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Worries About Supply of COVID-19 Monoclonal Antibody Treatment After FDA Recommends Doubling the Dose
Worries About Supply of COVID-19 Monoclonal Antibody Treatment After FDA Recommends Doubling the Dose
Worries About Supply of COVID-19 Monoclonal Antibody Treatment After FDA Recommends Doubling the Dose
February 28, 2022
Agency says evidence points to Evusheld being more effective against omicron variants if doses are doubled.
FDA Expands Heart Indication for Blockbuster Jardiance
FDA Expands Heart Indication for Blockbuster Jardiance
FDA Expands Heart Indication for Blockbuster Jardiance
February 26, 2022
The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.
Second mRNA COVID-19 Vaccine in Primary Series Can Be Extended to 8 Weeks for Some Individuals
Second mRNA COVID-19 Vaccine in Primary Series Can Be Extended to 8 Weeks for Some Individuals
Second mRNA COVID-19 Vaccine in Primary Series Can Be Extended to 8 Weeks for Some Individuals
February 25, 2022
This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.
Sanofi, GSK Seeking Approval for COVID-19 Vaccine
Sanofi, GSK Seeking Approval for COVID-19 Vaccine
Sanofi, GSK Seeking Approval for COVID-19 Vaccine
February 24, 2022
Sanofi and GSK today announce will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.
FDA Approves Pyrukynd, the First Disease-Modifying Treatment for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
FDA Approves Pyrukynd, the First Disease-Modifying Treatment for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
FDA Approves Pyrukynd, the First Disease-Modifying Treatment for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
February 24, 2022
Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.
FDA Eyeing Second COVID-19 Booster Shot Approval
FDA Eyeing Second COVID-19 Booster Shot Approval
FDA Eyeing Second COVID-19 Booster Shot Approval
February 22, 2022
The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.
CDC Study Shows mRNA Vaccination During Pregnancy Protects Infants From COVID-19
CDC Study Shows mRNA Vaccination During Pregnancy Protects Infants From COVID-19
CDC Study Shows mRNA Vaccination During Pregnancy Protects Infants From COVID-19
February 21, 2022
The CDC released the first real world data February 15 in a Morbidity and Mortality Weekly Report (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax).
Bayer Receives FDA Fast-Track Designation for Next-Generation Anticoagulant
Bayer Receives FDA Fast-Track Designation for Next-Generation Anticoagulant
Bayer Receives FDA Fast-Track Designation for Next-Generation Anticoagulant
February 18, 2022
Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.
Optum Launches Specialty Fusion to Lower Drug Costs
Optum Launches Specialty Fusion to Lower Drug Costs
Optum Launches Specialty Fusion to Lower Drug Costs
February 17, 2022
The solution, available immediately to all large health plans, is meant to simplify care for patients with complex conditions.
Despite Narrow Confirmation, Associations Praise New FDA Commissioner Califf
Despite Narrow Confirmation, Associations Praise New FDA Commissioner Califf
Despite Narrow Confirmation, Associations Praise New FDA Commissioner Califf
February 16, 2022
FDA Delays Controversial COVID-19 Vaccine Decision for Young Children
FDA Delays Controversial COVID-19 Vaccine Decision for Young Children
FDA Delays Controversial COVID-19 Vaccine Decision for Young Children
February 15, 2022
The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial.
CMS Aduhelm Decision Would “Significantly” Limit Anti-Amyloid Antibody Drugs
CMS Aduhelm Decision Would “Significantly” Limit Anti-Amyloid Antibody Drugs
CMS Aduhelm Decision Would “Significantly” Limit Anti-Amyloid Antibody Drugs
February 14, 2022
Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.
FDA Approves Fleqsuvy, a Concentrated Baclofen Oral Suspension, for the Treatment of Spasticity in Patients with Multiple Sclerosis
FDA Approves Fleqsuvy, a Concentrated Baclofen Oral Suspension, for the Treatment of Spasticity in Patients with Multiple Sclerosis
FDA Approves Fleqsuvy, a Concentrated Baclofen Oral Suspension, for the Treatment of Spasticity in Patients with Multiple Sclerosis
February 10, 2022
The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.
BioMatrix Named as a Preferred Provider for AscellaHealth
BioMatrix Named as a Preferred Provider for AscellaHealth
BioMatrix Named as a Preferred Provider for AscellaHealth
February 9, 2022
BioMatrix Specialty Pharmacy is now included as a preferred provider in AscellaHealth’s home infusion pharmacy network.
