Weekly Digest

Just a few months after Fitbit roped in FDA clearance for an algorithm that could be embedded into its eponymous health-tracking wearables to detect atrial fibrillation, the technology is ready to hit the ground running.

By the end of 2023, Novartis plans to shutter its Sandoz oral solid dosage plant in Wilson, North Carolina, where the company’s soon-to-be-spun-off generics division makes products like tablets and capsules for Canada and the U.S. The site’s roughly 246 employees have already been alerted to the closure, the company said.

A new interim analysis of Bristol Myers Squibb's anticoagulant milvexian as a treatment for secondary strokes shows a mixed bag of data. The drug failed its primary endpoint, but a reduction in stroke incidence among three dosing groups beat the company's expectations.

This week on "The Top Line," we discuss just how deep—and broad—the Alzheimer’s pipeline is despite major players dominating the headlines. We also chat about our research into the 2012 class of Fierce 15 and where those biotechs are now.

More shots have been fired in the patent proxy war between CAR-T giants Gilead Sciences and Bristol Myers Squibb as Gilead moved to parry a recent BMS petition to the U.S.’ high court.

Beam Therapeutics is disclosing more details about a clinical hold placed on its phase 1-ready CAR-T. The FDA's questions centered on more data from controls and results from off-target editing tests.

AstraZeneca CEO Pascal Soriot told The Telegraph that annual COVID-19 booster shots are “not a good use” of taxpayer money in all people. His comments come a week after Soriot said that the company was considering getting out of the vaccine business altogether.

Situating the BioButton under Medtronic’s umbrella will be especially beneficial in helping hospitals navigate the growing shortage of healthcare workers and rising healthcare costs, per BioIntelliSense CEO James Mault, M.D.

At the European Society of Cardiology’s annual meeting, AstraZeneca presented data that could boost Farxiga in the competitive heart failure market. It is the first heart failure drug to show it can reduce the risk of death in patients regardless of their ejection fraction status.

Takeda is handing the rights of two assets back over to Finch, including one that the two have collaborated on for more than five years. Finch says it will try and find new partners for the programs.

Alongside Teva, Amneal Pharmaceutical, Purdue subsidiary Rhodes Pharmaceuticals and Novartis’ soon-to-be-spun-off generics unit Sandoz have generic extended-released Adderall on back order, according to a recent supply update from the American Society of Health-System Pharmacists, which tracks drug shortages.

Power, which is focused on improving access to clinical trial studies, debuted with $7 million in seed funding to break through barriers that currently hamper patient recruiting efforts.

United Therapeutics has struck a blow to Liquidia Technologies’ generic formulation of Tyvaso. With a court ruling the generic infringes a United patent, Liquidia faces the prospect of being kept off the market until 2027—unless it gets the decision overturned or prevails in a related dispute.

How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers

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

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

TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases.

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.

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.

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.

See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead.

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.

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?

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

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

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?

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