The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

XTalks

FEBRUARY 8, 2021

Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.

Production 78

Production Insulin Branding Generic Drugs 78

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

Drugs 298

Drugs Manufacturing Production Pharmacy 298

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. J Neurol Sci. 2003;206(2):165–71.

Trials 52

Trials Medicine Production Containment 52

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up. Particle distribution.

Production 130

Production Manufacturing Development Bioequivalency 130

Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.

Development 246

Development Drugs Bioavailability In-Vivo 246

The Pharma Data

MAY 3, 2021

India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine ( Press ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52