CDC’s Advisory Committee Is Recommending Shortened Interval for COVID-19 Boosters for Immunocompromised Patients
CDC’s Advisory Committee Is Recommending Shortened Interval for COVID-19 Boosters for Immunocompromised Patients
CDC’s Advisory Committee Is Recommending Shortened Interval for COVID-19 Boosters for Immunocompromised Patients
February 8, 2022
Patients who are immunocompromised are advised to get a three-dose series and then a fourth dose.
FDA Clears First Treatment for Rare Anemia
FDA Clears First Treatment for Rare Anemia
FDA Clears First Treatment for Rare Anemia
February 7, 2022
Drugs works by interfering with the classical complement pathway.
New Biosimilars Forum Director Discusses Biosimilar Opportunities, Challenges
New Biosimilars Forum Director Discusses Biosimilar Opportunities, Challenges
New Biosimilars Forum Director Discusses Biosimilar Opportunities, Challenges
February 4, 2022
The Biosimilars Forum Board of Directors recently appointed Juliana M. Reed as its new executive director and Formulary Watch got the scoop from Reed first hand.
FDA: Ukoniq Under Investigation for Possible Risk of Death
FDA: Ukoniq Under Investigation for Possible Risk of Death
FDA: Ukoniq Under Investigation for Possible Risk of Death
February 4, 2022
The agency said data from a trial testing the PI3 kinase inhibitor as a treatment for chronic lymphocytic leukemia prompted the concern.
FDA Approves First Generic to Restasis Eye Drops
FDA Approves First Generic to Restasis Eye Drops
FDA Approves First Generic to Restasis Eye Drops
February 3, 2022
FDA approved the first generic version of Restasis 0.05% eye drops to increase tear production in patients whose production is suppressed due to dry eye.
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
February 2, 2022
Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.
Moderna’s COVID-19 Vaccine Receives Full FDA Approval
Moderna’s COVID-19 Vaccine Receives Full FDA Approval
Moderna’s COVID-19 Vaccine Receives Full FDA Approval
February 1, 2022
FDA is requiring postmarketing surveillance studies to further assess the risk of myocarditis and pericarditis from the vaccine, which is being sold under the brand name Spikevax.
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
Immunocore Snags Approval of First T Cell Receptor Cancer Therapy
January 31, 2022
The new therapy treats patients with unresectable or metastatic uveal melanoma.
health care cost
NSCLC Drugs Raised Prices Despite Evidence of Price Competition
NSCLC Drugs Raised Prices Despite Evidence of Price Competition
January 29, 2022
Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.
Regeneron, Sanofi Pull FDA Application for Libtayo
Regeneron, Sanofi Pull FDA Application for Libtayo
Regeneron, Sanofi Pull FDA Application for Libtayo
January 28, 2022
Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
January 27, 2022
The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
Gilead Discovers Millions Worth of Counterfeit HIV-1 Meds Distributed
January 26, 2022
More than $250 million worth of counterfeit and illegally resold versions of Gilead Sciences’ HIV medications Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) and Descovy (emtricitabine and tenofovir alafenamide) were distributed to pharmacies and patients.
FDA Monoclonal Antibody Decision Pulled Into Political Fray
FDA Monoclonal Antibody Decision Pulled Into Political Fray
FDA Monoclonal Antibody Decision Pulled Into Political Fray
January 25, 2022
Experts says Regeneron and Eli Lilly’s antibody treatments won’t work against omicron, but Florida Gov. Ron DeSantis calls the FDA’s decision to pause the emergency use authorization “just wrong.”
FDA Expands Emergency Use of Gilead’s Remdesivir for COVID-19
FDA Expands Emergency Use of Gilead’s Remdesivir for COVID-19
FDA Expands Emergency Use of Gilead’s Remdesivir for COVID-19
January 24, 2022
Clinics Claim California's New Medicaid Drug Program Could Remove Existing Services
Clinics Claim California's New Medicaid Drug Program Could Remove Existing Services
Clinics Claim California's New Medicaid Drug Program Could Remove Existing Services
January 23, 2022
The new Medi-Cal Rx program that debuted Jan. 1 has alarmed health clinics that say the state's Medicaid will lose money and have to cut services.
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
Mark Cuban Cost Plus Drug Company Launches Online Pharmacy, PBM
January 21, 2022
The company joins the wide array of online pharmacy services, such as Amazon Pharmacy, that have popped up in recent years. Cuban has also launched a namesake PBM.
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