Pharmaceutical Technology

AUGUST 12, 2022

A specifically engineered HER2-directed antibody drug conjugate (ADC), Enhertu is being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca. Enhertu is claimed to be the first HER2-directed therapy to receive approval for treating HER2 mutant metastatic NSCLC patients. “We In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Bio Pharma Dive

SEPTEMBER 29, 2020

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

FDA Approval 353

FDA Approval Antibody Vaccination Vaccine 353

Pharmaceutical Technology

MARCH 8, 2023

Shorla Oncology CEO and co-founder Sharon Cunningham said: “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this US FDA approval. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

FDA Approval 246

FDA Approval Drugs Production Development 246

Pharmaceutical Technology

MARCH 1, 2023

Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper. Developed using VelocImmune technology of Regeneron, Kevzara binds to the IL-6 receptor specifically and inhibits IL-6-mediated signalling.

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

FEBRUARY 2, 2023

It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

Bio Pharma Dive

NOVEMBER 11, 2024

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

FDA Approval 285

FDA Approval Branding Development 285

Pharmaceutical Technology

MARCH 10, 2023

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

FDA Approval 284

FDA Approval Drugs Protein Marketing 284

Bio Pharma Dive

MAY 24, 2023

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

FDA Approval 287

FDA Approval Development Drugs 287

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

Pharmaceutical Technology

JANUARY 9, 2023

In a separate development, Eisai has submitted a supplemental Biologics License Application (sBLA) to the US FDA for traditional approval of Leqembi. The post US FDA approves Eisai-Biogen’s antibody for Alzheimer’s appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Bio Pharma Dive

DECEMBER 6, 2023

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

FDA Approval 301

FDA Approval Drugs Development 301

Pharmaceutical Technology

AUGUST 8, 2022

With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019. A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

SEPTEMBER 19, 2022

bluebird bio was granted a rare paediatric priority review voucher following approval. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

Pharmaceutical Technology

JUNE 27, 2022

BMS US Hematology senior vice-president and general manager Ester Banque said: “As part of our commitment to developing innovative cancer treatments for patients with critical unmet need, Breyanzi offers a potentially curative option for more patients.

FDA Approval 264

FDA Approval Development Drugs 264

Bio Pharma Dive

MARCH 7, 2023

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

Protein 360

Protein FDA Approval Drugs Development 360

Bio Pharma Dive

OCTOBER 14, 2020

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

Antibody 261

Antibody FDA Approval Drugs Development 261

XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

FDA Approval 59

FDA Approval Gene Therapy Gene Genetics 59

Bio Pharma Dive

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

FDA Approval 237

FDA Approval Antibody Drugs Development 237

Pharmaceutical Technology

MAY 26, 2023

Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer.

Gene Therapy 264

Gene Therapy Gene FDA Approval Manufacturing 264

Bio Pharma Dive

AUGUST 10, 2020

The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test.

Gene Sequencing 246

Gene Sequencing FDA Approval Gene Development 246

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma managing director Antonia Riel-Köllmann stated: “As the third generation of my family dedicated to developing high-quality European pharmaceuticals, it’s a privilege to bring this life-sustaining therapy, which represents the company’s first product launch in the US, to the global market.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. Rykindo has also been approved as a single agent or as adjunctive therapy to lithium or valproate to treat bipolar I disorder in these patients.

FDA Approval 162

FDA Approval Production Development Marketing 162

Fierce Pharma

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA (..)

FDA Approval 138

FDA Approval Development 138

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). The post Lilly’s Jaypirca received FDA approval to treat MCL appeared first on Pharmaceutical Technology.

FDA Approval 147

FDA Approval Trials Drugs Development 147

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. The regulatory approval represents the completion of the Cytogam technology transfer process from CSL Behring, its previous manufacturer.

FDA Approval 130

FDA Approval Manufacturing Production Protein 130

Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. A VEGF inhibitor, Eylea is jointly developed by Bayer and Regeneron Pharmaceuticals.

FDA Approval 130

FDA Approval Trials Development Drugs 130

Bio Pharma Dive

MARCH 19, 2024

clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.

Gene Therapy 176

Gene Therapy Gene FDA Approval Development 176

Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. Co-Authors: Ken Phelps. President and Founder.

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Development Production Regulation Clinical Trials 232

Bio Pharma Dive

SEPTEMBER 20, 2021

The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency.

FDA Approval 184

FDA Approval Drugs Development 184

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The dual FLT-3 and Aurora kinase inhibitor EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

Pharma Mirror

OCTOBER 4, 2021

Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

Genome Project 299

Genome Project Drugs FDA Approval Genomics 299

Pharmaceutical Technology

SEPTEMBER 5, 2022

Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.

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Development Bioequivalency Generic Drugs Production 242

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. TGCT is a rare, non-cancerous tumor that develops inside or near joints.

FDA Approval 59

FDA Approval Drugs Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

FDA Approval 130

FDA Approval Genetics Trials Medicine 130