Pfizer, BioNTech Snag Fast Track for COVID-19-Flu Vaccine Combo
Building on the success of the companies’ COVID-19 vaccines, Pfizer and BioNTech have begun a phase 1 trial of a combined flu-COVID-19 vaccine.
KRAS-Targeted Lung Cancer Drug Carries $237,000 Annual Price Tag
The FDA issued an accelerated approval for Mirati’s Krazati for patients with KRAS-mutated non-small cell lung cancer. The agency also approved a companion diagnostic to identify eligible patients.
FDA Expands Updated COVID-19 Vaccines EUA to Children
The bivalent vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 and a component of omicron lineage BA.1.
Pharmacy Groups Criticize Express Scripts’ Tricare Decision
Independent pharmacies are no longer part of Tricare’s pharmacy network for uniformed service members and their families. The pharmacy groups say this will impact 400,000 beneficiaries.
Salvat Submits NDA for Ear Infection Drug
If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.
Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s
Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.
Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl
Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.
Compounding Pharmacies to Help Alleviate Amoxicillin Shortage
The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
FDA Proposes Prescription-to-OTC Naloxone
The agency is encouraging sponsors to submit applications for low-dose, nonprescription naloxone products.
GSK Limits Use of Zejula for Some Cancer Patients
After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.
Hospital Demand for Amoxicillin Increases While Shortage Continues
Vizient saw a 43% surge in demand for all amoxicillin products in the acute care setting from September to October, but fill rates have dropped 25%.
FDA: Bebtelovimab Does Not Neutralize New Omicron Subvariants
Bebtelovimab is used to treat COVID-19, but omicron subvariants BQ.1 and BQ.1.1 may be resistant, the FDA said.
FDA Approves Melanoma Drug to Treat Blood Cancers
Cotellic, an oral inhibitor of MEK1 and MEK2, was approved to treat patients with histiocytic neoplasms based on a phase 2 trial conducted solely at Memorial Sloan Kettering Cancer Center.
Amoxicillin in Shortage Due to Increased Demand
Several suppliers of the widely-used antibiotic have limited or no availability of some formulations.
Centene Selects Express Scripts to Administer Pharmacy Benefits
Express Scripts will manage pharmacy benefits for about 20 million Centene members.
FDA Clears Novel Liver Cancer Combo Treatment
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
Novavax COVID-19 Vaccine Booster Gets FDA EUA
Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
OptumRx’s Top Pipeline Drugs to Watch This Fall
Arash Sadeghi, Pharm.D., discusses three drugs in development, which treat a rare kidney disease, hemophilia B, and an advanced form of age-related macular degeneration.
AMA Analysis: Lack of Competition Among PBMs in Local Markets
The lack of competition and the vertical integration of PBMs and insurers can have a negative impact on patients’ access to and cost of prescription drugs, AMA said.
FDA Announces Adderall Shortage
Until supply is restored, the FDA suggests the use of alternatives such as the extended-release version of amphetamine mixed salts.
Eiger Will Not Submit EUA For COVID-19 Treatment
The FDA had indicated that it would not issue an emergency use authorization without additional data for peginterferon lambda to treat patients with mild-to-moderate COVID-19.
U.S. to Buy up to $10.7 Million of Monkeypox Treatment
SIGA indicated that $5.1 million of oral Tpoxx is targeted for delivery in 2022.
Kroger Health to Terminate Express Scripts Agreement
The retailer indicated that Express Scripts’ drug pricing model is unstainable for Kroger and its customers.
New Report: Generics, Biosimilars Saved $373 Billion
In 2021, patients in the United States received 6.4 billion prescriptions, 91% of which were generic and biosimilar medicines.
HHS ups COVID-19 Med Bebtelovimab Availability
Bebtelovimab is available under an emergency use authorization, and the HHS is making doses available to those who are uninsured and underinsured.
WHO Recommends Against Using 2 COVID-19 Treatments
World Health Organization said there is a lack of evidence of clinical effectiveness of the monoclonal antibodies Xevudy and Regen-Cov against the COVID-19 variants that are currently circulating.
Texas Ruling on HIV PrEP Could Impact Other Preventive Coverage
A Texas judge ruled that coverage for HIV pre-exposure prophylaxis (PrEP) violates religious freedom but there is concern that cancer screenings and other preventive services could be affected.
HHS Funds U.S. Monkeypox Vaccine Manufacturing
HHS is providing $11 million to Grand River Aseptic Manufacturing to accelerate manufacturing of the Jynneos monkeypox vaccine. The facility will be operational later this year.
Pharmacies Face Adderall Back Orders
Labor shortages and Drug Enforcement Agency quotas have led to supply shortages of Adderall and its generics, which are used to treat attention deficit hyperactivity disorder.
Humira Biosimilars a Question Mark for Hospitals
Payer coverage and the prior authorization process continue to be barriers for the adoption of biosimilars, according to a new Vizient survey.
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