As expected, the FDA hit Avanir Pharmaceuticals Inc. late Wednesday with a complete response letter (CRL) related to the new drug application (NDA) for AVP-825, a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally with a breath-powered delivery technology for the acute treatment of migraine.
Half of the more than 100 firms targeted by a group of hackers out to intercept confidential data regarding potentially market-moving disclosures are biotech companies, according to a new report by the Milpitas, Calif.-based security firm FireEye.
The approval this fall of Merck & Co. Inc.'s lauded Keytruda (pembrolizumab) for melanoma – well ahead of its Oct. 28 PDUFA date – opened the door for the promising class of programmed cell death-1 (PD-1) inhibitors, and represented another stride in the steady march of immunotherapy in cancer.
Following up its March deal with Bristol-Myers Squibb Co. (BMS) centered on a pair of undisclosed checkpoint inhibitors, Five Prime Therapeutics Inc. entered a new arrangement with BMS that brings $30 million up front and may hold the key to getting around resistance problems.
Extending the FDA's priority review voucher (PRV) program to include the Ebola virus would not need an act of Congress, but one of its inventors – David Ridley at Duke University – is doing what he can to make the moves happen there.
As analysts congratulated Neostem Inc. on phase II data with its autologous stem cell therapy for acute myocardial infarction (AMI) and the "incredibly pleased" company hailed the results as "exciting," Wall Street bludgeoned the shares (NASDAQ:NBS), which ended Tuesday at $4.78, down $2, or 29.5 percent.
Merck & Co. Inc. tipped its hand a week earlier in SEC paperwork regarding what the outcome of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) might mean for the pharma firm's bottom line, but the world had to wait until Monday morning to find out how the experiment could help or hinder developers of anti-cholesterol protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
With encouraging interim phase II data in hand and a large phase III trial under way, Celldex Therapeutics Inc. is making plans to talk with regulators about the chances for approval of rindopepimut (rindo), an immunotherapy vaccine targeting epidermal growth factor variant III (EGFRvIII) in glioblastoma multiforme (GBM).
With its injectable version of a topical stain approved to detect eye damage – the first-ever therapeutic use of rose Bengal – on the runway for phase III trials in melanoma, Provectus Biopharmaceuticals Inc. has offered the FDA a comparator-study protocol, while pursuing earlier-stage work with PV-10 in breast and liver tumors as well.
With a fix for the longstanding problem of non-compliance in dosing exenatide to type 2 diabetes patients, Intarcia Pharmaceuticals Inc. reaped a potential $1 billion partner in Les Laboratoires Servier for ITCA 650, a once-per-year pump that can be implanted in the doctor's office.
