Policy & Regulation: Page 11
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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 -
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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 -
Explore the Trendline➔
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TrendlineArtificial intelligence & machine learning
After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.
By PharmaVoice staff -
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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 -
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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 -
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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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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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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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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$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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As AI proliferates in pharma, regulators look to catch up in clinical trials
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.
By Amy Baxter • May 1, 2024 -
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WuXi partnerships at risk as lawmakers target Chinese ties to biopharma
Why the legislation could throw a wrench into the supply chain for advanced therapies and how the industry has responded.
By Amy Baxter • April 22, 2024 -
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3 patent expirations in 2024 and how companies are pivoting
As the cliffs approach, pharma companies are tackling the sales hit with diverging strategies.
By Amy Baxter • April 17, 2024 -
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Deep DiveUkraine was pharma’s ‘darling’ of clinical trials. As war drags on, will the industry come back?
New clinical trial starts are picking back up, but are still far below their bustling pre-war level.
By Meagan Parrish • April 16, 2024 -
Permission granted by eClinical Solutions
Q&AHow pharma’s surging M&A is impacting the industry’s tech sector
As dealmaking in biopharma picks up, the CEO of eClinical Solutions sees an opportunity for clinical software companies to make acquisitions easier to close.
By Michael Gibney • April 11, 2024 -
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Cutting pills. Rationing insulin. How Americans struggle to pay for drugs.
More than 20% of Americans are forgoing prescription medications due to costs, according to a recent survey.
By Amy Baxter • April 9, 2024 -
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Biosimilar uptake appears to finally be on the upswing, and Biocon Biologics is betting on the sector’s future
Biosimilars promise market competition for branded biologics, which in theory could drive down prices. But so far, winning market share has been a struggle.
By Michael Gibney • April 9, 2024
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