MDMA nears momentous FDA filing

Today’s Big News

Sep 15, 2023

RayzeBio overshoots expectations with $311M IPO while Neumora hits $250M target


BMS trims anti-TIGIT pipeline and a handful of other early- to-midstage meds


MDMA approval filing nears after drug hits again in phase 3, showing consistent PTSD improvements


Delayed TIL 2024: FDA resource constraints push back decision on Iovance cell therapy


Carl June, Vertex execs and Parkinson's scientists win Breakthrough prizes 


Chutes & Ladders—Madrigal snags Sanofi's Bill Sibold as CEO


As White House mulls microbe research, microbiologists chime in with calls for standardized practices

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

RayzeBio overshoots expectations with $311M IPO while Neumora hits $250M target

Anyone wanting to end the week on a hopeful note could do worse than to check out the duo of biotech IPOs that made it over the line. RayzeBio has just revealed it overshot expectations by raising $311 million, while Neumora Therapeutics was squarely on target with a $250 million offering.
 

Top Stories

BMS trims anti-TIGIT pipeline and a handful of other early- to-midstage meds

As the TIGIT class gets closer to possible clinical success, Bristol Myers Squibb is trimming one of its candidates.

MDMA approval filing nears after drug hits again in phase 3, showing consistent PTSD improvements

MAPS Public Benefit Corporation has shown off phase 3 data it hopes will secure a landmark approval for MDMA in the U.S. next year. The second phase 3 success is the result of almost 40 years of work to show that psychedelics can treat post-traumatic stress disorder (PTSD) when used to enhance therapy.

IQVIA supports sites and participants through patient-centric trial experiences

With IQVIA’s clinical trial solutions and flexible site support strategies, decentralized trial elementss are being leveraged to enhance patient- centered care as well as support sites through hands- on enablement and implementation of DCT platforms these services.

Delayed TIL 2024: FDA resource constraints push back decision on Iovance cell therapy

The FDA has provided yet another twist in the Iovance Biotherapeutics saga. After years of delays, the biotech was on track to receive an approval decision on its tumor-infiltrating lymphocyte melanoma therapy this year only for the FDA to delay the deadline because of “resource constraints.”

Carl June, Vertex execs and Parkinson's scientists win Breakthrough prizes

CAR-T cell therapy pioneer Carl June, M.D., and scientists from Vertex Pharmaceuticals are among the life sciences winners of 2024 Breakthrough Prizes, awards established by a group of influential tech titans as a means to recognize major achievements in basic science research.

Chutes & Ladders—Madrigal snags Sanofi's Bill Sibold as CEO

Bill Sibold has left Sanofi after a 12-year run, departing for Madrigal Pharmaceuticals, where he is taking the top spot.

As White House mulls microbe research, microbiologists chime in with calls for standardized practices

Scientists from leading research institutions called for standardized practices, greater public transparency and more in a new report on gain-of-function research, which comes as the White House deliberates a new framework for how such studies are regulated.

Johnson & Johnson unleashes power of the ampersand as it follows Sanofi, GSK in major rebrand

Sanofi tapped tech and GSK took out the scissors during their rebrands, but Johnson & Johnson is changing up its iconic logo and name for the “next chapter” in its corporate story.

Rise and shine: AWAK Technologies takes in $20M for portable dialysis system

A new day has dawned for AWAK Technologies, the maker of a kidney dialysis machine so small that it can fit in a shoulder bag for on-the-go treatments.

At least 67,000 Kaiser Permanente workers vote to authorize strike, allege bad faith bargaining

The total could grow by nearly 20,000 more as other unions tally their votes. The large nonprofit would need to reach a contract deal by Sept. 30 to avoid the walk-off.

Amgen, AstraZeneca focus on asthmatic punk rocker to show how Tezspire can unleash lust for life

Amgen and AstraZeneca are returning to the TV party to show how Tezspire can help punks with a lust for life rise above their asthma symptoms and take complete control of their lives.

Mammogram AI shows more promise, performing as well as radiologists in breast cancer screening study

Developed by the South Korea-based company Lunit, the Insight MMG program has previously collected green lights for use in the U.S. and Europe.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Cannes Lions, top paid CEOs, and a drug shortage

This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage

 

Resources

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.
Whitepaper

Plan for success with your process liquid and buffer preparation

Learn how process liquids and buffers impact your total cost of ownership (TCO) and how outsourcing can revolutionize your approach, ensuring quality standards and improving productivity.
 

Industry Events

The MedTech Conference

The MedTech Conference

 

Upcoming Fierce Events