Rifampicin

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, AIDS, Hospitals, Health, Pharmaceutical, ARV, Week, Research, Doctor of Philosophy, CROI, Science, CAPRISA, TLD, Fever, Coinfection, TB, STR, Common, Health care, Organization, DTG, Drug resistance, Genotype, HBV, Fungal infection, Principal, Rifampicin, Seroconversion, Tablet, ALT, TDF, Conference, Safety, Biomarker, Pharmacokinetics, Integrase, Metabolism, Emtricitabine, Aes, Gilead Sciences, MD, FDA, Upper respiratory tract infection, Food, Cell, Risk, Prevalence, COVID-19, Death, Patient, HIV/AIDS, Tuberculosis, INSIGHT, HIV, Vaccine

“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

Elutia Submits CanGarooRM® Antibiotic-Eluting Biomatrix for FDA Clearance

Retrieved on: 
Monday, December 18, 2023
Neurostimulation, Food, Research, FDA, Minocycline, Rifampicin, Infection, Patient, Medical device

SILVER SPRING, Md., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®. Tailored for use with cardiac implantable electronic devices (CIEDs), such as pacemakers and internal defibrillators, CanGarooRM addresses a $600 million market, currently served by only one competitor. The decision to file came after the Company received feedback from a pre-submission meeting with the FDA. The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.

Key Points: 
  • SILVER SPRING, Md., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®.
  • The decision to file came after the Company received feedback from a pre-submission meeting with the FDA.
  • The Company anticipates an approval decision in the first half of 2024 and is now preparing for commercial launch.
  • “We believe the clearance of CanGarooRM will be a transformational event for Elutia and allow patients to thrive without compromise,” said Dr. Randy Mills, President and CEO of Elutia.

ACTG Announces Launch of Clinical Trial Evaluating Novel Treatment for Tuberculous Meningitis

Retrieved on: 
Thursday, December 7, 2023
TBM, Infection, NIAID, Tuberculous meningitis, Research, Vanderbilt University, DRS, University of California, Mortality, Spinal cord, Ageing, Membrane, Brain, Pyrazinamide, Linezolid, UM1, Inflammation, University, HIV, Bangladesh Technical Education Board, Tuberculosis, University of North Carolina, ACTG, Rifampicin, Pharmaceutical industry

LOS ANGELES, Dec. 07, 2023 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of the IMAGINE-TBM study (Improved Management with Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM, also known as A5384). IMAGINE-TBM is a phase 2, randomized, open-label trial comparing a six-month regimen of high-dose rifampicin, high-dose isoniazid, linezolid, and pyrazinamide to the nine-month standard-of-care regimen for the treatment of tuberculous meningitis.

Key Points: 
  • IMAGINE-TBM is a phase 2, randomized, open-label trial comparing a six-month regimen of high-dose rifampicin, high-dose isoniazid, linezolid, and pyrazinamide to the nine-month standard-of-care regimen for the treatment of tuberculous meningitis.
  • Tuberculous meningitis is a life-threatening infectious disease that causes inflammation of the membranes that surround the brain and spinal cord.
  • Even with standard-of-care treatment, outcomes are poor, with high rates of mortality and chronic disability among those who survive.
  • ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair).

Elutia Reports 26% Year-Over-Year Sales Growth of Proprietary Products and Strengthened Balance Sheet in Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Circulatory system, FDA, Marketing, Quality control, Rifampicin, Partnership, Growth, Minocycline, Rare-earth element, Airline, Medical device, Pharmaceutical industry, Video game

SILVER SPRING, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix products, today provided a business update and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Successfully completed transformation to Elutia, establishing a high growth company dedicated to developing and marketing propriety drug eluting biomatrices.
  • Achieved a significant 44% year-over-year increase in SimpliDerm® net sales and an 11% year-over-year growth in CanGaroo® net sales.
  • Net sales for the third quarter of 2023 were $6.1 million, compared to $5.8 million in the third quarter of 2022.
  • Elutia will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its third quarter 2023 financial results and performance.

Elutia Announces Sale of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million

Retrieved on: 
Monday, September 18, 2023
Therapy, Food and Drug Administration, Minocycline, RM, Rifampicin, Patient, Physician, Berkeley, Earnout, Defibrillation, Food, Wound healing, Pharmaceutical industry

SILVER SPRING, Md., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix products, today announced the divestiture of the Company’s Orthobiologics business unit to Berkeley Biologics LLC, a wholly owned subsidiary of GNI Group Ltd. Elutia will receive cash proceeds of up to $35 million, comprised of an upfront payment at closing of $15 million plus potential earnout payments of up to $20 million over a five-year period. The transaction is expected to close in the fourth quarter of 2023.

Key Points: 
  • This transaction represents a pivotal milestone in Elutia’s progress toward pioneering the drug-eluting biomatrix.
  • The Company continues to make progress towards gaining U.S. Food and Drug Administration clearance for CanGaroo® RM, the Company’s lead drug-eluting product.
  • Elutia is targeting the first half of 2024 for the launch of CanGaroo RM.
  • “With the development of the drug-eluting biomatrix, we are creating a new biosurgery paradigm to deliver better surgical outcomes.

