The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

NOVEMBER 29, 2021

The FDA previously granted Cytalux orphan-drug , priority and fast track designations. The FDA granted the approval to On Target Laboratories, LLC. National Cancer Institute: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer FDA Approved Drugs: Questions and Answers. ###. Related Information.

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The Pharma Data

OCTOBER 29, 2021

Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. Scemblix is the first FDA-approved CML treatment that binds to the ABL myristoyl pocket1. Bosulif ® (bosutinib) * at 24 weeks (25vs.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

JULY 8, 2021

KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. 1) as determined by an FDA-approved test.

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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]

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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S.,

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. LABORATORY ABNORMALITIES. Some patients treated with ZOKINVY developed laboratory abnormalities. Related Articles: Zokinvy (lonafarnib) FDA Approval History. PALO ALTO, Calif.,

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Drug Discovery World

DECEMBER 13, 2023

Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2. Our brands: Bethyl Laboratories and Abcore ® Two companies under the Fortis Life Sciences umbrella —Bethyl Laboratories and Abcore— support custom antibody discovery and manufacturing.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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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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Drug Discovery World

JULY 2, 2024

Superlab Suisse, a provider of laboratory and research spaces, is a great example of this mix of regionality and reproducibility. This also means there is no shortage of skilled workers thanks to the universities and the well-established apprenticeship system, for example, in the field of biology laboratory technicians.

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Drug Discovery World

MAY 9, 2024

RA: Why are there currently no effective pharmacological FDA-approved treatments for concussion? MW: Historically, efforts to develop therapeutics for brain injury have focused on moderate and severe TBI (traumatic brain injury). Rest in a darkened room was thought to be sufficient to treat the mild form of TBI known as concussion.

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Drug Discovery World

MARCH 16, 2023

With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. The cell and gene therapy (CGT) market is rapidly expanding, and projections suggest it will reach over $90B by 2023.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Most common laboratory abnormalities (?

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Drug Discovery World

APRIL 23, 2024

Although not a test to diagnose concussion, a biomarker test developed by Abbott Laboratories helps to determine whether a patient should receive a CT scan to rule out haemorrhage. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI.

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ASPET

JANUARY 31, 2024

Unfortunately, GBM has a ~100% recurrence rate, but after recurrence there are no FDA-approved therapies to limit tumor growth and enhance patient survival, as these tumors are resistant to TMZ.

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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.

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Agency IQ

MAY 3, 2024

With the new LDT final rule, FDA works to clarify what emergency response will look like going forward The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations. In the U.S. IVDs are defined at 21 CFR 809.3(a), The rule amends 21 CFR 809.3(a)

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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.

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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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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.”.

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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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Codon

JUNE 18, 2024

These algae are “one of the most interesting, at least one of the most striking, of the plankton,” wrote Klebahn, who transported the cells back to his laboratory in Hamburg, one hundred kilometers to the south. Fished from Nature At least a dozen laboratories are currently using gas vesicles to study living organisms.

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The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] 1) as determined by an FDA-approved test. 1)] as determined by a U.S.

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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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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.

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The Pharma Data

FEBRUARY 23, 2022

For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV). Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S.

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The Pharma Data

JANUARY 21, 2021

Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated. Hepatotoxicity: Hepatic adverse events were reported.

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. Grade 3 or 4 laboratory abnormalities (?2%) The most common Grade 3 or 4 laboratory abnormalities (?2%)

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The Pharma Data

NOVEMBER 20, 2020

The EUA for the combination treatment applies to hospitalized patients ages 2 years and older with suspected or laboratory-confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

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Drug Discovery World

FEBRUARY 22, 2024

She adds: “The research from Dr Coulombe’s laboratory is generating a lot of interest and hope in the community.” Her husband and Foundation co-founder, Éric Tailleur, agrees: “It clearly suggests that Riluzole could be used as a drug to treat this disease.”

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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.

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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.

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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. .

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