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FDA Approves Therapy for Bile Duct Cancer
FDA Approves Therapy for Bile Duct Cancer
FDA Approves Therapy for Bile Duct Cancer
October 3, 2022
Taiho’s Lytgobi is approved to treat advanced or metastatic advanced bile duct cancer in patients with FGFR2 gene fusions.
Wellcare Expands Medicare Drug Coverage, Adds Amazon as Preferred Pharmacy
Wellcare Expands Medicare Drug Coverage, Adds Amazon as Preferred Pharmacy
Wellcare Expands Medicare Drug Coverage, Adds Amazon as Preferred Pharmacy
October 3, 2022
A new formulary design will be offered on the Value Script and Value Plus plans; it will contain medications used to treat diabetes and will cost only $11 per 30-day supply.
FDA Approves Amylyx’s ALS Therapy
FDA Approves Amylyx’s ALS Therapy
FDA Approves Amylyx’s ALS Therapy
September 30, 2022
Now with the brand name Relyvrio, the new therapy should be available within four to six weeks. It will have a wholesale acquisition cost of $158,000 per year.
FDA Approves Duxipent for Rare Skin Disorder
FDA Approves Duxipent for Rare Skin Disorder
FDA Approves Duxipent for Rare Skin Disorder
September 30, 2022
Dupixent is the first treatment approved to treat prurigo nodularis, a chronic skin disorder characterized by the presence of hard, itchy nodules.
Eugia US Recalls One Lot of Acyclovir
Eugia US Recalls One Lot of Acyclovir
Eugia US Recalls One Lot of Acyclovir
September 29, 2022
Dark red, brown and black particulates were seen inside of one vial. Acyclovir is used to treat genital herpes and shingles.
IQVIA: Payers Increase Exclusions for Oncology Drugs
IQVIA: Payers Increase Exclusions for Oncology Drugs
IQVIA: Payers Increase Exclusions for Oncology Drugs
September 29, 2022
Jing Yang from IQVIA discusses how national payers are using formulary exclusions for oncology therapeutics.
FDA Approves Fourth Avastin Biosimilar
FDA Approves Fourth Avastin Biosimilar
FDA Approves Fourth Avastin Biosimilar
September 29, 2022
Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.
FDA Accepts NDA for Therapy for Rare Immunodeficiency Disease
FDA Accepts NDA for Therapy for Rare Immunodeficiency Disease
FDA Accepts NDA for Therapy for Rare Immunodeficiency Disease
September 28, 2022
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 29, 2023, for a decision on leniolisib as a treatment for APDS, a rare primary immunodeficiency.
New Report: Generics, Biosimilars Saved $373 Billion
New Report: Generics, Biosimilars Saved $373 Billion
New Report: Generics, Biosimilars Saved $373 Billion
September 28, 2022
In 2021, patients in the United States received 6.4 billion prescriptions, 91% of which were generic and biosimilar medicines.
Optum’s Efforts Combat Opioid Misuse and Abuse
Optum’s Efforts Combat Opioid Misuse and Abuse
Optum’s Efforts Combat Opioid Misuse and Abuse
September 28, 2022
Carl Black, pharmacist-in-charge at Optum Rx, talks about how the PBM has decreased dispensed opioids by 62% since 2018.
FDA Approves Omlonti for Glaucoma
FDA Approves Omlonti for Glaucoma
FDA Approves Omlonti for Glaucoma
September 27, 2022
Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension
First PBM Integrates with Mark Cuban Cost Plus Drug Company
First PBM Integrates with Mark Cuban Cost Plus Drug Company
First PBM Integrates with Mark Cuban Cost Plus Drug Company
September 27, 2022
Rightway offers access to generic drugs offered by Cost Plus Drug through its mobile app.
HHS ups COVID-19 Med Bebtelovimab Availability
HHS ups COVID-19 Med Bebtelovimab Availability
HHS ups COVID-19 Med Bebtelovimab Availability
September 27, 2022
Bebtelovimab is available under an emergency use authorization, and the HHS is making doses available to those who are uninsured and underinsured.
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence
September 26, 2022
But researchers found that only a small percentage of plans use available real-world evidence studies and economic evaluations in their coverage policies.
