While new legislation has pushed prescription drug pricing high up the political agenda for US lawmakers, the issue has also come into the spotlight again for Chinese regulators, which have just launched new investigations into two officials. While the two countries are taking drastically different routes to tackling pricing, the developments show compliance risks remain high in China.

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.

Kenny, a mainstay of our publications for three decades, has passed away in London.

As legislation authorizing Medicare price 'negotiation' clears the Senate and appears on its way toward enactment after years of efforts by US congressional Democrats, and opposition by Republicans and the pharmaceutical industry, the bill continues to be tweaked.

The difficulties in getting advanced therapies, such as Novartis’ CAR T therapy Kymriah, to patients have shifted and manufacturing capacity is no longer the biggest issue.

A budget-neutral fix that would extend the time before small molecule drugs are subject negotiations but increase the minimum discounts for the products is floated as the pricing legislation moves toward a Senate floor vote.

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.

Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.

Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.

A special podcast looks at the implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps, of the US Supreme Court’s historic overturning of Roe v. Wade.

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.

The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.

One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.

Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.