XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). TROP2 is a protein that is widely present in most tumors associated with NSCLC. This antibody guides the therapy to the cancer.

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

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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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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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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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Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez. Haemophilia A is caused by insufficient levels of the clotting protein factor VIII, while patients with haemophilia B lack adequate factor IX levels.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Delveinsight

AUGUST 4, 2020

MorphoSys, Incyte gets an early FDA nod for Monjuvi, an alternative to CAR-T for B-cell malignancies. Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly.

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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. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

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Delveinsight

AUGUST 13, 2020

Roche has transferred its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics. The licensing agreement comes almost two years after Roche dropped the tumor microenvironment modulator after putting it through a clutch of early-phase studies in solid tumor patients. Roche offloads clinical-phase cancer drug to Celleron.

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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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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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Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Currently, the only other viable malaria vaccine, known as RTS,S/AS01 (Mosquirix), has a demonstrated efficacy of 55.8

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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.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

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The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?1%,

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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. Cohort 3: patients on mechanical ventilation.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. A second liver biopsy will be performed after 18 months.

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The Pharma Data

DECEMBER 8, 2020

Recently released interim Phase 1 further indicates that 90 days following the second vaccination, trial participants retained high levels of neutralizing antibodies, suggesting that mRNA-1273 can generate durable neutralizing antibodies across all age groups including in older and elderly adults. About Moderna. Posted: December 2020.

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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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XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. What Is a Surrogate Endpoint?

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pharmaphorum

DECEMBER 8, 2020

AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. Bamlanivimab is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

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XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Important Information about bamlanivimab Bamlanivimab has not been approved by the FDA for any use. .

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The Pharma Data

AUGUST 3, 2021

For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. Cost of Sales margin increased 1.6 Tax Rate increased 5.6 In May, the U.S.

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also 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. government allocation program. Regeneron Pharmaceuticals, Inc.

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XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

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Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

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Delveinsight

AUGUST 10, 2021

FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC. This approval was based on Phase III KEYNOTE-522 trial (NCT03036488) and became the first immunotherapy regimen to be approved in high-risk early-stage TNBC , marking a milestone for breast cancer patients.

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The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. Monoclonal Antibodies.

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The Pharma Data

JANUARY 6, 2021

as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

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The Pharma Data

JANUARY 12, 2021

as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Authorized Use. Source: Moderna, Inc. .

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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