Formulary Watch |

All News - Page 48

Prime Therapeutics Removes Three Products from Medicare Formularies
Prime Therapeutics Removes Three Products from Medicare Formularies
Prime Therapeutics Removes Three Products from Medicare Formularies
March 9, 2022
Generics are now available for the three therapies: Cystadane, Selzentry, and AmBisome.
Teva Launches First Generic to Blockbuster Cancer Med
Teva Launches First Generic to Blockbuster Cancer Med
Teva Launches First Generic to Blockbuster Cancer Med
March 8, 2022
This is the first generic available for Revlimid in the United States.
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
FDA Issues Complete Response Letter for Long-Acting HIV Therapy
March 8, 2022
The FDA cited issues related to the compatibility of lenacapavir and the vial used. The agency has not requested new clinical studies.
Three Companies Recall Immune Globulin Products
Three Companies Recall Immune Globulin Products
Three Companies Recall Immune Globulin Products
March 8, 2022
A total of 28 lots have been recalled because of a high rate of allergic reactions.
Novartis Updates Safety Label of Egaten
Novartis Updates Safety Label of Egaten
Novartis Updates Safety Label of Egaten
March 7, 2022
Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.
FDA Okays a Third Biosimilar to Neupogen
FDA Okays a Third Biosimilar to Neupogen
FDA Okays a Third Biosimilar to Neupogen
March 7, 2022
Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Civica Plans to Sell Lower-Cost Insulins
Civica Plans to Sell Lower-Cost Insulins
Civica Plans to Sell Lower-Cost Insulins
March 7, 2022
Once approved, the insulins will be available to patients for no more than $30 per vial.
FDA OKs Vonjo for Certain Myelofibrosis Patients
FDA OKs Vonjo for Certain Myelofibrosis Patients
FDA OKs Vonjo for Certain Myelofibrosis Patients
March 5, 2022
Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
March 3, 2022
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
FDA Clears New CAR-T Therapy for Multiple Myeloma
FDA Clears New CAR-T Therapy for Multiple Myeloma
FDA Clears New CAR-T Therapy for Multiple Myeloma
March 2, 2022
FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.
Employers Face Barriers With Adopting Biosimilars
Employers Face Barriers With Adopting Biosimilars
Employers Face Barriers With Adopting Biosimilars
March 1, 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
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.
<1
...
444546474849505152
...
226>
© 2024 MJH Life Sciences

All rights reserved.