pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Chemotherapy 126

Chemotherapy Immunization FDA 126

Roots Analysis

OCTOBER 4, 2023

They are designed to recognize and bind to two specific molecules, such as a tumor cell and an immune cell, or two different parts of the same molecule. During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. during the period 2023-2035.

Chemotherapy 40

Chemotherapy Immunization FDA 40

Pharmaceutical Technology

JULY 29, 2022

The Omicron variant spreads more easily than earlier variants of the virus that cause Covid-19, including the Delta variant, and also has the ability to sometimes evade immunity from vaccines, previous infection, or both. Similarly, last month, the FDA recommended that vaccine manufacturers add Omicron BA.4 1 sub-lineage on 19 July.

Vaccines 52

Vaccines Packaging Immunization FDA 52

European Pharmaceutical Review

MARCH 7, 2024

Firstly, alpha particles exhibit greater biological effectiveness by inducing irreparable DNA double-strand breaks, minimising the risk of resistance or immune escape in tumour cells. Based on these promising results, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to AlphaMedix in February 2024.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunization FDA 52

PharmaShots

MAY 23, 2023

Propelled by constant innovatory winds, the Cell and Gene therapy market is anticipated to grow by 20 percent year-over-year through 2025. The company first received the US FDA approval for its gene therapy Zynteglo in Aug 2022 for treating adult and pediatric patients with ß-thalassemia. Total Revenue: $1.9B

FDA 58

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 58

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

pharmaphorum

JANUARY 10, 2022

The first mRNA-based vaccines were brought onto the market in 2020, with Pfizer/BioNtech and Moderna receiving emergency use authorisation from the US Food and Drug Administration (FDA) for the prevention of COVID-19. The breakthrough was hailed as a revolution for disease treatment and particularly a major success against the pandemic.

Vaccines 111

Vaccines Immunization FDA 111

The FDA Law Blog

AUGUST 14, 2022

Medicare Part D redesign: The IRA changes Medicare Part D starting in 2025 by lowering the patient out-of-pocket (“OOP”) limit to $2,000, adjusted annually in subsequent years. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

Vaccines 98

Vaccines Immunization 98

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

FDA 52

FDA Communication Immunization 52