Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms
Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.
China’s State Council has released a wide-ranging set of policy incentives intended to eliminate regulatory barriers and improve market access for innovative drugs.
Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.
Anti-PBM sentiment continues to rise, but industry observers still question whether the reforms being discussed will be effective.
EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.
Any Trump Administration policy involving international pricing should include foreign governments paying higher prices, as well as lowering US prices, CEOs say.
A TD Cowen survey explored expectations about the impact of the Inflation Reduction Act, access to 340B discounts and general price trends.
If all goes to plan, improvements the national health technology assessment agency wants to make to its drug review procedures – including the tailored, complex and accelerated access reviews – could become effective for applications received in the first half of 2025.
Major foreign pharma industry groups in Japan are threatening to pull out of a planned public-private council initiative over a proposed sales tax on certain drugs to fund drug discovery.
The policies for China’s biopharma industry in 2024 centered around innovative small molecules, biologics and cell and gene therapies. Regulation changes for the industry in 2025 could be a continuation of that.
A draft royal decree would pave the way for more transparency in pricing and reimbursement decision-making processes and boost competition to increase the participation of generic medicines.
Multiple industry groups in Japan warn that a decision to implement an "off-year" drug price revision in April will reverse other recent policy moves to support innovation.
Data illustrates the 2025 Medicare Part D plan landscape, including changes in premiums and plan options.
Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.
If successful, the new CMS cell and gene therapy access model eventually could expand to oncology or hemophilia products, an Avalere Health expert said.
The much-anticipated report from the US Centers for Medicare and Medicaid Services is heavily redacted and lacks a specific justification for the prices, but preserves agency flexibility to shape the program going forward.
The FDA will stay open, but its rare disease priority review voucher program will wind down after not being renewed on 20 December. PBM reform and other industry priorities also were nixed at the last minute in an effort to avoid a government shutdown.
EU legislators must be “mindful” that any changes made to the EU orphan medicines framework and its incentive structure will impact drugmakers and patients for the next two decades, says Soraya Bekkali, head of Europe, Canada, and international at Alexion.