Archive for December 2021

Amylyx Pharmaceuticals has scored a priority review by the FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for amyotrophic lateral sclerosis (ALS). Source: Drug Industry Daily

With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval marks the Denmark-based company’s first U.S. biologic. Source: Drug Industry Daily

FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints. Source: Drug Industry Daily

In terms of approvals of new products, 2021 was the second-best year for cell and gene therapies and tissue products (The best year was 2016, when nine therapies were approved.). Source: Drug Industry Daily

People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest. Source: Drug Industry Daily

The FDA has approved Novartis’s new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago because of manufacturing concerns. Source: Drug Industry Daily

Over the past year, President Biden touted that the nearly $2 trillion Build Back Better Act would bolster the nation’s social safety net, fight climate change and introduce drug pricing reform. Source: Drug Industry Daily

High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Source: Drug Industry Daily

Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year. Source: Drug Industry Daily

Novartis announced that it will acquire the UK-based ocular gene therapy company Gyroscope Therapeutics, giving Novartis a one-time gene therapy for geographic atrophy (GA), a leading cause of blindness. Source: Drug Industry Daily