Aziyo Biologics Rebrands as Elutia to Reflect Strategic Focus on Drug Eluting Biomatrices

Retrieved on: 
Wednesday, September 6, 2023
Hospital-acquired infection, DEB, Medicine, Minocycline, RM, Rifampicin, Mastectomy, Pain management, Growth, Defibrillation, Wound healing, Medical device

SILVER SPRING, Md., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”) today announced a change of the Company’s name to Elutia Inc. The rebranding reflects the strategic focus to develop and commercialize proprietary drug-eluting biomatrix technology aimed at improving surgical outcomes. The name change becomes effective today, September 6, 2023. The Company’s stock will begin trading on Nasdaq under the new ticker symbol “ELUT” on September 7, 2023.

Key Points: 
  • SILVER SPRING, Md., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”) today announced a change of the Company’s name to Elutia Inc.
  • The rebranding reflects the strategic focus to develop and commercialize proprietary drug-eluting biomatrix technology aimed at improving surgical outcomes.
  • “We are excited to introduce Elutia, where we exist to humanize medicine by pioneering drug-eluting biomatrix or DEB technology,” said Dr. Randy Mills, President and Chief Executive Officer of Elutia.
  • To address this, Elutia is developing SimpliDerm® RM incorporating our proprietary DEB technology.

Aziyo Biologics Provides Update on FDA Submission for CanGaroo® RM Antibacterial Envelope

Retrieved on: 
Monday, March 20, 2023
CDER, CDRH, File, FDA Center for Devices and Radiological Health, Minocycline, Rifampicin, Patient, Center for Drug Evaluation and Research, Device, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Environment, Food, Medical device, Research

SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo® RM Antibacterial Envelope, the Company’s next-generation biomaterial envelope.

Key Points: 
  • SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, provides an update on its submission to the U.S. Food and Drug Administration (FDA) for the CanGaroo® RM Antibacterial Envelope, the Company’s next-generation biomaterial envelope.
  • The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body.
  • The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope.
  • As previously announced, the Company submitted a 510(k) premarket notification for the CanGaroo RM Antibacterial Envelope to the FDA in April 2022 .

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Israeli Ministry of Health

Retrieved on: 
Monday, November 28, 2022
Digoxin, Abdominal pain, PARK, Diarrhea, Liver, CYP3A4, Food, Ciclosporin, Ministry, CYP2D6, BioCryst Pharmaceuticals, HAE, Patient, Plasma kallikrein, Rifampicin, Back pain, Kallikrein, Disease, Vomiting, Hereditary angioedema, Gastroesophageal reflux disease, BCRP, Berotralstat, RESEARCH, Plasma, Safety, Pharmaceutical industry, Dietary supplement, Dentistry, Health, QT

With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.

Key Points: 
  • With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.
  • The approval of ORLADEYO is a major advancement for the HAE community in Israel.
  • The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions.
  • The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

Nitrosamine Impurities in Rifampin - What Does it Mean for Your Drug-Drug Interaction (DDI) Study? Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, November 21, 2022
Doctor of Philosophy, Drinking water, Phenytoin, Nitrosamine, MNP, Mitotane, FDA, CYP3A, CYP3A4, Cancer, Diet, DDI, Human, Risk, Rifampicin, Enzalutamide, Food, US Foods, Drug development, Carbamazepine, Bureau of Oceans and International Environmental and Scientific Affairs, Pharmaceutical industry, Dietary supplement, EU

TORONTO, Nov. 21, 2022 /PRNewswire-PRWeb/ -- N-Nitrosamine impurity findings in marketed formulations of rifampin have disrupted drug development. As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products during pharmacokinetic drug-drug interaction studies. However, due to recent impurity issues, its application in these studies has been suspended in both the US and EU. This webinar will examine the root cause of rifampin impurity and describe the industry and regulatory response to this issue. In addition, the featured speakers will address alternative approaches and CYP3A inducers to encourage the continuation of drug-drug interaction studies and drug development.

Key Points: 
  • As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products during pharmacokinetic drug-drug interaction studies.
  • This webinar will examine the root cause of rifampin impurity and describe the industry and regulatory response to this issue.
  • The speakers propose overcoming rifampin impurity challenges with the use of phenytoin for healthy volunteer pharmacokinetic drug-drug interaction studies.
  • For more information, or to register for this event, visit Nitrosamine Impurities in Rifampin What Does it Mean for Your Drug-Drug Interaction (DDI) Study?

BioCryst Presents Real-World Data Showing Rapid and Sustained HAE Attack Rate Reduction After Beginning ORLADEYO® (berotralstat), Regardless of Prior Prophylactic Therapy

Retrieved on: 
Thursday, November 10, 2022
ACAAI, GLOBE, AES, Convention, IV, Danazol, Gastroesophageal reflux disease, Plasma, Kallikrein, Internal medicine, Adult, Back pain, BioCryst Pharmaceuticals, Plasma kallikrein, Abdominal pain, Nasdaq, Hereditary angioedema, Diarrhea, Incidence, Kentucky International Convention Center, BCRP, HAE, Rifampicin, Liver, Patient, Type 2, Safety, Ciclosporin, Lanadelumab, Berotralstat, RESEARCH, Disease, PARK, CYP3A4, Poster, University, SC, CYP2D6, Food, Digoxin, Vomiting, American College, Pharmaceutical industry, Medical device, Dietary supplement, Dentistry, QT

Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.

Key Points: 
  • Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.
  • Regardless of prior prophylaxis, a rapid reduction in median attack rates was observed early (1.67 attacks/month at baseline to a median attack rate of 0.33 attacks/month in days 1-90).
  • Upon initiating ORLADEYO treatment, the reduction in median attack rates from baseline over the 1360 days period was consistent for patients regardless of their prior prophylaxis therapy.
  • Regardless of baseline attack rate, patients reported a reduction in attack rates when treated with ORLADEYO.