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Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.
(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.
(NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. About the REGN-COV2 Trial in Hospitalized Patients. Cohort 1A: patients not requiring oxygen.
15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.
RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases.
We intend to use PWS as the anchor indication and will further investigate additional orphan disease opportunities in due course.”. Disease Highlights.
What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? There are a lot of drug development challenges that are, in some cases, unique to neuroscience, including neurological diseases, psychiatric disorders, and rare diseases affecting the nervous system.
Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany.
Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. This press release features multimedia.
The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and Merck. About Ridgeback Biotherapeutics.
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. Specifically, it is being examined in adults who are hospitalized with COVID-19. Kate Krav-Rude/Shutterstock. before expanding it into Europe.
It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
“Buprenorphine is the most important medication in our arsenal for treating opioid use disorder, which is currently one of the most lethal diseases for Americans.” As a result, some clinicians are hesitant to pursue this DEA license or even engage in treatment of patients with OUD.
In addition, OBI-833 can elicit a beneficial immune response in NSCLC patients and had rendered some TKI-treated patients a durable stable disease status. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. Department of Hematology and Oncology, Taipei Medical University Hospital, Taipei, Taiwan.
Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs. and Europe.
In line with our global leadership and our 7 0-year history of pro tecting people with influenza v accine s , w e will always focus on developing product s that demonstrate protection beyond flu , as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia.
Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.
Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. This press release features multimedia. In the U.S.,
Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved in the U.S. Outside of the U.S., About Regeneron.
As a global leader in respiratory and allergy, we remain committed to reimagining medicine for patients living with chronic respiratory diseases like asthma.”. GLY certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. g) and medium-dose (150/50/80?g)
Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About PNEU-PATH.
Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S.
The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., today announced that the U.S. A decision on U.S. FDA approval is expected in the second half of this year.
“Data from the DISCOVER-1 and DISCOVER-2 studies demonstrating Tremfya reduced fatigue through 52 weeks provide evidence of an additional treatment benefit for patients with active PsA,” said Alyssa Johnsen, vice president, Rheumatology Disease Area Leader, Janssen Research & Development. Humanigen’s Lenzilumab. Equillium’s Itolizumab.
Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. “Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. In February 2022, the U.S.
Fourteen newly licensed medicines have been accepted for use on NHS Scotland by the Scottish Medicines Consortium (SMC), bringing a raft of new treatment options for conditions including epilepsy, depression and cancer.
At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. million in 2020 despite a very limited access of patients to hospitals due to the COVID-19 crisis. “We Cash position and financing runway. million in the fourth quarter of 2020, and to a total of €5.6 GenSight Biologics S.A.
REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. In total, 47% of participants were male and 53% were female. .
1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. About Severe Asthma
Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide. 6-8 Patients with severe asthma account for twice as many asthma-related hospitalizations.
The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease.
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PLYMOUTH MEETING, Pa. ,
. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”
We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. Albert Bourla, Pfizer Chairman and CEO. “We About BioNTech.
will reduce the number of people in the high-risk population being hospitalized. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. “The Emergency Use Authorization in the U.K. About BioNTech.
By Leah Eisenstadt February 29, 2024 Credit: Courtesy of (clockwise, from top left) National Park Service; Rainer Zenz, Creative Commons license; Len Charnoff/Flickr, public domain; Riki7, public domain; National Park Service; Rufus46, Creative Commons. The work appears in Proceedings of the National Academy of Sciences (PNAS).
. “While COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks. and 14.7%, respectively) and placebo (44.4% and 18.0%, respectively) groups.
Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D., In the U.S.
29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.
— Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury — Gilead Sciences, Inc. At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury.
Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,
alone, according to the Centers for Disease Control and Prevention. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. 4 But the same barriers still exist today.
While disease progression is slower in patients with later-onset SMA, there are significant unmet needs. “We SMA is a rare, genetic neuromuscular disease caused by a lack of a functional SMN1 gene, resulting in the irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic movement.
Most square centimeters of our built environments transmit next to no disease (think of walls, which we rarely so much as brush in passing), but some are touched with extraordinary frequency. Diarrheal diseases—attributed to viruses, such as noroviruses, which are spread via fomite transmission—killed about 1.5
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.
Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients: who are hospitalized due to COVID-19, OR. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Some of these events required hospitalization. Adverse Events.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
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