life sciences companies, attorneys say at a Food and Drug Law Institute conference.

Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.

In an interview with the Pink Sheet, Laura and John Arnold Foundation VP Health Care Mark Miller discusses the foundation’s ongoing drug pricing priorities.

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna anti-itch lotion, Zeasorb anti-fungal product, Desenex athlete’s foot treatment and Mineral Ice pain-relieving gel. Deals also helps UK pharma pay for its $5.1bn acquisition of oncology drug firm Tesaro.