Faced with a CBO estimate that H.R. 5651 will increase federal spending in fiscal years 2013 through 2022, the House Energy and Commerce Committee applies a section that speeds FDA decisions on some petitions to biosimilars. This contrasts with the Senate bill, which allows FDA to require brand companies to sell products covered by limited distribution systems to generic firms.
The House Energy and Commerce Committee revised its FDA Reform Act (H.R. 5651) May 25 to provide for earlier market entry of biosimilars subject to some citizen petitions in an effort to reverse an unfavorable spending projection for the bill – a change that creates dueling visions for cost savings once the legislation reaches conference committee.
The new version of H.R. 5651 will go to the House floor May 30 as a substitute for the bill reported out of committee ([A#00120514019])
Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.
Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.
