Introducing the Fierce 50

This Week

Jun 30, 2023

UPDATE: Lilly's next obesity drug just cut an average of 58 pounds—prompting an all-out phase 3 blitz


Introducing the Fierce 50: Honoring healthcare and biopharma champions fighting for patient care


FDA slaps 2 US manufacturers with warning letters for lax testing and operations


Coming and going paid off for biopharma CEOs in 2022


Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups


On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold

 

Featured

UPDATE: Lilly's next obesity drug just cut an average of 58 pounds—prompting an all-out phase 3 blitz

Fifty-eight pounds. That’s how much weight patients lost on average at the end of 48 weeks when taking Eli Lilly’s next-generation obesity treatment. Twenty four percent of their body weight.
18-19
Jul
July 18-19, 2023 | Jersey City, NJ
 

Top Stories

Introducing the Fierce 50: Honoring healthcare and biopharma champions fighting for patient care

The Fierce 50 is a groundbreaking project that shines a spotlight on the true powerhouses driving advancements in medicine, fostering innovation and shaping the future of biopharma and healthcare.

FDA slaps 2 US manufacturers with warning letters for lax testing and operations

The FDA recently hit two small U.S. manufacturing companies with separate warning letters that cited lax testing and operational procedures at each of their production locations.

Coming and going paid off for biopharma CEOs in 2022

For the first time in a decade, compensation for chief executives at S&P 500 companies declined in 2022. But you won’t find any evidence of the slide in biopharma. In an industry often said to be immune to economic headwinds, its top execs were again well compensated, with most getting significant bumps in pay

Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.

On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold

The Inflation Reduction Act's drug pricing reforms have sent shock waves through the drug development world, with executives arguing the legislation stands to stymie the development of innovative new medicines.

After early win in Type 1 diabetes, Vertex joins forces with Lonza on new cell therapy production plant where it plans to employ 300

To support production of VX-880 and a second clinical candidate for Type 1 diabetes, VX-264, Vertex and Lonza are teaming up on process development and scale-up for the manufacturing of the drugmaker’s portfolio of stem cell-derived, fully differentiated insulin-producing islet cell therapies.

Lilly forks over $2.4M to settle federal agency's age discrimination lawsuit

Eli Lilly will pay out $2.4 million as part of a settlement agreement with the U.S. Equal Employment Opportunity Commission, which sued the company in September over claims it had changed its hiring preferences in 2017 to prioritize recruitment of more millennials to its workforce.

Biogen shareholders vote in Susan Langer as director despite relationship with former board member

Despite the controversy surrounding a relationship with departing director Alex Denner, Susan Langer has secured enough investor support to join Biogen’s board.

Pfizer's Litfulo enters the scene in alopecia with adolescent nod to rival Lilly's Olumiant

Late last week, the FDA gave a green light to Pfizer’s once daily oral JAK inhibitor ritlecitinib—now christened Litfulo—in adults and children ages 12 and over with severe alopecia areata. Lilly’s rival JAK Olumiant, which became the first med the FDA specifically approved for alopecia in June 2022, is only cleared for use in adults.

Illumina begins layoffs in plan to cut more than $100M in expenses this year

Just a couple of months after laying out a plan to shave off at least $100 million from its 2023 expenses, Illumina is beginning to make those cost-cutting moves.

BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

Ipsen wins FDA AdComm rare disease vote in split decision despite doubts about its data

An FDA advisory committee voted 10 to four in favor of Ipsen’s rare disease drug palovarotene despite members of the panel expressing significant concerns with the data. The vote boosts the prospects of the French drugmaker finally starting to deliver a return on its $1 billion bet on the drug candidate.

Pfizer drops oral obesity drug after seeing liver safety concern, focuses on less-convenient candidate

Pfizer is dropping one of its oral obesity drug candidates after seeing elevated liver enzymes in clinical trials. The setback leaves the Big Pharma’s near-term prospects resting on a candidate that is given twice as often as rival weight loss medicines in development at Eli Lilly and Novo Nordisk.

ADA: Abbott pushes for widespread CGM use in Type 2 diabetes with WeightWatchers, ADA collabs

Abbott unveiled a new partnership with the American Diabetes Association and kicked off its previously announced WeightWatchers collaboration during the ADA’s annual scientific sessions in San Diego on Saturday.
 

Resources

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Enhance the cost-effectiveness of your GMP chemical supply chain

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Autoantibodies: Powerful Biomarkers in Cancer Precision Medicine

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Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
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Commercializing Gene Therapies, Part 4 – Market Entry

This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies.
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Using longitudinal RWD to better understand and engage patients

Traditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories.
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Integrated Market Access Strategies Are Needed Now More Than Ever

Building a Sustainable Blueprint for a Holistic Market Access Strategy
 
 

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