Combination drugs

Vertex to Initiate Phase 3 Development Program for New Once-Daily Triple Combination Regimen in People With Cystic Fibrosis

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Other Health, Health, Pharmaceutical, Clinical trials, Drugs, Orphan drugs, Health sciences, Health, Cystic fibrosis, Breakthrough therapy, Combination drugs, Elexacaftor/tezacaftor/ivacaftor, Organofluorides, Tezacaftor, VX, Ivacaftor, the Phase 3 Program, VX-121/Tezacaftor/VX-561, Cystic Fibrosis, THE PHASE 3 PROGRAM, VX-121/TEZACAFTOR/VX-561, CYSTIC FIBROSIS

Complete data from the Phase 2 clinical study of VX-121/tezacaftor/VX-561 and the VX-561 Phase 2 monotherapy study will be presented at a later date.

Key Points: 
  • Complete data from the Phase 2 clinical study of VX-121/tezacaftor/VX-561 and the VX-561 Phase 2 monotherapy study will be presented at a later date.
  • The primary endpoint in both studies is the absolute change from baseline in ppFEV1, which will be analyzed for non-inferiority to TRIKAFTA.
  • Both studies will also assess absolute change from baseline in ppFEV1 and sweat chloride for superiority to TRIKAFTA.
  • The VX-121/tezacaftor/VX-561 program was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of cystic fibrosis.

Evofem Biosciences to Report Second Quarter 2021 Results and Provide Corporate Update on Wednesday, August 11, 2021

Retrieved on: 
Wednesday, July 28, 2021
Chemical substances, Chemistry, Tartrates, Physical sciences, Combination drugs, Barrier contraception, Lactic acid/citric acid/potassium bitartrate, Spermicide, Vagina, Bitartrate, Acids in wine, Lactic

SAN DIEGO, July 28, 2021 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ:EVFM) will hold a webcast and conference call to discuss financial results and business highlights for the second quarter endedJune 30, 2021on Wednesday, August 11, 2021 at 4:30 p.m.

Key Points: 
  • SAN DIEGO, July 28, 2021 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ:EVFM) will hold a webcast and conference call to discuss financial results and business highlights for the second quarter endedJune 30, 2021on Wednesday, August 11, 2021 at 4:30 p.m.
  • The webcast (live and archived) and related slide presentation can be accessed through https://evofem.investorroom.com/2021Q2Results or directly at https://edge.media-server.com/mmc/p/h6zpy9h5 .
  • Atelephone replay will be available for 24 hours after the call at(855) 859-2056 (U.S.) or(404) 537-3406 (International), conference ID 9190716.
  • The Company launched its first FDA-approved commercial product, Phexxi (lactic acid, citric acid and potassium bitartrate), inthe United StatesinSeptember 2020.

Myovant Sciences Announces European Commission Approval for RYEQO® for the Treatment of Women With Uterine Fibroids

Retrieved on: 
Tuesday, July 20, 2021
Drugs, Chemical compounds, Chemistry, Combination drugs, Estrogens, Estranes, Prolactin releasers, GnRH antagonists, Relugolix/estradiol/norethisterone acetate, Uterine fibroid, Relugolix, Estradiol

With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition.

Key Points: 
  • With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition.
  • Todays approval of RYEQO, the first and only once-daily long-term treatment for women with uterine fibroids in Europe, marks a major milestone in expanding non-invasive treatment options for this common and potentially debilitating disease, said David Marek, Chief Executive Officer of Myovant Sciences, Inc.
  • Through our partnership with Gedeon Richter, we look forward to supporting even more women suffering from uterine fibroids.
  • RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

EPI Health and MC2 Therapeutics announces U.S. Launch of Wynzora® Cream for Plaque Psoriasis (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)

Retrieved on: 
Monday, July 19, 2021
Drugs, Steroids, Organ systems, Corticosteroids, Combination drugs, Antipsoriatics, Glucocorticoids, Calcipotriol/betamethasone dipropionate, Betamethasone dipropionate, Betamethasone, Psoriasis, Calcipotriol

"Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment ofplaque psoriasis, with proven efficacy, safety and tolerability.

Key Points: 
  • "Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment ofplaque psoriasis, with proven efficacy, safety and tolerability.
  • Until now they could not be combinedinto an aqueous cream, which is less greasy and more user-friendly than other formulations."
  • Wynzora Cream is based on PADTechnology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in aconvenient-to-use aqueous formulation.
  • Wynzora (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque psoriasis inadults.It is notknown ifWynzoraCream is safeand effectivein children.

