FDA urged to collaborate more to boost rare disease approvals

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Today’s Big News

Sep 13, 2024

Zenas, MBX and Bicara all head to Nasdaq in hot day for biotech IPOs


FDA pushed to be more open, collaborative to accelerate rare disease R&D


In wake of Q2 revenue drop, Charles River cuts 3% of workforce


Fierce Biotech Layoff Tracker 2024: Cidara cuts 30% of team; Charles River lays off 3% of workforce


Chutes & Ladders—Cue Biopharma queues up J&J vet as CBO


Atea finally gives up COVID ambitions after antiviral fails to reduce hospitalizations, deaths in phase 3


Neurocrine's bid to save schizophrenia prospect fails

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Featured

Zenas, MBX and Bicara all head to Nasdaq in hot day for biotech IPOs

It’s a busy Friday for biotech IPOs, with Zenas BioPharma, MBX and Bicara Therapeutics all going public.
 

Top Stories

FDA pushed to be more open, collaborative to accelerate rare disease R&D

The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by the National Academies of Sciences, Engineering, and Medicine.

In wake of Q2 revenue drop, Charles River cuts 3% of workforce

In the wake of a second quarter that saw revenues decline by 3.2%, contract research organization Charles River Laboratories is laying off 3% of its workforce, a spokesperson confirmed to Fierce Biotech in an emailed statement.

Fierce Biotech Layoff Tracker 2024: Charles River lays off 3% of workforce after Q2 revenue drop; Cidara cuts 30% of team

We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. 

Chutes & Ladders—Cue Biopharma queues up J&J vet as CBO

After 25 years at Johnson & Johnson and 30 in the industry, Lucinda Warren is moving on to new pastures at Cue Biopharma as its first chief business officer.

Atea finally gives up COVID ambitions after antiviral fails to reduce hospitalizations, deaths in phase 3

Atea Pharmaceuticals’ antiviral has failed another COVID-19 trial, but the biotech still holds out hope the candidate has a future in hepatitis C.

Neurocrine's bid to save schizophrenia prospect fails

Neurocrine Biosciences’ schizophrenia program pivot has failed. The biotech was unable to replicate the cognition signal it saw in an earlier midphase study, prompting it to stop development of luvadaxistat.

FDA greenlights over-the-counter hearing aid features for Apple's AirPods

The agency’s clearance marks its first for a piece of over-the-counter hearing aid software—and hails the long-awaited entry of the consumer tech giant to the sector.

ESMO: Novartis, Daiichi, Gilead, Astellas and AZ excel in analysis of clinical value from new cancer meds

Using the ESMO Magnitude of Clinical Benefit Scale, a group of Harvard researchers has scored companies according to the value of the cancer drugs they have brought to the market. Among the standout drugmakers in the analysis were Novartis, Daiichi Sankyo and AstraZeneca.

Fierce Pharma Asia—Akeso, Summit's Keytruda-beating data; BIOSECURE's House passage; Candid's $370M debut

Akeso and Summit Therapeutics' ivonescimab showed strong efficacy against Merck's Keytruda in a phase 3 trial in China. The BIOSECURE Act sailed through a full House vote despite some objections. Candid Therapeutics amassed $370 million in series A funds with two T-cell engagers licensed from China. And more.
 
Fierce podcasts

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A closer look at the Fierce 50

In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report.
 

Resources

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Unique Solutions for Drug Discovery and Development

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Overcoming drug development hurdles with phase-appropriate technology transfers

Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market.

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Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
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Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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