Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs like opioids. “We want to make sure the promotional materials accurately convey the risks associated with these drugs, convey responsible use of opioids, and do not inadvertently
Drugs
Merck says it is discontinuing developing two Covid-19 vaccine candidates, V590 and V591 based on Phase 1 data showing that the immune responses were inferior to those seen following natural infection and those reported for other Covid-19 vaccines. The Pfizer and Moderna mRNA vaccines that are currently on
Drugs
FDA has accepted for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). Odevixibat is described as a potent, once-daily, non-systemic ileal bile acid transport inhibitor being developed to treat patients with rare pediatric cholestatic liver diseases, including
Drugs
FDA has approved an Aurinia Pharmaceuticals NDA for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN), which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. Approval is based on data from
Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibb’s Opdivo (nivolumab) for treating patients with advanced renal cell carcinoma (RCC), which is the most common form of kidney cancer. “This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib
Drugs
FDA has given the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investigational AAV9 gene therapy being evaluated for treating Wilson Disease. “"The seamless Phase 1/2/3 clinical trial design will allow us to efficiently evaluate safety
Drugs
NJ attorney general Gurbir S. Grewal has announced a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve allegations that he unlawfully bribed New Jersey doctors as part of a nationwide kickback scheme to boost sales of the company’s opioid drug Subsys. This is the first
Drugs
FDA has accepted for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease. The agency is expected to make a review decision in May. Esbriet was originally approved in 2014 for treating idiopathic pulmonary fibrosis. The submission is based on data from a pivotal,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development Under the BPCI Act, should be revised to provide more complete guidance related to interchangeable products, including on: * consideration for developing presentations, container closure systems, and delivery
Drugs
FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for treating HIV-1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known
Drugs
FDA has accepted two Bristol-Myers Squibb sBLAs for new indications for its Opdivo (nivolumab). The first sBLA is to treat patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency granted the application priority review and set a PDUFA goal date
Drugs
FDA has accepted for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with or without aura in adults. The company says INP104 is intended to be delivered directly into the vascular-rich upper nasal space using Impel’s proprietary
Drugs
FDA has denied without comment an 11/1/19 GlaxoSmithKline petition asking that the agency review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling in light
Drugs
FDA has approved Merck’s Verquvo (vericiguat), a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Merck says
Drugs
FDA reportedly has verbally notified Histogen that the agency has additional questions about the company’s IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect
Drugs
FDA has deferred a review action on GlaxoSmithKline’s PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufacturing site inspection due to Covid-19 concerns. The company is telling several media outlets that while the site inspection has not occurred yet, it is
Drugs
L.E.K. Consulting says that FDA approval for a new drug is no guarantee of commercial success. In a report on lessons learned from the company’s Launch Monitor, L.E.K. says that to drive real value, biopharma companies must execute the launch process flawlessly. “As history shows,
Drugs
FDA has removed a partial clinical hold on a Pieris Pharmaceuticals Phase 1 study of PRS-343 that was issued while the company conducted an additional in-use and compatibility study requested by the agency. Currently-enrolled patients were permitted to continue to receive treatment, the company said, but no
Biologics
FDA commissioner Stephen Hahn and senior advisor Colin Rom say the agency has signed a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through the adoption
Drugs
FDA has released the 39-page FDA-483 containing 13 detailed observations issued following a 9/10-11/5/2020 inspection at Novel Laboratories, doing business as Lupin, Somerset, NJ. The inspection observations were: * failing to clean and sanitize at appropriate intervals equipment and utensils to prevent malfunctions and contamination
Drugs
FDA has granted accelerated approval to Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis. The approval was based on data from the ANDROMEDA (NCT03201965) trial in 388 patients with measurable disease and at least one affected
Drugs
FDA has approved a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on data from the DESTINY-Gastric01 (NCT03329690) trial in patients with