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FDA, EMA Accept Submissions for Alopecia Therapy
FDA, EMA Accept Submissions for Alopecia Therapy
FDA, EMA Accept Submissions for Alopecia Therapy
September 10, 2022
The FDA is expected to make a decision on Pfizer’s ritlecitinib in the second quarter of 2023.
Prime Updates Toviaz on Medicare Formularies
Prime Updates Toviaz on Medicare Formularies
Prime Updates Toviaz on Medicare Formularies
September 9, 2022
Because of a generic is now available, Toviaz has been removed and up-tiered on Prime’s Medicare formularies.
FDA Approves Longer-Lasting Treatment for Frown Lines
FDA Approves Longer-Lasting Treatment for Frown Lines
FDA Approves Longer-Lasting Treatment for Frown Lines
September 9, 2022
Daxxify enters the injectable botulinum toxin market as a twice-a year treatment for frown lines.
Study: JAK Inhibitors May Have Different Side Effects
Study: JAK Inhibitors May Have Different Side Effects
Study: JAK Inhibitors May Have Different Side Effects
September 8, 2022
Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.
Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid
Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid
Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid
September 8, 2022
Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.
FDA Advisory Committee Supports Approval of AMX0035 for ALS
FDA Advisory Committee Supports Approval of AMX0035 for ALS
FDA Advisory Committee Supports Approval of AMX0035 for ALS
September 8, 2022
In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.
Prime Develops Predictive Model to Identify Savings in Breast Cancer
Prime Develops Predictive Model to Identify Savings in Breast Cancer
Prime Develops Predictive Model to Identify Savings in Breast Cancer
September 7, 2022
Prime Therapeutics’ predictive model was able to identify members with high breast cancer pharmacy and medical claims to help clients better manage drug spend.
Seres Completes Rolling BLA for Microbiome Therapeutic
Seres Completes Rolling BLA for Microbiome Therapeutic
Seres Completes Rolling BLA for Microbiome Therapeutic
September 7, 2022
If approved, SER-109 to treat recurrent C. diff infections could be the first-ever FDA approved oral microbiome therapeutic.
FDA Approves Stimufend, a Biosimilar to Neulasta
FDA Approves Stimufend, a Biosimilar to Neulasta
FDA Approves Stimufend, a Biosimilar to Neulasta
September 7, 2022
Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.
FDA: Eiger’s COVID-19 Treatment not Supported by Data
FDA: Eiger’s COVID-19 Treatment not Supported by Data
FDA: Eiger’s COVID-19 Treatment not Supported by Data
September 6, 2022
The FDA would not issue an emergency use authorization for Eiger BioPharmaceuticals’ peginterferon lambda to treat patients with mild-to-moderate COVID-19.
FDA Accepts NDA for Novel Dry Eye Disease Therapy
FDA Accepts NDA for Novel Dry Eye Disease Therapy
FDA Accepts NDA for Novel Dry Eye Disease Therapy
September 6, 2022
If approved, NOV03 would be the first prescription eye drop to address excessive tear evaporation. The FDA has assigned a PDUFA action date of June 28, 2023.
FDA Approves Imfinzi for Metastatic Biliary Tract Cancer
FDA Approves Imfinzi for Metastatic Biliary Tract Cancer
FDA Approves Imfinzi for Metastatic Biliary Tract Cancer
September 6, 2022
A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.
FDA Approves Oral Suspension for Gastric Ulcers
FDA Approves Oral Suspension for Gastric Ulcers
FDA Approves Oral Suspension for Gastric Ulcers
September 5, 2022
Konvomep, an oral liquid of omeprazole and sodium bicarbonate, will be available in the first quarter of 2023
FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis
FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis
FDA Approves Orkambi for Expanded Use in Children with Cystic Fibrosis
September 4, 2022
With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.
HHS Funds U.S. Monkeypox Vaccine Manufacturing
HHS Funds U.S. Monkeypox Vaccine Manufacturing
HHS Funds U.S. Monkeypox Vaccine Manufacturing
September 3, 2022
HHS is providing $11 million to Grand River Aseptic Manufacturing to accelerate manufacturing of the Jynneos monkeypox vaccine. The facility will be operational later this year.
