US FDA advisory committee panelists argue that prospective, randomized Phase III trials fail to reflect real-world treatment decisions.

US Centers for Medicare and Medicaid Services announces first-year results from its medication therapy management model, intended to optimize prescription drug use among Medicare beneficiaries.

With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.

Amid ongoing talks to denuclearize North Korea, the two Koreas are gearing up for bilateral cooperation in various industries including the health and medical sector, if and when international sanctions on the North are lifted. A new report suggests possible ways the two sides can initially work together in the area, with a focus on infectious diseases.

NICE, the health technology appraisal body for England and Wales, has rejected criticism that access to cancer drugs is worsening in the UK. The institute pointed to the revamped Cancer Drugs Fund which it said meant more positive recommendations.

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.

The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.

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.