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FDA Issues Complete Response Letter for Cosibelimab in Cutaneous Squamous Cell Carcinoma
The FDA cited issues related to an inspection of Checkpoint Therapeutics’ third-party contract manufacturing organization.
FDA Approves Adbry for Atopic Dermatitis in 12 to 17 Year Olds
The price for of Adbry is $1,810.87 for a two pack of syringes.
FDA Approves Welireg for Advanced Kidney Cancer
Welireg is now also indicated for patients whose renal cell carcinoma has progressed after treatment with PD-1 or PD-L1 inhibitor and a TKI therapy.
FDA Sets Review Date for Bispecific Antibody for Solid Tumor
The FDA has set a target date of June 12, 2024, for tarlatamab to treat adult patients with advanced small cell lung cancer. If approved, it would be the first bispecific antibody for a solid tumor.
MAPS Submits NDA for Psychedelic Therapy for PTSD
The application for midomafetamine is the first NDA submission for any psychedelic-assisted therapy.
FDA Sets Review Date for Marstacimab to Treat Hemophilia
Marstacimab is being reviewed to prevent or reduce the frequency of bleeding episodes in people with hemophilia A or B. The FDA has set an action date in the first quarter of 2024.
FDA Approves Two Gene Therapies for Sickle Cell Disease
The FDA has approved the gene therapies Lyfgenia and Casgevy to treat patients with sickle cell disease. Casgevy is the first FDA-approved gene therapy to use the CRISPR gene editing technology.
FDA Sets Review Date for Elafibranor for Rare Liver Disease
If approved, elafibranor would be a second-line treatment for patients with primary biliary cholangitis. The Prescription Drug User Fee Act action date is June 10, 2024.
What We’re Reading: Sickle Cell Disease and Exa-cel Gene Therapy
New Lung Cancer Drug Augtyro is Now Available
Augtyro, approved last month, launched with a month wholesale acquisition $29,000 for patients with ROS1-positive non-small cell lung cancer.
FDA Approves Fabhalta, an Oral Treatment for Rare Blood Disorder
Fabhalta was approved to treat patients with paroxysmal nocturnal hemoglobinuria and will have a wholesale acquisition cost of $550,000 per year.
FDA Approves Jaypirca for Leukemia/Lymphoma Indication
Jaypirca is also approved to treat mantle cell lymphoma. It has a list price of $21,000 for a 30-day supply.
Pfizer Stops GLP-1 Obesity Trial Because of High Discontinuation Rates
Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. Pfizer is now conducting a pharmacokinetic study for a once-daily formulation.
FDA Sets Review Date for Zoryve in Atopic Dermatitis
The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.
FDA Issues Complete Response for Novel Dry Eye Therapy
Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.
FDA Sets Review for Nasal Opioid Rescue Drug
The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.
FDA Approves First Treatment for Rare Noncancerous Tumors
Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.
FDA Sets Review Date for Therapy for Rare Connective Tissue Disorder
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.
Generic News: New Approvals and New Research
Newly launched include generics of Spiriva HandiHaler, Forteo, Livalo and Farxiga.
Janssen Submits Supplemental Application for Rybrevant in NSCLC
Janssen is seeking approval for use after Tagrisso in patients with metastatic non-small cell lung cancer.
FDA to Hold Advisory Meeting for Abecma in Earlier Treatment of Multiple Myeloma
A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
FDA Approves First-in-Class Therapy for HR Positive Breast Cancer
Truqap is an AKT kinase inhibitor that, along with Faslodex, reduced the risk of disease progression or death by 50%.
FDA Approves Augtyro to Treat ROS1 Positive Lung Cancer
Augtyro will be available in mid-December to treat patients with metastatic ROS1-positive non-small cell lung cancer. It has a list price of $29,000 a month.
Bimzelx, the Newest Psoriasis Treatment, is Now Available
Bimzelx is the first dual IL-17 A/F inhibitor to treat moderate-to-severe plaque psoriasis. It launches with a list price of $7,200 per syringe.
Bayer to Withdraw Cancer Drug Aliqopa from Market
Aliqopa was granted accelerated approval in September 2017 to treat adult patients with relapsed follicular lymphoma.
FDA Approves Chikungunya Virus Vaccine
Ixchiq was approved through the FDA Accelerated Approval pathway.
FDA Approves Oral Therapy for Metastatic Colorectal Cancer
Fruzaqla is the first inhibitor of all three VEGF receptor kinases. The list price is $25,200 for a 28-day supply of a 5 mg dose and $6,300 for a 28-day supply of 1 mg dose
FDA Approves Enzyme Replacement Therapy for Rare Clotting Disorder
Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme.
Lilly’s Weight Loss Drug Approved by the FDA
Tirzepatide, with the brand name Zepbound, is expected to be available by the end of the year in six doses at a list price of $1,059.87, which is about 20% lower than semaglutide.
FDA Approves Novel Therapy for Gastroesophageal Reflux
Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It will be available in December and has a list price of $650 for a 30-count bottle.