Regulatory

51. How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws 9/26/2022

    Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.

52. Tips For Filing Regenerative Medicine Patents 8/26/2022

    The patent eligibility requirement of U.S. patent law creates obstacles for the regenerative medicine sector. This article examines common regenerative medicine claims for cell and gene therapies as well as biologics that are likely patent ineligible and provides potential claim amendments and other strategies to be successful.

53. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

54. Heightened Standards For Satisfying Written Description In Pharma Patents 7/27/2022

    In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.

55. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

    ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

56. RWD/RWE: To Replicate Or Continue To Learn In The Real World? 6/23/2022

    In addition to using real-world evidence (RWE) for clinical- and cost-effectiveness, it is also now being used for regulatory reviews of safety, efficacy, and quality. This article covers different types of decision-making using RWD/RWE across pharma companies, healthcare providers (HCPs), healthcare systems, payers and health technology assessment (HTA) agencies, regulators, and patients.

57. How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery 6/17/2022

    With “low-hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.

58. FDA Publishes Guidance For Biopharma Container And Carton Label Design 6/13/2022

    The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

59. 2 Years After Germany's Regulation For Digital Health Apps, What Can We Learn? 6/10/2022

    At the end of 2019, the Digital Healthcare Act introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany. Many consider the act a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Two years and 28 approved digital health apps later, what can we learn?

60. FDA Finds Drug Shortages Are Mostly Caused By Quality Issues 6/6/2022

    New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.