News Archive

• Emergent’s supplemental new drug application is the first prescription-to-over-the-counter switch application in history to be granted Priority Review by the FDA.
• NARCAN® (naloxone HCI) Nasal Spray 4 mg, the first intranasal form of naloxone approved by the FDA in 2015, is designed for community use for the treatment of known or suspected opioid overdose.

GAITHERSBURG, Md., Dec. 06, 2022 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE:EBS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray, as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose. The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023.

The opioid epidemic is an ongoing national public health issue and has been exacerbated by the escalating use of synthetic opioids, namely fentanyl. According to the Centers for Disease Control and Prevention, deaths related to synthetic opioids increased nearly 60 percent from 2019 to 2020,¹ and in 2021 alone, more than 71,000 people died from opioids containing fentanyl.²

University of Maryland College Park (UMCP) graduates are some of the most sought-after graduates in the country – Maryland is the No. 1 state for technology and science workforce and second in graduate or professional degree attainment. The state is also the second-largest recipient of federal funding in Maryland and 10th in the nation among public universities, according to Ken Porter, director of UM Ventures for UMCP.

UMCP is one of five universities working in partnership with TEDCO as part of our Maryland Innovation Initiative (MII), established in 2012 as a technology transfer program with the goal to grow and accelerate promising technologies through venture creation. Porter is a member of the MII board.

WASHINGTON, Dec. 2, 2022 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking.

In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST). The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo.

3D Model of ATP Synthase – molecular motor (enzyme) that powers cells, generating chemical energy in the form of ATP molecules.

The 1997 Nobel prize in Chemistry was awarded to John Walker and Paul Boyer for solving the structure and mechanism of the enzyme ATP synthase which is involved in the synthesis of adenosine triphosphate (ATP). ATP is a molecule that provides energy to drive many processes in living cells.

Maryland Manufacturing Extension Partnership joins City/County consortium to expand third Biotech Bootcamp in Frederick

FREDERICK, MD. (PRWEB) DECEMBER 01, 2022

Following the completion of two successful sessions, Frederick Community College, Frederick County Workforce Services, The City of Frederick Department of Economic Development, and the Frederick County Office of Economic Development are pleased to announce the next “Biotech Bootcamp” will be held in Frederick in January 2023. Maryland Manufacturing Extension Partnership (Maryland MEP) has joined the Frederick consortium to provide additional programming support aimed at expanding the program’s footprint in the future.

A year marked mostly by biopharma mergers and acquisitions (M&A) in the hundreds of millions of dollars could end with a blockbuster, depending how far Horizon Therapeutics (HZNP) gets, and how quickly its talks with a trio of potential suitors, all of them being corporate giants.

Horizon shares jumped 27% from $78.76 to $100.29 on Wednesday, the first trading day after the company announced that it was in M&A talks with Amgen (AMGN), Johnson & Johnson (JNJ)’s Janssen Global Services, and Sanofi (SAN, SNY), confirming a report in The Wall Street Journal.

Over the past four fiscal years, there have been 1,977 initial public offerings (IPOs) completed by companies headquartered in the U.S., according to PitchBook, yielding more than $549 billion in capital invested. These companies are located in 45 states, D.C., and Puerto Rico. Almost 20% of those companies are no longer publicly held, having been returned to private ownership, been acquired, merged or gone out of business.

Across the four years, data shows a spike of IPO size and count in 2021, with a total IPO count of 956 and total IPO size of $315.7 billion for the year.

Image: https://ssti.org

After creating the satellite-radio industry and developing a drug for her daughter’s serious disease, Martine Rothblatt is leading her biotech to test another boundary of what’s possible.

The 68-year-old entrepreneur’s newest mission is to create an endless supply of organs. Her company, the $12 billion Maryland-based biotech United Therapeutics, has already put gene-edited pig hearts, lungs, and kidneys into humans in clinical studies. Rothblatt now hopes to start making organs with 3D printing to solve the organ-supply crisis, with over 100,000 Americans on waiting lists for transplants.

Image: Martine Rothblatt, CEO of United Therapeutics, previously founded the satellite-radio pioneer SiriusXM. Elijah Nouvelage/REUTERS

Cancer continues to be a leading cause of mortality worldwide, accounting for nearly 10 million deaths in 2020. Alongside growing incidence rates each year, knowledge of molecular and tumor biology has also increased and notably affected cancer treatment paradigms. Until recently, cancer therapeutics focused on four main types of treatment: surgery, chemotherapy, radiotherapy, and targeted therapy. However, over the past ten years, immunotherapy has emerged as a novel and revolutionary approach to cancer treatment.