Remove Biosimilars Remove Drug Development Remove Regulations
article thumbnail

Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

As demand for these therapies continues to surge, particularly with the emergence of biosimilars, the necessity for strict quality controls during development and manufacturing becomes paramount. These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success.

article thumbnail

Pharma Contract Sales Outlook 2025–2030: Multilingual Teams Drive Global Expansion

The Pharma Data

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Hyman, Phelps & McNamara Enters its 45th Year Continuing to Expand its Capabilities to Meet Client Needs

FDA Law Blog: Biosimilars

Naomis insights and experience will solidify an already strong team of lawyers and regulatory experts helping our clients navigate the drug approval process, noted Director James Valentine. We were sad when he left to gain valued experience as a federal prosecutor but are absolutely thrilled and honored to welcome him back.

Nurses 59
article thumbnail

Teva and Bioeq Announce Commercial Partnership for Biosimilar

The Pharma Data

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

article thumbnail

FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

FDA 104
article thumbnail

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

The Pharma Data

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

article thumbnail

Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.