News Archive

GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

“Margie’s deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval,” said Stanley C. Erck, Novavax President and Chief Executive Officer.

This week, interim Phase III data was released for the Oxford / AstraZeneca Vaccine, co-invented by our portfolio company Vaccitech. From late December, assuming the full dataset has been analysed and confirmed to meet formal regulatory requirements, AstraZeneca has announced that they believe they will be in a position to provide a vaccine for a quarter of the world’s population. The vaccine will not just benefit the UK, EU and US who have ordered millions of doses, but the developing world, too. The Serum Institute of India has already begun producing 1 billion doses for the global south.

What’s the world’s largest charitable foundation? Nope, its not the Bill and Melinda Gates Foundation. Not even the Wellcome Trust.

It’s Novo Nordisk Foundation, a $65bn endowment headquartered in Copenhagen.

Top Reasons to  Attend:

• The world may have stopped, but your professional development doesn’t have to. 
• Education and networking from the comfort of your own couch. 
• Loads of partnering opportunities. 
• The programming is tops in the industry. 
• It’s a great value — in fact it’s a great year for the whole office to attend. 
• It’s an important investment in your future.

Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.

At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”

When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.

Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent. 

Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins. 

Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead. 

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics’ next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.

The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.

Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS