Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Cooley LLP ordered by Published Date Descending.
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Q3 Government Settlements Round-Up: Life Sciences
Health regulatory news and issues.
United States
4 Oct 2019
Proposed Rule Issued By CMS Re: Expansion Of Open Payments Reporting
Manufacturers also should consider potential system enhancements and other changes that will be necessary to implement these updates if the Proposed Rule is finalized by CMS.
United States
6 Aug 2019
FCC Makes $100 Million Available For Telehealth Experiments
At its July 10 meeting, the FCC adopted a Notice of Proposed Rulemaking, which proposes the creation of a three-year "Connected Care Pilot program."
United States
15 Jul 2019
New Bill To Exempt Low-Revenue Companies From SOX 404(B) - Have We Reached An Inflection Point?
That's because, in 2016, the House passed the Fostering Innovation Act of 2015—the very same bill.
United States
15 Feb 2019
AdvaMed Code Of Ethics Updated Effective January 1, 2020
The Advanced Medical Technology Association (AdvaMed) announced earlier this month the availability of an updated Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code).
United States
4 Feb 2019
The Department Of Health And Human Services Issues Guidelines On GDPR's Territorial Scope
We have outlined key information about the five cybersecurity threats and ten cybersecurity practices presented in the Cybersecurity Guidelines below.
United States
15 Jan 2019
Federal Sunshine Act Reporting Requirements Expanded To Other Prescribers
Because this change applies to all data submitted on or after January 1, 2022, companies must begin collecting reportable data on January 1, 2021.
United States
9 Nov 2018
Cooley Alert: Agreements Involving Biosimilars Must Be Reported To FTC And DOJ Under New Law
Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law.
United States
23 Oct 2018
Agreements Involving Biosimilars Must Be Reported To FTC And DOJ Under New Law
Consultation with antitrust counsel, both in structuring settlement agreements and in submitting filings, is therefore advisable.
United States
22 Oct 2018
HHS Releases Plan To Require Drug Makers To List Prices On TV Ads
Yesterday, the Department of Health and Human Services ("HHS") through the Centers for Medicare and Medicaid Services ("CMS") ...
United States
17 Oct 2018
PhRMA Releases Updated Guiding Principles On DTC Advertising
PhRMA Releases Updated Guiding Principles on DTC Advertising.
United States
16 Oct 2018
Deal Or No Deal – Government Opens The (First) Box
The UK Government has been publishing technical notices, setting out its plans in the event that the UK and the EU fail to reach agreement before March 2019.
10 Oct 2018
New Draft Guidance Regarding Data Sharing On Clinicaltrials.Gov And Civil Money Penalties
The FDA has the authority to impose CMPs of up to $11,569 for all violations of Section 402(j) adjudicated in a single proceeding.
United States
1 Oct 2018
HHS Announces Innovation And Investment Summit
Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary's Innovation and Investment Summit (DSIIS).
United States
27 Sep 2018
Court Dismisses Lawsuit Challenging CA S.B. 17 But Gives Leave To Amend
This week a California judge dismissed a lawsuit filed in December 2017 by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CA S.B. 17.
United States
7 Sep 2018
FDA Releases Draft Guidance Regarding Indications And Usage Section Of Drug Labeling
The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, "Indications and Usage Section of Labeling for Human Prescription Drug...
United States
24 Jul 2018
Will A Spoonful Of Sugar Make The Medicine Go Down? – UK Parliament's Proposal To Minimise The "Brexit Effect" On The UK's Life Sciences Sector
Recently, the UK House of Commons Health and Social Care Committee published a report on its two-stage investigation into Brexit's effect on the life sciences sector.
4 Apr 2018
Teva v. Novartis: Federal Circuit Expands the Ability of Generic Drug Companies To Sue Pioneer Drug Companies For Declaration Of Patent Noninfringement And Invalidity
A new Federal Circuit decision promises to lead to more patent suits between generic drug companies and pioneer drug companies. Following the Supreme Court's explicit direction in its MedImmune v. Genentech opinion, the Federal Circuit has overturned its prior restrictive test for the right of generic drug companies to bring declaratory judgment actions against pioneer drug companies.
United States
11 Apr 2007
Federal Court Rules Gene Fragments are not Patentable
The U.S. Court of Appeals for the Federal Circuit has given its answer to the long standing question of whether or not gene fragments are patentable. In a 2-1 decision on September 7, 2005, the Court upheld the rejection by the U.S. Patent and Trademark Office of a claim to five expressed sequence tags in a patent application owned by Monsanto as unpatentable for lack of utility under 35 U.S.C. § 101.
United States
18 Nov 2005
How to Set a Patent Strategy
Getting a new drug to market may cost as much as $800 million. With this type of investment, patents are necessary to protect market exclusivity.
United States
24 Jun 2005
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