News + Resources
“Fast Facts”: Early-Stage Companies Count on M&A to Bring Biopharmaceutical Breakthroughs to Patients
The United States is home to more than 2,300 life sciences companies – including more than 85 percent of the world’s small, early-stage biopharmaceutical companies – each competing to bring new treatments and cures to patients.
Innovations Advanced by M&A: The First Therapy for Pompe Disease
From the complex scientific and regulatory expertise required, to the enormous capital investment needed for state-of-the-art facilities and clinical trials, many companies cannot navigate this path alone. Mergers and acquisitions (M&A) are fundamental to shepherding medicines along the path to market, and to patients in need. Such was the case for a first-of-its-kind treatment for Pompe disease.
House Committee on Small Business Urges FTC, DOJ to Consider Consequences of Recent Merger Guidelines on Early-Stage Companies
Last week, the House Committee on Small Business wrote to the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ), emphasizing that the merger guidelines “threaten to deter M&A transactions before they even get off the ground,” chilling a critical pathway for small companies.
‘Material Differences’ & ‘Less Burden’: FTC, DOJ Signal Forthcoming Changes to Proposed HSR Rules
Speaking to antitrust experts at the ABA’s 2024 Spring Antitrust Meeting, Andrew Forman, deputy assistant attorney general at the Department of Justice’s (DOJ) Antitrust division, suggested that the Federal Trade Commission (FTC) and DOJ’s forthcoming changes to the Hart-Scott Rodino (HSR) premerger notification rules will reflect substantive changes from their initial proposal.
Innovations Advanced by M&A: A Cure for Inherited Blindness
The 2019 merger between Roche and Spark Therapeutics was instrumental in helping to expand the global reach of Luxturna, a first-in-class gene therapy approved as a one-time treatment for biallelic RPE65 mutation-associated retinal dystrophy – a rare, inherited form of vision loss.
FTC & DOJ Focus on ‘Nascent Competition’ Ignores Unique Market Dynamics in the Life Sciences
The Federal Trade Commission (FTC) and Department of Justice (DOJ) have increasingly focused on the impact that mergers and acquisitions (M&A) in the life sciences could have on “nascent competition” – the competition that might eventually exist between therapies already on the market and those in early-stage development. However, this new approach is not only highly speculative, it also ignores complex realities and unique dynamics in life sciences research and development.
ITIF Report Finds Balanced Competition Policies Critical to Preserve U.S. Leadership in Biopharmaceutical Innovation
In its recent report “Not Again: Why the United States Can’t Afford to Lose its Biopharma Industry,” the Information Technology & Innovation Foundation (ITIF) highlights the important role of balanced competition policies in establishing and maintaining U.S. leadership in biopharmaceutical innovation.
A Timeline of the FTC & DOJ’s Flawed Approach to Life Sciences M&A
In recent years, the Federal Trade Commission (FTC) and Department of Justice (DOJ) have taken an increasingly aggressive approach towards life sciences mergers and acquisitions (M&A). This new approach not only represents a substantial pivot away from the Agencies’ own long-standing precedent of balanced, bipartisan antitrust policy, but also risks obstructing the many complementary relationships that M&A fosters, which are responsible for bringing innovative new treatments and cures to patients.
On Capitol Hill, PULSE Partners Highlight Unique Importance of Life Sciences M&A
On February 29, PULSE partners from across the country met with policymakers on Capitol Hill to provide a real-world perspective on the critical role of pro-innovation mergers and acquisitions (M&A) and other collaborations in the life sciences industry.
Overreach in M&A Enforcement: The Impact on Pro-Innovation Deals That Aren’t Ever Pursued
In recent months, the Federal Trade Commission (FTC) and Department of Justice (DOJ) have pursued an increasingly aggressive new approach towards mergers and acquisitions (M&A). Taken together, the Agencies’ recently finalized Merger Guidelines and proposed premerger notification rule under the Hart-Scott-Rodino (HSR) Act illustrate a dramatic shift towards greater scrutiny of even procompetitive M&A, which could have a significant impact on innovation.