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
September 26, 2022
Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
Pfizer, BioNTech Submit Updated COVID-19 Vaccine for Children
Pfizer, BioNTech Submit Updated COVID-19 Vaccine for Children
Pfizer, BioNTech Submit Updated COVID-19 Vaccine for Children
September 26, 2022
The companies have also initiated a phase 1/2/3 study to evaluate different doses and dosing regimens of the BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
September 23, 2022
While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
FDA Advisory Committee Gives Positive Vote for Microbiota-based C. Diff Therapy
September 23, 2022
RBX2660 — now with the brand name Rebyota — is a potential first-in-class microbiota-based live biotherapeutic that aims to reduce recurrent C. difficile infection.
Report: Generic Drug Spending Rose Due to Formulary Placement
Report: Generic Drug Spending Rose Due to Formulary Placement
Report: Generic Drug Spending Rose Due to Formulary Placement
September 22, 2022
An Avalere review finds that the proportion of generic drugs covered on lower tiers (with generally lower out-of-pocket costs for patients) in Part D plans have decreased.
FDA Advisory Committee Votes Against Poziotinib for NSCLC
FDA Advisory Committee Votes Against Poziotinib for NSCLC
FDA Advisory Committee Votes Against Poziotinib for NSCLC
September 22, 2022
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.
FDA Grants Accelerated Approval of Retevmo for Tumor Agnostic RET Gene Fusions
FDA Grants Accelerated Approval of Retevmo for Tumor Agnostic RET Gene Fusions
FDA Grants Accelerated Approval of Retevmo for Tumor Agnostic RET Gene Fusions
September 22, 2022
This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.
FDA Approves Lower Dose Gadolinium-Based Contrast Agent
FDA Approves Lower Dose Gadolinium-Based Contrast Agent
FDA Approves Lower Dose Gadolinium-Based Contrast Agent
September 21, 2022
Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.
WHO Recommends Against Using 2 COVID-19 Treatments
WHO Recommends Against Using 2 COVID-19 Treatments
WHO Recommends Against Using 2 COVID-19 Treatments
September 21, 2022
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.
FDA Approves First Generic of Tazorac Gel
FDA Approves First Generic of Tazorac Gel
FDA Approves First Generic of Tazorac Gel
September 20, 2022
Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.
FDA Reschedules Advisory Committee Meeting for COVID-19 Treatment
FDA Reschedules Advisory Committee Meeting for COVID-19 Treatment
FDA Reschedules Advisory Committee Meeting for COVID-19 Treatment
September 20, 2022
Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.
Study: Medical Debt can Lead to Housing, Food Insecurity
Study: Medical Debt can Lead to Housing, Food Insecurity
Study: Medical Debt can Lead to Housing, Food Insecurity
September 20, 2022
Hospitalization, disability, having private high-deductible, Medicare Advantage, or no coverage were risk factors associated with medical debt.
FDA Accepts sNDA for Tukysa for HER2 Positive Colorectal Cancer
FDA Accepts sNDA for Tukysa for HER2 Positive Colorectal Cancer
FDA Accepts sNDA for Tukysa for HER2 Positive Colorectal Cancer
September 19, 2022
There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.
Bluebird bio’s Gene Therapy for CALD Gets Accelerated Approval
Bluebird bio’s Gene Therapy for CALD Gets Accelerated Approval
Bluebird bio’s Gene Therapy for CALD Gets Accelerated Approval
September 19, 2022
Skysona, with a wholesale acquisition cost of $3 million, is the first FDA approved therapy to slow progression of neurologic dysfunction in boys with this neurodegenerative disease.
FDA Approves IV Aponvie for Postoperative Nausea
FDA Approves IV Aponvie for Postoperative Nausea
FDA Approves IV Aponvie for Postoperative Nausea
September 19, 2022
Aponvie is the same formulation as Cinvanti, which is an injectable emulsion for prevention of chemotherapy-induced nausea and vomiting.
Servier Selects Onco360 as Pharmacy Partner for Tibsovo
Servier Selects Onco360 as Pharmacy Partner for Tibsovo
Servier Selects Onco360 as Pharmacy Partner for Tibsovo
September 16, 2022
Approved in May 2022, Tibsovo is the first therapy targeting cancer metabolism for older patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
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