pharmaphorum

AUGUST 19, 2022

” HAE is a rare genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide that can result in unpredictable and potentially life-threatening recurring attacks of debilitating and painful swelling in various parts of the body, which can last for several days. It is administered as an intravenous injection.

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The Pharma Data

DECEMBER 16, 2020

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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Genetics FDA Approval Antibody Medicine 52

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. New treatment options are critically needed for FL.

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FDA Approval Drugs Antibody Medicine 52

The Pharma Data

JANUARY 19, 2021

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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Genetics FDA Approval Antibody Medicine 52

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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Vaccination Vaccine Protein Antibody 52

The Pharma Data

NOVEMBER 30, 2020

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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Genetics FDA Approval Antibody Medicine 52

The Pharma Data

OCTOBER 27, 2020

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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Genetics FDA Approval Antibody Medicine 52

Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study. In trying to fix the problem, the immune system causes even more damage,” said Evseenko.

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Clinical Trials Clinical Trials Trials Drugs 52

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. 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.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. 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. futility analysis).

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Antibody Trials Production Clinical Trials 52

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. The currently approved CD-19 CAR products are autologous, ex vivo cellular therapies.

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In-Vivo Clinical Trials Clinical Trials FDA Approval 52

XTalks

AUGUST 15, 2023

Approximately 10 to 15 percent of patients with mCRPC have alterations in the BRCA gene — this subset of patients is likely to have aggressive disease, poor outcomes and a shorter survival time, according to information in a press release from Johnson & Johnson announcing Akeega’s FDA approval.

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XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Clinical Trial Behind Spevigo.

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FDA Approval Clinical Trials Clinical Trials Dermatology 52

The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator.

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XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

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Development Drugs Clinical Trials Clinical Trials 52

The Pharma Data

MAY 31, 2022

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., There are approximately 75,000 people in the U.S.

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Genetics Antibody Medicine Trials 52

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. Blueprint Medicines wins the Financing award this year after securing significant financing partnerships worth up to $1.25bn. Innovation.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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XTalks

MARCH 28, 2024

For CRC, treatment options that are targeting genetic mutations such as BRAF , KRAS and HER2 have been developed. Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Yang Liu and CFO Abid Ansari – Xtalks Life Science Podcast Ep.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

The Pharma Data

MARCH 4, 2021

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupixent is approved in the U.S. Detailed results from this Phase 3 trial will be published later this year. Source link:[link].

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Genetics Medicine Antibody Trials 52

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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The Pharma Data

FEBRUARY 13, 2022

FDA a ccepts Dupixent ® (dupilumab) for Priority Review in c hildren a ged 6 m onths to 5 y ears with m oderate-to-severe a topic d ermatitis. If approved, Dupixent will be the first biologic medicine available in the U.S. The target action date for the FDA decision on this investigational use is June 9, 2022. In the U.S.,

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Medicine Genetics Antibody Allergies 40

The Pharma Data

FEBRUARY 19, 2022

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. About Dupixent.

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Genetics Antibody Trials Medicine 40

The Pharma Data

NOVEMBER 29, 2020

Naxitamab is a monoclonal antibody that targets GD2, which is found on neuroblastoma and other related tumors. The antibody is designed to destroy GD2-expressing cancer cells by antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC). The FDA approved the drug on November 24.

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Genetic Disease Antibody Licensing Licensing 52

The Pharma Data

JUNE 7, 2022

“We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” Lilly unites caring with discovery to create medicines that make life better for people around the world.

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Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

OCTOBER 30, 2020

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. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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Production Antibody Manufacturing Trials 52

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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FDA Approval Drugs Sales Development 52

The Pharma Data

MARCH 23, 2023

The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33). Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.

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Trials Antibody Genetics Development 40

pharmaphorum

DECEMBER 23, 2020

But there was some considerable progress in other fields of medicine even though research efforts were diverted away, reports Richard Staines. There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Reduce cost.

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RNA Antibody Life Science Protein 52

Drug Discovery World

MAY 29, 2024

He says: “If you compare that with what’s happening within the monoclonal antibody space, for instance, everybody’s got standardised processes with standardised equipment. That takes a lot of effort, and some very clever people to get that amount of genetic information into a single plasmid DNA.

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Gene Therapy Gene Genetics DNA 109

The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 versus 38.9%). .” Source link: [link].

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FDA Approval Gene Trials Development 52

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

JUNE 5, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior VP and chief scientific officer, Vaccine Research and Development at Pfizer, in the company’s news release.

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Vaccination Vaccine FDA Approval Protein 98

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

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Worldwide Clinical Trials

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. Edaravone (Radicava ORS) (Oral) The oral suspension uses the same active ingredient as the approved IV infusion for edaravone and may be taken orally or via a feeding tube.

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