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Life Sciences › Pharmaceutical Industry › Drug Approvals

Robins Kaplan LLP

ANDA Approvals

Robins Kaplan LLP on

New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Goodwin

European Commission Approves Celltrion’s AVTOZMA (CT-P47)

Goodwin on

​​​​​​​On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more

Brownstein Hyatt Farber Schreck

FDA’s Drug Review Gold Standard

Brownstein Hyatt Farber Schreck on

Robert F. Kennedy Jr., President-elect Trump’s nominee for secretary of health and human services, has said one of his mandates from the president-elect is to return agencies to the gold standard of scientific review. This...more

Goodwin

Update on Recent International Biosimilar Approvals

Goodwin on

​​​​​​​Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more

Wilson Sonsini Goodrich & Rosati

FDA Issues New Guidance on Charging for Investigational Drugs

Wilson Sonsini Goodrich & Rosati on

Conducting a clinical trial is a notoriously expensive endeavor that is necessary not only for ultimate drug approval, but even to progress to the next phase of drug investigation and development. An unfortunate consequence...more

Smart & Biggar

Update on biosimilars in Canada - October 2021

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Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

Morgan Lewis - As Prescribed

A Closer Look at Accelerated Approval and Confirmatory Trials

Morgan Lewis - As Prescribed on

The accelerated approval pathway (i.e., the pathway that permits FDA to rely on surrogate or intermediate endpoints for the approval of a drug for serious conditions with unmet medical needs) has proven to be an important...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Smart & Biggar

First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada

Smart & Biggar on

Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more

Hogan Lovells

Japan considers utilization of “compassionate use” exception to fast-track COVID-19 treatments

Hogan Lovells on

While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...more

Hogan Lovells

China adds 30 drugs to its "urgently needed" list

Hogan Lovells on

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...more

Smart & Biggar

Health Canada and CADTH launch new initiative to provide early parallel scientific advice

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On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer...more

Hogan Lovells

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

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On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more

Knobbe Martens

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

Knobbe Martens on

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

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This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

Foley & Lardner LLP

Trump's Proposed 2018 Budget Will Double FDA User Fees

Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Morrison & Foerster LLP

No Patent for You

Morrison & Foerster LLP on

Patent eligibility restrictions hit life sciences and tech - After years of issuing rulings limiting what can be patented, the Supreme Court turned its attention squarely toward patent eligibility in the life sciences...more

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