Remove Generic Drugs Remove Life Science Remove Marketing Remove Production
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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

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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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “genericdrugs of the biopharma world. What is a Biosimilar?

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Drug discovery hotspots: India’s Genome Valley

Drug Discovery World

Could India become an important centre of drug discovery innovation? Diana Spencer explores the evolution of the Hyderabad life sciences hub. It is emerging markets like India that analysts expect to spearhead the global growth of the pharmaceutical sector 1.

Genome 52
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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Ontario proposes removing barrier to listing “well-established drugs” on its public formulary

Pharma in Brief

Background A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit ( ODB ) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.

Drugs 52
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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

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Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

XTalks

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.