Scienmag

FEBRUARY 25, 2022

Several FDA-approved drugs — including for type 2 diabetes, hepatitis C and HIV — significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. UNIVERSITY PARK, Pa.

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Pharmaceutical Technology

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favourable benefit-risk assessment; without that favourable assessment, the drug should not have the status of being FDA-approved.” Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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Pharmaceutical Technology

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favourable benefit-risk assessment; without that favourable assessment, the drug should not have the status of being FDA-approved.” Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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Scienmag

FEBRUARY 8, 2022

A team of scientists led by Cold Spring Harbor Laboratory (CSHL) have discovered that disulfiram, an FDA-approved drug, prevents the immune system from producing toxic webs known as neutrophil extracellular traps (NETs).

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pharmaphorum

OCTOBER 12, 2021

The research by a team of National Institutes of Health (NIH) scientists found that people who took bumetanide, a generic drug usually used to treat heart failure and oedema, had a significantly lower prevalence of Alzheimer’s compared to those not taking the drug.

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pharmaphorum

NOVEMBER 12, 2021

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The tool meanwhile could also be applied to new outbreaks of other novel viral infections as they emerge, according to the scientists.

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Scienmag

APRIL 2, 2021

Promising candidates include widely used transplant-rejection drug cyclosporine PHILADELPHIA – A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that are already approved by the Food and Drug Administration (FDA) for treating other (..)

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pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Partnering with EraCal builds upon the success of Novo Nordisk’s Wegovy (semaglutide) chronic weight management drug, which was approved by the FDA in June 2021.

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XTalks

AUGUST 2, 2022

Biopharmaceutical company Incyte received approval from the US Food and Drug Administration (FDA) for Opzelura (ruxolitinib) cream 1.5 The approval is groundbreaking as it makes Opzelura the first and only FDA-approved treatment for repigmentation in vitiligo. Approximately 1.5

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World of DTC Marketing

JUNE 28, 2021

The clinical evidence supporting the approval of the drug is at best “weak.” ” How could the FDA approve a drug with such poor clinical data? Scientists still don’t know for sure what causes Alzheimer’s. SUMMARY: The debate around Biogen’s Alzheimer’s drug continues to rage.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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pharmaphorum

AUGUST 9, 2021

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. Sanofi said it will launch Nexviazyme at the same price as Myozyme/Lumizyme, which remains the only other FDA-approved therapies for Pompe.

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The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

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Scienmag

MARCH 16, 2021

Phase 2 clinical trial could begin immediately for clofazimine, an FDA-approved drug on WHO’s List of Essential Medicines Credit: Sanford Burnham Prebys Medical Discovery Institute LA JOLLA, CALIF.

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pharmaphorum

JANUARY 11, 2023

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

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Pharmaceutical Technology

MARCH 7, 2023

Scientists are now looking at drugs to help address mood changes during perimenopause that fill this gap. Scientists analysing depression during and after perimenopause have found that antidepressants are a potential treatment for moderate to severe symptoms. It remains to be seen if this approach could also work for perimenopause.

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Pharmaceutical Technology

APRIL 28, 2023

The partnership, which started with a handful of scientists in a single laboratory, is now BMS’ largest R&D facility outside the United States, accommodating several hundred scientists working in therapeutic areas including cardiovascular, fibrosis, immunology, and oncology. Profile Syngene International Ltd.

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XTalks

DECEMBER 19, 2022

The success of Iyuzeh can be credited to scientists who were able to solubilize and stabilize latanoprost so that it does not require refrigeration at any point during manufacturing, distribution, or storage, like competing brands and generic latanoprost do. The NDA FDA approval is a milestone for the Thea Group.

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Camargo

OCTOBER 14, 2020

In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device. Regulatory Scientist. Co-Authors: Ken Phelps. President and Founder.

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XTalks

JUNE 1, 2022

BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution. Xtalks learned more about BONESUPPORT and its first FDA-approved drug-device combination product Cerament G through an email interview with BONESUPPORT’s CEO Emil Billbäck.

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pharmaphorum

AUGUST 12, 2022

Barbey is co-author of the paper and a research scientist at Cumulus, which started a pair of clinical trials of the EEG headset combined with cognitive tasks earlier this year to see if it can help chart the course of neurodegenerative diseases, including Alzheimer’s.

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FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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pharmaphorum

FEBRUARY 1, 2022

He has worked on Visensia, the world’s first FDA-approved multivariate patient monitoring system, and the SEND system, which is now used to monitor 20,000 patients each month in the NHS. Since 2008, he has translated his work into the biomedical context for healthcare applications.

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Camargo

OCTOBER 14, 2021

Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food. Senior Scientist, CMC Services. Sponsors may submit proposals for excipients that meet these criteria for preliminary review. Ryan Key, PhD.

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Pharmaceutical Technology

APRIL 5, 2023

It will be six years since the US FDA approval of Kymriah in August this year. Bruce Levine [BL]: We now have six approved CAR-T therapies. BL: [It is] distressing as a scientist to work on something that patients cannot access. This interview has been edited for clarity and length.

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FDA Law Blog

NOVEMBER 5, 2023

This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.” The comprehensive agenda for the symposium can be accessed in its entirety here.

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pharmaphorum

OCTOBER 5, 2021

The UCSF scientists say one reason for the lacklustre effects to date is that implants have been targeted at a single area of the brain, delivering constant electrical stimulation. Chang implanted then implanted NeuroPace’s RNS System neurostimulation device, which is already FDA-approved to treat epilepsy.

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pharmaphorum

JANUARY 28, 2022

That includes Lilly’s Alzheimer’s candidates, currently headed by amyloid-targeting drug donanemab which was filed for FDA approval in the IUS last October.

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XTalks

NOVEMBER 26, 2020

To create a user-friendly app for this model, an FDA approval must be obtained. The study found a 98.5 percent success rate among the people who received a positive COVID-19 test result, which includes 100 percent of those that were asymptomatic and reported they had no symptoms but tested positive.

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Camargo

NOVEMBER 15, 2021

The potential negatives are the costs associated with re-tooling current processes and with obtaining regulatory approval for the retooled process. Camargo’s talented team of technical and CMC scientists can help sponsors navigate new regulatory guidance documents and advise them on whether CM is a good fit for their processes.

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XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. Why is the approval of Lunsumio a significant milestone for Genentech and Roche?

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The Pharma Data

DECEMBER 16, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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XTalks

JULY 28, 2021

In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at the Alzheimer’s Association International Conference (AAIC) 2021 this week.

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The Pharma Data

JANUARY 19, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

NOVEMBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

OCTOBER 27, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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