Despite a February adcom meeting urging the agency to wait for more data, the FDA has approved Karyopharm Therapeutics Inc.'s selinexor, in combination with dexamethasone (dex), as a new treatment for certain adults with relapsed refractory multiple myeloma (MM). The approval covers patients who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. Read More
The FDA placed a clinical hold Wednesday on a phase I trial by Unum Therapeutics Inc. after a patient experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection, and grade 4 respiratory distress. Read More
HONG KONG - Incyte Corp. entered a collaboration and licensing deal to flip its greater China rights to an investigational anti-PD-1 monoclonal antibody to Zai Lab Ltd., of Shanghai. The candidate, INCMGA-0012, is currently being evaluated as a monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer. Read More
In late May, Novartis AG's Avexis Inc. unit gained FDA approval for Zolgensma (onasemnogene neparvovec) to treat spinal muscular atrophy, and other companies are looking to follow suit developing drugs to treat a variety of diseases of the central nervous system (CNS). Read More
With regulatory science always lagging innovation, ambiguity has long been a certainty at the FDA and is likely to become even more so as the pace of new technologies quickens. Read More
The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control. Read More
Academic sponsors of clinical trials in the EU are the worst offenders when it comes to not posting completed trial results in the EudraCT database. Read More
Karuna Therapeutics Inc., of Boston, said it closed its IPO of about 6.4 million shares, which includes the full exercise of the underwriters' overallotment of 836,718 shares, priced at $16 per share. Gross proceeds were about $102.6 million. Read More
Arbutus Biopharma Corp., of Warminster, Pa., sold part of its royalty interest on future global net sales of Onpattro (patisiran, Alnylam Pharmaceuticals Inc.) to OMERS, the defined benefit pension plan for municipal employees based in the Province of Ontario, Canada. Read More
In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice requirements. Read More
