News & Analysis as of

Biotechnology

Dechert LLP

Overview of financing options for French biotech companies

Dechert LLP on

The trajectory of a biotech company is often full of ups and downs, influenced by unpredictable changes in market conditions. It is therefore imperative for biotech companies to be agile in finding the most appropriate...more

Faegre Drinker Biddle & Reath LLP

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more

McGuireWoods Consulting

House Passes the BIOSECURE Act

On September 9, 2024, the House of Representatives passed the BIOSECURE Act by 306 to 81 votes. Before the congressional recess, House Speaker Mike Johnson (R-LA) had announced he would bring the BIOSECURE Act (H.R. 8333) to...more

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.

NIFA Announces $5.3 Million Investment in Biotechnology Risk Assessment Research

The Biotechnology Risk Assessment Grants (BRAG) program supports the development of new information that will assist federal regulatory agencies in making evidence-based decisions about the effects of genetically engineered...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

WilmerHale

Royalty Financings and Similar Revenue Monetizations Surge in Difficult Life Sciences Fundraising Environment

WilmerHale on

Many biopharmaceutical companies are facing challenges raising cash through traditional equity markets. While venture investment activity saw a slight increase in the first half of 2024 as compared to the equivalent period in...more

Gardner Law

Navigating the Biosecure Act: Implications for Biotechnology and Pharmaceutical Companies

Gardner Law on

The Biosecure Act, introduced in January 2024 (H.R. 7085), has garnered significant bipartisan support and is increasingly poised to become law, heightening its impact on the life sciences industry. The bill, now amended to...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James...

Maynard Nexsen on

This week, hosts Matthew and Heather welcome back James Chappell, President and CEO of SCbio, to discuss the organization’s new program, SCbioDrive, an accelerator program for emerging life sciences companies. The group...more

Foley Hoag LLP - Public Companies & the Law

Biotech Public Markets Finally Thawing(?): Two Massachusetts Biotechs file S-1s

In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...more

MoFo Life Sciences

Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting In Allergan USA V. MSN Laboratories

MoFo Life Sciences on

On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of...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

Kilpatrick

7 Key Takeaways - The Federal Circuit's New § 112 Attack on Biotechnology: Diagnosis and Prescription

Kilpatrick on

Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Bergeson & Campbell, P.C.

APHIS Announces New Flexibility for BRS Importation Permits in APHIS eFile

On August 2, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced a new flexibility for BRS importation permits in APHIS...more

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

Napoli Shkolnik on

A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more

MoFo Life Sciences

Microbes, Biotech Investigations, And Impacts: Midsummer Regulatory Updates From USDA-APHIS

MoFo Life Sciences on

After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more

Bergeson & Campbell, P.C.

Biotechnology Regulatory Services Will Hold Annual Stakeholder Meeting on November 14, 2024; Stakeholders Can Suggest Topics until...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting will on November 14, 2024. The meeting will take...more

Fenwick & West LLP

More Than Just Coffee and Rain: 10 Facts About Seattle’s Tech Community

Fenwick & West LLP on

With Seattle Tech Week around the corner, here are 10 facts about the community that reveal why so many industry giants, startups, and investors choose Washington...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Perkins Coie

USDA APHIS Invites Stakeholder Comments on Regulation of Modified Microbes

Perkins Coie on

In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more

Fenwick & West LLP

Update on the BioSecure Act

Fenwick & West LLP on

The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...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

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

McDermott Will & Emery on

The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Foley & Lardner LLP

Patenting Power Plays For AI Drug Discovery

Foley & Lardner LLP on

In April 2024, BioPharmaTrend published a comprehensive review of the past and current state of artificial intelligence (AI) drug discovery, using the 2012 advent of modern deep learning as a starting point. The review...more

1,575 Results
 / 
View per page
Page: of 63

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide