SPOTLIGHT -
FDA Grants EUA for Novavax COVID-19 Vaccine
The U.S. government pre-purchases 3.2 million initial doses of the Novavax COVID-19 vaccine.
U.S. Hikes Purchases of COVID-19 Vaccine, Treatment
The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.
New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier
The FDA is accepting comments on the proposed rule through Oct. 26, 2022.
Biogen Terminates Aduhelm Clinical Trial
The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.
FDA Expands EUA for Moderna, Pfizer-BioNTech COVID-19 Vaccines to Children 6 Months and Up
On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of both vaccines.
FDA Committee Recommends Expanding COVID-19 Vaccines to Infants, Children
The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.
Hemophilia A Treatment Earns Breakthrough Therapy Designation
Efanesoctocog alfa is a new class of factor VIII therapy with once-weekly prophylactic dosing. The application for approval expected to be filed mid year.
Nephron Recalls More Than 2 Million Doses of Epinephrine, Other Injections
The recalls were made because the medications failed sterility testing.
FDA Committee Recommends EUA for Novavax’s COVID-19 Vaccine
Novavax’s COVID-19 vaccine demonstrated 90.4% efficacy with a low number of serious and severe adverse events, including myocarditis.
New Global Coalition Aims to Improve Access to Cancer Medicines
The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.
FDA Clears First At-Home Combo COVID-19, RSV and Flu Test
The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.
FDA Okays Lilly’s Novel Diabetes Drug
Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.
FDA Approves Olumiant for New COVID-19 Indication
Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
FDA Limits Janssen’s COVID-19 Vaccine
The move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.
AstraZeneca’s Blockbuster Cancer Drug Granted Priority Review for Rare Cancers
The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
UnitedHealthcare Won’t Cover Aduhelm; Biogen CEO to Step Down
UnitedHealthcare considers Aduhelm unproven and not medically necessary for treating Alzheimer’s disease.
CVS Specialty, Elixir Among Pharmacies Distributing Cancer Drug Lenvima
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
Moderna Seeks EUA for COVID-19 Vaccine for 6 Months to 6 Years
Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.
Biden Expands COVID-19 Antiviral Access, FDA expands Veklury to Kids
Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.
WHO Issues New Recommendations on Paxlovid, Remdesivir for COVID-19
The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.
Cancer, Scleroderma Treatments Granted Orphan Drug Designation
The FDA has granted orphan drug designation to a potential first-in-class therapy for scleroderma and a PD-1 inhibitor for small cell lung cancer.
FDA Issues EUA for First COVID-19 Breath Test
The InspectIR Systems Breathalyzer test can provide results in three minutes.
FDA Clears First Elcys Generic
The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.
CMS Finalizes Narrow Aduhelm Medicare Coverage
CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
FDA Grants Breakthrough Therapy Designation to Treat Rare Disease vEDS
A phase 3 trial is expected to begin by the end of the second quarter.
FDA Seeks Funding for Pandemics, Cancer Drugs, and Generic Drug Approvals
The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.
FDA Authorizes Second COVID-19 Vaccine Booster
The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.
ViiV Healthcare Updates the Label for HIV-1 Med Cabenuva
The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.
New Campaign Highlights Generic Drug Markups
Some generics have as much of a 10,000-times increase from the manufacturers weighted average manufacturers price to what a patient could pay at the pharmacy if they chose to pay the cash price.
BMS’s Opdualag Snags Approval for Melanoma
Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.