News & Analysis as of

Pharmaceutical Industry

Diabetes Monitoring Technology Moving Toward Consumer Convenience

by Knobbe Martens on

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via...more

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

by Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

Antibody Patents Are Not Immune to § 112: Amgen Inc. v. Sanofi, Aventisub LLC

by K&L Gates LLP on

In Amgen v. Sanofi, the Federal Circuit held that evidence that first came into existence after the priority date may be considered in determining whether a genus patent claim satisfies the written description requirement...more

More on Venue -- Plexxikon v. Novartis Pharmaceutical Corp. (N.D. Cal. 2017)

The sequel to the original summer blockbuster movie, Jaws, had as a tagline "Just when you thought it was safe to go back in the water." This sentiment can describe much of U.S. patent law over the last decade and a half,...more

Jury Verdict Overturned in Pepcid® Dispute After Court Finds Insufficient Evidence of Infringement

Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

by Hogan Lovells on

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive...more

Saudi Arabia Update – November and December 2017

by Dentons on

Legal developments - Saudi Arabia anti-corruption drive and protection of corporates - In the wake of Saudi Arabia’s headline-grabbing anti-corruption drive in November, Crown Prince Mohammed bin Salman instructed the...more

Federal Circuit Affirms Sandoz Win on Preemption Grounds

by Goodwin on

The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s “patent dance.” The panel...more

FDA Approves Ixifi® (infliximab-qbtx), Third Biosimilar of Remicade® in U.S.

by Goodwin on

The FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric...more

Health Alert (Australia) 11 December 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 1 December 2017 - Laerdal Medical Pty Ltd and Comptroller-General of Customs AATA 2427 - CUSTOMS – whether subject goods accessory –...more

New Legislation Increases Access to Medical Products for Military Applications

by Hogan Lovells on

Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

by Shook, Hardy & Bacon L.L.P. on

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Office of Civil Rights Issues Guidance on HIPAA in Light of Opioid Crisis

by Burr & Forman on

With an increased focus on opioid use and addiction, the Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance related to the Health Insurance Portability and Accountability Act of...more

EU-Japan Economic Partnership Agreement

by Dechert LLP on

The EU and Japan have reached agreement on “the biggest bilateral trade agreement ever negotiated by the European Union”, covering a combined market of over 600m people and 30% of global GDP....more

SEC Brings Enforcement Action for Inadequately Documented Perks but Does Not Impose Penalty

The SEC charged a biopharmaceutical company with committing a series of accounting controls and disclosure violations, including the failure to properly report as compensation millions of dollars in perks provided to its...more

FDA Approves Sanofi’s Admelog, the First Short-Acting Follow-On Insulin

by Goodwin on

The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of...more

FDA Releases New “Refuse to File” Guidance

by Goodwin on

The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to...more

FDA Provides Guidance on 3D-Printed Medical Device Products

by Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

EMA published an assessors’ guidance document in connection with explanatory note to GVP module VII

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a guidance document for assessors. The guidance document is written in a questions-and-answers form. It should be read in combination with the explanatory note to GVP module...more

Magistrate Judge Recommends Dismissal of Amgen v. Coherus (Pegfilgrastim) Suit

by Goodwin on

We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim...more

EMA launched improved version of EudraVigilance

by Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

FDA Includes Patent Submission Date Updates In Orange Book

by Tarter Krinsky & Drogin LLP on

The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more

Aligning a Product's Marketing, Regulatory and IP Plans

by Pepper Hamilton LLP on

Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD). Originally published in Law360 - September 8, 2017....more

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