Pharma
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Is the FDA ‘finished’? Leadership drain hits agency hard.
Amid widespread staff reductions at health agencies, a number of key officials have bid farewell to pharma’s top regulator.
By Amy Baxter • April 2, 2025 -
Permission granted by Pfizer
ProfileFormer Pfizer CSO Mikael Dolsten on writing his next chapter, embracing AI and asking the ‘big questions’
Dr. Mikael Dolsten, Pfizer’s former chief scientific officer, is embarking on a journey of curiosity and interconnectedness in his post-Big Pharma career.
By Michael Gibney • April 1, 2025 -
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TrendlineClinical trial diversity
As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.
By PharmaVoice staff -
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With government health info in limbo, drugmakers lose credible sources
The lack of clear communication from the government could spark wide-ranging issues in pharma — from sowing confusion about clinical trial design to further eroding public trust.
By Alexandra Pecci • April 1, 2025 -
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In the obesity triple-agonist blockbuster race, a familiar battle looms: Novo vs. Lilly
The two market leaders are targeting new obesity alternatives in their pipelines with an eye toward a triple threat.
By Amy Baxter • March 31, 2025 -
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FDA’s ‘mixed signals’ on diversity have entangled clinical trials. Here’s how pharma can push ahead.
The agency is still unclear about where it will stand on clinical trial diversity, but companies are looking for answers and leaning toward good science.
By Meagan Parrish • March 28, 2025 -
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HHS announces sweeping reorganization, including cuts of 10K workers
Along with shrinking the HHS’ workforce further, the reorganization announced Thursday will cut the department from 28 divisions to 15, and close five regional offices.
By Rebecca Pifer • March 27, 2025 -
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How AZ and Amgen’s Tezspire respiratory data ups the ‘level of ambition’ in immunology
After Tezspire reduced the need for nasal polyp surgery by 98% in patients with a severe respiratory condition, the biopharma giants are even more ambitious for the next wave of biologic medicines.
By Michael Gibney • March 27, 2025 -
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Rx-to-OTC rule gets pushed back — again
A delay of the prescription-to-OTC rule signals health agencies’ ongoing reluctance to implement new regulations.
By Amy Baxter • March 26, 2025 -
Jacob Bell/PharmaVoice
Biogen plots new global headquarters in Kendall Square
The big biotech signed a 15-year lease for approximately 580,000-square-feet of space in “Kendall Commons,” a development project spearheaded by MIT.
By Jacob Bell • March 25, 2025 -
Permission granted by Novavax
ProfileThe industry heavyweight behind Novavax’s push to bounce back
As it returns from the brink, the vaccine developer has brought in Dr. Ruxandra Draghia-Akli — and her industry and public health chops — to lead R&D.
By Alexandra Pecci • March 25, 2025 -
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Lilly, Novo expand DTC reach of obesity meds after compound win
The FDA delisted semaglutide and tirzepatide from its shortage list, putting an end to copycat GLP-1s.
By Amy Baxter • March 24, 2025 -
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How pharma could feel the pain of a recession
Pharma has long been considered “recession proof,” but an economic downturn could still hurt the industry in numerous ways.
By Meagan Parrish • March 21, 2025 -
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Vaccine makers face mRNA backlash as states seek further restrictions
A handful of states are targeting the technology at the same time the Trump administration is cutting research funding and revoking vaccine contracts.
By Amy Baxter • March 19, 2025 -
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The key factors shaping China’s biopharma boom
Chinese companies are involved in one-fifth of pharma’s clinical development programs, but trade wars and regulatory hurdles could stymie dealmaking.
By Alexandra Pecci • March 19, 2025 -
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Drug developers ‘haven’t even scratched the surface’ of what radiopharma can do
Even with Big Pharmas pouring billions into the space, the potential of radiopharmaceuticals remains largely untapped.
By Kelly Bilodeau • March 17, 2025 -
Permission granted by Roche
Q&ARoche’s obesity deal with Zealand Pharma tees up rival for GLP-1s
The new $5.3 billion deal with the Swiss pharma giant gives Zealand a significant partner to advance its amylin analog obesity shot and create a new combination product.
By Amy Baxter • March 17, 2025 -
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Lawmakers tease out pharma’s influence over RFK Jr. through probe into Mar-a-Lago meetings
HHS head Robert F. Kennedy Jr. has long been an opponent of pharma influence in government. U.S. lawmakers are asking whether unofficial Mar-a-Lago meetings point to a change of heart.
By Michael Gibney • March 13, 2025 -
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Takeda’s $770M deal deepens Big Pharma’s omics push
The pharma giant announced a new partnership with BridGene Biosciences that will use its IMTAC platform for drug discovery.
By Alexandra Pecci • March 13, 2025 -
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IRA reforms, including a small molecule fix, could be on the table. Will Trump and the GOP make the leap?
Industry insiders are pushing to fix the small molecule ‘penalty’ by setting their hopes on a Republican majority.
By Amy Baxter • March 12, 2025 -
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The first new type of drug for Tourette syndrome in over 50 years is close to the FDA’s doorstep
Emalex Biosciences is full steam ahead with a targeted 2026 approval and launch for its novel drug.
By Amy Baxter • March 11, 2025 -
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Pricing transparency is in the spotlight — and that could be good news for drugmakers
An opaque system of rebates and discounts makes understanding a drug’s true price near impossible, even for experts. Can efforts to bring transparency into that system now pan out?
By Michael Gibney • March 11, 2025 -
Permission granted by Biogen
What’s driving pharma’s layoffs in 2025
Familiar foes in the industry have claimed a slew of jobs in recent months.
By Meagan Parrish • March 10, 2025 -
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As tariffs loom over pharma manufacturing, a reshoring effort is underway — but not without challenges
Experts say cost and other barriers present challenges to returning to U.S. shores.
By Kelly Bilodeau • March 10, 2025 -
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The time is ripe for pharma M&A. Why are drugmakers holding out?
The M&A resurgence has been predicted for years, but the industry is still holding out, partly because the ideal range for biotech valuations has been harder to find.
By Michael Gibney • March 6, 2025 -
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With patent losses on the horizon, Amgen refocuses its business strategy
The company's vice president and general manager of U.S. business operations explains how Amgen is going to deliver on its “ambitious growth aspirations.”
By Alexandra Pecci • March 5, 2025
