Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

XTalks

MARCH 10, 2025

The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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Allergies FDA Approval Antibody Trials 66

XTalks

APRIL 11, 2025

The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). This marks BioconBiologics seventh biosimilar cleared for use in the US.

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Antibody Marketing Clinical Trials Clinical Trials 109

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

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Antibody Engineer FDA Approval Development 130

XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. These antibodies play a crucial role in providing protection by effectively neutralizing the cytotoxic lethal toxin and edema toxin of B. The recommended administration involves two doses, each of 0.5 Overall, 66.3

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FDA Approval Vaccine Vaccination Antibody 98

XTalks

OCTOBER 16, 2024

Stelara now has a new biosimilar option on the market, as Dong-A ST’s Imuldosa (ustekinumab-srlf) has received approval from the US Food and Drug Administration (FDA) for the treatment of several autoimmune conditions. Imuldosa’s approval followed a rigorous review process by the FDA.

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FDA Approval Marketing Pharmacy Development 103

pharmaphorum

AUGUST 4, 2021

BMS said the decision to withdraw the product came in part because other treatments for PTCL have become available that have “redefined treatment across PTCL and other haematologic conditions.” The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

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XTalks

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure.

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Allergies FDA Approval Drugs Protein 100

Pharmaceutical Technology

SEPTEMBER 2, 2022

lenalidomide) + a steroid ± an anti-CD38 antibody. Last month, the European Medicines Agency's (EMA) approval of Johnson & Johnson’s (J&J) anti-CD3/BCMA bispecific antibody Tecvayli (teclistamab) marked the fourth anti-BCMA biologic to enter the R/R MM market. Should CAR-T cells, or antibodies be used first?

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Antibody Sales FDA Approval Production 147

Pharmaceutical Technology

JANUARY 18, 2023

In June last year, Eli Lilly submitted a new drug application to the National Medical Products Administration (NMPA) of China for Galcanezumab to prevent episodic migraine in adult patients. The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP).

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Antibody FDA Approval Gene Production 130

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Hympavzi is administered once weekly.

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FDA Approval Antibody Drugs Clinical Trials 105

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

Pharmaceutical Technology

MAY 19, 2023

Roche’s anti-CD20 monoclonal antibody Rituxan/MabThera (rituximab) is one of the most successful oncology drugs of all time. Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014.

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Sales Production Marketing FDA Approval 147

pharmaphorum

OCTOBER 31, 2022

The Galien Foundation, which acknowledges “extraordinary scientific innovations that improve the human condition”, has awarded its Best Biotechnology Product 2022 accolade to Regeneron Pharmaceuticals, Inc.’s s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn).

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XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

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FDA Approval Gene Therapy Antibody Gene 98

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. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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FDA Approval Vaccine Vaccination Clinical Trials 102

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The FDA approval paves the way for the immunotherapy to undergo review in other countries. With up to 2.3

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Insulin FDA Approval Research Development 246

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Amivantamab overview Amivantamab-vmjw (Rybrevant) is a low-fucose human immunoglobulin G1-based bispecific antibody developed using recombinant DNA technology. It is based on DuoBody technology platform.

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Recombinant DNA Technology Production Antibody FDA Approval 100

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.

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Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. GlobalData’s Pharma Intelligence Center shows 19 autologous CAR-T cell products in Phase I, and nine products in Phase II, globally.

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XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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Antibody Clinical Trials Clinical Trials Medicine 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.

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Drugs Antibody Clinical Trials Clinical Trials 105

XTalks

OCTOBER 23, 2024

Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN. IgAN, also known as Berger’s disease, occurs when IgA antibodies build up in the kidneys, leading to inflammation.

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Trials Clinical Trials Clinical Trials Antibody 101

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 5 variant spike protein. 5 and the wild-type viral strain.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. In October 2023, the bispecific antibody got a label expansion to retinal vein occlusion.

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FDA Approval Clinical Trials Clinical Trials Sales 104

XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Product logo and product image courtesy of Bristol Myers Squibb. Immunotherapy techniques use monoclonal antibodies to target malignant cells.

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FDA Approval Gene Therapy Antibody Gene 52

XTalks

JANUARY 20, 2025

Key drivers of the acquisition included Allergans robust product portfolio, particularly in ophthalmology, neuroscience and aesthetics. Blockbuster products like Botox (botulinum toxin) and Restasis (cyclosporine) provided Actavis with high-margin, branded revenue streams that complemented its existing generic drug business.

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Marketing Botox Life Science Pharma Companies 104

XTalks

NOVEMBER 1, 2024

Price of Ocrevus: $78,858 annually Why it sold so well: Ocrevus is a therapeutic monoclonal antibody that offers a unique scientific approach to treating MS. Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval.

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FDA Approval Drugs Botox Sales 85

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US.

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Antibody Licensing Licensing FDA Approval 52

Pharmaceutical Technology

APRIL 28, 2023

Its scope includes Syngene providing integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. until 2026. Syngene’s collaboration with Zoetis started in 2011.

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pharmaphorum

AUGUST 19, 2022

If approved, garadicimab will slot into CSL’s product line alongside two C1 esterase inhibitor medicines, namely Berinert which is administered by intravenous injection to treat HAE attacks, and Haegarda which is given twice-weekly as a subcutaneous injection for prevention. It is administered as an intravenous injection.

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Antibody Sales FDA Approval Genetics 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

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

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. Due to their size, cells can absorb them where they release products. This design protects antibodies from the innate immune system.

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Drug Delivery Vaccine Vaccination Research 147

pharmaphorum

JUNE 13, 2022

ADC Therapeutics is looking to add a second approved antibody-drug conjugate to its portfolio after reporting strong phase 2 results with camidanlumab tesirine (cami) in relapsed/refractory Hodgkin lymphoma at the EHA annual meeting. “These results offer hope to patients and doctors who need a new option.”

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Drugs Antibody FDA Approval Doctor 98

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. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

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Drugs Sales Antibody FDA Approval 105