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). log 10 copies/mL for combined doses).

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Antibody Trials Production Clinical Trials 52

World of DTC Marketing

APRIL 11, 2021

Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus.

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Vaccination Vaccine Clinical Trials Clinical Trials 303

pharmaphorum

DECEMBER 2, 2021

The drug – called UCB0599 – targets a protein called alpha synuclein that tends to get misfolded and accumulates into clumps in the brains of Parkinson’s patients, and is thought to damage neurons – somewhat analogous to amyloid and tau proteins in Alzheimer’s disease.

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The Pharma Data

MARCH 31, 2023

i for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive Notes CMG901 CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, a promising therapeutic target in gastric cancers.

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Licensing Licensing Antibody Drugs 40

pharmaphorum

NOVEMBER 5, 2021

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. billion in peak annual sales if it gets approved for all its target indications.

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Pharmaceutical Technology

FEBRUARY 22, 2023

The patent battle between Amgen and Sanofi over their cholesterol-lowering antibodies has divided big pharma in the past months. Both drugs are monoclonal antibodies that inhibit the protein PCSK9. Since April 2020, Sanofi is responsible for Praluent outside of the US, while Regeneron handles its sale in the US.

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Antibody Drugs Sales Protein 262

The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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Antibody Development Engineer Licensing 40

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8 mg/kg dose with an ORR of 73.6

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FDA Approval Antibody Immune Response Drugs 97

pharmaphorum

OCTOBER 21, 2022

The acquisition of DJS Antibodies, a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins – such as G protein-coupled receptors (GPCRs) – will extend AbbVie’s present discovery research capabilities, through DJS’ proprietary HEPTAD platform.

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Antibody Protein Research Medicine 59

Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

pharmaphorum

OCTOBER 27, 2021

Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen and Eisai with a head-to-head trial against their recently-approved Aduhelm drug. Cortexyme trial disappoints. gingivalis detectable in their saliva at the start of the trial.

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Trials Drugs Sales Bacteria 52

pharmaphorum

JULY 13, 2021

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. According to analysts at GlobalData – sales are set to rocket to $3.5 billion by 2025.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S.

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Antibody Clinical Trials Clinical Trials Manufacturing 52

Drug Discovery World

APRIL 8, 2024

Following this, Benjamin Cravatt, Professor and the Norton Gilula Chair in Biology and Chemistry at The Scripps Research Institute, discussed activity-based protein profiling (ABPP) and its use in discovering drug candidates for cancer-relevant proteins.

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In-Vivo In-Vitro Antibody Protein 52

pharmaphorum

AUGUST 31, 2022

BIVV001 is a Factor VIII replacement therapy that is being developed as a successor to Eloctate (efmoroctocog alfa), Sanofi and Sobi’s current Factor VIII drug that is dosed every four days and has seen its sales decline in an increasingly competitive market. The drug was one of the primary drivers for Sanofi’s $11.6

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Drugs Marketing Sales Protein 52

pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. ” The post CureVac and GSK try again with COVID-19 vaccine appeared first on. .

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Vaccination Vaccine Protein Antibody 64

pharmaphorum

JUNE 4, 2021

Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline. . The technology behind the drug was licensed from Weill Cornell Medicine and Johns Hopkins University in the US.

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Antibody Licensing Licensing Sales 57

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

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. The half life of the new drug – one of the main draws for Sanofi’s $11.6

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Sales Protein Gene Therapy Regulation 92

The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. BARCELONA, Spain , Jan.

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Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

APRIL 20, 2021

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings. . Approval would push Padcev earlier on in the course of treatment for some patients.

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Antibody Sales Drugs Trials 52

The Pharma Data

AUGUST 10, 2020

All revenue from sales of the vaccine in the regions covered by the deal will be split between Novavax and SIIPL, after agreed deductions. The candidate is built upon a stable, prefusion protein and includes Novavax’s Matrix?M M adjuvant. Matt Fellows. Source link.

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Vaccination Vaccine Licensing Licensing 52

XTalks

JUNE 30, 2023

Hemophilia A is a rare genetic bleeding disorder that is caused by a mutation in the gene that encodes the key blood clotting protein factor VIII (FVIII). Severe hemophilia A is usually treated with FVIII replacement therapy or an antibody-based drug to improve the ability of blood to clot and reduce the likelihood of bleeding.

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

MAY 2, 2024

The firm predicts sales of KarXT could reach $2.8 Current drugs on the market for schizophrenia include Lundbeck and Otsuka’s Rexulti (brexpiprazole) and Eli Lilly’s Prozac (fluoxetine), but these drugs derive the majority of their sales from other conditions, including severe forms of depression or Alzheimer’s agitation.

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Drugs FDA Approval Sales Vaccination 52

XTalks

MAY 1, 2023

XTALKS WEBINAR: Patient-Centricity in Clinical Trials Sites — The Trinity of Patient, Sites and Sponsors Live and On-Demand: Monday, June 12, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how the Patient Concierge program increases study participants’ engagement and decreases dropout. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. 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.

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XTalks

APRIL 11, 2024

On the other hand, Abecma is now approved as a third-line treatment for patients with triple-class-exposed disease, which means previous treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. Plasma cells help fight infections by producing antibodies.

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FDA Approval Manufacturing Trials Clinical Trials 52

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Soliris is in clinical trials to prove its efficacy in the treatment of pediatric refractory gMG.

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Marketing Antibody Drugs Sales 85

pharmaphorum

JULY 8, 2022

The deal expands Sobi’s position in orphan diseases within haematology, one of its core focus areas, and also includes a $50 million payment Zynlonta (loncastuximab tesirine) is approved in the EU and another $330 million in milestone payments tied to other regulatory and sales objectives.

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Licensing Licensing Sales Marketing 52

pharmaphorum

DECEMBER 18, 2020

Originally approved in 2011 as an IV therapy for adults with SLE, a debilitating autoimmune disease, GSK got a green light for the subcutaneous formulation in 2017 and last year extended the label of the antibody to include paediatric patients aged over five.

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FDA Approval Contract Manufacturing Sales Trials 74

pharmaphorum

FEBRUARY 9, 2022

Closely related to this is the fact that global spending on oncology drugs reached $164 billion in 2020, with drug sales growing at a compound annual growth rate of 14.3% While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response.

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Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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Vaccination Vaccine Gene Therapy RNA 98

pharmaphorum

SEPTEMBER 21, 2021

Antibody-drug conjugate (ADC) specialist Seagen has claimed its fourth product approval in the US, getting the nod from the FDA for Tivdak as a second-line monotherapy for recurrent or metastatic cervical cancer. Seagen and Genmab are hosting a conference call later today to discuss further details of the new product.

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pharmaphorum

APRIL 28, 2021

The RNA interference (RNAi) drug is designed to treat haemophilia A and B patients by suppressing antithrombin (AT), a protein that inhibits blood clotting. Sanofi has since revised the dosing protocol for the fitusiran trials to a 50 mg dose administered every other month, which it thinks should keep most patients in the 15% to 35% AT range.

Drugs 52

Drugs Sales Allergies RNA 52

pharmaphorum

MARCH 31, 2021

The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is found much more abundantly in solid tumours. billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial.

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Licensing Licensing Sales Gene Therapy 98