Remove 2019 Remove Licensing Remove Regulations
article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

article thumbnail

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “Following the successful delivery of more than 170 million doses to the U.S. CEO and Co-founder of BioNTech. “We AUTHORIZED USE IN THE U.S.:

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

article thumbnail

Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

article thumbnail

Ascentage Pharma Enters into an Agreement with University of Michigan to obtain an exclusive license for a MDM2 Degrader using PROTAC Technology

The Pharma Data

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. 2019, 62 , 445?447. On October 28, 2019 , Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK. SUZHOU, China and ROCKVILLE, Md. ,

article thumbnail

ATUZAGINSTAT

New Drug Approvals

gingivalis DNA was detected in postmortem cortices from people with AD and healthy controls, and in CSF of AD patients ( Jan 2019 news on Dominy et al., Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators.

article thumbnail

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth). During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn. Any failure to comply with this restriction may constitute a violation of such laws or regulations.