News & Analysis as of

Research and Development Pharmaceutical Industry Prescription Drugs

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

Seyfarth Shaw LLP on

On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

Manatt, Phelps & Phillips, LLP

[Webinar] The NCATS Alliance: Speeding the Process of Bringing New Treatments to Patients - March 15th, 1:00 pm - 2:00 pm ET

Featuring Francis Collins, M.D., Ph.D., Senior Advisor to President Biden and Former Director of the National Institutes of Health, and Joni Rutter, Ph.D., NCATS Director, Plus a Panel of Health Care Leaders From Pfizer,...more

Nelson Mullins Riley & Scarborough LLP

Heartburn for Valisure: Controversial Testing Lab Under Fire

In early December, a federal judge tossed plaintiffs’ expert evidence and dismissed some 2,450 lawsuits in the sprawling litigation involving the heartburn medication Zantac. U.S. District Judge Robin L. Rosenberg’s December...more

Goodwin

JSR Life Sciences Launches New “Similis Bio” Business Division to Accelerate Biosimilar Development

Goodwin on

JSR Life Sciences recently announced its launch of a new business division, “Similis Bio,” intended to help biosimilar drug developers “improve the efficiency and cost of biosimilar development.” Specifically, Similis Bio...more

Proskauer - Life Sciences

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Hogan Lovells

Safeguarding drug development at academic institutions

Hogan Lovells on

Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more

Womble Bond Dickinson

Computer Science Meets Medicine in Drug Discovery

Womble Bond Dickinson on

AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - February 2021: Are We Nearly There Yet? The Search for a Disease Modifying Drug for...

Dechert LLP on

Background - Osteoarthritis (OA) is the most prevalent joint disease, estimated to affect 250 million people worldwide with prevalence increasing due to aging populations and growing levels of obesity. OA causes a...more

Robins Kaplan LLP

[Remote Event] Health Care Antitrust Under President Biden - What Health Care Companies May Expect By Way Of Antitrust Policy And...

Robins Kaplan LLP on

After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: All Eyes Were on Biotech in 2020 - Some Investor Observations

Dechert LLP on

It is now a year since the WHO declared an International Public Health Emergency after the first international case of a novel coronavirus infection was identified outside of China. We remain right in the middle of spiralling...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biogen and ViGeneron to Collaborate on Ophthalmic Gene Therapy Development

Earlier this week, Biogen and ViGeneron signed a global collaboration and licensing agreement to develop gene therapies for inherited eye diseases. The companies will use Munich-based ViGeneron’s proprietary adeno-associated...more

Womble Bond Dickinson

Finding a New Way to Fight a Deceptive Disease

Womble Bond Dickinson on

Cancer is a horribly painful and debilitating illness, but would you ever call it “diabolical”? What about “conniving”? You might after you hear about the latest research out of Vanderbilt University showing that cancer cells...more

Seyfarth Shaw LLP

FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

Seyfarth Shaw LLP on

On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....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

Hogan Lovells

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

Hogan Lovells on

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more

Kramer Levin Naftalis & Frankel LLP

Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19

SARS-CoV-2, the virus that causes COVID-19, is a novel coronavirus never before seen in humans. To date, it has caused 60,000 deaths in the United States – 56,000 of those in the last month alone. There does not yet exist an...more

Hogan Lovells

The Belgian AFMPS warns about risk of hemolysis associated with the use of hydroxychloroquine

Hogan Lovells on

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more

Kramer Levin Naftalis & Frankel LLP

A Therapeutic Solution for COVID-19: Repurposing Existing Drugs

For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

Morgan Lewis on

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

Hogan Lovells on

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Downs Rachlin Martin PLLC

Vermont Legislative Update 01-24-2020 - An analysis from DRM's Government and Public Affairs Team

Global Warming Solutions Act: asking for too much or not enough? The House Committee on Energy and Technology took testimony this week on the The Global Warming Solutions Act. University of  Vermont Professor Jon Erickson...more

46 Results
 / 
View per page
Page: of 2

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