The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.
The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
Unlock this story instantly and join 126,900+ biopharma pros reading Endpoints daily — and it’s free.
All the big R&D trends are on display in this new list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 60 new drug approvals for last year, topping the 59 in 2020. That’s a close second to the 64 OKs that came out of the FDA in 2018. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.
Unlock this article along with other benefits by subscribing to one of our paid plans.
The FDA quietly announced on Tuesday that just before New Year’s eve, the agency again paused all of its non-mission-critical inspections in the US, likely leading to an even larger backlog of inspections worldwide.
The pause, which will last at least two weeks, is meant to ensure the safety of FDA employees and the companies it regulates as the agency further adapts to the spread of Omicron.
Jeff Albers and Kate Haviland (Brad Bahner Photography/PR Newswire)
After a busy 2021 brought Blueprint Medicines its fourth FDA approval, the company is kicking off the new year with plans to shake up its C-suite.
Jeff Albers, Blueprint’s CEO for the past eight years, will be stepping down April 4 and transitioning to the executive chairman position, the biotech announced Wednesday morning. He will be replaced by COO Kate Haviland, who moves into both the chief executive and president roles. Christina Rossi also nabs a promotion from chief commercial officer to COO.
Unlock this story instantly and join 126,900+ biopharma pros reading Endpoints daily — and it’s free.
For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
Shoshana Shendelman, Applied Therapeutics CEO/founder
When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were then on a smooth road toward an accelerated approval, with plans to file an NDA in the third quarter of 2021.
Regulators, though, apparently changed their mind.
Applied has decided to hold on submitting an NDA for AT-007 as a treatment for galactosemia, the company disclosed, following discussions with the FDA in which the agency indicated that ‘clinical outcomes data will likely be required for approval.’
Tom Riga, Spectrum Pharmaceuticals CEO
Covid-19 has been a rough go for many drugmakers, but few more so than Spectrum Pharmaceuticals, which has seen inspection delays and unwanted CRLs haunt its chance at a first approval. Feeling the sting, Spectrum will now downsize to keep the lights on through the year.
Spectrum will cut 30% of its workforce and pivot its R&D efforts around its two furthest-along drugs as part of a restructuring effort that will pave the company’s cash runway out into next year, it announced Wednesday.
https://endpts.com/fda-roundup-agency-restructures-chief-scientists-office-first-vote-on-rob-califf-as-commissioner-pushed-to-next-week/
