COVID-19 put into perspective the importance of the pharma industry to the global economy. Goodwin London Life Sciences partner Andrew Harrow reflects on 2020’s impact on the pharma sector, particularly biotech, and discusses what 2021 might look like for industry deals and investment. Full article here.
Goodwin’s 2nd Annual Goodwin + KPMG @ JPMorgan Symposium kicked off Day Two of our Symposium with an overview of the effects of the pandemic on the biopharma market by Dale Raine, Managing Director and Co-Head of the European Healthcare Investment Banking at Lazard in conversation with Goodwin Life Sciences…
Goodwin held the 2nd Annual Goodwin +KPMG @ JPMorgan Symposium on Wednesday, January 27th and Thursday, January 28th. The Symposium kicked off with industry luminary, Noubar Afeyan, Chairman and Co-Founder of Moderna sitting down for a fireside chat with Vice Chairman, Global Chair of M+A and Goodwin partner, Stuart Cable….
Idenix’s Pharmaceuticals’ patent (U.S. Patent No. 7,608,597) was invalidated for having a genus that was “too broad.” The trial judge ruled that the patent did not enable a person of skill in the art to select a single compound from the “billions and billions” of compounds encompassed by the genus….
On February 3, 2021 Goodwin FDA Regulatory partner, Julie Tibbets, Products Litigation + Counseling partner, Nilda Isidro, and Risk Management & Insurance counsel Brian Mukherjee discussed what drug and biologic companies with late-stage product candidates can do to best position their products to mitigate the risks that come with transitioning from clinical trials to…
On January 19, 2021, the FDA issued guidance for licensed and investigational cellular and gene therapy (CGT) manufacturers during the COVID-19 pandemic. This new guidance supplements the recommendations provided in FDA’s June 2020 guidance regarding manufacturing controls to prevent contamination in drugs, risk assessment of SARS-CoV-2 as it relates to…
What is an accelerator? An accelerator is an entity that provides a fixed-term, cohort-based program designed to accelerate growth and support disruptive and innovative early-stage businesses. They can be generalist or specialist and are located all around the world. Who are they? Probably the most well-known accelerator is Y Combinator…
University tech transfer offices (TTOs) and venture capital firms (VCs) work closely together to advance certain technologies and discoveries from the lab to the market. However, because there are different motivations and incentives for TTOs and VCs while negotiating licensing agreements, tensions often arise during these negotiations. At a meeting…
On January 12, 2021, the U.S. Food and Drug Administration (FDA) published its Action Plan for further development of the Agency’s framework for regulatory oversight of artificial intelligence (AI) and machine learning (ML) based Software as a Medical Device (SaMD). The Action Plan identifies several opportunities for SaMD developers to…
In recent posts, we reviewed “down-rounds” and hedging COVID-19 pandemic risks in M&A. This post complements them and focuses on early-stage life sciences companies and their potential investors. While the customary development timelines for life sciences companies may seem less prone to risks associated with COVID-19, the pandemic still resulted…