BioTech 365

AUGUST 17, 2021

FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors Second FDA Approval of PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in … Continue reading →

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FDA Approval Clinical Development Antibody Development 40

The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020.

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Development Antibody Clinical Development FDA Approval 52

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. However, despite initial optimism, the development of these inhibitors has faced significant challenges.

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Development Drugs Trials FDA Approval 40

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. Read Dr. Laport’s responses below to learn more!

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FDA Approval Drugs Antibody Medicine 52

XTalks

AUGUST 15, 2023

struck a worldwide collaboration (excluding Japan) and license agreement with niraparib developer Tesaro (acquired by GSK in 2019) for exclusive rights to the drug in prostate cancer. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. A month earlier, Bristol-Myers Squibb paid $200 million upfront for rights to a TIGIT drug developed by Agenus called AGEN1777 in a deal that could be worth up to $1.56

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Drugs Antibody Pharma Companies Development 88

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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Antibody Trials Production Clinical Trials 52

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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Antibody Medicine Production Trials 52

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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Drugs FDA Approval Antibody Development 40

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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Antibody Trials Drugs FDA Approval 98

The Pharma Data

NOVEMBER 18, 2021

With this FDA blessing, pembrolizumab may address a critical unmet treatment need and has the implicit to come a new standard of care in the adjuvant setting for meetly named cases.”. Merck has the assiduity’s largest immuno-oncology clinical exploration program.

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FDA Approval HR Trials Drugs 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Roche’s Chief Medical Officer and Head of Global Product Development. with Xolair since its initial approval in 2003.

FDA Approval 52

FDA Approval Clinical Development Allergies Medicine 52

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. 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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Licensing Licensing Vaccination Vaccine 52

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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Antibody Trials Production Clinical Trials 40

Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . With its recent award of $3.35 Overcoming sector challenges .

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Development In-Vivo Compound Screening Clinical Development 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. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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Antibody Production Trials Medicine 40

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. Breaking news: The FDA has approved Aducanumab, the first FDA-approved drug that delays decline due to Alzheimer’s.

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FDA Approval Drugs Trials Clinical Trials 87

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. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Innovation.

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Insulin Production Development Genetics 130

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. .

Clinical Development 52

Clinical Development FDA Approval Vaccination Vaccine 52

pharmaphorum

SEPTEMBER 8, 2022

Ben Hargreaves examines what advantages radiopharmaceuticals offer in the treatment of cancer and why there has been interest from big pharma in developing these types of therapies. This is why the recent surge in development for radiopharmaceuticals is drawing attention. The drug was added to Novartis’ portfolio through a $2.1

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Manufacturing Development Drugs Antibody 95

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.

Licensing 52

Licensing Licensing Drugs Sales 52

XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. The data showed a 98.9

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FDA Approval Vaccination Vaccine In-Vitro 59

The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Dupixent is currently approved across these indications in the U.S. Additional regulatory filings outside of the US are also planned in 2022.

Genetics 52

Genetics Antibody Medicine Trials 52

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. 4, 2020 08:00 UTC. CHENGDU, China.–(

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Vaccination Vaccine Immune Response Protein 52

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.

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RNA Antibody Life Science Protein 52

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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Drugs Marketing Sales FDA Approval 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Delveinsight

AUGUST 2, 2020

The company has also signed a licensing agreement with Ono Pharmaceutical , a Japanese pharma company, transferring exclusive rights to develop and commercialise anamorelin in Japan, South Korea, and Taiwan. Apart from the products as mentioned earlier, Tetra Bio?Pharma,

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Marketing Pharma Companies Development Hormones 94

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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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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FDA Approval Vaccination Vaccine Clinical Trials 102

Delveinsight

AUGUST 13, 2020

Roche offloads clinical-phase cancer drug to Celleron. Roche has transferred its anti-CSF1R monoclonal antibody emactuzumab to Celleron Therapeutics. Even so, the decision marked the end of the interest of Roche in developing the asset. F2G raises USD 60.8 Million for late-phase antifungal R&D. F2G has raised USD 60.8

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Trials Research Drugs Protein 52

The Pharma Data

JANUARY 31, 2021

Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

DECEMBER 23, 2020

Originally developed to treat late-stage EGFR-mutated disease, the ADAURA study tested Tagrisso as an adjuvant treatment in patients with early disease following surgery. A molecule codenamed DNL151, currently in phase 1 development, has been selected to progress into late-stage clinical studies that are expected to begin in 2021.

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Marketing Gene Silencing Gene Drugs 74

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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Sales Clinical Development Development Containment 52

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. and Roche will develop, manufacture and distribute it outside the U.S. TARRYTOWN, N.Y. ,

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Production Antibody Manufacturing Trials 52

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 feature of the hAd5 vaccine distinguishes it from other vaccines.

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Vaccination Vaccine Immune Response Protein 52

The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History. AstraZeneca.

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Trials Clinical Trials Clinical Trials Immune Response 52