article thumbnail

Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

Sales 52
article thumbnail

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA rejects Provention’s type 1 diabetes drug teplizumab

pharmaphorum

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

Drugs 98
article thumbnail

FDA sets August decision date for Provention’s type 1 diabetes drug

pharmaphorum

Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status. Teplizumab is thought to work by binding to CD3, preventing the activation of T cells that attack and kill insulin-producing pancreatic beta cells in the autoimmune disease.

Drugs 52
article thumbnail

Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

Drugs 52
article thumbnail

Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the Estimation

FDA Law Blog

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. After all, it is fairly common for firms to use shipment (or sales) as a denominator in a risk estimate.

Insulin 40
article thumbnail

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

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.