CYP1A2

Pulmocide Announces New Clinical Data Confirming Low Potential for Drug-Drug Interactions with Inhaled Opelconazole

Retrieved on: 
Monday, October 16, 2023

The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.

Key Points: 
  • The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.
  • “Opelconazole was specifically designed to be administered via inhalation in order to achieve high lung concentrations and low systemic uptake.
  • These low systemic levels, now observed in multiple clinical trials and in the UK Special Needs provision, have been estimated to be too low to have an inhibition or induction of a drug-drug interaction effect.
  • We are encouraged that these clinical trial results confirm this low potential for Cytochrome P450 drug-drug interactions for opelconazole.”

Myriad Genetics Announces Enhancements to the GeneSight® Test to Personalize Mental Health Medication Treatment Decisions Based on Smoking Status

Retrieved on: 
Monday, August 7, 2023

SALT LAKE CITY, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics , Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, announced enhancements to the GeneSight ® Psychotropic test, a pharmacogenomic test for mental health medications.

Key Points: 
  • SALT LAKE CITY, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics , Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, announced enhancements to the GeneSight ® Psychotropic test, a pharmacogenomic test for mental health medications.
  • The GeneSight report will now include information on how a patient's smoking status may impact their body's metabolism of certain medications.
  • Many factors may influence medication outcomes in addition to genetics.
  • “Taking smoking status into consideration helps ensure the test provides an even more complete picture of patients’ potential outcomes with certain medications,” said Holly Johnson, Ph.D., director of Medical Affairs, Myriad Genetics.

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

Retrieved on: 
Friday, May 12, 2023

SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.

Key Points: 
  • SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.
  • Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause.
  • "The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women."
  • The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials.

Lennham Consumer Products Announces Publication of Manuscripts Describing Clinical and Non-Clinical PK and Safety of d9-Caffeine

Retrieved on: 
Friday, July 29, 2022

Lennham Consumer Products, a start-up focused on the creative use of deuterium chemistry to improve well-known products, today announced the publication of two manuscripts describing the clinical and non-clinical pharmacokinetics (PK) and safety of d9-caffeine.

Key Points: 
  • Lennham Consumer Products, a start-up focused on the creative use of deuterium chemistry to improve well-known products, today announced the publication of two manuscripts describing the clinical and non-clinical pharmacokinetics (PK) and safety of d9-caffeine.
  • Results indicate that both d9-caffeine and normal caffeine were well tolerated, and no adverse events for insomnia were reported.
  • The second manuscript, published in Food and Chemical Toxicology, reports on studies examining the non-clinical safety, pharmacology, and pharmacokinetics of d9-caffeine.
  • In 2019, Lennham set out to improve caffeine by creating an enhanced version that provides the same benefits but lasts longer.

Intercept Announces Closing of Transaction with Advanz Pharma to Transfer Rights to Commercialize Ocaliva® for PBC Outside the U.S.

Retrieved on: 
Friday, July 1, 2022

As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.

Key Points: 
  • As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.
  • Upfront consideration for the transaction is $405 million, subject to working capital, closing costs, France reimbursement liability and other adjustments.
  • OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
  • OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.

Aquestive Therapeutics and Haisco Pharmaceutical Group Enter Licensing and Supply Agreement for Riluzole Oral Film for ALS Treatment in China

Retrieved on: 
Thursday, March 3, 2022

Around 85% of ALS patients suffer from a progressive loss of bulbar functionality.1 Swallowing food and liquids becomes more difficult over time.

Key Points: 
  • Around 85% of ALS patients suffer from a progressive loss of bulbar functionality.1 Swallowing food and liquids becomes more difficult over time.
  • This agreement with Haisco will allow ALS patients in China to access EXSERVAN, a riluzole oral film, which will provide a meaningful treatment option to those who have to discontinue their treatment because of difficulties swallowing a tablet.
  • Pursuant to the agreement, Haisco will lead the regulatory and commercialization activities for EXSERVAN in China.
  • EXSERVAN, an oral film formulation of riluzole, was developed by Aquestive using its PharmFilminnovative drug delivery technology.

First Platform for Massively Multiplexed Single-Cell In Situ Spatial Genomics Now Broadly Available to U.S. Market

Retrieved on: 
Tuesday, January 18, 2022

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    Through MERSCOPE, a one-of-a-kind single-cell spatial genomics platform technology, Vizgen is ushering in a new era in genomics.
  • We are working with our customers to bring new platform capabilities and applications throughout the year and continue to lead this new era of spatial genomics.
  • Vizgen is dedicated to pioneering the next generation of genomics, providing tools that demonstrate the possibilities of in situ single-cell spatial genomics, setting the standard for the spatial genomics field.
  • The company's MERSCOPETM Platform enables massively multiplexed, genome-scale nucleic acid imaging with high accuracy and unrivaled detection efficiency at subcellular resolution.