The wear and tear of time leaves millions of people struggling with painful, grating osteoarthritis each year. But repairing the cartilage damage at the root of the problem can be a tricky business. Real cartilage does not regenerate naturally, nor do any approved drugs promote its regeneration. Orthotrophix Inc. is working to change that with a new targeted peptide that stimulates cartilage production.
Three clinical-stage companies, Minerva Neurosciences Inc., Cymabay Therapeutics Inc. and Dance Biopharm Inc. filed for initial public offerings (IPO) on Nasdaq in hopes of harnessing millions of dollars from enthusiastic investors and riding momentum from a first quarter in which 28 biotech IPOs raised $2.2 billion.
Drugmakers' love for the FDA's orphan drug program burnt brightly in 2013. The agency granted three-quarters of the record 346 requests for orphan designations in fiscal 2013 and approved 33 orphan drugs for sale.
Alkermes plc said Tuesday that favorable phase III data on its long-acting injectable antipsychotic (LAI), aripiprazole lauroxil, will support its filing an FDA new drug application for the investigational schizophrenia treatment in the third quarter, positioning the company to benefit from trends favoring LAIs.
Oncothyreon Inc. said that Merck KGaA has started a phase III trial of its out-licensed cancer vaccine tecemotide in patients with unresectable, locally advanced stage III non-small-cell lung cancer (NSCLC). The new trial seeks to confirm an overall survival (OS) benefit for certain patients and, if successful, could magnify the potential for Merck to acquire Oncothyreon in the future.
Hay fever sufferers will have a new option this spring with Wednesday’s FDA approval of Greer Laboratories Inc.’s Oralair, the first under-the-tongue allergen extract approved in the U.S. to treat allergic rhinitis with or without conjunctivitis.
Anacor Pharmaceuticals Inc. has enrolled the first patient in a pair of pivotal phase III trials of AN2728, its lead topical anti-inflammatory candidate for the treatment of atopic dermatitis and psoriasis that could eventually offer a new alternative to corticosteroids and topical immunomodulator therapies for the common skin conditions.
Syndax Pharmaceuticals Inc. filed for an initial public offering (IPO) Friday under the Jumpstart Our Business Startups Act of 2012. The oncology-focused biotech with an FDA breakthrough designation for its lead program, entinostat, plans to use proceeds from the Nasdaq offering to support trials of the therapeutic and a new drug application for its use in treating metastatic breast cancer.
Investors met Applied Genetic Technologies Corp.’s Nasdaq debut Thursday with tepid interest as the clinical-stage developer of treatments for orphan eye diseases moved to raise $50 million through an initial public offering (IPO) priced at $12 per share, $1 below its intended $13 to $15 range.
