Pharma in Brief
FEBRUARY 25, 2024
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).
XTalks
JUNE 15, 2022
The editorial team also discussed a new global biosimilars awareness campaign launched by Sandoz, Novartis’ biosimilars and generics drug division. The campaign is aimed at addressing global health inequity and inequality by increasing access to advanced medicines like biosimilars.
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Pharmaceutical Technology
MAY 3, 2023
Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.
Pharma in Brief
APRIL 25, 2021
These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,
World of DTC Marketing
JUNE 22, 2022
Between 2019 and 2021, Alphabet’s venture-capital arms, Google Ventures, and Gradient Ventures, and its private-equity unit, CapitalG, made about 100 deals, a quarter of Alphabet’s combined total, in life sciences and health care. Then there is the cost of generic drugs.
XTalks
MARCH 15, 2024
LillyDirect was launched at the beginning of this year to provide a digital end-to-end healthcare experience that includes access to the company’s drugs with home delivery and telehealth services. Launched last year, RxPass is a prescription drug subscription that offers medications for a monthly subscription of $5 for Amazon Prime members.
FDA Law Blog
MARCH 6, 2024
He’ll be speaking on “Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines.” His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations.
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