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Fresenius Kabi Recalls Seven Lots of Sodium Acetate
Fresenius Kabi Recalls Seven Lots of Sodium Acetate
Fresenius Kabi Recalls Seven Lots of Sodium Acetate
March 12, 2022
The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.
Recent Generic Approvals
Recent Generic Approvals
Recent Generic Approvals
March 11, 2022
The FDA has granted first approval for cartridges for use with Apokyn for Parkinson’s. Other approvals include: a generic of anticancer therapy Vidaza, the antibacterial Erythrocin, and the anti-epilepsy therapy Lamictal.
B. Braun Recalls Sodium Chloride Injection
B. Braun Recalls Sodium Chloride Injection
B. Braun Recalls Sodium Chloride Injection
March 11, 2022
B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
March 11, 2022
This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
FDA Approves Purdue’s Opioid Overdose Reversal Nalmefene
March 10, 2022
The company will distribute nalmefene for no profit, which is part of the company’s bankruptcy filing and settlement with states.
Recent Regulatory Submissions
Recent Regulatory Submissions
Recent Regulatory Submissions
March 10, 2022
Supplemental applications have been submitted for the cancer therapies Nubeqa and Tibsovo, the gout treatment Krystexxa, and Oxlumo, which treats a rare disease.
NCCN Includes Besremi on Cancer Treatment Guideline
NCCN Includes Besremi on Cancer Treatment Guideline
NCCN Includes Besremi on Cancer Treatment Guideline
March 10, 2022
Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis
March 9, 2022
With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
March 9, 2022
Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.
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
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