Pharmaceutical Industry

News & Analysis as of

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Big Pharma Seeks Exemption From Patent Law

Implementation of the America Invents Act (“AIA”) has brought substantial changes to the patent law of the United States over the last several years. One of the most significant provisions of the AIA was the creation of inter...more

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

New registration rules and calculation methodology for maximum manufacturer's sale prices for vital and essential drugs

On October 1, 2015, the new versions of the following regulations will come into legal force and effect: - The Rules for the state registration and re-registration of maximum sale prices set by pharmaceutical...more

Many questions for, but not many answers from, the FDA on biosimilars implementation after last week's hearing

The US Senate Committee on Health, Education, Labor and Pensions on September 17, 2015 convened a hearing entitled Biosimilars Implementation: A Progress Report from the FDA. Dr. Janet Woodcock, Director of the Center for...more

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part Two of Two

The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

Antitrust Matters - September 2015

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

EPA Proposes Hazardous Waste Rule for Pharmaceuticals

A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals. EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266...more

Health Alert (Australia) - September 21, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Australian Capital Territory (ACT) 4 September 2015 - Hobbs v Tym & Anor [2015] ACTSC 276 The Supreme Court has...more

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

Patent Update: Infringement and “Non-Infringing Alternatives”

If you are a patent owner, you are entitled to damages if someone infringes your patent. The measure of damages is compensatory damages, lost profits or a “reasonable royalty”. Is it fair for the infringer to say that the...more

EPA Proposes New Rules Regarding Waste Pharmaceuticals for Healthcare Facilities and Reverse Distributors

The Resource Conservation and Recovery Act (RCRA), which is the federal statute that regulates the generation, handling, transportation and disposal of hazardous waste, was enacted in 1976. Since that time, EPA has largely...more

EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

EPA’s New Draft Hazardous Waste Rules Promote Flexibility, but Devil is in the Details

On August 31, 2015, EPA released two proposed hazardous waste rules under the Resource Conservation and Recovery Act (RCRA) that will be soon be available for public comment after they are published in the Federal Register....more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

Apotex Follows the Pre-Suit Information Exchange Provisions of the BPCIA

In the first skirmishes between biosimilar makers and innovator companies, biosimilar makers attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) through the...more

1,343 Results
View per page
Page: of 54

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.