All the big R&D trends are on display in this new, record-topping list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 61 new drug approvals for last year, topping the 59 OKs that had tied a record in 2020. 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.
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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.
Photo by Anthony Behar/Sipa USA)(Sipa via AP Images
Children between the ages of 12 and 15 years old are now eligible for a third dose of the Pfizer-BioNTech vaccine after the FDA authorized it Monday, as well as a third shot for those between 5 and 11 who are immunocompromised.
The FDA also shortened the time between the completion of a primary vaccine and a booster shot to five months for Pfizer’s jab, although Moderna’s booster interval remains at 6 months. The moves come as Omicron has ripped through the US, causing the number of positive cases to skyrocket.
Elizabeth Holmes leaves federal court after the verdict in San Jose, CA, Jan. 3, 2022 (Nic Coury/AP Images)
The Theranos saga has captivated the pharma world over the last two decades, from its founding to its sharp rise and even sharper decline. And late Monday, its founder and former CEO Elizabeth Holmes was found guilty on several counts related to misleading investors, with each carrying a maximum of up to 20 years in prison.
Jurors returned the verdict Monday evening, finding Holmes guilty on one count of conspiracy to commit wire fraud and three counts of wire fraud against specific investors, with several news outlets reporting on the result. Holmes was found not guilty on four counts related to defrauding patients and jurors deadlocked on three counts of misleading individual investors.
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.’
We’re talking weeks here, not months. — Stanley Erck, CEO of Novavax, to analysts on August 5.
In the U.S., we expect to submit our complete regulatory package to the FDA before the end of this year. — Erck on November 4.
Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month… — Novavax statement on December 31.
You can add one more broken promise from Novavax $NVAX on its Covid-19 vaccine application to the FDA.
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It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.
Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.
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Michel Vounatsos, Biogen CEO
A Korean business publication reported Wednesday that Samsung is in the process of making a buyout bid for Biogen, raising equal parts skepticism and anticipation around a possible deal.
The report from the Korea Economic Daily says that the Samsung Group – which has a long-term biosimilar partnership with Biogen – has offered to acquire Biogen for some $42 billion, a 20% improvement over the $35 billion recorded ahead of the report. That’s far less than what Biogen was trading for when hopes of a major windfall from their controversial Alzheimer’s drug Aduhelm still percolated.
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Five years after little Leo Pharma put up its dukes and $115 million in cash to acquire and advance tralokinumab for atopic dermatitis, the Danish biotech has crossed the regulatory finish lines with a year-end approval at the FDA.
The drug will be sold as Adbry and there’s no immediate word on pricing.
This is the 50th new drug approval from CDER this year, totting up to 60 for the year if you add 10 major biologic OKs to the mix. That marks a record number of new approvals from the agency, tipping the scales after hitting 59 in 2020 and 2018. And it’s an indication that despite a long litany of setbacks in CMC in other areas, the drumbeat of new approvals continues at chart-topping levels after the long and disastrous dry spell of the early 2000s — despite a global pandemic.
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BridgeBio CEO Neil Kumar had all but reserved the champagne to celebrate the success of its big Phase III study for acoramidis, designed to stabilize transthyretin and slow or halt the progression of TTR amyloidosis. They had bought out full rights to the drug in late 2020 and borrowed the first $450 million of a $750 million loan, adding to a hefty debt load while confidently predicting a straight march to the FDA in 2022.
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https://endpts.com/2021s-nda-list-includes-some-extraordinary-accomplishments-hitting-a-new-record-on-approvals-was-just-one/
