News & Analysis as of

Clinical Trials Pfizer

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

Goodwin on

Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

Goodwin on

The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021

Hogan Lovells on

In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 19

Hogan Lovells on

In Washington: President Biden on Thursday doubled to 200 million his administration’s goal for the number of COVID-19 vaccination shots to administer in his first 100 days in office. The U.S. is set to reach Biden’s original...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 16

Hogan Lovells on

In Washington: The House Budget Committee approved legislation for a $1.9 trillion coronavirus relief package on Monday evening, with a full House vote is expected at the end of this week. So far, House Democrats expect a...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Akerman LLP - Health Law Rx

COVID-19 and Possible Silver Bullets: Update on Vaccine Development

As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 17

Hogan Lovells on

In Washington: White House communications director Alyssa Farah said Tuesday that the White House still hopes for a coronavirus relief package, probably post-election. Speaking on Fox & Friends, Farah said President Trump...more

Goodwin

Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Goodwin on

Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in...more

Smart & Biggar

Rx IP Update - May 2018

Smart & Biggar on

An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

Goodwin

Pfizer and Celltrion Healthcare Reveal New Data For infliximab biosimilar Inflectra®

Goodwin on

Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra...more

Goodwin

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

Goodwin

Bevacizumab Biosimilar Update

Goodwin on

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer....more

Goodwin

Pfizer Announces Results from Trial With its Proposed Humira Biosimilar

Goodwin on

Pfizer announced today that PF-06410293, its proposed biosimilar to Humira® (adalimumab), has demonstrated equivalent efficacy to Humira® in a clinical study. The clinical study gathered data from a 12 week trial in which...more

Goodwin

Success for Pfizer’s Trastuzumab Biosimilar in Phase 3 Clinical Trials

Goodwin on

Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat...more

Goodwin

Biosimilars Development Updates

Goodwin on

According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70%...more

16 Results
 / 
View per page
Page: of 1

"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