Why a 'fundamental shift' in regulatory submissions is on the way

Deloitte's senior manager of R&D and regulatory practices explains how technology and strategy must converge to smooth out the bulky drug approval process.

By Michael Gibney • July 11, 2022

The CEO of Dr. Reddy's N. America is using 'controlled explosions' to keep the generics giant growing

Marc Kikuchi weighs in on the company’s plans to pump up its pipeline and sales in the coming years.

By Meagan Parrish • July 7, 2022

Explore the Trendline➔

Rare diseases

As drug developers find promise in the rare diseases, deals and treatments are on the rise

By PharmaVoice staff

Dave Ross of Seqirus talks 'milestone' influenza vax vote

In a unanimous decision, a CDC committee calls for a preferential flu vaccine recommendation for people aged 65 and older for the first time. 

By Alexandra Pecci • July 5, 2022

The oncology market is surging despite a decline in routine screenings

A new report from IQVIA reveals the current challenges — and promise — in cancer drug R&D.

By Kelly Bilodeau • June 28, 2022

#DIA2022: Building 'guardrails' in the FDA's accelerated approval program

Regulatory experts weigh in on ways to enhance the controversial drug approval approach.

By Karissa Waddick • June 21, 2022

TikTok tutorial: How pharma can embrace the video platform's educational potential

Ogilvy Health’s director of social strategy, Katie Ferrigno, busts myths and provides tips on how biopharmas can take advantage of TikTok’s unique features to connect with patients.

By Karissa Waddick • June 15, 2022

As cancer innovations thrive, patient access is the next piece of the puzzle

Why enhanced clinical trials and diagnostics are keys to boosting patient access to cancer care.

By Michael Gibney • June 8, 2022

Aduhelm's Medicare woes leave questions about lofty premiums

A single drug’s effect on the premiums that Medicare beneficiaries pay is raising questions about how these levels are set and what factors play a part.

By Kelly Bilodeau • June 2, 2022

SIGA prepares to kick production for monkeypox treatment into high gear

‘We’re not bored,’ the company’s science chief says as SIGA Technologies looks to ramp up supplies of its therapeutic.

By Meagan Parrish • May 31, 2022

PBMs under fire for drug prices defend their worth

A new Senate bill is putting PBMs in the crosshairs of lawmakers — but they argue that they're more than just middlemen.

By Michael Gibney • May 26, 2022

The UK-based company that's striving to overcome the limitations of T cell receptor innovation

Etcembly’s CEO, Michelle Teng, shares why a platform approach to T cell receptors can advance and democratize innovation.

By Kim Ribbink • May 23, 2022

A potential COVID-19 EUA could turn this small biotech into a household name

Veru’s CEO discusses the impact of the upcoming FDA decision on its treatment targeting severely ill COVID-19 patients.

By Meagan Parrish • May 19, 2022

Ironwood Pharmaceuticals is charting a course to become a giant in GI

Ironwood’s CEO, Tom McCourt, discusses the company’s strategy for leveling up in the GI market. 

By Karissa Waddick • May 19, 2022

BriOri BioTech sets the stage for the comeback of Vioxx

With a topical pain-relieving ointment in development, the emerging biotech is aiming to give the tarnished NSAID a new life.

By Kelly Bilodeau • May 17, 2022

It's time to acknowledge access as a prescribing barrier

A new survey reveals how red tape limits patient access to doctor-preferred specialty drugs. 

By Karissa Waddick • May 11, 2022

FDA draft guidance may turn diversity in clinical trials from nice-to-have into a must-have

New guidance from the FDA will ‘up the ante’ for diversity considerations. Here’s how your company can prepare.

By Kelly Bilodeau • May 10, 2022

Laura Randa's aim to break down mental healthcare barriers for disabled patients

Despite the proliferation of mental health apps, many aren’t accessible for people with disabilities. The CEO of Toivoa plans to change that.

By Alexandra Pecci • April 27, 2022

Real-world data is making drug development more true to life

How RWD is moving from the background to the spotlight in pharma’s development process.

By Kelly Bilodeau • April 26, 2022

The cannabis vanguard: A rare disease company looks to pioneer in the space

Zynerba’s CEO shares his views on advances in cannabidiol treatments for neuropsychiatric illnesses and the regulatory environment for CBD-based drugs.

By Jared Whitlock • April 21, 2022

A psychedelic pill for alcoholism? The CEO of Clearmind Medicine says 'Yes.'

Known to provide a “euphoric” experience, MEAI started out as a recreational drug used as an alcohol substitute. Now, Adi Zuloff-Shani says it may even treat alcohol addiction.

By Alexandra Pecci • April 21, 2022

A pharma mystery: Cancer-causing impurities drive joint search for answers

Pharmaceutical industry insiders and regulators are striving to overcome the ‘blind spots’ that contribute to nitrosamine contamination.

By Michael Gibney • April 19, 2022

How pharma can up its social media game

Health Union’s VP of community development, Sara Hayes, discusses how pharma marketers can better reach online patient communities. 

By Karissa Waddick • April 18, 2022

Inflation is forcing prioritization of healthcare spending — are you ready?

Inflation means your customers' money doesn't travel as far as it did a few weeks ago.

April 18, 2022

What now? Alzheimer's drugmakers ponder the path to approval

Why Medicare’s unprecedented decision to limit coverage for Aduhelm could have a chilling effect on Alzheimer’s R&D.

By Kelly Bilodeau • April 14, 2022

Biotech goes Hollywood

A few years ago, the biotech venture world in LA was almost ‘nonexistent’ — now Joseph Panetta, CEO of Biocom California, says the region is undergoing a major change.

By Taren Grom • April 13, 2022