XTalks

MAY 12, 2023

In March, the US Food and Drug Administration (FDA) approved Daybue (trofinetide) , the first and only treatment for Rett syndrome. Daybue (trofinetide) is the first and only FDA-approved drug for Rett syndrome. What safety and efficacy results were observed in the Phase III trial of Daybue?

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XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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Bioengineer

JULY 23, 2021

MUSC Hollings Cancer Center part of promising clinical trial for aggressive lymphoma. MUSC Hollings Cancer Center was one of 28 clinical sites around the world that participated in the LOTIS-2 trial to test the efficacy of Loncastuximab tesirine, a promising new treatment for aggressive B-cell lymphoma. Original Source.

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Intouch Solutions

AUGUST 5, 2021

It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it. “I The reasons vary, but one of the most recent shortages of synthetic estrogen has largely been chalked up to a delay in FDA approval.

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XTalks

AUGUST 30, 2022

The webinar also featured Kelsey Carter, MS, Clinical Trial Manager at Medpace who discussed the site, operational and regulatory challenges for neuroscience trials with direct CNS administration along with the strategies to mitigate these challenges. Figure 3 ). Targeting the CNS directly has been successful in modern medicine.

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The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

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The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D.

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The Pharma Data

DECEMBER 11, 2020

Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. Who is first in line? Centers for Disease Control and Prevention.

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The Pharma Data

DECEMBER 17, 2020

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

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The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. UZEDY will be available in the U.S.

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FDA Approval Clinical Trials Clinical Trials Nurses 40

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. The safety of the vaccines is continuously monitored.”.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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FDA Approval Bacteria Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 8, 2021

Data from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce the favourable safety and efficacy of this therapy for those living with NMOSD, including patients with concomitant autoimmune diseases (CAIDs). P6: Neuromuscular Disorders and Clinical Trials. P6: Neuromuscular Disorders and Clinical Trials.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

At ESMO 2022, updated results from Bristol Myers Squibb Co's Phase I/II Checkmate-358 clinical trial with Opdivo (nivolumab) and an Opdivo combination with the CTLA-4 inhibitor Yervoy (ipilimumab) pushed the PD-1 inhibitor’s scope with positive results in patients regardless of the tumor’s PD-L1 status.

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The Pharma Data

NOVEMBER 20, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Data from these trials will be used to support a future BLA submission.

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The Pharma Data

NOVEMBER 21, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Data from these trials will be used to support a future BLA submission.

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The Pharma Data

JANUARY 26, 2021

In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. It remains under review by the FDA. Bamlanivimab FDA Approval History. See Limitations of Authorized Use. Posted: January 2021.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

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Medicine Production FDA Approval Trials 40

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

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Medicine Production FDA Approval Trials 52

The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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The Pharma Data

AUGUST 11, 2020

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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pharmaphorum

DECEMBER 15, 2020

Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.

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