News & Analysis as of

Biotechnology

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

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

Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

by Knobbe Martens on

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...more

UK Government Announces Life Sciences Sector Deal

by Hogan Lovells on

The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

by Hogan Lovells on

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more

EMAmsterdam: Hogan Lovells welcomes its new neighbour

by Hogan Lovells on

By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more

Important Opposition To The PUPPERS Act (H.R. 3197) Mounts.

by Fox Rothschild LLP on

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans...more

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

Biotech Institute's Growing Patent Portfolio -- U.S. Patent No. 9,095,554 and the Path Forward

As with any billion dollar market, patents are an important consideration for the cannabis industry. Despite its current classification as a Schedule I drug under the Controlled Substances Act, however, the U.S. Patent and...more

Biotechnology Risk Assessment Research Grants Program Accepting Applications

by Bergeson & Campbell, P.C. on

On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program. The...more

Wrap-Up of Federal and State Chemical Regulatory Developments, November 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA)...more

Pharma and Biotech: Key Trends and Legal Risks

by Latham & Watkins LLP on

How to thrive amid uncertainty? This was the question we explored at the 35th FT Global Pharmaceutical and Biotechnology Conference. Here are five key industry trends and corresponding practical legal tips to help companies...more

Brexit Bill - Impact on patents

by Hogan Lovells on

The UK government’s draft EU Withdrawal Bill (the “Brexit Bill“) aims to incorporate EU directives and regulations into UK domestic law in their current form immediately following Brexit (“Retained EU Law“).  This article...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Global Patent Prosecution Newsletter - November 2017

An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues - We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more

USDA Withdraws Proposed Rule on the Importation, Interstate Movement, and Environmental Release of Certain GE Organisms

by Bergeson & Campbell, P.C. on

On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19,...more

Senators Introduce Bipartisan Bill To Establish Renewable Chemicals Tax Credit

by Bergeson & Campbell, P.C. on

On October 18, 2017, Senator Debbie Stabenow (D-MI) introduced to the Senate the Renewable Chemicals Act of 2017 (S. 1980), which aims to establish a short-term tax credit for the production of renewable chemicals and for...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

BIO Requests Reauthorization Of Biobased Assistance Program

by Bergeson & Campbell, P.C. on

On October 19, 2017, the Biotechnology Innovation Organization (BIO), an Associate member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that it and its member companies sent a letter to the House...more

Congressmen Send Bipartisan Letter On Regulating Agricultural Biotechnology To USDA, FDA, EPA

by Bergeson & Campbell, P.C. on

On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug...more

FDA, USDA, and EPA to Hold Public Sessions on Agricultural Biotechnology

by Bergeson & Campbell, P.C. on

On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s...more

American Process and Byogy Renewables Launch Phase 1 Of DOE-Funded Biofuels And Bioproducts Project

by Bergeson & Campbell, P.C. on

On October 9, 2017, American Process Inc. and Byogy Renewables, Inc. announced the launch of Phase 1 of its “Advanced Biofuels and Bioproducts with AVAP (ABBA)” project following the completion of negotiations with the U.S....more

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

by K&L Gates LLP on

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more

678 Results
|
View per page
Page: of 28
Cybersecurity

"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 using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*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.