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Pfizer, BioNTech Snag Fast Track for COVID-19-Flu Vaccine Combo
Pfizer, BioNTech Snag Fast Track for COVID-19-Flu Vaccine Combo
Pfizer, BioNTech Snag Fast Track for COVID-19-Flu Vaccine Combo
December 13, 2022
Building on the success of the companies’ COVID-19 vaccines, Pfizer and BioNTech have begun a phase 1 trial of a combined flu-COVID-19 vaccine.
KRAS-Targeted Lung Cancer Drug Carries $237,000 Annual Price Tag
KRAS-Targeted Lung Cancer Drug Carries $237,000 Annual Price Tag
KRAS-Targeted Lung Cancer Drug Carries $237,000 Annual Price Tag
December 13, 2022
The FDA issued an accelerated approval for Mirati’s Krazati for patients with KRAS-mutated non-small cell lung cancer. The agency also approved a companion diagnostic to identify eligible patients.
Biocon Biologics Completes $3 Billion Acquisition of Viatris’ Biosimilars
Biocon Biologics Completes $3 Billion Acquisition of Viatris’ Biosimilars
Biocon Biologics Completes $3 Billion Acquisition of Viatris’ Biosimilars
December 12, 2022
The acquisition provides Biocon Biologics with eight commercial biosimilars, and is part of Viatris’ efforts to pay down debt related to phase 1 research and the company’s acquisition of two ophthalmology businesses.
Alnylam Submits sNDA for Onpattro in ATTR Amyloidosis with Cardiomyopathy
Alnylam Submits sNDA for Onpattro in ATTR Amyloidosis with Cardiomyopathy
Alnylam Submits sNDA for Onpattro in ATTR Amyloidosis with Cardiomyopathy
December 10, 2022
A phase 3 study demonstrated that Onpattro improved functional capacity, health status and quality of life compared with placebo in this patient population.
FDA Accepts Biogen’s Application for Actemra Biosimilar
FDA Accepts Biogen’s Application for Actemra Biosimilar
FDA Accepts Biogen’s Application for Actemra Biosimilar
December 9, 2022
The acceptance of Biogen’s application follows regulator’s acceptance of an application by Fresenius Kabi for another Actemra biosimilar.
FDA Expands Updated COVID-19 Vaccines EUA to Children
FDA Expands Updated COVID-19 Vaccines EUA to Children
FDA Expands Updated COVID-19 Vaccines EUA to Children
December 9, 2022
The bivalent vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 and a component of omicron lineage BA.1.
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.
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