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Enzyme Replacement Therapy Adzynma Launches with $245,000 Annual Price
Enzyme Replacement Therapy Adzynma Launches with $245,000 Annual Price
November 29, 2023
Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme to treat patients with the rare hereditary blood clotting disorder congenital thrombotic thrombocytopenic purpura
FDA Sets Review Date for Zoryve in Atopic Dermatitis
FDA Sets Review Date for Zoryve in Atopic Dermatitis
FDA Sets Review Date for Zoryve in Atopic Dermatitis
November 29, 2023
The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.
FDA Issues Warning about Seizure Medications
FDA Issues Warning about Seizure Medications
FDA Issues Warning about Seizure Medications
November 29, 2023
Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.
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FDA Issues Complete Response for Novel Dry Eye Therapy
FDA Issues Complete Response for Novel Dry Eye Therapy
November 28, 2023
Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.
source: Orexo
FDA Sets Review for Nasal Opioid Rescue Drug
FDA Sets Review for Nasal Opioid Rescue Drug
November 28, 2023
The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.
Photo courtesy of SpringWorks Therapeutics
FDA Approves First Treatment for Rare Noncancerous Tumors
FDA Approves First Treatment for Rare Noncancerous Tumors
November 28, 2023
Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.
FDA Sets Review Date for Therapy for Rare Connective Tissue Disorder
FDA Sets Review Date for Therapy for Rare Connective Tissue Disorder
November 27, 2023
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.
Novartis Recalls Two Additional Lots of Sandimune
Novartis Recalls Two Additional Lots of Sandimune
Novartis Recalls Two Additional Lots of Sandimune
November 27, 2023
This is the second recall of Sandimmune related to the formulation of crystals in some bottles.
Report: Part D Premiums Could Rise Because of IRA Cap on Drug Costs
Report: Part D Premiums Could Rise Because of IRA Cap on Drug Costs
Report: Part D Premiums Could Rise Because of IRA Cap on Drug Costs
November 24, 2023
A recent report predicts there could be an increase in premiums for Medicare Part D prescription drug plans in California, Florida, New York, Pennsylvania and Texas.
Analysis Finds Biosimilars Can Reduce Total Cost of Care
Analysis Finds Biosimilars Can Reduce Total Cost of Care
Analysis Finds Biosimilars Can Reduce Total Cost of Care
November 23, 2023
A simulation study estimated the impact of biosimilar substitution on total cost of care and provider financial performance in the final performance period of the Oncology Care Model.
Generic News: New Approvals and New Research
Generic News: New Approvals and New Research
Generic News: New Approvals and New Research
November 22, 2023
Newly launched include generics of Spiriva HandiHaler, Forteo, Livalo and Farxiga.
Janssen Submits Supplemental Application for Rybrevant in NSCLC
Janssen Submits Supplemental Application for Rybrevant in NSCLC
Janssen Submits Supplemental Application for Rybrevant in NSCLC
November 21, 2023
Janssen is seeking approval for use after Tagrisso in patients with metastatic non-small cell lung cancer.
FDA to Hold Advisory Meeting for Abecma in Earlier Treatment of Multiple Myeloma
FDA to Hold Advisory Meeting for Abecma in Earlier Treatment of Multiple Myeloma
FDA to Hold Advisory Meeting for Abecma in Earlier Treatment of Multiple Myeloma
November 21, 2023
A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
CVS Caremark Switches Up Biosimilar Coverage in 2024
CVS Caremark Switches Up Biosimilar Coverage in 2024
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 20, 2023
New biosimilars have been added and others removed from CVS Caremark’s standard formulary. One notable change is with the Humira biosimilars. The PBM has removed Amjevita and now prefers Hyrimoz and an unbranded biosimilar.
FDA Approves First-in-Class Therapy for HR Positive Breast Cancer
FDA Approves First-in-Class Therapy for HR Positive Breast Cancer
FDA Approves First-in-Class Therapy for HR Positive Breast Cancer
November 20, 2023
Truqap is an AKT kinase inhibitor that, along with Faslodex, reduced the risk of disease progression or death by 50%.
Bayer Recalls One Lot of Vitrakvi Because of Contamination
Bayer Recalls One Lot of Vitrakvi Because of Contamination
Bayer Recalls One Lot of Vitrakvi Because of Contamination
November 20, 2023
Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.
