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Drug Pricing › Biosimilars › Biotechnology

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

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On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

MoFo Life Sciences

Medicare Drug Price Negotiation Program Final Guidance

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On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more

Hogan Lovells

JPM2023 Trendspotting: takeaways from Biotech Showcase

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At the recent J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry led in-person discussions with industry experts on topics that will guide...more

Hogan Lovells

Inflation Reduction Act’s Drug Price Negotiation Program explained

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In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

Proskauer - The Patent Playbook on

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Patent Thickets and Regulatory Challenges Cited as Major Factors Limiting Price Reductions in the Biologic Drug Space

Rothwell, Figg, Ernst & Manbeck, P.C. on

The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

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Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

WilmerHale

M&A: The Last Refuge for Biotechs Seeking Funding

WilmerHale on

These are tough times in the biotech and pharmaceutical industries: Funding is drying up, investors are fleeing the space, the IPO door is pretty firmly shut, valuations are dropping, activists are lurking and the headlines...more

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