Woman of the Week: Denali Therapeutics’ Cindy Dunkle

As chief people officer, Dunkle is harnessing the company’s unique culture to foster innovation.

By Taren Grom • March 1, 2023

Do R&D costs justify the price of drugs? Nope, new study says

A BMJ study found that spending on drug sales vastly outstripped spending on drug development.

By Alexandra Pecci • March 1, 2023

Explore the 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

Reata’s stock plummets amid sudden FDA neuro office shakeup

The FDA’s longtime neuroscience head Billy Dunn stepped down, leaving industry reeling over how the agency’s new acting director could handle upcoming approval decisions.

By Karissa Waddick • Feb. 28, 2023

As clinical trials face a hiring crunch, here’s how research organizations can pivot

Staffing shortages are causing inefficiencies in clinical trials, but one leading CRO is finding ways to adapt.

By Kelly Bilodeau • Feb. 27, 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

Why patient care is a public affair

The VP of public affairs at Kyowa Kirin discusses her role in advocating for advocacy.

By Taren Grom • Feb. 23, 2023

Woman of the Week: Alltrna’s Michelle Werner

The first-time CEO has her sights on addressing thousands of diseases with the company’s tRNA platform.

By Taren Grom • Feb. 22, 2023

Why the pharma industry is digging deep in rare disease

The rare disease market is set for major growth in the decade to come, and pharma companies are securing their footholds now.

By Michael Gibney • Feb. 21, 2023

Despite rare disease market growth, pharma leaders see development obstacles ahead

Investment in rare disease research is increasing, but a recent poll of PharmaVoice readers found that roadblocks remain.

By Karissa Waddick • Feb. 17, 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

Woman of the Week: Bristol Myers Squibb’s Ester Banque

The 30-year veteran is heading up the “transformation” of one of the pharma giant’s most important therapeutic portfolios: hematology.

By Taren Grom • Feb. 15, 2023

For Complement’s CEO, storytelling could be just as critical as data

Dr. Rafiq Hasan has his sights on bringing lessons learned at Bayer to ophthalmology-focused Complement Therapeutics.

By Alexandra Pecci • Feb. 14, 2023

The post-COVID outlook for decentralized clinical trials

The COVID-19 pandemic had many pharmas turning to DCTs as a way to keep the clinical wheel turning. Can the industry keep that flexibility going forward? 

By Michael Gibney • Feb. 14, 2023

Brian Fox is bringing ‘fresh eyes’ to ad agency Klick

Why the recently appointed president of commercial solutions sees near limitless potential to expand Klick’s footprint across the life sciences — and how generative AI is playing a role.

By Karissa Waddick • Feb. 13, 2023

Why are there gaps in mental healthcare? Often it’s flawed trial methodology

Sunovion Pharmaceuticals has developed a more precise way to track symptoms that could be broadly adopted across the industry.

By Kelly Bilodeau • Feb. 10, 2023

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

Bayer, Astellas switch CEOs amid major inflection points

Bayer’s Bill Anderson and Astellas’ Naoki Okamura will be charged with setting the companies on growth trajectories for 2023.

By Karissa Waddick • Feb. 9, 2023

The unique playbook of Biohaven’s CEO

Vlad Coric’s offbeat business strategy paid off once with a Pfizer buyout. Can he do it again?

By Meagan Parrish • Feb. 8, 2023

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

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

Execs at Pfizer, Novartis, Amgen and GSK tackle shifting priorities — reflecting the state of Big Pharma

A menagerie of earnings calls this week showed where the Big Pharma players stand in 2023.

By Michael Gibney • Feb. 2, 2023

Woman of the Week: Bayer’s Dr. Yesmean Wahdan

The VP of medical affairs and women’s health is focused on an audacious goal to meet the needs of 100 million women globally.

By Taren Grom • Feb. 1, 2023

This biotech CEO secured two billion-dollar Big Pharma deals during the pandemic

With the industry focused on cancer and COVID-19, Marc de Garidel made deals centered on cardio.

By Michael Gibney • Jan. 31, 2023