Roots Analysis

DECEMBER 18, 2023

This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker.

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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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XTalks

JUNE 20, 2023

Columvi is a bispecific antibody designed to bind to CD3 on the surface of T cells and CD20 on the surface of B cells in a novel 1:2 structural format where one region of the antibody binds to CD3 and two to CD20. As part of the accelerated approval, Roche will have to conduct confirmatory trials for Columvi.

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pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

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pharmaphorum

JANUARY 30, 2022

The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug Eylea. Analysts at GlobalData think that faricimab and another Roche-developed product will be the main derivers of the market in the coming years.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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Delveinsight

AUGUST 2, 2020

The dynamics of the cancer cachexia market is expected to gain momentum as several companies are testing the waters, advancing cancer cachexia pipeline. Earlier clinical evidence showcased administration of the therapy resulted in a statistically significant and dose-proportional increase in body weight.

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Marketing Pharma Companies Development Hormones 94

pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The approval of aducanumab, now given the name Aduhelm, comes after a three-month extension to the FDA’s review period.

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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. Senior Vice President and Head of Global Clinical Development at 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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pharmaphorum

DECEMBER 23, 2020

2020 also saw some of the first “tumour agnostic” cancer drugs get to market, with Bayer’s Vitravki (larotrectinib) getting funding in the UK for tumours with confirmed neurotrophic tyrosine receptor kinase (NTRK) gene fusions.”.

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Drug Discovery World

OCTOBER 4, 2022

Oligomerix’s portfolio of compounds is expected to provide a potentially lower-cost treatment alternative and/or complement to the newly emerging high-cost therapeutic options such as the monoclonal antibody products. Erhardt adds that despite the ever-increasing number of people with AD, there has been an erosion of market value (from $4.2

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The Pharma Data

DECEMBER 9, 2020

The Swiss company’s antibody-drug conjugates are highly potent to deliver the payload only once bound to the tumor cells, giving them a leg up on traditional cancer therapies that can’t distinguish between tumor cells and healthy cells. It has shown remarkably high safety and tolerability measure during non-clinical development. .

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Roots Analysis

NOVEMBER 3, 2023

There are several types of NAMPT inhibitors, including small molecules, peptides, and antibodies. Despite their potential therapeutic benefits, NAMPT inhibitors have faced several challenges in clinical development. Financial Constraints: Financial constraints have also played a role in the failure of NAMPT inhibitors.

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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. Financing recognises companies and institutions that have raised significant capital during the research period whether it be through corporate finance, the capital markets or fund raising.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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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. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Nuance Pharma .

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pharmaphorum

AUGUST 23, 2021

The drug’s US patent protection expires last year, but Samsung Bioepis and Biogen are still waiting for FDA approval, with a decision due in November. Lucentis was first approved in Europe in 2007 for wet AMD and grew quickly thereafter thanks to a string of additional indications.

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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 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

DECEMBER 10, 2020

The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. ImmunityBio’s hAd5 vaccine generated robust neutralizing antibody activity that was present 14 days post-final vaccination. This press release features multimedia. Graphic: Business Wire).

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XTalks

MAY 31, 2023

Between 2021 and 2022, the biotech IPO market experienced a notable decline as investors grew increasingly cautious due to the uncertainties surrounding the pandemic and economic downturn. Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery.

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Drug Discovery World

DECEMBER 13, 2023

In the ever-evolving landscape of therapeutic development, the role of antibodies has become increasingly apparent. Antibodies are used as therapeutics, components of therapeutics such as antibody-drug conjugates (ADC) and CAR-T cells, and as companion diagnostic tools.

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Life Science Antibody Manufacturing In-Vivo 59

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Updates from the clinical pipeline include: Dupixent ® (dupilumab). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus.

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Sales Production Manufacturing Antibody 52

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

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Delveinsight

NOVEMBER 29, 2020

Recent years started witnessing the emergence of novel treatment approaches that have been keeping the Retinal vein occlusion market in a hyped-up state. Looking at the potential of the pipeline therapies they hold once approved, pharmaceutical companies are charting out a seemingly exciting course in the market.

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Marketing Pharma Companies Drug Delivery Clinical Trials 52

The Pharma Data

SEPTEMBER 1, 2020

Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

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Trials Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

DECEMBER 10, 2020

BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Bahrain, and Canada. Posted: December 2020.

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The Pharma Data

NOVEMBER 20, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Source: Pfizer Inc. . Posted: November 2020. Source link.

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The Pharma Data

DECEMBER 11, 2020

To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the vaccine, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time with dry ice. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally.

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The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell. Forward-Looking Statements.

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The Pharma Data

NOVEMBER 9, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Source: Pfizer, inc. Posted: November 2020. Source link.

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XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

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Pfizer

JULY 26, 2022

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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Pfizer

JULY 8, 2022

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. INTERCHANGEABILITY.

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Pfizer

JULY 19, 2022

Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. INTERCHANGEABILITY.

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XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

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