Policy & Regulation: Page 5
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Q&ABird flu puts BARDA back in the spotlight
BARDA director Gary Disbrow explains the agency’s focus, how companies can get their “foot in the door” and why platforms are so important for preparedness.
By Alexandra Pecci • July 23, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
By Susan Kelly , Elise Reuter • July 16, 2024 -
Explore the Trendline➔
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TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
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Has pharma emerged from the ‘age of uncertainty’?
An industry reeling from a precarious market is showing signs of stabilizing as the future becomes a little less cloudy, an Evaluate report suggests.
By Michael Gibney • July 16, 2024 -
Rebecca Pifer/PharmaVoice
As feds crack down on PBMs for drug costs, Big Pharma could lose some of the heat
Drugmakers pointed the finger at PBMs for being the culprit behind rising drug prices in the U.S. for years — now, an ongoing FTC investigation has their back.
By Michael Gibney • July 11, 2024 -
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The FDA pushes concrete plans to further diversity in clinical trials
The long-awaited guidance offers a more detailed road map for pharma.
By Kelly Bilodeau • July 8, 2024 -
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The IRA will lower U.S. drug spending, CMS finds — but not for awhile
As the first 10 drugs undergo price negotiations with the U.S. government, the latest spending projections reveal soon-to-be-implemented price caps will have an impact by 2027.
By Amy Baxter • July 1, 2024 -
Courtesy of Novo Nordisk
Will the real Ozempic please stand up? Lilly, Novo face uphill counterfeit battle
Weight loss market leaders are warning patients and healthcare providers about the risks associated with knockoff versions of their popular obesity meds — and taking legal action.
By Amy Baxter • June 26, 2024 -
Permission granted by Geron
After 33 years, Geron’s first approval marks a turn in Nobel-winning science
The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.
By Alexandra Pecci • June 26, 2024 -
Jens Schluete via Getty Images
Q&ACan Moderna’s COVID-flu combo shot improve flagging vaccination rates?
A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.
By Michael Gibney • June 25, 2024 -
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NIH-funded trials fall flat on diversity goals
Many clinical trials aren’t meeting enrollment inclusion checkpoints — and some aren’t even setting targets, according to a recent OIG report.
By Amy Baxter • June 20, 2024 -
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Despite adcomm rejection, Lykos CEO sees future for MDMA drug
Although the rebuff makes approval “a bit more challenging,” Lykos is moving forward with the psychedelic-based treatment for PTSD.
By Alexandra Pecci • June 12, 2024 -
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FDA’s platform designation aims to ease R&D pain points
A new program creates approval pathways for multiple drugs developed on the same platform.
By Amy Baxter • June 11, 2024 -
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Deadline looms for Chinese biotech contracts
The latest version of The Biosecure Act working its way through Congress could make waves in the U.S. biotech industry.
By Amy Baxter • May 31, 2024 -
Permission granted by Cravath, Swaine & Moore
As Senate’s gaze lands on patents, a former US PTO chief calls the effort a ‘broad misunderstanding’
To lower drug prices, lawmakers are turning to the drug patent system to outlaw some common practices — but a former patent agency director says it’s the wrong way to go.
By Michael Gibney • May 30, 2024 -
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FTC request may signal trouble for Novo/Catalent deal
As Novo Nordisk aims to secure its manufacturing foothold for GLP-1s, regulators are digging for clues of anti-competitive behavior.
By Kelly Bilodeau • May 29, 2024 -
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Where competition is heating up in pharma
The stage is set for potential blockbuster-level showdowns targeting these three indications.
By Meagan Parrish • May 24, 2024 -
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Drug shortages, cost concerns and iffy access — how DTC and telehealth could even the playing field
Companies like UpScriptHealth led the charge with online prescriptions decades ago, and now the industry is catching on to solve some of healthcare’s most pressing issues.
By Michael Gibney • May 22, 2024 -
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Why H5N1 has scientists and regulators on edge
While the H5N1 threat to humans is still low, the recent influenza outbreak in cattle is presenting strange and challenging hurdles for containment.
By Meagan Parrish • May 17, 2024 -
Permission granted by Novartis
Big Pharma leaders juggle pricing and access as IRA and supply constraints loom large
Execs from J&J, Novartis, Novo Nordisk and AbbVie sound off on the Inflation Reduction Act, supply issues and launch preparations in a tricky environment.
By Michael Gibney • May 16, 2024 -
Courtesy of AbbVie
Biosimilars are gaining ground. The IRA could push them even further next year.
As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.
By Amy Baxter • May 13, 2024 -
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5 trends impacting drug spend in the U.S.
Key factors changing how much Americans spend on prescriptions.
By Kelly Bilodeau • May 13, 2024 -
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Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown
The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.
By Michael Gibney • May 9, 2024 -
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As drug shortages reach record highs, regulators float next steps
With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.
By Kelly Bilodeau • May 6, 2024 -
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FDA’s new diagnostic rules draw pharma criticism
Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.
By Amy Baxter • May 6, 2024 -
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$4M+ gene therapies? How payers can adapt to a new reality of pricey ‘cures’
Pricey gene therapies promise great benefit to patients but pose a threat to the payer landscape — ICER and a Tufts think tank are offering potential solutions.
By Michael Gibney • May 2, 2024
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