News & Analysis as of

Pharmaceutical Industry

Patterson Belknap Webb & Tyler LLP

In False Ad Dispute Between Inhaler Companies, Court Grants PI Enjoining Unsupportable Clinical Superiority Claims

In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a...more

Goodwin

Global Trends And Opportunities In Life Sciences Real Estate – Spotlighting The US And The UK

Goodwin on

An aging global population, a once-in-a-century pandemic and the continued convergence of scientific breakthroughs like cell and gene therapies and artificial intelligence are among just a few of the key factors that continue...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Rejects Pharmaceutical Manufacturer’s Proposed Beneficiary Cost-Sharing Program

On September 18, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion, No. 20-05 (the Opinion), that a pharmaceutical manufacturer’s (Requestor) proposed...more

Hogan Lovells

OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

Hogan Lovells on

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more

Fenwick & West Life Sciences Group

Rock Health Summit 2020 Takeaways: Digital Health Is Firing on All Cylinders

When investors survey the digital health sector today, they see nearly every number trending upward. There is more deal volume than VCs have seen in past years, with the third quarter of 2020 outpacing anything they’ve...more

Smart & Biggar

New Interim Order for COVID-19 drugs has wide-reaching impact, allowing Minister to unilaterally expand indication for...

Smart & Biggar on

On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order), which introduces a new pathway to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 2020)

Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided.  The Federal Circuit recently reinforced the primacy of these rubrics in...more

Hogan Lovells

Anti-benefits regulations: the last piece of the regulatory puzzle published

Hogan Lovells on

Decree no. 2020-730 of 15 June 2020 and the ministerial orders of 7 August 2020 have completed and specified the new anti-benefits regulations which will come into force on 1 October 2020...more

Bergeson & Campbell, P.C.

EAASM Report on Patient Safety and Nanomedicines Calls for Centralized Regulatory Procedure

On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines: The need for a centralised regulatory procedure. According...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

California Governor vetoes bill to establish the Genetic Information Privacy Act

Hogan Lovells on

California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...more

Arnall Golden Gregory LLP

Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic...

It has been almost seven months since the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency on January 31, 2020 due to the Coronavirus Disease 2019 (COVID-19).  The Food and...more

Quinn Emanuel Urquhart & Sullivan, LLP

September 2020: Life Sciences Litigation Update

Traditional Commercial Patent Incentives in the Spotlight in the Race to Develop a COVID-19 Vaccine - As the COVID-19 pandemic continues to persist, the race to develop a vaccine barrels forward. Due to the breadth of the...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

Epstein Becker & Green on

This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Bradley Arant Boult Cummings LLP

Drug Patent Invalid Due to Poor Quality Translation

In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more

Proskauer - Minding Your Business

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

K&L Gates LLP

340B Update: Congress and the Administration Respond to Drug Manufacturers' 340B Contract Pharmacy Actions

K&L Gates LLP on

In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies....more

Hogan Lovells

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

Hogan Lovells on

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more

Goodwin

Lotus and CKD Announce Biosimilar Collaboration

Goodwin on

On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

Stinson LLP on

This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

Foley Hoag LLP - Drug Pricing Policy Watch

Maine Establishes a Prescription Drug Affordability Board

Following the recent trend in northeast states, Governor Janet Mills recently signed into law An Act To Establish the Maine Prescription Drug Affordability Board, which according to advocates is designed to lower prescription...more

Alston & Bird

Class Action & MDL Roundup – Summer 2020

Alston & Bird on

Welcome back to the Class Action & MDL Roundup! Our summer edition covers notable class actions from the second quarter of 2020. In this edition, the Judicial Panel on Multidistrict Litigation (JPML) weighed in on several...more

Latham & Watkins LLP

UK Issues New Guidance for Medical Device Regulation After Brexit

Latham & Watkins LLP on

The MHRA offers new guidance on how medical devices will be regulated in the UK from 1 January 2021. On 1 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical...more

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Privacy Officer
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10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
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Sausalito, California 94965

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