Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Oblon, McClelland, Maier & Neustadt, L.L.P
Often in writing applications there is a tendency to denigrate prior art techniques.
BakerHostetler
Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.
Fish & Richardson PC
Decisions in the Amgen v. Sandoz case involving Sandoz's biosimilar versions of Amgen's Neupogen® and Neulasta® drugs have provided significant guidance to biosimilar litigants over the years.
Pearl Cohen Zedek Latzer Baratz
Under the terms of the research pact, Orgenesis will receive an exclusive license on the technology developed at Columbia.
Reed Smith
Today's case in a nutshell is the dismissal on forum non conveniens grounds of a claim brought in the United States by a woman from a Spain.
Foley & Lardner
The Personalized Medicine Coalition, or the "PMC" is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services,
BakerHostetler
The acting commissioner covered opioids, the safety of imported foods and possible changes to the cosmetics regulatory regime during his address to attendees at the 2019 FDLI Annual Conference.
Ropes & Gray LLP
On April 24, 2019, the Food and Drug Administration ("FDA") released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,"
Singh & Associates
On April 12, 2019, the USFDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration ...
Oblon, McClelland, Maier & Neustadt, L.L.P
James Love wrote an article entitled "Patent Strategy and The Internet of Medical Things," featured in Med Device Online.
Reed Smith
Agency Promises More Frequent Drug/Device HCPCS Code Update Opportunities, Bars MACs from Adopting New Blanket Noncoverage Policies without Evidence Review
Reed Smith
Margulis v. Stryker Corp., 2019 US Dist LEXIS 68555 (S.D. Fla. Apr. 23, 2019), is another case in which the plaintiffs filed a product liability claim
Sheppard Mullin Richter & Hampton
Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911
BakerHostetler
FDA Issues Draft Guidance to Aid Companies in Initiating Voluntary Recalls – The
Mintz
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the "grace period" the Agency has extended for certain regenerative medicine product developers to
Akin Gump Strauss Hauer & Feld LLP
Currently, CMS bases new technology add-on payments on the cost to the hospital for the new medical technology.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has released its proposed rule to update the Medicare acute inpatient prospective payment system
Orrick
On April 4, 2019, just three months after the publication of the European Commission (EC) report on "Competition enforcement in the pharmaceutical sector,"
Akin Gump Strauss Hauer & Feld LLP
These two discrete matters may not signal a new government enforcement strategy to hold private equity and venture capital investors liable under the False Claims Act,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program.
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Reed Smith
Today, Reed Smith is hosting a client roundtable in London, "Identifying and Mitigating Risk in a Changing Global Economy," for life sciences clients.
Arnold & Porter
For all the headlines and law firm advisories that pore over the Department of Justice's (DOJ) annual False Claims Act (FCA) ...
Reed Smith
If the promise of adaptive artificial intelligence (sometimes called "Machine Learning") is to be achieved in the medical area, FDA's regulation of medical devices is going to have to graduate from
Hogan Lovells
Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device products and other medical devices that incorporate AI/ML algorithms
Cooley LLP
That's because, in 2016, the House passed the Fostering Innovation Act of 2015—the very same bill.
Reed Smith
That's what we thought when we ran across Restatement §920 recently – it was by accident; we were researching something else.
Ropes & Gray LLP
On March 19, 2019, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) of the Senate Finance Committee ("SFC") wrote a letter (the "POD Letter") to the HHS Office of Inspector General ("OIG")
Wilson Elser Moskowitz Edelman & Dicker LLP
With increased reliance on telemedicine, many physicians question whether the elimination of in-office, face-to-face patient encounters increases their potential medical practice liability risks.
Fish & Richardson PC
Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
The current trajectory of innovation is resulting in the convergence of biological and electronic discoveries into hybrid technologies that incorporate aspects of both scientific disciplines.
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