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New antibiotic for treating MRSA, KIMYRSA, now commercially available

New antibiotic for treating MRSA, KIMYRSA, now commercially available
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Christine Ann Miller , John Harlow , Drug Administration , Melinta Therapeutics , Chief Executive Officer , Chief Commercial , கிறிஸ்டின் ஆண்டு மில்லர் , ஜான் ஹார்லோ , தலைமை நிர்வாகி அதிகாரி , தலைமை வணிகரீதியானது ,

Melinta Therapeutics and Hikma Sign Exclusive Licensing Agreement for Two Novel Anti-Infectives for the Middle East and North Africa Region

Published: Apr 29, 2021

MORRISTOWN, N.J. (BUSINESS WIRE) Melinta Therapeutics (Formerly known as Rib-X Pharmaceuticals, Inc.) (Melinta) and Hikma Pharmaceuticals PLC (Hikma) today announced they have entered into an exclusive licensing agreement for Vabomere
® (meropenem and vaborbactam) and Orbactiv
® (oritavancin), two novel anti-infective injectable products, for the Middle East and North Africa (MENA) region.
In the United States, Orbactiv
® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections due to designated susceptible Gram-positive pathogens and Vabomere
® is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative pathogens. ....

United States , United Arab Emirates , United Kingdom , Christine Ann Miller , Mazen Darwazah , Pharmaceuticals Inc Melinta , Hikma Pharmaceuticals , Melinta Therapeutics , Ribx Pharmaceuticals , Middle East , North Africa , Executive Vice Chairman , Chief Executive Officer , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது அரபு அமீரகங்கள் , ஒன்றுபட்டது கிஂக்டம் , கிறிஸ்டின் ஆண்டு மில்லர் , மஜேன் தர்வாசா , ஹிக்மா மருந்துகள் , நடுத்தர கிழக்கு , நிர்வாகி துணை தலைவர் , தலைமை நிர்வாகி அதிகாரி ,

Melinta antibiotic for MRSA & other serious skin infections wins FDA approval

MedCity News
Melinta antibiotic for MRSA & other serious skin infections wins FDA approval
Melinta Therapeutics already sells an antibiotic for serious skin infections. But FDA approval of Kimyrsa gives clinicians another option to offer patients, one with more convenient dosing.
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Melinta Therapeutics can now add another antibiotic to its portfolio after the FDA on Monday approved the company’s infused treatment for serious skin infections such as MRSA.
Approval of oritavancin, which will be marketed under the name Kimyrsa, covers the treatment of acute bacterial skin and skin structure infections (ABSSSI). The New Haven, Connecticut-based company already sells another oritavancin-based product, Orbactiv. But Kimyrsa will offer the prospect of a single, one-hour infusion compared to Orbactiv, which is infused over the course of three hours. Approved in 2014, Orbactiv was developed as an alternative to vancomycin, an antibiotic that is infuse ....

New Haven , United States , Christine Ann Miller , Medicines Company , Jolla Pharmaceuticals , Tetraphase Pharmaceuticals , Agency For Healthcare Research , Healthcare Research , Melinta President , Ann Miller , Weight Loss , Medical Devices , Healthcare Innovation , Medcity News , San Francisco , Life Sciences , Rock Health , Startup Advice , Startup Funding , Patient Monitoring System , Motion Sensors , Healthcare It , Foodborne Pathogens , Diagnostics Company , Diagnostic Platforms , Minimally Invasive Surgery ,

Stewardship / Resistance Scan for Mar 16, 2021

FDA approves Melinta s Kimyrsa for skin infections
Melinta Therapeutics of Morristown, New Jersey, announced yesterday that the US Food and Drug Administration (FDA) has approved Kimyrsa (oritavancin) for treatment of adult patients with acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive pathogens, including methicillin-resistant
Staphylococcus aureus (MRSA).
Kimyrsa delivers a complete course of the lipoglycopeptide antibiotic oritavancin in a single, 1-hour 1,200 milligram (mg) intravenous infusion. The drug is an updated version of Orbactiv, which was approved by the FDA in 2014 for treatment of ABSSSIs and is infused over 3 hours.
The safety and efficacy of Kimyrsa was previously established in randomized clinical trials that showed that a single 1,200 mg infusion of Orbactiv was as effective 7 to 10 days of twice daily vancomycin in treating 1,987 ABSSSI patients, including 405 with documented MRSA infection. FDA ....

United States , New Jersey , Christine Ann Miller , Katie Wilson , Melinta Kimyrsa , School Food Alliance , Us Centers For Disease , Drug Administration , Natural Resources Defense Council , Us Department Of Agriculture , Ann Miller , Disease Control , Infection Control , Hospital Epidemiology , Upper Northeast , Control Hosp , Urban School Food Alliance , Certified Responsible Antibiotic Use Standard , Natural Resources Defense , ஒன்றுபட்டது மாநிலங்களில் , புதியது ஜெர்சி , கிறிஸ்டின் ஆண்டு மில்லர் , கேடீ வில்சன் , பள்ளி உணவு கூட்டணி , எங்களுக்கு மையங்கள் க்கு நோய் , இயற்கை வளங்கள் பாதுகாப்பு சபை ,

MRSA: KIMYRSA (oritavancin) receives FDA approval for treatment of ABSSSI

Melinta Therapeutics, LLC (Melinta), today announced that the U.S. Food and Drug Administration (FDA) has approved KIMYRSA™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant
Staphylococcus aureus (MRSA).
Image/NIAID
KIMYRSA is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion.
“The approval of KIMYRSA demonstrates Melinta’s commitment to provide innovative therapies to patients with acute and life-threatening illnesses,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time. We believe that with the approval of KIMYRSA and product availability this summer, physicia ....

Christine Ann Miller , Emergency Department , Drug Administration , Melinta Therapeutics , Chief Executive Officer , Emergency Room , கிறிஸ்டின் ஆண்டு மில்லர் , அவசரம் துறை , தலைமை நிர்வாகி அதிகாரி , அவசரம் அறை ,