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All News - Page 28

Janssen Submits BLA for Another Bispecific Antibody for Multiple Myeloma
Janssen Submits BLA for Another Bispecific Antibody for Multiple Myeloma
Janssen Submits BLA for Another Bispecific Antibody for Multiple Myeloma
December 9, 2022
Talquetamab is a bispecific antibody that targets both CD3 on T cells and GPRC5D, which is overexpressed on myeloma cells.
Out-of-Pocket Costs Impact Medication Access for Some Medicare Beneficiaries with Schizophrenia
Out-of-Pocket Costs Impact Medication Access for Some Medicare Beneficiaries with Schizophrenia
Out-of-Pocket Costs Impact Medication Access for Some Medicare Beneficiaries with Schizophrenia
December 9, 2022
Low-income subsidies can eliminate much of the out-of-pocket costs that patients must pay.
EmsanaRx and Mark Cuban’s Pharmacy Offer New Program
EmsanaRx and Mark Cuban’s Pharmacy Offer New Program
EmsanaRx and Mark Cuban’s Pharmacy Offer New Program
December 8, 2022
The EmsanaRx Plus program is connecting employers to the discounted drugs offered through Mark Cuban Cost Plus Drug Company. The program will be available beginning March 1, 2023
FDA Requests Removal of Pepaxto Indication for Multiple Myeloma
FDA Requests Removal of Pepaxto Indication for Multiple Myeloma
FDA Requests Removal of Pepaxto Indication for Multiple Myeloma
December 8, 2022
Oncopeptides disagrees with the FDA about Pepaxto and will make a decision about next steps by the end of the first quarter of 2023.
Cost Savings Associated with Therapeutic Exchange of Stimulant Medications
Cost Savings Associated with Therapeutic Exchange of Stimulant Medications
Cost Savings Associated with Therapeutic Exchange of Stimulant Medications
December 8, 2022
Cost savings were not associated with an increase in adverse drug events.
Pharmacy Groups Criticize Express Scripts’ Tricare Decision
Pharmacy Groups Criticize Express Scripts’ Tricare Decision
Pharmacy Groups Criticize Express Scripts’ Tricare Decision
December 7, 2022
Independent pharmacies are no longer part of Tricare’s pharmacy network for uniformed service members and their families. The pharmacy groups say this will impact 400,000 beneficiaries.
KFF: COVID-19 Vaccine Costs to Rise if Federal Purchasing Ends
KFF: COVID-19 Vaccine Costs to Rise if Federal Purchasing Ends
KFF: COVID-19 Vaccine Costs to Rise if Federal Purchasing Ends
December 7, 2022
Health insurance premiums, especially in the ACA Marketplace, could increase if the federal government ends purchasing of COVID-19 vaccines and boosters.
FDA Accepts for Priority Review BLA for RSV Vaccine
FDA Accepts for Priority Review BLA for RSV Vaccine
FDA Accepts for Priority Review BLA for RSV Vaccine
December 7, 2022
If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.
Prime Therapeutics Completes $1.35B Deal to Acquire Magellan Rx
Prime Therapeutics Completes $1.35B Deal to Acquire Magellan Rx
Prime Therapeutics Completes $1.35B Deal to Acquire Magellan Rx
December 6, 2022
Magellan Rx's businesses includes a 1.7-million member PBM. The deal is struck amid a long-time trend toward consolidation in the pharmacy benefit management industry.
ICER: Drugs with Unsupported Price Increases Added $805 Million in Costs
ICER: Drugs with Unsupported Price Increases Added $805 Million in Costs
ICER: Drugs with Unsupported Price Increases Added $805 Million in Costs
December 6, 2022
Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.
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.
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