3 FDA decisions that could be delayed if the U.S. defaults on its debt

If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.

By Karissa Waddick • May 30, 2023

From FTC to SCOTUS, Amgen’s woes are potential ‘game changers’ for the industry

The two institutional battles offer a glimpse into the tension between pharma innovation and regulation that could reverberate across the industry.

By Michael Gibney • May 25, 2023

Explore the Trendline➔

Emerging biotech

After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

By PharmaVoice staff

Biden’s pick to lead the NIH faces an uphill battle

Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny. 

By Karissa Waddick • May 18, 2023

Major regulatory changes are coming to pharma in the EU — and industry’s weighing in

The European Union published a long-awaited proposal that could bring sweeping changes to its pharma sector last month, but the legislative fight has only just begun.

By Karissa Waddick • May 16, 2023

Years into the pandemic, only a handful of clinical trials are targeting long COVID — here’s one of them

Scientists at Stanford are testing Pfizer’s Paxlovid on long COVID symptoms and their efforts could provide clues for other conditions.  

By Kelly Bilodeau • May 15, 2023

AbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’

With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.

By Taren Grom • May 10, 2023

3 key FDA approval trends this year

Although approvals are off to a slow start in oncology, the agency has been living in the fast lane for neurological disorders and more.

By Kelly Bilodeau • May 8, 2023

Insulin prices have dropped — will Civica still be a disrupter in the field?

The nonprofit generics maker still sees a need for low-cost insulin despite recent moves by major drugmakers to slash the prices of their popular products. 

By Karissa Waddick • May 8, 2023

Woman of the Week: Jazz Pharmaceuticals’ Neena Patil

Patil’s dual interests in healthcare and law are at the intersection of her C-suite role.

By Taren Grom • May 3, 2023

Taking your biotech global? Here’s how you can navigate cultural norms

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

By Alexandra Pecci • May 2, 2023

A physician’s perspective on health equity, diversity and inclusion

Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

By Preeti Parikh, MD, Executive Medical Director, GoodRx • April 24, 2023

A new era of COVID innovation is here

With a $5 billion dollar infusion, a new White House program is helping catalyze development of next-gen treatments, from pan-coronavirus vaccines to enhanced antivirals. 

By Kelly Bilodeau • April 17, 2023

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

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

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

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