Pharmaceutical Industry

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FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

Hoffmann-La Roche Inc. v. Apotex Inc. (Fed. Cir.)

Hoffman-La Roche (“Roche”) appeals from the decision of the district court granting defendants summary judgment of invalidity as to claims 1-8 of the ’634 patent and claims 1-10 of the ’957 patent. The asserted claims...more

Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms. Inc. (Fed. Cir.)

Case Name: Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms Inc., 748 F.3d 1354 (Fed. Cir. Apr. 21, 2014) (Circuit Judges Newman, Linn and Wallach presiding; Opinion by Newman) (Appeal from D.N.J., Cavanaugh,...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Braintree Labs., Inc. v. Novel Labs., Inc. (Fed. Cir.)

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Dyk, Prost, and Moore presiding; Opinion by Prost, J.; Concurrence-in-part and Dissent by Dyk, J.; Dissent by...more

Court Report - July 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA 1:14-cv-00877; filed July 3, 2014 in the District Court of...more

Corruption Risks in Pharma Manufacturing in Russia

The Russian government has targeted the pharmaceutical industry for growth and development, adopting a program Pharma 2020 Strategy. This program aims to improve the competitiveness of the Russian pharmaceutical industry and...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

Allergan, Inc. v. Apotex, Inc. (Fed. Cir.)

Case Name: Allergan, Inc. v. Apotex, Inc., No. 2013-1245, -1246, -1247, 2014 U.S. App. LEXIS 10710 (Fed. Cir. June 10, 2014) (Circuit Judges Prost, Reyna and Chen presiding; Opinion by Prost, C.J.; Dissent-in-part by Chen,...more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

IPR Update -- The First Pharma IPR Decisions

Late last month, while many of us were getting ready to attend the BIO International Convention in San Diego, the Patent Trial and Appeal Board ("Board") issued four related inter partes review opinions, marking what many...more

The Inversion Craze: Will Today's Routine Tax Planning Be Retroactively Outlawed?

Alongside the more typical summer fare, such as coverage of the best beach reading and the latest action movie blockbuster, this summer the media have been abuzz with seemingly daily reports on the latest so-called...more

Medical Devices: recent developments in the UK and the US

As it becomes harder for rights holders to control the flow of infringing medical products, Baker Botts’ Neil Coulson and Mark Whitaker review developing case law on both sides of the Atlantic. Whether a company...more

Stampeding for the Exits: Pharmaceutical Companies and the Recent Wave of Inversions

Actavis, Pfizer, Medtronic, Abbvie and Salix have all recently announced plans to merge with foreign competitors and reincorporate in the U.K. or Ireland – a strategy commonly known as an “inversion” (Pfizer’s merger plans...more

Keeping Our Kids Healthy: Pediatric Medicine Development

Children are a precious commodity and it is important that they are cared for appropriately. Children deserve the best care so they can grow and live happy and fulfilled lives. Pediatric products development is in high demand...more

BioPharma Patents Quick Tips and News - May/June 2014

QUICK TIPS - 35 U.S.C. 112 Tips: 1) Does your U.S. Examiner assert that not enough representative species are described in the specification? MPEP Section 2163 II.A.3(a)(ii) says that “(t)he written...more

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...more

Has Codeine Harmed Your Child?

In August 2012, the U.S. Food and Drug Administration (FDA) issued a boxed warning — its strongest — to alert doctors and parents about the risks of administering codeine to children post-surgery. According to the FDA,...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

White Collar Watch - July 2014

In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract...more

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