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Last week, FDA's Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database.
Goodwin Procter LLP
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed ...
Dickinson Wright PLLC
The Food and Drug Administration regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics.
Goodwin Procter LLP
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo's ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Arnold & Porter
There are several aspects of the pharmaceutical industry's potential environmental footprint. Research and development require sophisticated equipment, controlled environments, and specialised materials.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall...
Arnold & Porter
In an effort to limit challenges for patient access, patient adherence to recommended treatment, or adoption of innovative products and services, providers, suppliers, and product manufacturers seek ways to address such roadblocks.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of public procurement and funding strategies for needed medical countermeasures during the pandemic.
Stites & Harbison PLLC
In December 2023, the U.S. Supreme Court heard oral arguments in the case of Harrington v. Purdue Pharma, L.P., Case No. 23-124. Purdue Pharma is the drug manufacturer of the prescription opioid...
Sheppard Mullin Richter & Hampton
The Federal Trade Commission ("FTC") has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency's...
Oblon, McClelland, Maier & Neustadt, L.L.P
In Medtronic, Inc. v. Teleflex Life Sciences Ltd. the Federal Circuit upheld the Patent Trial and Appeal Board (PTAB) decision that U.S. Patent No. 8,142,413 ("the '413 patent")...
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates...
In this episode, Dr. Alicia Jackson, co-founder and CEO of Evernow, discusses the importance of women's health research and the need for improved menopause care.
In this episode, cancer survivor Kaitlin Christine, the CEO and founder of Gabbi, shares her vision to make all late stage breast cancer obsolete...
In episode 24, Halle and Michael discuss the process of raising a seed round. They cover topics such as when to raise a seed round, building relationships with investors...
Goodwin Procter LLP
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.
This decision is an interesting development in the application of safe harbor law to medical devices.
Crowell & Moring LLP
Broad Interpretation of Safe Harbor: The Federal Circuit's decision underscores a broad interpretation of the safe harbor provision. Companies can be reassured that activities potentially...
Goodwin Procter LLP
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released...
Goodwin Procter LLP
On March 18, 2024, the FDA approved Orchard Therapeutics' LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy.
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