Drugs
Pharmaceutical company HLB and China’s Antengene say FDA has issued a second complete response letter (CRL) on rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic liver cancer. In May, FDA issued a complete response
Drugs
Despite Immunovant promising data from two batoclimab clinical studies for treating myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), the company says it is delaying its decision on whether to seek FDA approval until the results of ongoing Phase 3 studies in thyroid eye disease are available. Batoclimab is
FDA Policy/General
Former 15-year FDAer Henry Miller, now an American Council on Science and Health distinguished fellow, says uncertainty rules as FDA awaits the confirmation of commissioner-designate Martin Makary. Writing in his personal Pundicity online blog, Miller says that while specific priorities for Trump 2.0 are not yet clear,
Drugs
FDA has published a Federal Register notice with the OTC monograph drug facility fee rates under the OTC monograph drug user fee program for FY 2025, which started 10/1/2024 and runs to 9/30. The notice says the monograph drug facility fee is $37,556 and the contract
Drugs
FDA has issued Japan-based Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation. The company says the letter did not cite any clinical study-related efficacy or safety information, and no additional clinical studies are required. However,
Drugs
A 9/9-9/17/2024 FDA inspection at the Aspen Pharmacare drug manufacturing facility in Korsten, Gqeberha, South Africa, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/24 Warning Letter says the specific violations were: * failure to establish laboratory controls
Drugs
FDA has accepted a BLA submitted by Dr. Reddy’s Laboratories and Alvotech for AVT03, developed by Alvotech as a biosimilar of Amgen’s Prolia (denosumab) and Xgeva (denosumab). A statement from the companies says AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia, indicated to treat osteoporosis
Drugs
A 10/16-10/19/2023 FDA inspection at the Vegewax Candleworx drug manufacturing facility in Concord, Ontario, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/14/2024 Warning Letter says the specific violations were: * failure to test samples of
Drugs
The International Council for Harmonization (ICH) says two of its guidelines have reached Step 2b of the ICH process. The M11 updated technical specification document, incorporating comments received during the first public consultation, has entered the second round of public consultation, which will focus solely on the technical specification document.
Drugs
FDA has granted Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (a combined positive score of 1 or higher)
Drugs
Sarepta Therapeutics says that a young man with Duchenne muscular dystrophy (DMD) died following treatment with the company’s Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for DMD patients. A company statement says the patient suffered acute liver failure. It says that acute liver injury is a known
Drugs
Two Harvard University researchers who compared regulator treatment of first-in-class drugs in the U.S. and Europe say regulators need to carefully balance flexibilities with rigorous assessments of evidence for the drugs. Writing in Health Affairs, the researchers say they investigated FDA approval data for 186 first-in-
Drugs
FDA has granted Nurix Therapeutics an orphan drug designation for bexobrutideg (NX-5948) and its use in treating Waldenström macroglobulinemia (WM). Bexobrutideg is described by the company as an orally bioavailable, brain-penetrant degrader of BTK which is being evaluated in an ongoing Phase 1a/b clinical trial in adults
Drugs
An FDA BIMO (bioresearch monitoring program) 4/8-4/19/2024 inspection of three clinical investigations conducted by Dr. Mehran Bahrami in Adventura, FL, found objectionable conditions that indicate he did not adhere to laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A
Drugs
A 71/0-8/1/2024 FDA inspection at the Advanced Pharmaceutical Technology drug manufacturing facility in Elmsford, NY, found repeat significant violations of current good manufacturing practice (CGMP) regulations for combination products. A 3/14 Warning Letter says specific violations were: * failure to establish and follow appropriate written procedures
Drugs
FDA has granted Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with moderate-to-severe Sjögren’s disease (SjD). This follows the agency’s breakthrough therapy designation late last year for the therapy. Sjögren’s disease is a chronic
Drugs
Incyte says it will seek FDA approval for its oral small-molecule JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition characterized by painful nodules and abscesses that can cause tissue destruction and scarring. The company says the submission
Drugs
FDA has lifted a clinical hold against vTv Therapeutics’ cadisegliatin clinical program (CATT1 Phase 3 trial) evaluating the first-in-class oral adjunctive therapy to insulin for treating Type 1 diabetes. Cadisegliatin is described by the company as a liver-selective glucokinase activator that has been well tolerated in over
Drugs
AstraZeneca says recent data from the CALYPSO Phase 3 hypoparathyroidism trial showed that eneboparatide, an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with “statistical significance.” The company says the trial is evaluating the therapy’s use in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared
Drugs
Federal Register notice: FDA is withdrawing approval of eight ANDAs from multiple applicants after they told the agency that the drugs were no longer marketed. To view the notice, click here.
Drugs
FDA has granted Korro Bio an orphan drug designation for KRRO-110 for treating Alpha-1 Antitrypsin Deficiency (AATD). KRRO-110 is the first RNA editing oligonucleotide product candidate from Korro’s proprietary RNA editing platform, Oligonucleotide Promoted Editing of RNA, according to the company. It is currently being evaluated
Drugs
Dr. Reddy’s Laboratories is recalling (Class 1) one lot of levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL single-dose infusion bags because they are incorrectly labeled as levetiracetam in 0.82% sodium chloride injection 500 mg/100 mL single-dose bags. A recall notice