World’s Largest Cell and Gene Therapy Plant Opens

Recently, Swiss biotech company Lonza officially opened its new cell and gene therapy manufacturing plant in Pearland, near Houston, Texas. The facility’s 300,000 square feet make it the world’s largest manufacturing plant devoted to making these types of materials, according to a statement. “This facility has the potential to produce treatment for thousands of patients

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Hamilton Researchers find blood thinner reduces risk of death after non-cardiac surgery

Researchers have discovered that a blood-thinning drug, dabigatran, can significantly reduce the risk of death, heart attack, stroke, and other heart or blood-vessel complications in patients who have a heart injury following major, non-cardiac surgery. Every year, around eight million people in the world develop a condition called myocardial injury after non-cardiac surgery (MINS), which

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FDA approves investigational new drug application for treatment of mucopolysaccharidosis type IIIA

Swedish Biopharmaceutical company, Swedish Orphan Biovitrum AB has announced that the FDA has issued a “study may proceed” letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003 for the treatment of mucopolysaccharidosis type IIIA. In addition, SOBI003 was granted Fast Track status by the

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FDA give Novartis’ breast cancer treatment breakthrough status

Novartis’ CDK4/6 inhibitor Kisqali has acquired Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer. The FDA awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase

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Novo Nordisk gains approval for once per week diabetes drug by FDA

Novo Nordisk has acquired its first global approval for its once-weekly diabetes therapy Ozempic in the US. The FDA has approved the drug’s use alongside diet and exercise to improve glycaemic control in adults with type II diabetes. Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist that induced clinically meaningful and statistically significant reductions

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US FDA approval for Alexion’s Myasthenia Gravis Treatment, Soliris

Alexion has finally claimed FDA approval for its complement inhibitor Soliris in Myasthenia Gravis (MG), which could potentially add $1bn-plus in peak sales for the product. The US regulator has approved Soliris (Eculizumab) to treat adults with refractory generalised MG who are anti-acetylcholine receptor (AchR) antibody-positive, a patient group that “continues to suffer from significant

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