Mirati Therapeutics has taken the lid off updated data on KRAS inhibitor adagrasib in colorectal cancer. Having established itself as the front-runner in the space last year, the biotech has presented a new look at the data that largely reaffirm the earlier findings.

Yesterday was the long-awaited second meeting of the FDA’s independent expert panel to weigh in on Amylyx’s ALS drug, and this time, AMX0035 came away with a victory. New information Amylyx provided was able to sway some members to change their negative opinion from the last time they met.

An investigational malaria vaccine booster from the University of Oxford maintained high efficacy levels a year after the initial shots—a feat in a disease area that scientists have long struggled to develop effective vaccines and therapies.

LifeArc Ventures’ billion-pound investment strategy appears to be paying off, as the British life sciences VC fund saw its first portfolio company sold off in the form of Ducentis BioTherapeutics.

Scientists from McMaster University in Ontario have discovered that Pseudomonas aeruginosa kills its fellow bacteria by targeting them with an RNA-damaging toxin. The findings could open a door to developing new antibiotics, or at least be used to better understand bacterial physiology.

Many Gilead Sciences investors have lost faith in Trodelvy for HR-positive, HER2-negative breast cancer after disappointing tumor progression data. But the drug has now made a surprise comeback with a life extension benefit that came above industry watchers’ expectations, reigniting blockbuster hopes.

Wednesday at the European Society for Medical Oncology’s annual conference, trial data were presented showing that Seagen's Padcev and Merck's Keytruda perform well together against a form of bladder cancer and that Padcev is a strong contributor to the combo treatment.

GlaxoSmithKline inked trial software firm Medable to a four-year deal to use its platform for decentralized clinical trials and to recruit more diverse trial patient populations.

The legal troubles continue for Philips and the seemingly never-ending recall of around 5.5 million of its breathing support machines.

The FDA rejected Alvotech’s application to approve its biosimilar copycat drug of AbbVie’s blockbuster immunology asset Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

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

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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?

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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.