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Clovis Submits Supplemental Applications for Rubraca for Advanced Ovarian Cancer
Clovis Submits Supplemental Applications for Rubraca for Advanced Ovarian Cancer
Clovis Submits Supplemental Applications for Rubraca for Advanced Ovarian Cancer
September 15, 2022
The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.
FDA Approves Terlivaz for Kidney Dysfunction Syndrome
FDA Approves Terlivaz for Kidney Dysfunction Syndrome
FDA Approves Terlivaz for Kidney Dysfunction Syndrome
September 15, 2022
Terlivaz is the first approved therapy to treat hepatorenal syndrome, a rare form of kidney disfunction related to advanced liver disease.
Evernorth Adds to Digital Formulary
Evernorth Adds to Digital Formulary
Evernorth Adds to Digital Formulary
September 15, 2022
The additions include apps to help people better manage their sleep issues, anxiety, alcohol and opioid use disorders, and inflammatory conditions.
FDA Accepts NDA for Longer-Acting Aripiprazole
FDA Accepts NDA for Longer-Acting Aripiprazole
FDA Accepts NDA for Longer-Acting Aripiprazole
September 14, 2022
Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.
FDA Accepts BLA for Ultra Rare Enzyme Disorder
FDA Accepts BLA for Ultra Rare Enzyme Disorder
FDA Accepts BLA for Ultra Rare Enzyme Disorder
September 14, 2022
The FDA has granted priority review of velmanase alfa, an enzyme replacement, to treat patients with alpha-mannosidosis, a rare genetic disease. The FDA has assigned an action date in the first half of 2023.
PBMI: Real-world Impact of Pharmacogenomics
PBMI: Real-world Impact of Pharmacogenomics
PBMI: Real-world Impact of Pharmacogenomics
September 13, 2022
Jeffrey A. Shaman, Ph.D., chief science officer at Coriell Life Sciences, talked about how pharmacogenomics can inform medication management.
FDA Schedules Advisory Committee Meeting for Nonprescription Birth Control
FDA Schedules Advisory Committee Meeting for Nonprescription Birth Control
FDA Schedules Advisory Committee Meeting for Nonprescription Birth Control
September 13, 2022
If approved, Perrigo’s Opill could be the first-ever over-the-counter birth control pill. The advisory committee meeting is scheduled for Nov. 18, 2022.
FDA Accepts NDA for Rett Syndrome Drug
FDA Accepts NDA for Rett Syndrome Drug
FDA Accepts NDA for Rett Syndrome Drug
September 13, 2022
If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.
PBMI: Drug Benefit Design for Specialty Medications
PBMI: Drug Benefit Design for Specialty Medications
PBMI: Drug Benefit Design for Specialty Medications
September 12, 2022
Kali Panagos, Pharm.D., at ARMSRx, discusses the growing trend of copay assistance programs and alternative funding solutions that can help provide access to expensive specialty therapies.
Texas Ruling on HIV PrEP Could Impact Other Preventive Coverage
Texas Ruling on HIV PrEP Could Impact Other Preventive Coverage
Texas Ruling on HIV PrEP Could Impact Other Preventive Coverage
September 12, 2022
A Texas judge ruled that coverage for HIV pre-exposure prophylaxis (PrEP) violates religious freedom but there is concern that cancer screenings and other preventive services could be affected.
FDA Approves First-in-Class Therapy for Psoriasis
FDA Approves First-in-Class Therapy for Psoriasis
FDA Approves First-in-Class Therapy for Psoriasis
September 12, 2022
Developed by Bristol Myers Squibb, Sotyktu is the first approved TYK2 inhibitor. It is expected to be available later this month.
FDA Approves Rolvedon to Prevent Chemotherapy-related Infections
FDA Approves Rolvedon to Prevent Chemotherapy-related Infections
FDA Approves Rolvedon to Prevent Chemotherapy-related Infections
September 11, 2022
Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.
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.
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