SPOTLIGHT -
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
FDA Accepts Supplemental Application for Camzyos
The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.
FDA Grants Six Months Pediatric Exclusivity for Eylea
Eylea is being reviewed as a treatment for retinopathy in premature infants.
FDA Extends Review Time for Biogen’s ALS Therapy
If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.
Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate
Exela has received five reports of flying glass injuring skin, eye and/or other parts. The recall includes both Exela and Civica brands.
FDA Authorizes Updated COVID-19 Boosters for Younger Children
The bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 along with a component of omicron BA.1.
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
The FDA has assigned a target action date of Feb. 11, 2023.
FDA Issues CRL for Parkinson’s Therapy
The FDA is asking for additional analysis related to the infusion device used with SPN-830, which contains apomorphine to treat patients with Parkinson’s disease.
FDA Approves Heart Failure Therapy that Provides an Alternative to Hospital Treatment
Furoscix can be administered at home with the use of the On-Body Infusor, which delivers furosemide over five hours. It will be launched in the first quarter of 2023.
FDA Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants
Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
FDA Approves Label Expansion for Oxlumo
This approval for Oxlumo adds lowering plasma oxalate levels for patients with primary hyperoxaluria type 1, a rare and life-threatening metabolic disease.
Capital Blue Cross Teams up with Mark Cuban’s Pharmacy
In 2023, Capital Blue Cross members will be able to use their insurance cards at Mark Cuban Cost Plus Drugs. This is the first time the online pharmacy will accept insurance.
UPDATED: UnitedHealthcare Makes Formulary Changes for Medicare Plans
UnitedHealthcare is moving more drugs to the lower-cost tiers in its Medicare Advantage plans. Other plans will have $0 copays and insulin at a $25 copay.
FDA Accepts BLA for Takhzyro in Young Children with HAE
The FDA is expected to make a decision on approval in this patient population in the first half of 2023.
Mark Cuban Pharmacy Adds Products, Lowers Costs on Others
The online pharmacy has added 12 new products and lowered the costs of 39 medications.
Cigna to Offer Three Stand-alone Medicare Drug Plans
All plans have $0 copay options for select medications purchased through preferred home delivery.
Label Mix Up Leads to Recall of Clopidogrel and Atenolol
In one lot, a bottle containing clopidogrel was mislabeled as atenolol. This lot was sold to AmerisourceBergen and McKesson.
FDA Approves New Administration Method for Trogarzo in HIV
Trogarzo was approved with a new method of administration designed to make maintenance dosing easier for patients and healthcare providers.
FDA Approves Therapy for Bile Duct Cancer
Taiho’s Lytgobi is approved to treat advanced or metastatic advanced bile duct cancer in patients with FGFR2 gene fusions.
Wellcare Expands Medicare Drug Coverage, Adds Amazon as Preferred Pharmacy
A new formulary design will be offered on the Value Script and Value Plus plans; it will contain medications used to treat diabetes and will cost only $11 per 30-day supply.
FDA Approves Duxipent for Rare Skin Disorder
Dupixent is the first treatment approved to treat prurigo nodularis, a chronic skin disorder characterized by the presence of hard, itchy nodules.
Eugia US Recalls One Lot of Acyclovir
Dark red, brown and black particulates were seen inside of one vial. Acyclovir is used to treat genital herpes and shingles.
FDA Approves Fourth Avastin Biosimilar
Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.
FDA Approves Omlonti for Glaucoma
Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension
First PBM Integrates with Mark Cuban Cost Plus Drug Company
Rightway offers access to generic drugs offered by Cost Plus Drug through its mobile app.
Pfizer, BioNTech Submit Updated COVID-19 Vaccine for Children
The companies have also initiated a phase 1/2/3 study to evaluate different doses and dosing regimens of the BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.
FDA Grants Accelerated Approval of Retevmo for Tumor Agnostic RET Gene Fusions
This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.
FDA Approves Lower Dose Gadolinium-Based Contrast Agent
Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.
FDA Approves First Generic of Tazorac Gel
Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.