FDA sinks Allarity's kidney cancer plan
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Today's Rundown

Featured Story

UnitedHealth-Change Healthcare deal trial has begun. Here are 3 things to know

The battle over UnitedHealth's acquisition of Change Healthcare is underway. The trial over the $13 billion deal began Monday in District of Columbia federal court.

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Top Stories

AbbVie, bracing for biosim impact, scores another win against Humira antitrust allegations

With 132 patents for Humira, AbbVie has faced its share of critics alleging antitrust violations. Now, an appeals court ruled that AbbVie's Humira strategy holds up within the law.

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Allarity, after some forced clarity from FDA, pivots lead asset hopes to combo approach

After a meeting with the FDA, Allarity Therapeutics is abandoning hope that its lead clinical asset could be sold as a monotherapy for kidney cancer.

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PerkinElmer to rebrand as life-science-focused supplier, sell off other businesses in $2.45B deal

PerkinElmer is slimming down to focus solely on diagnostics and life sciences research, selling off its other businesses in a deal that will hand it $2.3 billion in cash. The funding is expected to allow the company to redouble its efforts in healthcare and attain a new name.

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Monkeypox tracker: White House picks response coordinator

Follow along with the latest monkeypox news and insights from the Fierce Healthcare team.

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After delay, CSL's $11.7B deal for Vifor poised to close next week

After an antitrust review knocked 2021’s biggest biopharma buyout off course in May, CSL’s $11.7 billion deal for Swiss kidney disease specialist Vifor Pharma appears to be back on track.

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Axcella misses primary endpoint in long COVID trial but plots path to market based on fatigue scores

Axcella’s phase 2a long COVID clinical trial has missed its primary endpoint. But with the study linking the drug to improved fatigue scores versus placebo, the biotech plans to meet with regulators to discuss its path to a registration trial.

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ResMed continues German expansion with acquisition of Mementor's insomnia digital therapeutic

With the pedal firmly to the metal in its U.S. business—thanks in no small part to rival CPAP machine maker Philips’ ongoing recall—ResMed has begun looking beyond its home turf to extend that winning streak.

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Elevance Health teams with Aledade on value-based primary care

Elevance Health is betting big on primary care with a new nationwide partnership with Aledade.

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Incyte hit 'unexpected slowdown' with Opzelura launch in eczema, but it's fixed now: exec

Incyte’s closely watched Opzelura cream launch for atopic dermatitis just hit a road bump, and its discount pressure remains heavy. But the company believes the problem has been solved and that it's on track to reach tis pricing goal.

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Genentech-AC Immune's Alzheimer's drug failed, but what have they learned from crenezumab?

Roche’s Genentech and AC Immune know they have a failed trial on their hands for the Alzheimer’s disease drug crenezumab. But the partners are still parsing through the data, trying to find signals that could inform the next wave of development in the neurodegenerative disease.

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Surgical robot maker Virtual Incision heads to space with NASA grant

Armed with a grant from NASA itself, robotic-assisted surgery will soon head for the final frontier.

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Resources

Whitepaper: Genetic Insights for Biopharmaceuticals

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Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

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

Article: Formulation Strategies When Transitioning From Vial to PFS

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

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

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

Case Study: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

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

Article: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

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

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

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.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

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?

On-Demand Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

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