FDA Approves New Class of Non-Opioid Pain Medication
The FDA has approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults, according to the agency.
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FDA Approves New Class of Non-Opioid Pain Medication
The FDA has approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults, according to the agency.
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Vertex’s Next-in-class Triple Combo Therapy for Cystic Fibrosis Gets FDA Priority Review
The drug candidate “raises the high bar set by Trikafta,” according to Vertex Pharma’s executive vice president and chief regulatory and quality officer.
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Ivacaftor Safe in CF Infants Aged 1 to 4 Months
A phase 3 clinical trial, ivacaftor (Kalydeco, Vertex Pharma) was generally safe to administer to infants aged 1-month to <4-months old, according to research published in Journal of Cystic Fibrosis.
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FDA Approves First CRISPR-based Therapy for Sickle Cell Disease
The FDA approved the first cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older. One therapy, Casgevy, is the first FDA-approved treatment to utilize the genome editing technology CRISPR/Cas9
Read MoreHealth Canada OKs Trikafta for Younger Children With Cystic Fibrosis
Health Canada granted market authorization for the expanded use of Trikafta to include children with cystic fibrosis ages 2-5 years who have at least one copy of the F508del mutation in the CFTR gene.
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FDA Grants Kalydeco Expanded Approval for Infants with Cystic Fibrosis
The medication now is approved for use in children with cystic fibrosis ages 1 month to less than 4 months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene.
Read MoreTrikafta triple-combo Therapy Safe for Cystic Fibrosis Patients Ages 6-11
According to a study published in AJRCCM, Vertex Pharma’s Trikafta (elexacaftor/tezacaftor/ivacaftor) is safe and efficacious in children 6 through 11 years of age with at least one F508del-CFTR allele. The safety and...
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Kaftrio One Step Closer to EU Expanded Approval for Cystic Fibrosis Patients
The European Medicines Agency’s CHMP adopted a positive opinion for a label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for certain cystic fibrosis patients.
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Top 10 Medical Innovations for 2021 Include Trikafta, Bubble CPAP
Cleveland Clinic announced the Top 10 Medical Innovations for 2021., which include the cystic fibrosis therapeutic Trikafta (#4), and bubble CPAP technology for preemies (#6).
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Vertex’s Cystic Fibrosis Pill Gets European Medicines Agency’s Backing
Vertex Pharmaceutical’s triple combination cystic fibrosis treatment, Kaftrio, is one step closer to coming to market after receiving a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
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Trikafta Approved by FDA for Cystic Fibrosis
Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, which is estimated to represent 90% of the cystic fibrosis population.
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Cystic Fibrosis: Costs Forcing Parents to Argentina for Orkambi Generic
According to BBC UK, parents of children with cystic fibrosis have resorted to medical tourism to purchase a generic of the CF drug Orkambi, which is not available through the National Health Service in the UK.
Read MoreLatest Trial Data on Vertex CF Therapies and New Combos Show Benefits
Vertex Pharmaceuticals recently presented data from several clinical trials of cystic fibrosis treatments showing positive outcomes for CF patients. These findings were presented at the North American Cystic Fibrosis...
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Vertex Reports Very Positive Ph1/Ph2 Data on Triple Therapies for CF
Vertex Pharmaceuticals Inc has reported positive data from Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis (CF).
Read MoreVertex Buys Experimental Cystic Fibrosis Drug
Vertex Pharma is acquiring an experimental, longer-acting version of its cystic fibrosis drug Kalydeco from Concert Pharmaceuticals for use in future combination regimens.
Read MoreCF Drug Orkambi Will Top $1B in Sales This Year
Vertex Pharmaceuticals Inc reports that its cystic fibrosis drug Orkambi remains on track to generate sales of at least $1 billion this year.
Read MoreFDA Approves Orkambi, New Treatment for Cystic Fibrosis
The FDA has approved Vertex Pharma’s Orkambi, the first drug directed at treating cystic fibrosis patients 12 years and older with two copies of the F508del mutation.
Read MoreCorbus Looks to Take on Vertex with Experimental CF Drug
Corbus, a small biopharmaceutical company, received $5 million from the Cystic Fibrosis Foundation last month to develop the drug, Resunab.
Read MoreFDA Approves Kalydeco for CF Patients with the R117H Mutation
Over 3,100 people in North America, Europe and Australia with the CF R117H mutation will have a new treatment option with the new Kalydeco approval.
Read MoreVertex Files for US and Europe Approval of Combination Drug for CF
Vertex’s pipeline combination lumacaftor-ivacaftor drug is indicated for the treatment of cystic fibrosis in patients carrying the F508del CFTR gene alteration.
Read MoreVertex Pharmaceuticals’ Kalydeco Wins FDA Panel Backing
An FDA Advisory Committee voted in favor of clearing Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco for an additional patient population.
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Vertex CF Drug Combo Significantly Improves Lung Function
Vertex Pharmaceuticals Inc says results from two Phase 3 studies of its lumacaftor-ivacaftor drug combination showed statistically significant improvements in lung function (ppFEV1) in cystic fibrosis patients (12+) who have two copies of the F508del mutation.
Read MoreFDA Approves Expanded Kalydeco Use for Cystic Fibrosis
The FDA has approved a supplemental New Drug Application for Kalydeco (ivacaftor) for use in eight additional mutations that cause cystic fibrosis.
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Kalydeco Wins The Wall Street Journal’s 2012 Technology Innovation Award
The drug, known to treat the underlying cause of cystic fibrosis, is recognized for having a wide impact in its field.
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