News & Analysis as of

Supply Chain Biosimilars

Axinn, Veltrop & Harkrider LLP

Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues?

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

ArentFox Schiff

CY 2023 Proposed HOPPS Rule– What Drug Manufacturers Need To Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #2

BakerHostetler on

Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more

Goodwin

COVID-19 Pandemic May Impact Biosimilars

Goodwin on

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars.  In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and...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

Sheppard Mullin Richter & Hampton LLP

10 FAQs About Blockchain and Life Sciences - August 2018

Blockchain is a rapidly emerging technology and has the potential to bring transformative changes to many industries. As more companies become aware of and study this technology, many questions arise. These questions relate...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

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Mintz

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

Mintz on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

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