ASPET

JULY 20, 2023

Nitrogen mustard (NM), a bifunctional alkylating agent and potent analog of SM, is used in laboratories to study mustard vesicant-induced ocular toxicity. Previously, we showed that SM-/NM-induced injuries ( in vivo and ex vivo rabbit corneas) are reversed upon dexamethasone (DEX) treatment, an FDA approved, steroidal anti-inflammatory drug.

FDA Approval 100

FDA Approval Laboratories Treatment FDA 100

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.

FDA Approval 52

FDA Approval Therapies Trials FDA 52

Broad Institute

JULY 17, 2024

Predictive models don’t eliminate laboratory experiments, but they can help researchers narrow the selection pool of potential drugs, allocating more time and resources to experiment on the more promising candidates. A fourth is in the works.

Pharmacokinetics 124

Pharmacokinetics Molecular Biology Drugs FDA 124

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

FDA Approval 40

FDA Approval FDA Disease Research Laboratories 40

Advarra

JULY 5, 2022

The results of glucose monitoring with a continuous glucose monitor (GCM) already approved by the Food and Drug Administration (FDA) is an example of a validated result. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

Research 97

Research FDA Approval FDA Packaging 97

The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. Thermo Fisher Scientific is at the forefront for enabling centralized data management for laboratories.

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

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.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

The Pharma Data

JANUARY 27, 2021

It is also one of the foremost suppliers of mass spectrometers with a significant installed based in clinical microbiology laboratories in hospitals world-wide. I look forward to updating the market when we have definitive clinical performance data.”.

Laboratories 52

Laboratories FDA Approval Hospitals Regulations 52

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.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

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.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

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.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

The Pharma Data

MARCH 30, 2021

“KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA. .

FDA 52

FDA FDA Approval Laboratories Doctors 52

The Pharma Data

SEPTEMBER 7, 2021

Because of its selectivity for oxycodone, the vaccine will not interfere with FDA-approved medications, including methadone, buprenorphine, naltrexone and naloxone, potentially offering a long-lasting, safe and cost-effective alternative that is complementary to standard medical intervention for opioid use disorders.

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

The Premier Consulting Blog

APRIL 15, 2024

We will use the term, nonclinical, to refer to any in vitro, ex vivo, or animal study conducted to support any stage of research and development of a new drug, such as proof-of-concept pharmacology studies through Good Laboratory Practice (GLP) toxicology studies. neurotoxicity) that require special assessments.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S. Set up your respiratory studies for success.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

sptlabtech

JUNE 27, 2022

Farruk Kabir | NGS Lab Manager | Aperture NextGen Laboratories Aperture NextGen Laboratories is an FDA approved CLIA lab for interdisciplinary clinical testing and research. "For the last couple of years, we've been Covid testing and have been very successful with the SPT Labtech liquid handlers."

Laboratories 52

Laboratories FDA Approval RNA FDA 52

The Pharma Data

NOVEMBER 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.

FDA Approval 52

FDA Approval Science Disease Laboratories 52

Drug Target Review

SEPTEMBER 19, 2023

Some of the complex 3D models such as organoids and organ-on-chips have brought in realistic make-over to the drug screening and paved way into implementing high content screening, laboratory automation and miniaturisation in primary drug screening process.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 The most common Grade 3 or 4 laboratory abnormalities (?2%)

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

Therapies 52

Therapies Virus DNA Compliance 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

Advarra

AUGUST 8, 2023

As of June 2023, 416 Phase III studies are listed, representing a growing pipeline of gene therapy products preparing to undergo consideration for FDA approval. Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review.

Therapies 52

Therapies Research Engineering Clinical Research 52

The Pharma Data

MARCH 4, 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 nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

FDA 52

FDA Disease Treatment Trials 52

The Pharma Data

DECEMBER 28, 2020

Forward-looking statements in this press release include, without limitation, the ability of Moleculin to receive the benefits of the Orphan Drug designation, some of which require FDA approval of Annamycin for the Orphan Drug indication, and the ability of Annamycin to demonstrate safety and efficacy in patients.

FDA 52

FDA Clinical Trials Drugs Pharmaceutical Companies 52

The Pharma Data

OCTOBER 29, 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.

Science 40

Science FDA Approval Pharmaceuticals Disease 40

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2.

FDA 52

FDA FDA Approval Licensing Licensing 52

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA 52

FDA Clinical Trials FDA Approval Treatment 52

The Pharma Data

MAY 2, 2022

AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

The Pharma Data

FEBRUARY 23, 2022

For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory. against any symptomatic COVID-19 disease in the seronegative population.

Vaccine 52

Vaccine Virus Trials Immune Response 52

The Pharma Data

JULY 12, 2021

online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval. “Academic labs and pharmaceutical and?

Clinical Trials 52

Clinical Trials Drugs Disease Trials 52

The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

JUNE 26, 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 nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Trials 52

Trials Treatment Therapies Disease 52

The Pharma Data

DECEMBER 1, 2020

“In our diligence process, we were impressed not only by the rigor of their platform and the extensive AI and drug development accomplishments of their team, but also by the nascent yet powerful applications of their platform to laboratory experiments for their drug discovery pipeline.

Engineering 40

Engineering FDA Approval Drugs Pharmaceuticals 40

The Pharma Data

JANUARY 6, 2021

Cyto-111 was conceived, expressed and purified in the laboratory of Konstantin Ichtchenko, Ph.D., Standard antibodies cannot access toxin already inside neurons, and thus BAT® (Botulism AntiToxin, a product of Emergent BioSolutions), the only FDA-approved antitoxin, is only effective while the toxin remains in the circulation.

Science 52

Science Molecular Biology Treatment Production 52