FDA Approves Novel Treatment for Rare Type of Psoriasis Flare
FDA Approves Novel Treatment for Rare Type of Psoriasis Flare
FDA Approves Novel Treatment for Rare Type of Psoriasis Flare
September 2, 2022
Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.
Amneal Submits NDA for Parkinson’s Disease Therapy
Amneal Submits NDA for Parkinson’s Disease Therapy
Amneal Submits NDA for Parkinson’s Disease Therapy
September 2, 2022
This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.
FDA Approves Xenpozyme for ASMD, a Rare Genetic Disorder
FDA Approves Xenpozyme for ASMD, a Rare Genetic Disorder
FDA Approves Xenpozyme for ASMD, a Rare Genetic Disorder
September 1, 2022
Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.
Spending on Specialty Drugs Maintains Double-Digit Growth
Spending on Specialty Drugs Maintains Double-Digit Growth
Spending on Specialty Drugs Maintains Double-Digit Growth
September 1, 2022
PSG’s latest Artemetrx specialty spend report finds that, as with 2020, claim utilization continues to drive the trend.
Pharmacies Face Adderall Back Orders
Pharmacies Face Adderall Back Orders
Pharmacies Face Adderall Back Orders
September 1, 2022
Labor shortages and Drug Enforcement Agency quotas have led to supply shortages of Adderall and its generics, which are used to treat attention deficit hyperactivity disorder.
Hikma Launches Ryaltris for Allergic Rhinitis
Hikma Launches Ryaltris for Allergic Rhinitis
Hikma Launches Ryaltris for Allergic Rhinitis
August 31, 2022
Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.
FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters
FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters
FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters
August 31, 2022
The approval of the updated bivalent boosters is based on data from clinical studies of the omicron variant BA.1, and animal data on the omicron BA.4 and BA.5 variant.
Hospira Recalls Another Lot of Propofol
Hospira Recalls Another Lot of Propofol
Hospira Recalls Another Lot of Propofol
August 31, 2022
This recall of propofol because of particulates seen in vials follows a previous one in July 2022.
Updated: Mark Cuban CostPlus Lowers Prices of 30 Drugs
Updated: Mark Cuban CostPlus Lowers Prices of 30 Drugs
Updated: Mark Cuban CostPlus Lowers Prices of 30 Drugs
August 30, 2022
The direct-to-consumer pharmacy also added 13 new products, and now carries almost 1,000 medications.
FDA Grants Priority Review to Weekly Hemophilia A Therapy
FDA Grants Priority Review to Weekly Hemophilia A Therapy
FDA Grants Priority Review to Weekly Hemophilia A Therapy
August 30, 2022
The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.
Survey: Consumers Worried about Prescription Drug Costs
Survey: Consumers Worried about Prescription Drug Costs
Survey: Consumers Worried about Prescription Drug Costs
August 29, 2022
Survey participants said their drug costs have gone up and almost a third had trouble paying for food and housing because of high drug costs.
AllianceRx Walgreens Pharmacy, Total Care Rx Chosen to Distribute to Hyftor
AllianceRx Walgreens Pharmacy, Total Care Rx Chosen to Distribute to Hyftor
AllianceRx Walgreens Pharmacy, Total Care Rx Chosen to Distribute to Hyftor
August 29, 2022
Hyftor was approved in April 2022 to treat patients with the rare disease facial angiofibroma associated with tuberous sclerosis complex.
Humira Biosimilars a Question Mark for Hospitals
Humira Biosimilars a Question Mark for Hospitals
Humira Biosimilars a Question Mark for Hospitals
August 29, 2022
Payer coverage and the prior authorization process continue to be barriers for the adoption of biosimilars, according to a new Vizient survey.
FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms
FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms
FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms
August 27, 2022
Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.
FDA Expands Imbruvica for Young Children with GVHD
FDA Expands Imbruvica for Young Children with GVHD
FDA Expands Imbruvica for Young Children with GVHD
August 25, 2022
Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.
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