pharmaphorum

DECEMBER 8, 2020

AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. Bamlanivimab is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

Drugs 99

Drugs Antibody FDA Approval Pharma Companies 99

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.

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Nurses 64

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

pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. Both the antibodies stem from research carried out at the institution. Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies.

Drugs 95

Drugs Antibody Clinical Trials Clinical Trials 95

The Pharma Data

NOVEMBER 21, 2020

Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. “The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic.

Antibody 40

Antibody Clinical Trials Clinical Trials Production 40

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.

Research 98

Research Hormones Protein Regulation 98

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]

FDA Approval 52

FDA Approval Production Research Doctors 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. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

Marketing 85

Marketing Antibody Drugs Sales 85

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

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. Benlysta binds and neutralises the B cell survival factor BAFF, while rituximab targets CD20, a protein found on the surface of B cells.

FDA Approval 75

FDA Approval Contract Manufacturing Sales Trials 75

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

Production 52

Production Gene Protein Vaccination 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. CAR T cells are T cells that have been trained to attack tumours.

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Manufacturing Gene Genome Genomics 98

The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. There are multiple heritable forms of FTD.

Genetics 52

Genetics Gene Antibody Development 52

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Currently, the SLE therapeutics market is revolving around only one drug i.e

Marketing 52

Marketing Sales FDA Approval Antibody 52

Drug Discovery World

APRIL 17, 2023

New bispecific antibody study results for multiple myeloma According to results of a phase I/II clinical trial presented today, patients with relapsed or refractory multiple myeloma who were treated with the two highest doses of REGN5459, a bispecific antibody targeting BCMA and CD3, experienced a 90.5% Read more here.

Research 52

Research Antibody Bioavailability Genetics 52

XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

XTalks

DECEMBER 24, 2020

SARS-CoV-2 is characterized by an outer surface speckled with spike proteins, giving it a crown-like appearance, hence the name “corona,” which is the Latin word for crown. The spike protein is critical for binding to ACE2 receptors on host cells — this interaction mediates the entry of the virus into cells. Drug Approvals.

Life Science 111

Life Science Vaccination Vaccine Gene 111

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. Vaccine efficacy was sustained at one year in the high-dose adjuvant group.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. Monoclonal Antibodies. Bioelectronic Platform.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

APRIL 8, 2021

Gantenerumab is a late-stage investigational anti-beta-amyloid antibody being evaluated in two Phase III studies (GRADUATE I and II), which are the only late-stage AD clinical trials to offer subcutaneous administration. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A., nM and 13.81

Clinical Trials 52

Clinical Trials Clinical Trials Trials Protein 52

XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Nizoral is prescribed off-label, while the others are FDA approved.

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

AUGUST 3, 2021

For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. Cost of Sales margin increased 1.6 Tax Rate increased 5.6 In May, the U.S.

Sales 52

Sales Production Antibody Development 52

XTalks

APRIL 12, 2021

GBA1 encodes for beta-glucocerebrosidase (GCase), a lysosomal enzyme that is responsible for regulating the organelle’s ability to get rid of glycolipids. But just three months later, Voyager faced another stumbling block in the form of an FDA-mandated clinical hold on the trial. Cellular accumulation of ?-synuclein

Gene Therapy 96

Gene Therapy Gene Trials Development 96

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

Research 112

Research Vaccination Vaccine Drugs 112

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

Medicine 40

Medicine Production FDA Approval Trials 40

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination 40

Vaccination Vaccine Production Sales 40