Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Yet the history of mAb therapies goes back over 30 years.

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The Pharma Data

DECEMBER 20, 2020

PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. Alloy’s first platform, the ATX-Gx(TM) mouse platform, is a suite of transgenic mice designed for best-in-class in vivo discovery of fully human monoclonal antibodies.

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XTalks

JANUARY 31, 2022

The third group will contain unimmunized individuals who will get three doses of the omicron shot. Neutralizing Antibody Data for Omicron Targeting. The study showed that antibody neutralization against omicron decreased by 6.3-fold Moderna will be evaluating its omicron targeting booster through extension of an earlier study.

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. Background In January 2022, JAMP Pharma Corporation ( JAMP ) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab).

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pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).

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pharmaphorum

OCTOBER 2, 2020

The rolling review, which is designed to speed up the assessment of a promising vaccine or drug by the EMA’s CHMP scientific committee, will continue until there is enough evidence available to support a marketing authorisation. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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pharmaphorum

NOVEMBER 28, 2021

The drug is – an oral spray containing cannabinoids THC and CBD which is already licensed and sold by other companies in some markets for neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis. Jazz acquired rights to Sativex when it completed its $7.2

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XTalks

JULY 14, 2021

In this episode, Ayesha talks about Nestlé’s marketing of Seres Therapeutics’ oral microbiome drug for recurrent C. Seres’ microbiome drug SER-109 aims to restore the healthy bacteria via an oral capsule that contains a protective species of gut bacteria. Nestlé to Market Seres’ Oral Microbiome Drug for C.

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Pharmaceutical Technology

APRIL 16, 2023

But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible. mL or less and use a prefilled syringe (PFS) with a staked needle as the drug’s primary container.

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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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pharmaphorum

AUGUST 6, 2020

This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term. However Blenrep is a very different drug, which works by latching on to the B-cells and delivering a lethal payload, while leaving most healthy tissues untouched.

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Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Their work formed the basis of what is now a promising cancer treatment that doesn’t require surgery or radiation. CAGR between 2020 and 2028.

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pharmaphorum

AUGUST 16, 2020

The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.

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XTalks

JANUARY 9, 2024

Novartis’ BRAF inhibitor Tafinlar (dabrafenib) along with MEK inhibitor Mekinist (tramelitinib) is currently used to treat anaplastic thyroid cancer, and the duo is being evaluated with Regeneron’s IgG4 monoclonal antibody targeting PD-1 Libtayo (cemiplimab) for BRAF -mutated anaplastic thyroid cancer. percent from 2023 to 2030.

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Roots Analysis

FEBRUARY 15, 2022

ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Given the growing clinical pipeline of ADCs, coupled to the various technological advancements, the market for ADC payloads and warheads is anticipated to witness substantial growth in the coming years.

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pharmaphorum

NOVEMBER 16, 2020

Called Phesgo , the new product contains the active substances in Herceptin (trastuzumab) – already facing lower-cost competition in the US and Europe – and Perjeta (pertuzumab), which are both used to treat HER2-positive breast cancers. billion in the same period as biosimilars ate into its market share. billion ($3.2

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The Pharma Data

DECEMBER 1, 2020

All financial reports are released before market open CET. is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. . .

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Pharmaceutical Technology

MARCH 22, 2023

Monoclonal antibodies (mAbs) are one crucial area where therapeutics are providing hope for people living with severe medical conditions that currently have limited treatment options. It contains anion exchange (AEX) fibrous chromatography media for the chromatographic capture of cells, debris, and soluble impurities.

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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 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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The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). About Lecanemab (BAN2401) Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. BioArctic has no development costs for lecanemab in AD.

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., In July 2020, the U.S.

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The Pharma Data

JULY 27, 2021

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

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The Pharma Data

JANUARY 27, 2021

RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). (Nasdaq: CASI), a U.S. Wei-Wu He , Ph.D., About BioInvent. The Company’s validated, proprietary F.I.R.S.T

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pharmaphorum

JANUARY 29, 2023

Abecma meanwhile, which came to market around a year before Carvykti, saw sales top the $100 million level in the third quarter of 2022, taking its nine-month tally to $263 million. Legend said last week that Carvykti made $55 million in the fourth quarter. BMS is due to report fourth quarter results on 2 February.

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The Pharma Data

JANUARY 12, 2021

where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. Dr. Graham stated: “I am excited to join Tiziana to help develop its unique monoclonal antibody platform for autoimmune diseases.

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Pfizer

SEPTEMBER 28, 2022

This application for a variation of the marketing authorization (MA) to include the Omicron BA.4/BA.5-adapted Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . The information contained in this release is as of September 28, 2022.

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The Pharma Data

DECEMBER 2, 2020

c/o Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com. This press release contains forward-looking statements. Legal Notice Regarding Forward-Looking Statements.

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The Pharma Data

DECEMBER 23, 2020

This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic.” Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. The Company is marketing these products globally, in over 150 countries.

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FDA Law Blog

DECEMBER 13, 2022

However, not all LDTs currently on the market would qualify for grandfathering. Of relevance here, the grandfathering provision applies to an LDT only if: The test is not for use with home specimen collection, unless the specimen is collected with a collection container, receptacle, or kit that—.

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pharmaphorum

NOVEMBER 29, 2022

Tecentriq is a monoclonal antibody designed to bind with PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blockings its interactions with both PD-1 and B7.1 IMvigor130 was the designated post-marketing requirement (PMR) to convert the accelerated approval to regular approval.

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Pfizer

JULY 8, 2022

A two-dose primary series of the vaccine (30-µg dose) elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021. The information contained in this release is as of July 8, 2022.

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The Pharma Data

DECEMBER 23, 2020

COVAXX is committed to providing an equitable distribution of UB-612 vaccine by prioritizing markets where the unmet need is greatest,” said Mei Mei Hu, co-founder and CEO of COVAXX. Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612.

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The Pharma Data

OCTOBER 15, 2020

Y-mAbs is a development-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics Inc. About Y-mAbs.

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Pfizer

JULY 26, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. The information contained in this release is as of July 27, 2022.

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The Pharma Data

JANUARY 4, 2021

IPH6101/SAR443579 is an NKp46-based NK cell engager (NKCE) that uses Innate’s proprietary multispecific antibody format. IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. MARSEILLE, France, Jan. MARSEILLE, France, Jan. Cell 2019 ).

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