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Maarika L. Kimbrell

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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

By Christopher J. Betti, Ph.D. , Christina A. MacDougall, Ph.D. , Benjamin H. Pensak , and Benjamin J. Stein
// January 17, 2025
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As the sector navigates a dynamic landscape of scientific advancements, economic pressures, and regulatory changes, stakeholders are increasingly leveraging strategic transactions to gain a competitive edge.
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Topics: Biologics, Biosimilars, Drugs, FDA, Healthcare, Innovative Drugs, Intellectual Property, Licensing, Life Sciences, Regulatory, Rulemaking

Advertising and Promotion Considerations for Biologics, Biosimilars, and Interchangeables

By Maarika L. Kimbrell
// April 30, 2024
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally.
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Topics: Biologics, Biosimilars, Guidance

Summer Forecast for SPACs

By R. Alec Dawson and Kevin S. Shmelzer
// June 15, 2021
Last year was a record-breaking one for capital raising in life sciences, and 2021’s first quarter was robust for special purpose acquisition company (SPAC) transactions. Now, after a second-quarter SPAC and initial public offering (IPO) slowdown, the outlook for summer SPACs has rebounded just in time for the Morgan Lewis Global Public Academy program, Going Public Through a SPAC: Current Issues for SPAC Sponsors and Private Companies 2021. Our panelists will discuss some of the most important legal issues for companies considering going public through a SPAC and for SPACs seeking an acquisition target. Topics covered will include the use of private investments in public equity (PIPEs), obtaining shareholder approval for a merger, and the required SEC filings and review process.
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Topics: Biologics, Biosimilars, Controlled Substances, Devices, Drugs, Gene Therapy, Generic Drugs, Immunobiological Drugs, In Vitro Diagnostic Devices, Innovative Drugs, Precision/Personalized Medicine, Regenerative Medicine

Revamped Purple Book Offers Greater Patent Transparency for Biologics

By Jacqueline R. Berman
// May 18, 2021
The Purple Book—a database containing information about all licensed biological productsis set for a revamping that offers more patent transparency regarding reference biologics.
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Topics: Biologics, Biosimilars, FDA, Legislation
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