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. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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XTalks

OCTOBER 26, 2020

Provention is developing an investigational anti-CD3 monoclonal antibody called PRV-031 (teplizumab), which is designed to delay onset, or prevent T1D in at-risk individuals. The company began rolling submission of a biologic license application (BLA) to the FDA for teplizumab back in April.

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FDA Law Blog

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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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. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.

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The Pharma Data

NOVEMBER 18, 2021

Domvanalimab is an Fc-silentanti-TIGIT antibody in Phase 2 and Phase 3 studies innon-small cell lung cancer (NSCLC) and AB308 is an Fc- enabledanti-TIGIT antibody under Phase 1 evaluation. The parties anticipate the sale to close by time- end. Terms of the Exercised Options and Amendment to the Agreement.

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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

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. million in the second quarter of 2021 for its COVID-19 antibodies. million of revenue in the second quarter of 2021 from COVID-19 antibodies, $170.0 Excluding $148.9

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XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. 2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. billion in 2022, a 32.44

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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. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. The single seasonal dosing of the drug is a large advance, he noted.

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Pharmaceutical Technology

FEBRUARY 3, 2023

This is really what has been very challenging for upscaling viral vector production and what leads some companies that have in-licensed projects with a huge amount of viral vector to slightly panic about future production,” she says. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. 1] BioNews. Hemophilia News Today.

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The Pharma Data

APRIL 27, 2021

For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions.

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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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The Pharma Data

NOVEMBER 5, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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pharmaphorum

JULY 18, 2022

You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. CD4s are present to stimulate B cells, so they keep producing antibodies, whereas CD8 or inner cells go after infected cells, killing them before the virus spreads.

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The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.

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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 Bemarituzumab.

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Pfizer

DECEMBER 13, 2021

The teams started changing existing filling lines, building formulations booths and new filling lines, constructing packaging lines and a “freezer farm,” while recruiting and training new colleagues. All those were investments at risk, that’s the bet we took,” says Van Steenwinkel. Understanding mRNA COVID-19 Vaccines.

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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pharmaphorum

DECEMBER 13, 2021

It, too, announced plans to invest $500 million in a new facility in Africa for the production, fill/finish and packaging of mRNA vaccines. Known as Endless RNA – a circular form of RNA – this type of drug would continuously express therapeutic proteins inside the body and is designed to replace antibodies.

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., Ilya Trakht, Ph.D., 2018) PLoS One.

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The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. In June, the company and Acceleron Pharma Inc. Regulatory.

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The Pharma Data

OCTOBER 14, 2020

The treatment consists of three monoclonal antibodies of similar structure, atoltivimab, maftivimab and odesivimab, that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. Inmazeb, previously called REGN-EB3, was created using Regeneron’s VelocImmune® platform and associated VelociSuite® technologies.

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