SPOTLIGHT -
FDA Issues CRL for Teva’s Schizophrenia Drug
Teva Pharmaceutical and MedinCell, the drug’s developers, didn’t provide a reason for the complete response letter.
The FDA Accepts NDA for Novel Therapy for CKD-Related Anemia
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 1, 2023, for daprodustat.
FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer
The PDUFA date for Enhertu in the lung cancer indication is in the third quarter of 2022.
Generics Recently Launched in the United States
Generic launches include equivalents of Combigan, Abraxane, Cytotec, Solu-Medrol, and Tobradex.
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
Vonjo is the first therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, a bone marrow cancer.
FDA Okays Third Biosimilar of Avastin
Amneal's Alymsys is approved to treat several cancers.
The FDA Extends Review of REGEN-COV
The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.
Mylan Recalls One Batch of Insulin Glargine
Some vials have been found to be missing a label.
Aeglea Submits BLA for Pegzilarginase for Rare Metabolic Disease
If approved, pegzilarginase would be the first treatment for ARG1 deficiency, a rare progressive disease.
FDA Accepts Resubmitted BLA for Rolontis
The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.
FDA Approves Novel Therapy for Schizophrenia and Bipolar
Igalmi is the first and only film that dissolves under the tongue that treats adults with agitation associated with schizophrenia or bipolar. BioXcel expects to launch the therapy in the second quarter of 2022.
FDA Grants Accelerated Approval for Vijoice to Treat Rare Disorder
Novartis’ Vijoice is the first approved treatment for PIK3CA-related overgrowth spectrum, a group of rare disorders.
Telix Launches Imaging Agent Illuccix
Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
FDA Extends Review of Vaxneuvance for Infants and Children
The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.
FDA Issues CRL for Vadadustat for Anemia
The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.
FDA Approves Cabenuva for Adolescents with HIV
The long-acting HIV medication is now available for those 12 years and older living with HIV-1.
FDA Approves Higher Dose of Ozempic
Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.
Bausch + Lomb Launches Xipere for Macular Edema
Xipere is a targeted treatment that is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.
FDA Approves Fintepla for Difficult-to-Treat Seizure Disorder
Fintepla was approved to treat Lennox-Gastaut syndrome, which first appears in childhood and can affect neurodevelopmental, cognitive, and motor functions.
Study: Relistor SC Can Reduce Hospitalizations and Health Care Costs
This real-world study found that patients who received Relistor SC during an emergency department visit for opioid induced constipation had lower costs and hospital lengths of stay.
FDA Misses PDUFA Date for BMS’ Reblozyl for Rare Blood Disorder
Reblozyl is being reviewed to treat anemia in patients with beta thalassemia. The new date is June 27, 2022.
Adamis Recalls Four Lots of Symjepi
The recall was related to syringes in these lots malfunctioning.
FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer
Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.
Sandoz Recalls 13 Lots of the Muscle Relaxer Orphenadrine
The recall of orphenadrine was due to the presence of the cancer-causing nitrosomine.
AllianceRx Walgreens Prime Continues as Exclusive Pharmacy for Cystaran
Cystaran is a topical ophthalmic therapy that is used to treat a rare genetic disorder.
FDA Issues CRL for Natpara for Hypoparathyroidism
The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.
Pfizer Recalls Blood Pressure Drug Accuretic
The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.
FDA Approves Keytruda for Advanced Endometrial Cancer
The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.
FDA Approves First Therapy for Rare, Genetic Seizure Disorder
Ztalmy was approved for seizures associated with CDKL5 deficiency disorder in patients two years of age and older. It is expected to be available in July 2022.