5 final FDA action dates to watch this year

A potential flurry of regulatory activity could be on the horizon yet this year — and several key drug approvals are at stake.

By Michael Gibney • Dec. 1, 2022

10 of our most popular articles in 2022

Methadone, rock ‘n’ roll, clinical trial overhauls — here’s a look at our most-read stories of the year.

By Meagan Parrish • Nov. 30, 2022

The next era of Greater Boston’s biotech boom

How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.  

By Karissa Waddick , Shaun Lucas , Julia Himmel • Nov. 22, 2022

Can a formal needs assessment simplify Speaker Bureau compliance?

In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action.

Nov. 21, 2022

Why the IRA will drive up the country’s drug bill — not lower it

On the surface, the Inflation Reduction Act is designed to lower drug prices, but its impact on innovation incentives could produce a landscape of new medicines that are costlier for patients.

By John LaMattina • Nov. 14, 2022

3 ways pharma can weather a recession

If “winter is coming” in the form of a recession, pharmas can take advantage of an inherent resiliency by crushing these three fundamentals.

By Michael Gibney • Nov. 10, 2022

What pharma could gain — or lose — from the midterms

With control of the House and Senate both up for grabs, and potentially leaning Republican, here’s what the midterm elections mean for pharma. 

By Karissa Waddick • Nov. 7, 2022

Acumen cruises into the fast lane with novel Alzheimer’s treatment

The company’s distinct amyloid-beta target, which just won a fast track designation, could give it an edge over the competition.

By Meagan Parrish • Nov. 3, 2022

How Europe’s energy crisis is impacting pharma

Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

By Karissa Waddick • Nov. 2, 2022

Riches, rags, riches: Is Biogen the Cinderella of biotechs?

Biogen and Eisai's new Alzheimer's drug is wowing investigators, and it might help the companies get past previous failures.

By Michael Gibney • Oct. 27, 2022

Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

By Taren Grom • Oct. 26, 2022

Biosimilars will gain ground in 2023 with Humira launches — and that’s just the beginning

In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

By Michael Gibney • Oct. 24, 2022

Think your company could be on HHS’ drug price negotiation list? Here’s how to navigate next steps

Know what to expect from the CMS over the next few months as it implements the drug reforms laid out in the Inflation Reduction Act.

By Karissa Waddick • Oct. 18, 2022

BIO’s interim CEO and Alvotech’s new chief quality officer could spell big changes for biotech

What these life science organizations’ latest executive-level appointments mean for the industry.

By Karissa Waddick • Oct. 14, 2022

Beyond buzzwords: Making a practice of diversity, equity and inclusion

Watch Dr. Preeti Parikh, executive medical director at GoodRx, explain how she sees parallels between her mother’s challenges to promote health equity as a physician, and current diversity, equity, and inclusion (DE&I) challenges in the workplace.

Oct. 10, 2022

Her antibiotic company failed. Now she’s helping others avoid the same fate.

The chief of R&D at CARB-X explains why she believes small antibiotics companies can succeed despite market turmoil.

By Karissa Waddick • Oct. 6, 2022

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