New FDA rule would add oversight of lab-made tests

Editor's Note: Last call to nominate the Fiercest Women in Life Sciences! Nominations close today, Sept. 29, at 11:59 p.m. ET.

Today’s Big News

Sep 29, 2023

Decadeslong regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua 


Structure posts early oral obesity findings but delays larger readout after data collection mistake


FDA publishes proposal to increase regulatory oversight of lab-developed tests


PTC deepens layoffs as DMD drug faces loss of authorization across Europe


Teva continues its transformation, hiring Fox to take over U.S. business

 

Featured

Decadeslong regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.
 

Top Stories

Structure posts early oral obesity findings but delays larger readout after data collection mistake

Structure Therapeutics has shared an early look at the efficacy of its oral GLP-1 receptor agonist, linking the candidate to a 5% reduction in weight after four weeks.

FDA publishes proposal to increase regulatory oversight of lab-developed tests

The FDA has put forward its official pitch for regulating laboratory-developed tests, a long-awaited proposal that would bring those products more in line with how the agency approaches other in vitro diagnostics.

PTC deepens layoffs as DMD drug faces loss of authorization across Europe

PTC Therapeutics has announced that its layoffs will now go deeper and wider than previously announced as European regulators consider halting sales of the company’s Duchenne muscular dystrophy drug.

Teva continues its transformation, hiring Christine Fox to take over US business

Teva Pharmaceuticals' new CEO Richard Francis has continued his transformation of the Israeli company, bringing on Christine Fox as the new head of its U.S. commercial business, replacing 15-year Teva veteran Sven Dethlefs, who departs Nov. 17. Fox arrives from Novartis, where she has been the global president of gene therapies for nearly two years.

Abbott analysis finds FreeStyle Libre CGM and GLP-1 drug adherence rise when used together

They say a rising tide lifts all boats, and that certainly seems to be the case with the new wave of drugs and devices for diabetes management.

Adlai, building on the ashes of Novartis' failure, raises $57.5M IPO to run phase 3 cancer trial

Adlai Nortye has established the financial foundation to show whether its bet on an ex-Novartis asset will pay off, securing $97.5 million through an IPO and private placement to fund a phase 3 trial in head and neck cancer.

Exo officially enters handheld ultrasound race with launch of AI-powered Iris system

According to Exo, the Iris system is designed to replace traditional cart-based ultrasound mechanisms with a simple handheld probe, which connects to a smartphone to display its captured images.

Eli Lilly moves to settle with whistleblower who flagged alleged manufacturing shortfalls

After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlement talks.

ModeX nets up to $168M in BARDA bucks to develop therapies for viral infections

ModeX Therapeutics has won a BARDA contract worth up to $168 to develop next-gen antibodies against viral infection. The company inked a partnership with Merck earlier this year worth more than $800 million.

Proposed chemical ban would cause EU drug manufacturing to 'grind to a halt,' trade group warns

A proposed restriction on the use of fluorinated substances in Europe would have an “irredeemable impact” on the continent’s life sciences sector, the European Federation of Pharmaceutical Industries and Associations (EFPIA) warns.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Exploring AstraZeneca's environmental pledges

In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions.
 

Resources

eBook

Improving yield and reproducibility with advanced sample prep

Learn how to get better results from suboptimal biospecimens for NGS and protein analysis.
Whitepaper

Real-world data: The new growth guide for biotech and pharma in 2023

As the field of real-world data and evidence is constantly evolving, it can be hard to keep-up with best practices. Do you know the definitive characteristics of a high-quality dataset? What questions to ask if you decide to outsource your research to consultants? Here’s everything you need to know in one, must-have guide.

eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
Whitepaper

Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.
Whitepaper

Unlock potential in buffer preparation

Learn how outsourcing the buffer preparation can reallocate resources to support core activities of your bioprocess production.
Whitepaper

What Are the Benefits of Generative AI for Pharma?

From trial site feasibility and patient populations to data analysis, generative AI has the potential to revolutionize drug discovery and clinical trial recruitment at both the therapeutic area and indication level.
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
Whitepaper

Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.
Whitepaper

Biotech in the UK: Mapping the Runway to Success

15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond.
 

Industry Events

The MedTech Conference

Genesis 2023

 

Upcoming Fierce Events