Pharma in Brief

FEBRUARY 8, 2024

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. Dormant status: A drug listed as “Dormant” in Health Canada’s Drug Product Database means the drug is not presently being sold in Canada, but has not been withdrawn from the market. b) of the Regulations.

Production 52

Production Generic Drugs Bioequivalency Drugs 52

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development 242

Development Bioequivalency Generic Drugs Production 242

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

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

Production 78

Production Insulin Branding Generic Drugs 78

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.

Trials 52

Trials Medicine Production Containment 52

The Pharma Data

MAY 3, 2021

Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Siemens raises outlook as COVID-19 antigen tests blast past original sales target ( MedtechDive ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52