Allakos has achieved an undesired hat trick. Across three phase 3 trials, the biotech has now significantly reduced levels of a troublesome white blood cell without improving symptoms, driving it to rethink the development of an anti-Siglec-8 antibody that was once among the hottest prospects in biotech.

Jumping into the health and wellness sector once seemed like an easy win for some pharma companies, but the tough times are increasingly extending beyond biotech. That certainly seems to be the case for InMed Pharmaceuticals, which is backing out of the wellness area less than a year after the Canadian drug developer acquired cannabinoid company BayMedica.

This week on "The Top Line," we discuss Sarepta's phase 2 Duchenne muscular dystrophy clinical trial that was green-lit earlier this week after a clinical hold in June. We also chat the opposing results on either side of the pond for Illumina quest for Grail.

Using what was once a lesser-known regulatory option made world famous by the COVID-19 pandemic, the FDA has granted its first Emergency Use Authorization to a diagnostic test for monkeypox as cases continue to spread worldwide.

A surprise Keytruda failure in liver cancer spells good news not just for established immunotherapy player Roche but also for potential contenders Jiangsu Hengrui Pharma and a partnership between BeiGene and Novartis.

In 2020, Gina Bilotti filed a complaint against her former employer, Johnson & Johnson, alleging discrimination and retaliation spanning back three years. The complaint details numerous discriminatory practices by multiple executives at the company, painting a picture of a "boys club" culture. The lawsuit has now been dismissed as the parties reached an "amicable resolution."

The Biden administration issued a final rule that reverses the Trump-era "public charge" regulation, which can impact immigration healthcare.

Arthur Tzianabos, Ph.D., is stepping down from his role as Homology’s CEO, handing the reins over to Albert Seymour, Ph.D.

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

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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).

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

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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.

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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?

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.