Policy & Regulation: Page 2
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What 3 layoff stories reveal about pharma’s troubles
The factors driving the industry’s layoffs — and what could help turn the tide.
By Meagan Parrish • Sept. 6, 2024 -
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FDA adcomm reform talks heat up
As the agency considers eliminating adcomm votes from the approval process, members vie to have their voices heard.
By Amy Baxter • Sept. 3, 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 -
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After an FDA rejection, here’s what’s next in the psychedelics pipeline
By rejecting the first MDMA therapy earlier this month, the FDA signaled to the psychedelic drug sector that the road to approval isn’t clear cut.
By Amy Baxter • Aug. 28, 2024 -
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Pharmas’ IRA court losses mount. They keep pursuing them.
The final drug prices for Medicare’s negotiation program have been published, but pharma companies continue to push their legal strategies.
By Amy Baxter • Aug. 26, 2024 -
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Will the IRA squash new drugs? Those worries are likely exaggerated, studies say.
There’s no link between revenue and R&D from smaller biotechs, and that’s where most innovation comes from, according to new studies.
By Alexandra Pecci • Aug. 22, 2024 -
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Pharma’s concerns pile up months after Supreme Court’s landmark Chevron decision
The Supreme Court case added another layer of uncertainty on the regulatory front and opened up the Inflation Reduction Act to more legal attacks.
By Amy Baxter • Aug. 21, 2024 -
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The drugs hit hardest by Medicare price negotiations
The final negotiations slash drug prices between 38% and 79% for Medicare’s 2026 calendar year.
By Amy Baxter • Aug. 16, 2024 -
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Medicare reveals results of drug price negotiations
The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.
By Ned Pagliarulo • Aug. 15, 2024 -
Permission granted by Reed Tuckson
Lessons from COVID: Tuskegee impacts still erode trust in healthcare, but hope shines through
A long-time leader in public health and outreach to people of color, Dr. Reed Tuckson offers the lessons he learned from the COVID pandemic and how pharma can better serve those communities.
By Michael Gibney • Aug. 15, 2024 -
Permission granted by Moderna
Pfizer, GSK and Moderna execs remain optimistic about RSV vaccines despite CDC blowback
An advisory committee’s age group recommendations look like a major setback, but executives are painting a rosier picture.
By Michael Gibney • Aug. 6, 2024 -
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3 Big Pharma cancer drugs facing inflation penalties
The U.S. government will demand payment from Big Pharma to make up for dozens of drugs with prices that rose faster than the rate of inflation.
By Amy Baxter • July 31, 2024 -
Permission granted by Biogen
Sage’s recent trial failure adds pressure to its two-drug Biogen collab
The mid-stage failure leaves the success of the expensive partnership hanging on a drug that’s already suffered its own setback.
By Amy Baxter • July 29, 2024 -
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Citius’ first FDA decision date is approaching — and its CEO has millions on the line
Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.
By Amy Baxter • July 26, 2024 -
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Where Kamala Harris stands on three key pharma issues
The presumptive Democratic nominee has a long history of taking on pharma over drug prices and supporting women’s healthcare access.
By Amy Baxter • July 24, 2024 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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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