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Anti-Tau Alzheimer’s Treatment Slows Cognitive Decline
Anti-Tau Alzheimer’s Treatment Slows Cognitive Decline
Anti-Tau Alzheimer’s Treatment Slows Cognitive Decline
December 6, 2022
TauRx’s oral anti-tau therapy HMTM has shown in a phase 3 trial that it can stabilize cognitive decline in patients with Alzheimer’s disease.
Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products
Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products
Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products
December 5, 2022
Cigna and Express Scripts have not yet made a decision about which of the Humira biosimilars will be included but they will evaluate all products in the coming months.
FDA Accepts Resubmitted BLA for Fabry Disease
FDA Accepts Resubmitted BLA for Fabry Disease
FDA Accepts Resubmitted BLA for Fabry Disease
December 5, 2022
A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.
Salvat Submits NDA for Ear Infection Drug
Salvat Submits NDA for Ear Infection Drug
Salvat Submits NDA for Ear Infection Drug
December 5, 2022
If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.
FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma
FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma
FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma
December 2, 2022
In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.
FDA Accepts Application for Antibiotic for Drug-Resistant Infections
FDA Accepts Application for Antibiotic for Drug-Resistant Infections
FDA Accepts Application for Antibiotic for Drug-Resistant Infections
December 2, 2022
SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.
FDA Approves Second Indication for Brexafemme
FDA Approves Second Indication for Brexafemme
FDA Approves Second Indication for Brexafemme
December 2, 2022
Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.
FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy
FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy
FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy
December 1, 2022
I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.
Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s
Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s
Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s
December 1, 2022
Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.
FDA Approves Rebyota, the First-ever Microbiota Product
FDA Approves Rebyota, the First-ever Microbiota Product
FDA Approves Rebyota, the First-ever Microbiota Product
December 1, 2022
Rebyota is the first fecal microbiota product to prevent recurrence of C. diff infection, a serious and potentially life-threatening disease.
Survey: Oncology Doctors Say Prior Authorization Hurts Patients
Survey: Oncology Doctors Say Prior Authorization Hurts Patients
Survey: Oncology Doctors Say Prior Authorization Hurts Patients
November 30, 2022
Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.
Exela Pharma Expands Recall of Sodium Bicarbonate
Exela Pharma Expands Recall of Sodium Bicarbonate
Exela Pharma Expands Recall of Sodium Bicarbonate
November 30, 2022
Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.
FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol
FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol
FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol
November 30, 2022
If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
Genentech Withdraws Tecentriq Indication for Bladder Cancer
Genentech Withdraws Tecentriq Indication for Bladder Cancer
Genentech Withdraws Tecentriq Indication for Bladder Cancer
November 29, 2022
A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.
Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap
Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap
Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap
November 29, 2022
If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.
FDA Grants Priority Review for Duchenne Muscular Dystrophy Gene Therapy
FDA Grants Priority Review for Duchenne Muscular Dystrophy Gene Therapy
FDA Grants Priority Review for Duchenne Muscular Dystrophy Gene Therapy
November 28, 2022
If approved, SRP-9001 (delandistrogene moxeparvovec) would be the first gene therapy for Duchenne. The FDA action date is May 29, 2023.
FDA Issues CRL for Poziotinib for Lung Cancer
FDA Issues CRL for Poziotinib for Lung Cancer
FDA Issues CRL for Poziotinib for Lung Cancer
November 28, 2022
An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
Inflation Reduction Act and the Impact on Pharmaceutical Pricing and Investment Decisions
Inflation Reduction Act and the Impact on Pharmaceutical Pricing and Investment Decisions
Inflation Reduction Act and the Impact on Pharmaceutical Pricing and Investment Decisions
November 25, 2022
The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price.
Provention Bio Chooses Amber as Specialty Pharmacy for Tzield
Provention Bio Chooses Amber as Specialty Pharmacy for Tzield
Provention Bio Chooses Amber as Specialty Pharmacy for Tzield
November 24, 2022
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It is administered by intravenous infusion once daily for 14 consecutive days.
FDA Grants Priority Review of BLA for Dengue Vaccine
FDA Grants Priority Review of BLA for Dengue Vaccine
FDA Grants Priority Review of BLA for Dengue Vaccine
November 23, 2022
An FDA decision on Takeda’s dengue vaccine TAK-003 is expected within six months.
Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl
Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl
Authorities Seize Fake Drugs with Lethal Doses of Meth and Fentanyl
November 23, 2022
Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.
Updated: FDA Approves $3.5 million Gene Therapy Hemgenix for Hemophilia B
Updated: FDA Approves $3.5 million Gene Therapy Hemgenix for Hemophilia B
Updated: FDA Approves $3.5 million Gene Therapy Hemgenix for Hemophilia B
November 22, 2022
Hemgenix is the first one-time gene therapy treatment for adults with hemophilia B. It will have a list price of $3.5 million.
FDA Warns About Prolia in Patients with Kidney Disease
FDA Warns About Prolia in Patients with Kidney Disease
FDA Warns About Prolia in Patients with Kidney Disease
November 22, 2022
An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.
GSK Pulls Blenrep from U.S. Market
GSK Pulls Blenrep from U.S. Market
GSK Pulls Blenrep from U.S. Market
November 22, 2022
A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.
Compounding Pharmacies to Help Alleviate Amoxicillin Shortage
Compounding Pharmacies to Help Alleviate Amoxicillin Shortage
Compounding Pharmacies to Help Alleviate Amoxicillin Shortage
November 21, 2022
The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.
FDA Accepts for Priority Review BLA for Epcoritamab
FDA Accepts for Priority Review BLA for Epcoritamab
FDA Accepts for Priority Review BLA for Epcoritamab
November 21, 2022
If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.
FDA Updates Target Date for Pegcetacoplan
FDA Updates Target Date for Pegcetacoplan
FDA Updates Target Date for Pegcetacoplan
November 19, 2022
Appellis had submitted updated data for the pegcetacoplan in age-related macular degeneration, which is considered a major amendment to the NDA. The new PDUFA date is Feb. 26, 2023.
FDA Approves Alternate Dosing Schedule for Rylaze
FDA Approves Alternate Dosing Schedule for Rylaze
FDA Approves Alternate Dosing Schedule for Rylaze
November 18, 2022
Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
FDA Approves Second Interchangeable Lantus Biosimilar
FDA Approves Second Interchangeable Lantus Biosimilar
FDA Approves Second Interchangeable Lantus Biosimilar
November 18, 2022
Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.
FDA Approves First Drug that Delays Diabetes
FDA Approves First Drug that Delays Diabetes
FDA Approves First Drug that Delays Diabetes
November 18, 2022
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.
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