Policy & Regulation

Feds could soon bring COVID-style fight to superbug threat

COVID-19 has inspired renewed urgency in the need for weapons to combat antimicrobial resistant infections and new hope of government funding to meet the challenge.

By Karissa Waddick • Sept. 13, 2022

Drug recalls are ticking upwards — here’s how to avoid costly pitfalls

Supply chain challenges, labor shortages and increased FDA inspections are boosting recall risks — but careful planning can keep companies in the clear.

By Kelly Bilodeau • Sept. 8, 2022

Moderna’s lawsuit against Pfizer and BioNTech explained in 10 quotes

The biotech says that its competitors’ COVID-19 vaccine copied proprietary mRNA technology. Here’s a breakdown of the case.

By Karissa Waddick • Aug. 31, 2022

Hurdles remain in biosims market — but Alvotech is undeterred

The biosimilar developer is advancing a pipeline with high growth potential, including a copycat of Humira.

By Kelly Bilodeau • Aug. 29, 2022

3 ways pharma can prep for Biden’s sweeping drug pricing policies

Now that Medicare will be able to negotiate drug prices under the Inflation Reduction Act, the industry can expect to see some changes. Here are some tips on how to navigate the changing tide.

By Karissa Waddick • Aug. 18, 2022

The FDA is mulling an OTC approval for a birth control. Will politics factor in?

Analysts are watching how cultural and political debates around reproductive rights may impact HRA Pharma's OTC birth control application.

By Karissa Waddick • Aug. 15, 2022

Taking probiotics where they’ve never gone before

How Seed Health is transforming the microbiome therapeutic market with its pharma-focused drug development approach.

By Karissa Waddick • Aug. 2, 2022

Democrats think they've found a balance between drug innovation and pricing negotiation

A look at Congress’ push to pass drug pricing reform and why the latest attempt could actually succeed.

By Karissa Waddick • July 26, 2022

By the numbers: The rising danger of superbugs

A look at how the COVID-19 pandemic exacerbated one of the world’s greatest public health concerns.

By Karissa Waddick • July 20, 2022

Pfizer's former R&D head takes on drug pricing misconceptions in new book

John LaMattina has something to say about the industry — and he hopes patients are listening.

By Meagan Parrish • July 19, 2022

Making moves: Agios, BeiGene, Biocom California and more announce new key hires

The latest executive personnel changes from around the industry.

By Karissa Waddick • July 18, 2022

COVID won't evolve to become 'less deadly' — and RedHill is prepping for the long haul

RedHill Biopharma’s chief operating officer, Guy Goldberg, says the company’s oral COVID-19 therapy could still be needed on a global scale.

By Kim Ribbink • July 12, 2022

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

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

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

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