Policy & Regulation: Page 8
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Patient influencers are here to stay — where are the regulations?
As social media health influencers enter the world of pharma advertising, experts warn that more guardrails are needed to protect the industry and patients.
By Karissa Waddick • April 17, 2023 -
Fighting vaccine hesitancy may require a new approach from pharma
The COVID-19 pandemic highlighted an ongoing problem of vaccine hesitancy undermining public health efforts. One way pharmas can help is to change the narrative.
By Michael Gibney • April 13, 2023 -
Trendline
Commercialization, 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 -
After working at Merck during the Vioxx scandal, this former sales rep is on a mission to fix the system
The founder and CEO for the Accreditation Council for Medical Affairs is increasing accountability in pharma by emphasizing training, standards and ethics in medical affairs.
By Alexandra Pecci • April 11, 2023 -
Opinion
Leaders wave a magic wand at pharma’s thorniest issues
The major challenges pharma leaders would solve with a quick flick of an imaginary wand.
By PharmaVoice staff • March 31, 2023 -
Seamless clinical trials were created to make studies easier — instead, they’ve become more complex
Experts weigh in on how companies can design better trials that merge two phases into one.
By Meagan Parrish • March 29, 2023 -
SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi
The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.
By Michael Gibney • March 28, 2023 -
SVB’s collapse had limited impact on biopharmas — but a broader financial crisis could change the landscape
Although many pharma and biotech companies had deposits at the failed bank, most have reported little to no exposure.
By Michael Gibney • March 21, 2023 -
Making Moves
In the fallout from Aduhelm, Biogen’s leadership shakeup continues
The recent departure of neurodegenerative development head Samantha Budd Haeberlein is just the latest sign of a changing tide among Biogen’s post-Aduhelm leadership.
By Karissa Waddick • March 16, 2023 -
Biden doubles down on drug pricing in 2024 budget — but boosts R&D
The president’s 2024 budget proposal expands on last year’s drug pricing reforms, but also dramatically increases innovation investments.
By Karissa Waddick • March 13, 2023 -
Eli Lilly took price cuts into its own hands. Will other pharmas follow suit?
The pharma giant took the high road and cut prices before the feds made them. How will that affect the industry?
By Michael Gibney • March 7, 2023 -
FDA ups generics and biosimilar approvals for a shot at lower drug costs
As the Biden administration searched for drug-cost reducing measures, the FDA incentivized generic and biosimilar development in 2022.
By Karissa Waddick • March 6, 2023 -
Multimillion-dollar therapies are changing how payers foot the bill
With more gene therapies headed to market, novel payment methods are emerging from regulators and academia.
By Meagan Parrish • Feb. 28, 2023 -
Who is Vivek Ramaswamy — the biotech entrepreneur turned presidential candidate?
The former CEO of Roivant, who became the face of the “anti-woke” business movement, is now running for the 2024 Republican presidential nomination. Here’s what he stands for.
By Karissa Waddick • Feb. 27, 2023 -
Q&A // Biotech Spotlight
Cytokinetics looks to muscle into the cardiovascular market
With a scientific platform based on muscle biology, the late-stage biotech is addressing cardiovascular and neuromuscular diseases.
By Taren Grom • Feb. 24, 2023 -
Why FDA’s approach to orphan drug exclusivity is ripe for more legal challenges
Despite a court ruling, the FDA is sticking to its narrow orphan drug exclusivity approach. But confusion remains over the policy’s future.
By Karissa Waddick • Feb. 23, 2023 -
Marking one year as FDA commissioner, Califf lays out vision for agency’s future
Califf outlined hopes to address advisory committees, drug pricing, digital health and more.
By Karissa Waddick • Feb. 16, 2023 -
Q&A
Rocket Pharmaceuticals is ready for liftoff in the rare disease space
With two rare disease products on the launch pad for FDA submission in 2023 and a growing pipeline, Rocket is fueled for its next era of growth.
By Taren Grom • Feb. 10, 2023 -
3 ways the FDA’s restructuring plan could impact pharma
FDA’s food program is in for a major overhaul — here’s why pharma should pay attention.
By Karissa Waddick • Feb. 9, 2023 -
Profile
United by inequity: The healthcare disparities plaguing rare disease patients and Black Americans
Guided by her personal experiences, Tamar Thompson is aiming to improve rare disease care through her advocacy work at Alexion, AstraZeneca Rare Disease.
By Alexandra Pecci • Feb. 7, 2023 -
Making Moves
Roche, Chiesi and the FDA change major leadership roles as they strive for growth in 2023
From Roche’s new pharma chief to the departure of the FDA’s gene therapy head, these moves are bound to shake up the industry.
By Karissa Waddick • Feb. 6, 2023 -
Antitrust watchdogs have pharma in their sights, and the landscape is getting thornier
The FTC and DOJ are heightening antitrust enforcement, and pharma deals are a prime target.
By Karissa Waddick • Feb. 2, 2023 -
Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster
The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.
By Alexandra Pecci • Jan. 31, 2023 -
Drug price negotiations: 5 key dates to watch
As the CMS readies its new program for lowering drug costs, these are the moments that will matter most to pharma companies.
By Kelly Bilodeau • Jan. 23, 2023 -
FDA’s 2022 drug approvals fall short of recent norms
The U.S. agency’s lower number of novel drug approvals followed several controversies surrounding a 2021 Alzheimer’s approval.
By Alexandra Pecci • Jan. 19, 2023 -
After ‘limping along,’ Novavax sees a path forward
With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.
By Meagan Parrish • Jan. 18, 2023