Policy & Regulation: Page 4
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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?
Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.
By Meagan Parrish • Oct. 4, 2024 -
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Flu vaccination rates are falling despite record child deaths. Can innovation save the day?
As respiratory disease season approaches, experts are concerned about vaccination rates — but the industry is churning out new solutions to help.
By Michael Gibney • Oct. 3, 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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Behind the rise of BMS’ Cobenfy, the first new schizophrenia drug in decades
The FDA OK for KarXT, now known as Cobenfy, demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.
By Kelly Bilodeau • Sept. 26, 2024 -
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What the Fed’s rate cut means for biotech
Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.
By Ben Fidler • Sept. 20, 2024 -
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Getting IND ready — how companies can avoid common traps
Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.
By Alexandra Pecci • Sept. 18, 2024 -
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FDA inspection backlog overseas threatens new drug approvals
The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.
By Amy Baxter • Sept. 18, 2024 -
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Biopharma prepares to pivot from China as Biosecure Act advances
After the House of Representatives passed the Biosecure Act last week, U.S. biotechs could be forced to cut ties with five Chinese contract partners.
By Amy Baxter • Sept. 16, 2024 -
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Q&AHow Lilly’s sustainability goals come face to face with massive growth
Eli Lilly’s head of ESG is maintaining a focus on sustainability even as the company’s expansion plans in weight loss drive a larger footprint and more social scrutiny.
By Michael Gibney • Sept. 12, 2024 -
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A new way of determining a drug’s value — with health equity in mind
Quality-adjusted life years are an important tool to frame a drug’s cost effectiveness, but they leave out other determinants of health.
By Michael Gibney • Sept. 10, 2024 -
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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 -
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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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