News & Analysis as of

Biopharmaceutical Life Sciences

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...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

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

Perkins Coie

BioMaP-Consortium Hosts Inaugural Industry Day

Perkins Coie on

In previous Updates, we discussed the formation and growth of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), which was started by the Biomedical Advanced Research and Development Authority...more

Fenwick & West LLP

The BIOSECURE Act: Too Early to Call?

Fenwick & West LLP on

A congressional proposal to sever ties between United States and Chinese biopharmaceutical companies is far from a done deal, but its bipartisan support is a concrete reminder to consider options for supply chain...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

Epstein Becker & Green on

Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Goodwin

German Court Invalidates CureVac Patent in Ongoing BioNTech Lawsuit

Goodwin on

On December 19, a German court invalidated CureVac’s messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Goodwin

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Goodwin on

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Allen Matkins

Life Sciences Real Estate Update 8.24.23

Allen Matkins on

The average vacancy rate for laboratory and research and development space across the top 13 U.S. life sciences markets stood at 9% in the second quarter, up more than four percentage points from a year earlier and more than...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

Foley & Lardner LLP on

Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

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

Gene Therapy Approvals Gain Steam in 2023: Treatments Offer New Hopes for Rare Diseases

After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Morrison & Foerster LLP

China Eyes New Export Controls for Life Sciences Technologies

China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

Smart & Biggar on

Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

Knobbe Martens

BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

Knobbe Martens on

Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...more

McDermott Will & Emery

[Event] 2023 J.P. Morgan Healthcare Conference - January 10th, San Francisco, CA

Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] The Future of Telehealth and Its Implications for Biopharmaceutical Firms - December 14th, 3:00 pm - 4:00 pm ET

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The COVID-19 pandemic has entrenched telehealth into the fabric of modern health care...more

Wilson Sonsini Goodrich & Rosati

2022 Mid-Year Technology and Life Sciences "Non" IPO Report - Market Update and Playbook for Late-Stage Private Companies

Following a record-breaking year for initial public offerings (IPOs) in 2021, the U.S. capital markets screeched to a halt in 2022 with the lowest IPO activity levels seen in decades. This trend was observed across all...more

McDermott Will & Emery

2022 J.P. Morgan Healthcare Conference: Life Sciences Investment Forum

Despite offering one of the lowest total deal values on record, 2021 was an active M&A year. Due to the strong capital markets, a seller’s market continued, creating additional urgency for biopharma companies to accelerate...more

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