With Thursday's IPO pricings from Adaptive Biotechnologies Corp., Bridgebio Pharma and Morphic Holding Co., 2019 swallowed last year's record for the most money ever raised through biopharma IPOs in the month of June, bringing in $1.97 billion compared with $1.64 billion last year. Read More
Months sooner than expected, Zogenix Inc. said it's planning to resubmit an NDA for Fintepla (ZX-008, fenfluramine hydrochloride), a drug for seizures associated with Dravet syndrome (DS) that received a refusal to file (RTF) letter from the FDA in April. Read More
Alexion Pharmaceuticals Inc. gained expansion from the FDA of the label for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. Read More
The hunt is on for a dry eye disease (DED) therapy to replace Allergan plc's blockbuster, Restasis (ciclosporin), which the Dublin-based firm sought to shield behind the protective estate of 27 patents, including six famously assigned in 2017 to the Saint Regis Mohawk Tribe and then licensed back in perpetuity, seeking to prevent their expiry in 2024. Read More
Four more bills aimed at changing the trajectory of U.S. prescription drug prices are on their way to the Senate floor. The Senate Judiciary Committee gave a thumbs up Thursday to three bills intended to stop anticompetitive shenanigans and one that charges the Federal Trade Commission (FTC) with studying the role of supply chain middlemen to determine whether they're the good guys or the bad guys when it comes to drug prices. Read More
DUBLIN – Modag GmbH closed a €12 million (US$13.6 million) series A round to move a small-molecule drug that targets toxic oligomeric forms of alpha-synuclein into clinical trials in multiple system atrophy (MSA). Read More
PARIS – Six months after opening its first Biome digital innovation lab in San Francisco, Swiss pharma company Novartis AG announced the opening of its first European digital innovation lab, located at the head office of its subsidiary in Rueil-Malmaison, France. Read More
Preventive treatment for potential cardiac problems is incredibly common in the U.S., particularly among older patients. But the tools to assess an individual patient's risk of a major cardiac event have their limitations. Coronary computed tomography arteriography (CCTA) scans are a means of assessing heart health, but their use is typically restricted to patients with specific suspected indications. Read More
Velabs Therapeutics GmbH, of Heidelberg, Germany, said it closed a €3 million (US$3.4 million) series B financing round to advance its functional antibody screening program and to strengthen its own pipeline of preclinical functional antibodies against diseases with poor treatment options. Read More
Essa Pharma Inc., of Houston, updated its pending acquisition of Realm Therapeutics plc, of Malvern, Pa., stating that the court hearing to sanction the scheme of arrangement in the U.K. was postponed to July 8, due to a Realm shareholder opposing the scheme. Realm has a listing on the London AIM market. Read More
With the March 23 deadline looming for the FDA to deem as licensed biologics simple proteins, including insulin, that were originally approved under new drug applications (NDAs), the agency issued a proposed rule Thursday aimed at making the transition seamless with minimal impact to the affected products. Read More
