Policy & Regulation: Page 6
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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 -
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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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 -
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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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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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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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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene
AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.
By Amy Baxter • April 3, 2024 -
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After Amylyx drug failure, what’s next for ALS?
The company’s combo treatment Relyvrio was approved in 2022, but after failing a phase 3 trial, may be pulled from the market.
By Meagan Parrish • March 15, 2024 -
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Q&AFormer U.S. patent head on why federal march-in rights for drugs would be a ‘devastating’ mistake
A Biden administration proposal to seize patents for drugs deemed too pricey would have a ripple effect that cuts into the heart of innovation, says former U.S. PTO head Andrei Iancu.
By Michael Gibney • March 14, 2024 -
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The silver lining around Lilly’s Alzheimer’s delay could be a future with better drugs
Although a regulatory delay for Eli Lilly’s donanemab in Alzheimer’s disease is a competitive setback, researchers have their eye on better drug development as a result.
By Michael Gibney • March 12, 2024 -
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Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
By Jacob Bell • Updated March 8, 2024 -
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Could pharma’s legal attack on the IRA succeed in killing price negotiations?
An all-out blitz across U.S. courts is bolstering pharma’s goal to overturn Medicare drug price negotiations.
By Amy Baxter • March 6, 2024 -
Permission granted by Natalie Ferguson/American Gene Technologies
ProfileHIV isn’t ‘solved,’ but a doctor who treated some of the first patients hopes to finally deliver a cure
From San Francisco in the 80s to a gene therapy prospect, Dr. Marcus Conant looks back on his long fight against the virus — and if the industry is close to ending the epidemic.
By Michael Gibney • March 5, 2024 -
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Did the FTC get it wrong when it blocked the Sanofi-Maze deal?
In its zeal to stamp out anticompetitive practices and lower drug prices, a consultant said the FTC might have overlooked the unique considerations in rare disease drug development.
By Alexandra Pecci • March 4, 2024 -
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After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections
Impatience to fix long-held challenges to overseas drug facility inspections is growing on Capitol Hill.
By Amy Baxter • March 1, 2024 -
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How a 15-year-old Genzyme drug shortage became a legal smorgasbord of pharma’s thorniest issues
Rare disease treatments, drug shortages, a market monopoly and march-in rights all play a role in the story of newly revived litigation against Sanofi’s Genzyme.
By Alexandra Pecci • Feb. 26, 2024 -
Permission granted by Iovance Biotherapeutics
Behind the breakthrough cancer therapy that just won a historic FDA nod
The first-of-its-kind TIL therapy for solid tumors developed by Iovance Biotherapeutics won FDA approval last week.
By Kelly Bilodeau • Feb. 21, 2024 -
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Biden or Trump: How deeply will 2024’s election outcome impact pharma?
The election is still months away, but campaign promises are solidifying, and signal the benefits and drawbacks of each candidate for pharma.
By Michael Gibney • Feb. 20, 2024 -
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FDA inches closer to defining its regulatory role in AI
Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.
By Amy Baxter • Feb. 12, 2024 -
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Astellas’ science chief on the leap into new technologies
After a big 2023, Yoshi Shitaka said the company is banking on gene therapies, KRAS degraders and more to keep the momentum.
By Meagan Parrish • Feb. 9, 2024 -
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‘Beginning of the end’ for small molecules? VCs brace for Medicare investment gap
The "small molecule penalty" becomes even riskier for investors as the IRA negotiates prices, and VCs and lawmakers are looking to get a jump on those headwinds.
By Michael Gibney • Feb. 6, 2024 -
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Government hits patent thickets on multiple fronts
Patent thickets are the latest target in lawmakers' bid to lower drug prices.
By Alexandra Pecci • Feb. 5, 2024
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