Avoid plastic syringes from China: FDA

Today’s Big News

Dec 1, 2023

Pfizer cans twice-daily oral obesity program after half of patients leave trial while once daily continues  


AstraZeneca calls it quits on pair of trials for hyperkalemia drug it scored in buyout of ZS Pharma 


FDA recommends avoiding plastic syringes made in China amid safety investigation 


Altimmune, seeking edge on Lilly and Novo, puts heart health at center of phase 2 obesity data drop 


Novartis expands radiotherapy manufacturing network with $85M plant in China 

 

Featured

Pfizer cans twice-daily oral obesity program after half of patients leave trial while once daily continues

Pfizer is continuing to pinball between oral obesity assets. Months after making twice-daily danuglipron its top prospect, the Big Pharma has dropped the program after more than half of people taking the drug candidate dropped out of a midphase clinical trial.
 

Top Stories

AstraZeneca calls it quits on pair of trials for hyperkalemia drug it scored in buyout of ZS Pharma

AstraZeneca has put the kibosh on two late-stage Lokelma trials testing the hyperkalemia drug in patients with heart and kidney diseases. The studies were called off due to “substantially increased enrollment times and low event rates,” AZ said Friday.

FDA recommends avoiding plastic syringes made in China amid safety investigation

The FDA is looking into a spate of quality complaints regarding plastic syringes manufactured in China.

Altimmune, seeking edge on Lilly and Novo, puts heart health at center of phase 2 obesity data drop

Tiny Altimmune is slinging stones at the goliaths of the obesity market. Facing well set incumbents, the biotech pitched its midphase data as evidence that its GLP-1 candidate can carve out a niche in obesity patients at risk of cardiovascular events—but tolerability issues that marred an earlier data drop remain.

Novartis expands radiotherapy manufacturing network with $85M plant in China

When it comes to expanding radiotherapy manufacturing capacity for Lutathera and Pluvicto, Novartis is putting its money where its mouth is. The Swiss pharma is investing about $85 million to build a new radiotherapy facility in China.

Empatica plots wearable-based study to develop seizure prediction algorithm

After developing a wearable device that can automatically detect seizures in people with epilepsy and immediately notify their caregivers, Empatica is planning to take the technology even further.

Tang Capital’s Concentra back with another buyout offer, this time for LianBio

Tang Capital Partners’ Concentra Biosciences is back with yet another biotech buyout offer, this time proposing to acquire LianBio in an all cash deal.

J&J, AbbVie, Sanofi and many other companies face competition probe in Turkey

The companies, which include Pfizer, J&J, Sanofi, AbbVie, AstraZeneca, Merck and others are being probed for potentially violating Turkish competition law, according to a release from the country's government.

Chutes & Ladders—FDA names Chief Scientist Bumpus as new number 2

FDA swiftly promotes Chief Scientist Bumpus to replace Woodcock. Amylyx names new CMO with post-approval clinical development in the spotlight. Spyre names Turtle CEO and adds host of new hires.

As GSK's RSV shot nears blockbuster threshold, CEO sees plenty of 'headroom for growth'

As the battle between new respiratory syncytial virus vaccines heats up, GSK is “delighted” with the progress it's made so far with Arexvy, the company’s CEO Emma Walmsley said during a Reuters interview. Despite the vaccine's swift takeoff, there’s still “lots of headroom for growth," Walmsley added.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Fiercest Women in Life Sciences, meet the Fierce 50

In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech.
 

Resources

Whitepaper

Accelerate drug discovery with high-performance computing (HPC) powered by the cloud

Accelerate drug discovery with high-performance computing (HPC) powered by the cloud
Whitepaper

Effective Technology Transfers for Mammalian-Derived Biologics

As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. 

eBook

An Introduction to Organ-on-a-Chip Technology

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

Overcome Challenges and Secure Successful Technology Transfers of Complex Biological Products in Sterile Manufacturing

A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer.

Whitepaper

Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
Whitepaper

Plasmid DNA Design Considerations for Cell and Gene Therapy

Download our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications.
Whitepaper

Artificial Intelligence in Healthcare & Medical Affairs

This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.
 

Industry Events

Genesis 2023

 

Upcoming Fierce Events

5
Dec
Edison Ballroom, New York City
9-10
Jan
San Francisco, CA
16-18
Jan
Virtual Event
11-12
Mar
San Francisco, CA
18-20
Mar
Savannah, GA

View all events