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

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

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.

Antibody 52

Antibody Medicine Production Trials 52

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 89

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. New treatment options are critically needed for FL.

Drugs 52

Drugs FDA Approval Antibody Medicine 52

XTalks

NOVEMBER 20, 2023

However, despite this, the FDA did not extend approval to non-PI3K/AKT mutated breast cancer, perhaps based on additional data that they reviewed. The FDA has also been placing greater emphasis on overall survival, longer follow-up of studies and life expectancy in their review of oncology drugs. billion to $1.28

HR 98

HR FDA Approval Gene Trials 98

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. with Xolair since its initial approval in 2003. with Xolair since its initial approval in 2003. indications. In the U.S.,

FDA Approval 52

FDA Approval Clinical Development Allergies Development 52

pharmaphorum

DECEMBER 23, 2020

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. The antibodies produced as a result lodge in the kidneys, causing severe complications. months, compared with 6.7 Neurology on the march.

Marketing 96

Marketing Gene Gene Silencing Drugs 96

pharmaphorum

SEPTEMBER 8, 2022

It is a similar approach to that of another form of oncology treatment that is also experiencing a surge of interest, antibody-drug conjugates (ADCs). The company stated that there was “no indication of risk,” but it meant that the rollout and the clinical development of Pluvicto was hampered.

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Manufacturing Development Antibody Drugs 105

XTalks

AUGUST 15, 2023

Approximately 10 to 15 percent of patients with mCRPC have alterations in the BRCA gene — this subset of patients is likely to have aggressive disease, poor outcomes and a shorter survival time, according to information in a press release from Johnson & Johnson announcing Akeega’s FDA approval.

FDA Approval 52

FDA Approval Gene Hormones Drugs 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?

Marketing 94

Marketing Pharma Companies Development Hormones 94

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.

Antibody 40

Antibody Trials Production Clinical Trials 40

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.

Antibody 40

Antibody Production Trials Medicine 40

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

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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Vaccination Vaccine RNA Manufacturing 105

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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Licensing Licensing Drugs Sales 52

XTalks

JUNE 9, 2022

Evkeeza — generically known as evinacumab — is a monoclonal antibody. It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Ongoing and Future Studies.

Trials 52

Trials Antibody Genetics Gene 52

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

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. Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals.

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Insulin Production Development Genetics 130

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.

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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. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical 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.

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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. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

XTalks

JANUARY 5, 2021

In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity. The burden of clinical trials is on all patient groups and patient segments.

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Life Science Clinical Trials Clinical Trials Trials 98

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.

Drugs 40

Drugs FDA Approval Development Antibody 40

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. Additional regulatory filings outside of the US are also planned in 2022. There are approximately 75,000 people in the U.S.

Genetics 52

Genetics Antibody Medicine Trials 52

Delveinsight

AUGUST 17, 2020

million in 2019 and is anticipated to increase at a CAGR for the study period 2017-2030 owing to dynamic pipeline therapies in the mid-/ late-stage clinical development and rising gastroparesis prevalence. However, the drug is not FDA-approved but is available in some European countries.

Marketing 54

Marketing Trials FDA Approval Clinical Development 54

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.

Trials 52

Trials Clinical Trials Clinical Trials Immune Response 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. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. Cohort 3: patients on mechanical ventilation.

Production 52

Production Antibody Manufacturing Trials 52

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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Sales FDA Approval Drugs Clinical Development 40

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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Clinical Development Sales Development Containment 52

The Pharma Data

JUNE 26, 2021

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. The primary efficacy endpoint was confirmed ORR, and a key secondary endpoint was DOR, assessed by independent central review. About Libtayo.

Genetics 52

Genetics Antibody Trials Medicine 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

Delveinsight

NOVEMBER 29, 2020

Brolucizumab is a humanized single-chain antibody fragment (scFv). Single-chain antibody fragments are highly regarded in the drug-development chain owing to their small size, enhanced tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics.

Marketing 52

Marketing Drug Delivery Pharma Companies Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Trials 52

Trials Genetics Antibody HR 52

XTalks

APRIL 12, 2021

The last update on the clinical development of inzomelid came in December when a pharmacokinetic (PK) study initiated by Inflazome in early April was withdrawn by Roche, who attributed it to a “strategic decision by sponsor.”. According to Neuropore’s pipeline page, both UCB0599 and NPT520-34 remain in Phase I clinical development.

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Gene Therapy Gene Trials Development 96