EPI Health and MC2 Therapeutics announces U.S. Launch of Wynzora® Cream for Plaque Psoriasis (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)

Retrieved on: 
Monday, July 19, 2021
Drugs, Steroids, Organ systems, Combination drugs, Corticosteroids, Antipsoriatics, Calcipotriol/betamethasone dipropionate, Betamethasone dipropionate, Betamethasone, Psoriasis, Calcipotriol, Topical steroid

Now available: Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w0.005%/0.064%) once-daily topical treatment of plaque psoriasis in adults 18 years of age orolderintroduces useof PAD Technology.

Key Points: 
  • Now available: Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w0.005%/0.064%) once-daily topical treatment of plaque psoriasis in adults 18 years of age orolderintroduces useof PAD Technology.
  • "Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment ofplaque psoriasis, with proven efficacy, safety and tolerability.
  • Wynzora Cream is based on PADTechnology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in aconvenient-to-use aqueous formulation.
  • Wynzora (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque psoriasis inadults.It is notknown ifWynzoraCream is safeand effectivein children.

Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

Retrieved on: 
Monday, July 12, 2021
Drugs, Combination drugs, Hyaluronidase, Breakthrough therapy, Orphan drugs, Daratumumab/hyaluronidase, Halozyme, Daratumumab, Multiple myeloma

The approval marks Janssen's sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma.

Key Points: 
  • The approval marks Janssen's sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma.
  • "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."
  • DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.
  • Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Vertex Announces National Reimbursement Agreement in France for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) and SYMKEVI® (tezacaftor/ivacaftor) for Eligible Cystic Fibrosis Patients

Retrieved on: 
Monday, June 28, 2021
Biotechnology, Pharmaceutical, Health, Drugs, Orphan drugs, Health sciences, Cystic fibrosis, Health care, Breakthrough therapy, Combination drugs, Vertex Pharmaceuticals, Ivacaftor, Elexacaftor/tezacaftor/ivacaftor, Tezacaftor, Elexacaftor, Cystic Fibrosis, KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a Combination With Ivacaftor, SYMKEVI® (tezacaftor/ivacaftor) in Combination With Ivacaftor, CYSTIC FIBROSIS, KAFTRIO® (IVACAFTOR/TEZACAFTOR/ELEXACAFTOR) IN A COMBINATION WITH IVACAFTOR, SYMKEVI® (TEZACAFTOR/IVACAFTOR) IN COMBINATION WITH IVACAFTOR

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis (CF) medicines KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health Authorities for the cystic fibrosis (CF) medicines KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor.
  • Both medicines will be available for all eligible patients once the agreement has been published in the French Official Journal.
  • Through this national reimbursement agreement, eligible patients 12 years and older now have access to KAFTRIO and SYMKEVI.
  • The reimbursement agreement enables broad access to KAFTRIO for people with CF ages 12 years and older with one F508del mutation and one minimal function mutation.

Dapagliflozin is Well Tolerated in Hospitalized COVID-19 Patients

Retrieved on: 
Sunday, June 27, 2021
Anti-diabetic drugs, Drugs, Glucosides, SGLT2 inhibitors, Chloroarenes, Health care, Health sciences, Combination drugs, Dapagliflozin, Placebo

Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.

Key Points: 
  • Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.
  • Numerically fewer patients treated with dapagliflozin experienced organ failure or death (11.2% versus 13.8% with placebo, respectively), although this difference was not statistically significant.
  • Dapagliflozin was well tolerated, with numerically fewer serious adverse events than placebo, and these findings were also consistent in patients with and without type 2 diabetes.
  • The authors state that future trials are needed to further evaluate possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19.

Teva Announces Its Launch of the First Generic PERFOROMIST®, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML, Used to Treat Chronic Obstructive Pulmonary Disease (COPD), in the United States

Retrieved on: 
Tuesday, June 22, 2021
Managed care, Pharmaceutical, Health, Drugs, Chemical compounds, Health, Formamides, Formoterol, Phenols, Combination drugs, Chronic obstructive pulmonary disease, Beclometasone/formoterol/glycopyrronium bromide, Budesonide/formoterol, Formoterol Fumarate Inhalation Solution,, Teva, FORMOTEROL FUMARATE INHALATION SOLUTION,, TEVA

It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.

Key Points: 
  • It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.
  • It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.
  • Formoterol fumarate inhalation solution and certain other medicines may interact with each other.
  • If your COPD symptoms worsen over time, do not increase your dose of formoterol fumarate inhalation solution, instead call your healthcare provider.