Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Production Generic Drugs Bioequivalency Drugs 52

Camargo

NOVEMBER 11, 2020

Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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Development Bioequivalency Generic Drugs Production 242

XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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Production Insulin Branding Generic Drugs 78

The Pharma Data

AUGUST 5, 2020

There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. J Neurol Sci.

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Trials Medicine Production Containment 52

The Pharma Data

MAY 3, 2021

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Coronavirus Pandemic.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52