Policy & Regulation: Page 3
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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 -
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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 -
Explore the Trendline➔
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TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
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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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 -
Permission granted by Amylyx Pharmaceuticals
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
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