Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. A fully human anti-IL-7R?

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Development Clinical Trials Clinical Trials FDA Approval 130

Pharmaceutical Technology

JANUARY 18, 2023

Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezumab after receiving approval in Mainland China. The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP).

FDA Approval 130

FDA Approval Antibody Production Regulation 130

XTalks

OCTOBER 6, 2020

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial.

FDA Approval 71

FDA Approval Clinical Trials Clinical Trials Trials 71

Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma.

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies.

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 19, 2022

Australia’s CSL has said its one-monthly treatment for hereditary angioedema has shown it is safe and effective in a phase 3 trial, and will be filed for approval in its current financial year which ends on 30 June next year. The post CSL preps filings for once-monthly antibody for HAE appeared first on.

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Antibody Sales FDA Approval Genetics 52

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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Vaccination Vaccine Protein Antibody 52

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. director of the FDA’s Center for Drug Evaluation and Research. The issuance of an EUA is different than an FDA approval. Today, the U.S.

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Antibody Vaccination Vaccine FDA Approval 40

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. Teplizumab is thought to work by preventing the activation of T cells that attack those cells.

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Drugs FDA Approval Insulin Clinical Trials 52

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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FDA Approval Clinical Trials Clinical Trials Nurses 64

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

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Gene Therapy Gene Protein FDA Approval 98

XTalks

NOVEMBER 20, 2023

PI3K/AKT is a key intracellular signaling pathway that regulates cell survival and proliferation. The featured speakers will discuss innovative trial designs, methods of analysis and operational strategies to fulfill regulatory requirements. It was also given FDA priority review. billion to $1.28

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HR FDA Approval Gene Trials 98

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Premarket Approval (PMA) process (CBER). BLA process (CBER).

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Development Production Immune Response Licensing 161

pharmaphorum

DECEMBER 21, 2021

The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023. Anti-TIGIT antibodies are separated into groups, depending on the status of the Fc portion.

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Drugs Antibody Pharma Companies Development 98

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. Another potential lupus nephritis rival is Aurinia Pharma’s voclosporin, which hit the mark last year in the phase 3 AURORA trial.

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XTalks

OCTOBER 27, 2021

Ranibizumab is an anti-angiogenic monoclonal antibody fragment that targets vascular endothelial growth factor A (VEGF A). It received FDA approval in 2018. Some common adverse events in the trial included eye pain, conjunctival hemorrhage, conjunctival hyperemia and iritis, with some cases eye infection.

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Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Hahn , M.D.

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XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Trials Drug Delivery Drugs Gene 83

XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. billion Company: Pfizer Diseases it is FDA-approved to treat: COVID-19 Cost: The price of Paxlovid oral tablet is around $10 for a supply of 30 tablets.

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Sales FDA Approval Drugs Vaccination 64

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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FDA Approval Production Research Doctors 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Third-quarter sales of Leqvio were just $5 million, although that will reflect the lag between regulatory approval and reimbursement negotiations in European markets.

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Drugs Sales Antibody FDA Approval 105

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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Trials Gene Hormones Clinical Trials 98

pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. Like PD-1, LAG-3 is a negative regulator of T cells, suppressing their activity against cancer cells, so when that brake is released the immune system can attack and kill tumours.

FDA Approval 52

FDA Approval Regulation Drugs Trials 52

pharmaphorum

JULY 19, 2022

Merck said the LYNK-003 rial of Lynparza (olaparib) given as either a monotherapy or in combination with Roche’s CD20-targeting antibody Avastin (bevacizumab) in advanced colorectal cancer has been halted, as a look at the unblinded data showed little chance of a positive result.

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Trials Hormones FDA Approval Drugs 52

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

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Licensing Licensing Vaccination Vaccine 52

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Gene Therapy Gene FDA Approval Production 119

pharmaphorum

FEBRUARY 11, 2021

The accelerated development assumes that regulators are prepared to accept immunogenicity data from smaller trials, Pangalos said in the briefing to announce the firm’s quarterly results. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

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Vaccination Vaccine Regulation FDA Approval 78

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Research Hormones Protein Regulation 98

Pharmaceutical Technology

MARCH 23, 2023

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).

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FDA Approval Licensing Licensing Antibody 245

pharmaphorum

MAY 24, 2021

Johnson & Johnson’s Janssen division has claimed a first approval in the US for its bispecific antibody Rybrevant as a treatment for EGFR-mutated non-small cell lung cancer (NSCLC). billion last year from its approved indications in EGFR-mutated NSCLC.

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FDA Approval Antibody Drugs Marketing 52

Pharmaceutical Technology

MAY 22, 2023

Epkinly has been approved as the first and only T-cell-engaging bispecific antibody to treat adults with DLBCL not otherwise specified (NOS), including DLBCL arising from indolent lymphoma and high-grade B–cell lymphoma (HGBL), following two or more lines of systemic therapies.

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FDA Approval Clinical Trials Clinical Trials Antibody 130

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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