Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director.
Investigators have identified a second individual who remained cognitively normal into his late 60s despite having the PSEN1 E280A mutation, which causes a familial version of early-onset Alzheimer’s disease (AD). The likely source of protection, a mutation in a gene called Reelin, is distinct from the protective mechanism identified in the first case of an individual who was protected from the effects of PSEN1 E280A. That case was reported in 2019.
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress.
Barely a month and a half after its radioconjugate approach landed a potential $1.7 billion deal with Novartis AG, Bicycle Therapeutics plc drew another big radiopharma player to the table, signing a collaboration agreement with Bayer AG to use Bicycle’s peptide technology to discover and develop radiotherapies against cancer targets. Terms are similar to the Novartis deal, with Bayer paying $45 million up front and Bicycle eligible for development and commercial milestones totaling up to $1.7 billion, and underline the growing interest in the radiopharma space.
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.).
With the COVID-19 public health emergency ending in the U.S. next week, Congress is looking to use the lessons learned from the pandemic to draft a new iteration of the Pandemic and All-Hazards Preparedness Act to ensure the country is better prepared for the next pandemic.
While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.
Radiopharmaceuticals have been used for a long time for diagnostics, but radiopharma therapies are entering a new era in which they are becoming widely accepted as a key tool in the oncology armamentarium potentially providing patients with a big bump in efficacy with fewer side effects and less damage to healthy tissue. In this eight-part series, BioWorld takes a deep dive into this new treatment modality to explore what the new uses or alternatives are and what the future of radiopharmaceutical therapy might look like. Part one sets the stage and outlines the beginnings of the industry and some of the challenges drugmakers will need to overcome. The series takes a closer look at the different radiopharmaceutical moieties, the science behind them, the patient journey, the therapies in the pipeline, the regulatory landscape, and the supply chain vulnerabilities.
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years.
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