FDA Approves Augtyro to Treat ROS1 Positive Lung Cancer
FDA Approves Augtyro to Treat ROS1 Positive Lung Cancer
FDA Approves Augtyro to Treat ROS1 Positive Lung Cancer
November 16, 2023
Augtyro will be available in mid-December to treat patients with metastatic ROS1-positive non-small cell lung cancer. It has a list price of $29,000 a month.
What We’re Reading: Insurer Denies Gene Therapy, Evolution of the PBM, United Healthcare Sued
What We’re Reading: Insurer Denies Gene Therapy, Evolution of the PBM, United Healthcare Sued
What We’re Reading: Insurer Denies Gene Therapy, Evolution of the PBM, United Healthcare Sued
November 15, 2023
Express Scripts Launches New Cost Plus Drug Model
Express Scripts Launches New Cost Plus Drug Model
Express Scripts Launches New Cost Plus Drug Model
November 15, 2023
This is the latest offering by Express Scripts that aims to bring transparency to prescription drug costs.
Bimzelx, the Newest Psoriasis Treatment, is Now Available
Bimzelx, the Newest Psoriasis Treatment, is Now Available
Bimzelx, the Newest Psoriasis Treatment, is Now Available
November 14, 2023
Bimzelx is the first dual IL-17 A/F inhibitor to treat moderate-to-severe plaque psoriasis. It launches with a list price of $7,200 per syringe.
Is Home-Based CAR-T Therapy Possible?
Is Home-Based CAR-T Therapy Possible?
Is Home-Based CAR-T Therapy Possible?
November 14, 2023
The results of a recent feasibility study on the outpatient administration of cell therapies is creating growing interest in whether home-based management may be possible in the future.
Bayer to Withdraw Cancer Drug Aliqopa from Market
Bayer to Withdraw Cancer Drug Aliqopa from Market
Bayer to Withdraw Cancer Drug Aliqopa from Market
November 13, 2023
Aliqopa was granted accelerated approval in September 2017 to treat adult patients with relapsed follicular lymphoma.
What We’re Reading: Insurance Company Denials, State Efforts to Limit COVID Vaccines
What We’re Reading: Insurance Company Denials, State Efforts to Limit COVID Vaccines
What We’re Reading: Insurance Company Denials, State Efforts to Limit COVID Vaccines
November 13, 2023
FDA Approves Chikungunya Virus Vaccine
FDA Approves Chikungunya Virus Vaccine
November 13, 2023
Ixchiq was approved through the FDA Accelerated Approval pathway.
FDA Approves Oral Therapy for Metastatic Colorectal Cancer
FDA Approves Oral Therapy for Metastatic Colorectal Cancer
FDA Approves Oral Therapy for Metastatic Colorectal Cancer
November 10, 2023
Fruzaqla is the first inhibitor of all three VEGF receptor kinases. The list price is $25,200 for a 28-day supply of a 5 mg dose and $6,300 for a 28-day supply of 1 mg dose
FDA Approves Enzyme Replacement Therapy for Rare Clotting Disorder
FDA Approves Enzyme Replacement Therapy for Rare Clotting Disorder
FDA Approves Enzyme Replacement Therapy for Rare Clotting Disorder
November 10, 2023
Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme.
Cigna Makes Changes to Drugs Lists for 2024
Cigna Makes Changes to Drugs Lists for 2024
Cigna Makes Changes to Drugs Lists for 2024
November 10, 2023
Beginning Jan. 1, 2024, Cigna Healthcare’s formulary changes mostly impact generics and biosimilars.
Drug Spend for IBD Drugs Could Shift to Pharmacy Benefit
Drug Spend for IBD Drugs Could Shift to Pharmacy Benefit
Drug Spend for IBD Drugs Could Shift to Pharmacy Benefit
November 9, 2023
In her review of the specialty drug pipeline, Evernorth's Aimee Tharaldson said upcoming approvals for Crohn’s and colitis drugs could further shift the drug spend from the medical benefit to the pharmacy one.
Lilly’s Weight Loss Drug Approved by the FDA
Lilly’s Weight Loss Drug Approved by the FDA
Lilly’s Weight Loss Drug Approved by the FDA
November 8, 2023
Tirzepatide, with the brand name Zepbound, is expected to be available by the end of the year in six doses at a list price of $1,059.87, which is about 20% lower than semaglutide.
Postpartum Depression Therapy to Launch with $15,900 Price
Postpartum Depression Therapy to Launch with $15,900 Price
Postpartum Depression Therapy to Launch with $15,900 Price
November 8, 2023
Zurzuvae, the first oral therapy for postpartum depression, will launch in December.
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