News & Analysis as of

Biotechnology Manufacturers

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Foley & Lardner LLP on

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

Bergeson & Campbell, P.C.

DOD Announces Seven Awards via the Distributed Bioindustrial Manufacturing Program

On August 20, 2024, the U.S. Department of Defense (DOD) announced seven additional awards to bioindustrial firms via the Distributed Bioindustrial Manufacturing Program (DBIMP), bringing the DBIMP to 13 awards to date...more

Bergeson & Campbell, P.C.

Bipartisan Legislation Would Advance American Production of Renewable Chemicals

On August 1, 2024, Senators Sherrod Brown (D-OH) and Pete Ricketts (R-NE) introduced the Renewable Chemicals Act of 2024 (S. 4931), bipartisan legislation that would “advance the manufacturing of renewable biochemicals from...more

McDermott Will & Emery

Key Takeaways | Pharma and MedTech Manufacturing and Contract Development

McDermott Will & Emery on

During the session, the panelists discussed investment strategies in the Contract Development and Manufacturing Organization (CDMO) space, emphasizing factors like supply and demand dynamics, quality control, and the impact...more

Bergeson & Campbell, P.C.

Mixed Algae Conversion Research Opportunity Will Award up to $18.8 Million to Address R&D Challenges in Converting Algae to...

On April 10, 2024, the U.S. Department of Energy’s Bioenergy Technologies Office (BETO) and Office of Fossil Energy and Carbon Management (FECM) announced the MACRO: Mixed Algae Conversion Research Opportunity funding...more

Bergeson & Campbell, P.C.

EC Publishes Communication on Biotechnology and Biomanufacturing, Announces Targeted Actions

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024,...more

Hogan Lovells

New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Hogan Lovells on

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ever-increasing growth...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Troutman Pepper

Ready for the Biotech Bounce Back in 2024?

Troutman Pepper on

Heading into 2024, expectations for biotech venture capital (VC) and private equity (PE) investments were low following two lackluster years, but as we wrap up Q1, those expectations have been turned on their head after a...more

AEON Law

EU Study Shows Startups with IP 1000% More Likely to Be Funded

AEON Law on

The European Patent Office (EPO) and the European Union Intellectual Property Office (EUIPO) have released a 61-page study showing that EU startups that secure intellectual property (IP) rights protection are 10.2 times more...more

Bergeson & Campbell, P.C.

DOE and NSF Select Three Projects to Accelerate Biomanufacturing Innovation and Advance the U.S. Bioeconomy

On August 29, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that through the funding opportunity entitled “Accelerating Innovations in Biomanufacturing Approaches through...more

Morrison & Foerster LLP - Government...

Biden Executive Order Has Potential To Discourage U.S. Company Participation In Federal Research

A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more

Bergeson & Campbell, P.C.

EuropaBio Offers Recommendations on Biomanufacturing

On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted...more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

Hogan Lovells on

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

Bergeson & Campbell, P.C.

OMB Seeks Input on Bioeconomy-Related Industries and Products

The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging,...more

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

Recent FDA Discussion of Artificial Intelligence for Biosimilar Industry

Artificial Intelligence (AI) has long been associated with science fiction movies about dystopian futures, leading to fear among the general public about its potential impact. This is especially the case today for those in...more

Bergeson & Campbell, P.C.

DOD Publishes Biomanufacturing Strategy and RFI on Biomanufactured Products and Process Capabilities

As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to...more

Bergeson & Campbell, P.C.

White House OSTP Outlines Goals for U.S. Biotechnology and Manufacturing

As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing...more

Bergeson & Campbell, P.C.

Biden Administration Announces New Goals and Priorities to Advance Biotechnology and Biomanufacturing

As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in...more

Bergeson & Campbell, P.C.

National Academies Publishes Proceedings of Workshop on Successes and Challenges in Biomanufacturing

That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across...more

Allen Matkins

Life Sciences Real Estate Update -1.06.23 #1

Allen Matkins on

California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more

Bergeson & Campbell, P.C.

OSTP Publishes RFIs on Coordinated Framework for the Regulation of Biotechnology and National Biotechnology and Biomanufacturing...

As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology...more

Bergeson & Campbell, P.C.

EuropaBio Announces Biomanufacturing Platform

EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure...more

Kilpatrick

Executive Order Aims to Stimulate Innovation in Biotechnology and Biomanufacturing

Kilpatrick on

Expanding on policies established by President Obama and President Trump to promote advances in biotechnology, President Biden signed Executive Order 14081, entitled “Advancing Biotechnology and Biomanufacturing Innovation...more

Bergeson & Campbell, P.C.

CRS Publishes Primer on the Bioeconomy

The Congressional Research Service (CRS) published a CRS report, updated on September 19, 2022, entitled The Bioeconomy: A Primer. The report provides an overview of the bioeconomy, details the efforts of the United States...more

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