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Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in...

Maynard Nexsen on

This episode, Matthew and Heather chat with Paul Testa, an Executive Vice President of Kyowa Kirin, a pharma group that develops innovative specialty drugs to raise the health and well being of people across the globe. Paul...more

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

Polsinelli on

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...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

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

Haug Partners LLP on

Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more

White & Case LLP

President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition

White & Case LLP on

On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs. The Ensuring Innovation Act supports...more

Wilson Sonsini Goodrich & Rosati

2020 Life Sciences Securities Litigation Roundup

2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....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

Hogan Lovells

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

Hogan Lovells on

On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more

Womble Bond Dickinson

Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy?

Womble Bond Dickinson on

Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Patrick Malone & Associates P.C. | DC Injury...

FDA reviews go faster — but with less proof drugs are safer or more effective

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

Sheppard Mullin Richter & Hampton LLP

Day 2 Notes at the 2020 J.P. Morgan Healthcare Conference

The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

Smart & Biggar on

Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

Orrick, Herrington & Sutcliffe LLP

More Affordable and Innovative Medicines and Treatments in Europe – Has the Competition Enforcement Met the 2009 Objective?

A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more

Troutman Pepper

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

Troutman Pepper on

A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Mintz - Health Care Viewpoints

FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Knobbe Martens

FDA Offers Guidance on Streamlined Development of Treatments for Rare Bacterial Infections

Knobbe Martens on

On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more

Searcy Denney Scarola Barnhart & Shipley

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

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