Inovio Pharmaceuticals Inc. expects to start a late-stage U.S. study of the company’s experimental Covid-19 vaccine candidate in the second quarter of 2021, the drug developer’s chief executive officer said.

The U.S. Food and Drug Administration approved Kala Pharmaceuticals’ Eysuvis for the short-term treatment of dry eye disease. 

David Lickrish – president, founder and chief executive officer of Highland Therapeutics and Ironshore Therapeutics – spoke with BioSpace about the companies’ Jornay PM (methylphenidate HCL Extended-Release CLL Capsules) and how the new drug fits into the overall ADHD therapeutic market.

San Diego’s Halozyme Therapeutics tied up a licensing agreement with Connecticut-based Alexion Pharmaceuticals that could net the company $680 million.

Optinose announced that the U.S. FDA approved the company’s New Drug Application for XHANCE for treating nasal polyps in patients 18 years of age and older.

Noble, a leader in biopharmaceutical onboarding and device training, announced a global collaboration with BD (Becton, Dickinson and Company), a leading global medical technology company, for developing patient onboarding solutions including demonstration devices.

The FDA approved Neos’ Cotempla XR-ODT, the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients 6 to 17 years old.

As biologic medications administered through prefilled syringes continue to supplement and enter new therapeutic areas, more and more patients will need to embark on a learning curve that is possibly unlike any they have experienced prior.

Shares of Arrowhead Pharmaceuticals Inc. sank one day after the company said it would stop developing all drugs being tested on humans.

Dallas/Fort Worth, Texas-based Neos Therapeutics announced yesterday that the U.S. Food and Drug Administration (FDA) had found deficiencies in its New Drug Application (NDA) for Cotempla XR-ODT to treat attention deficit hyperactivity disorder (ADHD). As a result, they would not be discussing labeling and postmarketing requirements until further review.   Neos focuses on developing and […]