The latest drug development news and highlights from our US FDA Performance Tracker.

Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.

Genentech inks second settlement of trastuzumab biosimilar litigation; suits ongoing against Amgen, Celltrion/Teva, and Samsung with joint claim construction proceedings.

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

Following pricing reforms earlier this year that industry saw as generally unfavorable, major pharma associations in Japan present a united front in calling for a broad range of policy revisions to promote an ecosystem that better fosters and rewards innovation.

Company revealed that US FDA agreed to accelerated approval pathway for voxelotor in sickle cell disease, with focus on stroke prevention. Updated data from a key trial was also released at ASH.

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.

Like the fabled Rip Van Winkle, FDA guidance on post-approval changes for drug substances has awakened after a long nap to a changed world. Industry is urging FDA to revise its draft in a way that’s less prescriptive and more in line with the science- and risk-based approaches, outlined in ICH Q8, Q9 and Q12 guidelines, that have emerged in the years after the agency withdrew its BACPAC guidance.

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.

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

Bayer will sell Coppertone sunscreen and Dr. Scholl’s foot care brands to focus on growing its core consumer health brands. Although the plan represents ‘failure” in turning around sales for both brands, it is a ‘sensible’ move, say analysts.