Drugs
FDA has granted I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy (PMN). The designation was based on clinical data from the M-PLACE Phase 1b/2a proof-of-concept, open-label study, according to the company. “We believe that the cellular
Drugs
FDA has placed a partial clinical hold on a Nurix Therapeutics clinical study (NX-2127-001) that is evaluating NX-2127 in various B-cell malignancies. The company says the hold is based on its communication to the agency about its intention to transition to an improved manufacturing process. Nurix
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). Approval was based on data from KEYNOTE-966 (NCT04003636), a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 1,069 patients with locally advanced unresectable or
Drugs
Former FDAer Steve Lynn says an analysis of form FDA-483 inspection reports since 2000 shows the leading observations have remained essentially the same. Writing in a Regulatory Compliance Associates online post, Lynn asks how the industry, both the regulators and the regulated, can solve the systemic repeat observations. Using
Drugs
FDA expects to see the increase in cannabis research that has occurred in recent years to continue. Writing in an online post, CDER Office of the Center Director public health advisor Cassandra Taylor and CDER Office of Executive Programs project manager Schuyler Pruyn say that as the agency sees more
Drugs
A Florida federal judge has sentenced Marina Sievert to two years in federal prison for mail fraud and introducing into interstate commerce a foreign unapproved new drug. As part of her sentence, the court entered an order of forfeiture in the amount of $1.5 million, the proceeds of the
Drugs
Tonix Pharmaceuticals is discontinuing the development program for major depressive disorder candidate TNX-601 ER based on disappointing efficacy results from the company’s Phase 2 UPLIFT study. “The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total
Drugs
Five Sidley Austin attorneys say a 10/24 FDA draft guidance on communications from firms to healthcare providers on unapproved uses of approved or cleared medical products raises many questions. Writing in an online post, the attorneys say the revision of a 2009 final guidance on off-label reprints reflects
Drugs
FDA has issued NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firm’s Telangana, India, manufacturing facility 10/18 and citing significant GMP deficiencies. For example, agency investigators said the firm’s equipment and utensils are not cleaned and maintained at appropriate intervals. The
Drugs
Stakeholders have provided comments to FDA through a 10/14/22 discussion paper and 11/14-16/22 public workshop on the agency’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to foster a regulatory framework to support the adoption of advanced manufacturing technologies that could benefit patients. An
Drugs
FDA has lifted a clinical hold against Mersana Therapeutics’ Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynthen STING-agonist antibody drug conjugate that is designed to target a novel human epidermal growth factor receptor 2 (HER2) epitope and locally activate STING signaling in both tumor-resident immune
Drugs
FDA has granted Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntington’s disease (HD). SAGE-718 is described as a first-in-class investigational NMDA receptor-positive allosteric modulator (PAM) being developed as a potential oral therapy for cognitive disorders associated with NMDA
Drugs
A 9/26-10/3/22 FDA inspection at Ali Pharmaceutical Manufacturing in Omaha, NE, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 3/30 Warning Letter says specific deviations were: * failing to demonstrate that the firm’s manufacturing process
Drugs
A 6/27-7/8/22 FDA Bioresearch Monitoring Program inspection at Samm Solutions, doing business as BTS Research in San Diego, CA, identified objectionable conditions in the company’s role as the testing facility in two nonclinical laboratory studies. A 10/20 Warning Letter says FDA emphasized: * the study
Drugs
FDA has accepted for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare immunodeficiency. The agency has set a review action target date of 4/30/2024. The NDA is based
Drugs
FDA has issued a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. “Patients who have signs or symptoms of an eye infection after using these products should talk to
Drugs
GSK says a Phase 3 trial evaluating its Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer met its primary endpoint of overall survival (OS). The trial (RUBY/ENGOT-EN6/GOG3031/NSGO) is investigating dostarlimab plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab as
Drugs
Novartis says it will seek FDA accelerated approval after reporting favorable data from an interim analysis of the ongoing pivotal Phase 3 ALIGN study (NCT04573478) of atrasentan, an oral endothelin A receptor antagonist (ERA) for treating patients with IgA nephropathy (IgAN). The interim data show that the study met its
Drugs
Deciphera Pharmaceuticals says it will file an NDA in the second quarter of 2024 for vimseltinib for treating patients with tenosynovial giant cell tumor (TGCT) based on just-announced “positive top-line results” from the MOTION pivotal Phase 3 study of the drug in patients with TGCT not amenable to
Drugs
FDA has approved an Eli Lilly BLA for Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), described as the first interleukin-23p19 (IL-23p19) antagonist for treating moderately to severely active ulcerative colitis in adults. Approval was based on data from two Phase 3 trials (LUCENT)
Drugs
A New Braunfels, TX man, Evan Asher Field, was sentenced in federal court in San Antonio to five years in prison for selling unapproved drugs through the mail. According to a Justice Department release, Field and codefendant Michael Dominic Diaz purchased bulk quantities of various drugs, including synthetic opioids and
Drugs
FDA has approved Genentech’s Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion (RVO). This is the third indication for Vabysmo; it was previously approved for treating wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). The bispecific antibody’s latest approval was