FDA gives 1st full nod for rapid antigen COVID test

Today's Big News

Mar 9, 2023

An unlikely alliance? Pfizer CEO gave political cash to Senate GOP candidate Dr. Oz  


Vertex's next off-the-shelf diabetes cell therapy follows in predecessor's footsteps to the clinic  


QuidelOrtho's rapid antigen COVID test is first to receive regular clearance from the FDA  


Lilly's 10-year bet on treating Alzheimer's before symptoms start ends in failure  


AstraZeneca’s Imfinzi, Tagrisso deliver lung cancer trial wins. For one, a Keytruda showdown looms 

 

Featured

An unlikely alliance? Pfizer CEO gave political cash to Senate GOP candidate Dr. Oz

Months after Dr. Oz conceded in the Pennsylvania senate race, campaign finance records show that Pfizer CEO Albert Bourla, Ph.D., donated to his campaign, Stat first reported.
 

Top Stories

Vertex's next off-the-shelf diabetes cell therapy follows in predecessor's footsteps to the clinic

Vertex’s type 1 diabetes cell therapy turned heads when one patient's islet cell function was restored. Now, the pharma is readying version 2.0 for the clinic after the FDA cleared a similar treatment that uses a device to shield the cells from the body’s immune system.

QuidelOrtho's rapid antigen COVID test is first to receive regular clearance from the FDA

A previous version of QuidelOrtho's rapid antigen coronavirus diagnostic was the first to receive emergency use authorization from the FDA in May 2020.

Lilly's 10-year bet on treating Alzheimer's before symptoms start ends in failure

As the pile of failed Alzheimer’s disease programs grew ever larger, researchers identified trials in earlier- and earlier-stage patients as the key to efficacy. The flops were a case of right drug, wrong patients, the theory went. Eli Lilly put the idea to the test—and 10 years later has learned its drug was at fault all along.

AstraZeneca’s Imfinzi, Tagrisso deliver lung cancer trial wins. For one, a Keytruda showdown looms

AstraZeneca reported two trial wins in early-stage non-small cell lung cancer. For the immunotherapy Imfinzi, the detailed data will feed into an increasingly fierce market showdown.

Fierce Biotech Fundraising Tracker '23: Ring circles $86.5M; QurAlis catches $88M for ALS ambitions

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Novo Nordisk buys 104 acres in North Carolina, making room for more expansion

Novo Nordisk is adding to its already considerable presence in Clayton, N.C. The Danish company has purchased 104 acres for $6.8 million adjacent to its huge complex, where two plants pump out diabetes and obesity medicines.

Fallen Titan: Surgical robot maker delisted from Nasdaq amid mass layoffs, failed sell-off

After more than a year spent trying to coax its share price out of penny stock territory—to no avail—Titan Medical has been kicked off the Nasdaq.

Fierce Biotech Layoff Tracker 2023: Neoleukin cuts 70% of staff, CEO; CODA shuts down

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The surprising multibillion-dollar medtech megadeals

This week on "The Top Line," we discuss 2022's M&A trends in the medtech sector and the surprising multibillion-dollar megadeals. We also cover the top headlines from this week.
 

Resources

Executive Summary

Optimizing drug discovery in a fast-moving market

Read about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines.
Whitepaper

Answering your specific questions about mRNA/saRNA manufacturing

Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here.
Whitepaper

Proven Pharmaceutical Go-To-Market Model

Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success.

Research

Strategizing for Clinical Trial Diversity

Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials.
Whitepaper

The Power of Small & Safety: Nanoplasmid™️ Vector Platform

Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies.

Whitepaper

Leveraging Archetypes for Effective Launch Strategy

Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches.
On-Demand Webinar

Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
Whitepaper

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.
Research

Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

Case Study

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Research

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

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.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
 

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