PM Tracker

Several months after the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent.

For people that haven't seen improvements in their symptoms of major depressive disorder with regimens of traditional antidepressants, there is now a new technology to intercede for them.

Eiger and its COVID treatment are in a state of purgatory after murky FDA guidance suggests its unknown whether the company will nab emergency use authorization. In March, the company said the treatment passed a phase 3 test and slashed the risk of hospitalizations.

Amazon's acquisition, announced in July, would provide nearly 200 clinics, over 8,000 customers and a trove of member data, jumpstarting its presence in the employer primary care market. The online retailer has also already begun to unwind Amazon Care, its in-house take on hybrid primary and urgent care.

CDMO giant Lonza inked a deal with Touchlight to expand production and distribution of the biotech’s so-called doggybone DNA platform.

A newly launched clinical trial will add another layer to Freenome's cancer-spotting liquid biopsy, folding in real-world data to potentially improve the blood test’s accuracy and highlight ways to make it more accessible in actual clinical settings.

Sarepta Therapeutics has broken free from an FDA hold—put in place this June—on its phase 2 Duchenne muscular dystrophy (DMD) clinical trial.

Virginia’s Advanced Pharma Manufacturing and R&D Cluster is getting a $52.9 million boost. The funding comes as part of a $1 billion federal government competition to address critical manufacturing and supply issues in the U.S.

In recent years, artificial intelligence developers have changed the face of medicine with algorithms capable of detecting the earliest signs of cancer. Owkin, meanwhile, is taking a slightly different approach with its own cancer-spotting AI.

MedPAC is researching the benefits and downsides to introducing standardized plan options into the popular Medicare Advantage program.

How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation

Today’s healthcare systems are adapting to an ever changing landscape with declining margins, M&A pressures, and the need for staff flexibility due to shortages. Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens.

This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series).

Improve your congress competitive intelligence and cut down costs by 50%

Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success.

Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Simply load, scan, and insert your cartridge and come back to fully analyzed results in 75 minutes. Rethink your ELISA, with Ella.

Set a solid foundation for successful scale-up of buffer preparation.

Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

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

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry.

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.