Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

FDA Approval 79

FDA Approval Contract Manufacturing Sales Trials 79

Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Biopharmaceutical Excipient Manufacturing Market. Diverse Landscape of Biopharmaceutical Excipient Manufacturers.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval. percent, including three (4.1

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Roots Analysis

MARCH 13, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. The post Biopharmaceutical Excipient Manufacturing – Current Scenario and Future Trends appeared first on Blog.

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52

Drug Discovery World

SEPTEMBER 6, 2022

There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. Among these include Zolgensma, Novartis’ gene therapy drug for spinal muscular atrophy (SMA), which made headlines in the UK for its £1.79 million price point per dose.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

pharmaphorum

NOVEMBER 12, 2020

Earlier this year, UCB also bought a 47-acre UK R&D campus from Eli Lilly, saying it intends to develop it as a hub for R&D in “gene therapies, translational medicine and antibody discovery.”. The post UCB revs up its gene therapy drive with Handl acquisition appeared first on.

Gene Therapy 52

Gene Therapy Gene Manufacturing Contract Manufacturing 52

Roots Analysis

JANUARY 24, 2024

Continuous manufacturing process involves the production of pharmaceutical drug substance in a single run, while operating 24×7. In this process, the drug is developed from its base ingredients / raw materials and processed to the final product in one facility, without any hold time.

Manufacturing 40

Manufacturing Contract Manufacturing Production Marketing 40

Pharmaceutical Technology

APRIL 24, 2023

. “Biologics products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; Hospital products, which grew 10% operationally to $2.3

Vaccination 40

Vaccination Vaccine Production Sales 40