The US Labor Department also added a proposed rule requiring PBMs to disclose additional compensation information to certain employer-plan sponsors.
A key UK database of new medicines in drug company pipelines is being updated to future-proof horizon scanning in the UK and include vaccines.
By accepting qualified data from overseas trials to support drug registration in China, recently revised regulations for the implementation of the country’s Drug Administration Law aim to solidify regulatory pathways for use of such data and the more efficient market entry of innovative drugs.
The Brazilian government wants to boost the country’s capabilities to develop radical innovation that leads to new therapies for the national health system.
Japan is gearing up for a Lower House election in February and the result could affect biopharma policies. Multiple political parties have laid out reform plans in the area should they win.
Newly revised regulations for the implementation of China’s Drug Administration Law transition to a market authorization holder/product-centered regulatory approach in response to the rapidly changing biopharma environment.
The HHS OIG advisory pertains to manufacturer sales to patients. OIG will seek stakeholder input regarding possible additional guidance on manufacturer arrangements with pharmacies, pharmacy benefit managers, telemedicine vendors and marketers.
The Irish government has struck new in-principle agreements with the innovator and off-patent pharmaceutical sectors to help make the health care system more sustainable.
The process will pit breast cancer treatment competitors Kisqali and Verzenio against each other as CMS develops pricing offers.
Enactment of a law delinking PBM compensation from list prices would still be a long-sought victory for pharma.
The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.
President Trump says something will be "worked out" with South Korea following his declaration that tariffs on the country would be increased to 25%, due to what he views as delays in implementing a bilateral trade deal.
An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?
Heavy hitters Keytruda and Opdivo got a pass in the third round of price negotiation because of the expanded orphan drug exemption in President Trump’s One Big Beautiful Bill.
The grilling of several leading US insurance executives by two House committees suggested one benefit from the Most Favored Nation pricing deals is that for one day, someone else was on the hot seat.
Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.
While drug manufacturers are unlikely to “pull out of the EU entirely,” geopolitical shifts driven by US tariff threats will mark a “categoric shift” as big pharma tries to “placate the Trump administration,” an analyst says.
It is “integral” that a planned increase in genomic testing supports access to treatments such as advanced therapies, says England’s chief scientific officer. Blood cancer and rare diseases are among the conditions expected to benefit from the country’s testing push.
Canada is looking to expedite the review of certain drug classes by tapping trusted foreign regulators in a bid to get new medicines to patients sooner.
Brazilian authorities say that some pharmaceutical companies exploit court cases brought by patients to secure drug access to achieve higher prices.