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In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency's likely next steps.
Alston & Bird
Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses.
Alston & Bird
Last week, the U.S.-EU Trade and Technology Council (TTC) held an inaugural meeting and discussed supply chain issues. The White House COVID-19 Response Team reported a decrease in case rates and hospitalizations.
Marshall, Gerstein & Borun LLP
Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in treating debilitating diseases.
Oblon, McClelland, Maier & Neustadt, L.L.P
In its recent decision, the PTAB ("the Board") determined that all challenged claims of U.S. Patent No. 10,301,638 B2 were unpatentable under 35 U.S.C. § 328(a) for lack of written description and lack of enablement.
Oblon, McClelland, Maier & Neustadt, L.L.P
Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular.
Morrison & Foerster LLP
Deanne Maynard, Janet Xiao, and Stacy Cline Amin were featured in the Business Insider's coverage of lawyers helping life-sciences and biotech companies raise capital
Alston & Bird
Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs.
Foley & Lardner
The counterfeit business is booming. In fact, counterfeit goods account for a whopping 3.3% of global trade1 and cost the U.S. economy approximately $600 billion a year.2
Klein Moynihan Turco LLP
On October 7, 2021, California's Governor approved an amendment to AB-45 Industrial hemp products.
In our last post, we took a brief look back through history at FDA's approach to regulating medical device software and found that there is little distinction from the agency's approach to hardware devices.
Morrison & Foerster LLP
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel
Proskauer Rose LLP
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for.
Covington & Burling
The MCIT/RN Rule was intended to address concerns that delay or uncertainty around Medicare coverage hampered beneficiary access to innovative technologies.
Proskauer Rose LLP
The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals' privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit on the federal or state level.
Wolf, Greenfield & Sacks, P.C.
The end of the USPTO fiscal year (September 30) yields a flurry of TTAB decisions.
Seyfarth Shaw LLP
Health Care Beat is brought to you by Seyfarth's cross-disciplinary health care team. Each Beat will focus on key industry and legal trends, while identifying practical takeaways...
Beveridge & Diamond
It also follows FDA's October 2020 request for comment on the labeling of cell-cultured seafood products.
Arnold & Porter
The FDCA and the Public Health Service Act are the two key statutes governing the development, manufacturing, distribution, registration, licensing, clearance and approval of such products in the USA.
Alston & Bird
Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans.
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