Monthly Archives

January 2020

Emmes Studies Contribute to FDA Approval of a Medical Device That Estimates the Weight of Infants

By | News | No Comments
Monday, January 6, 2020

Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.

The Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments. This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries.

The Mercy babyTAPE was developed under the Best Pharmaceuticals for Children Act, which mandates the National Institutes of Health (NIH) to prioritize therapeutic areas in critical need of pediatric-specific treatment information, sponsor pediatric clinical trials, and submit the data for review by the U.S. Food and Drug Administration (FDA) for action on affected products.

Emmes coordinated operations and analyzed the data from the NIH-funded studies for the original Mercy TAPE devices, which are used in children ages 2-16 years. These were the first weight estimation devices developed under the BPCA program and the first weight estimation devices to be cleared by the FDA. The Mercy babyTAPE now brings the same weight estimation process to infants.

Click here to read the entire press release.

Precigen Receives FDA Orphan Drug Designation for PRGN-3006 UltraCAR-T™ in Patients With Acute Myeloid Leukemia (AML)

By | News | No Comments

GERMANTOWN, Md.Jan. 6, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) (clinical trial identifier: NCT03927261). Precigen announced in Q3 2019 that it had completed enrollment for the first cohort of this clinical trial and expects an initial data readout in the second half of 2020.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Medicines that receive the ODD designation may qualify for a number of incentives that help to expedite and reduce the cost of development, approval and commercialization.

“This regulatory designation underscores the critical medical need for new therapies to treat AML patients. AML is a progressive, debilitating and often fatal disease with limited treatment options,” said Helen Sabzevari, PhD, President and CEO of Precigen*. “As the first regulatory designation for our proprietary UltraCAR-T platform, this orphan drug designation helps to advance the PRGN-3006 investigational therapy and provides important incentives and support to deliver this medicine as rapidly as possible for those patients suffering from this disease.”

Click here to read the entire press release.

Five Biotechs to Watch in 2020

By | News | No Comments

2019 was a banner year for the biotech industry which is was brimming with innovation and growth, especially within the BioHealth Capital Region (BHCR). From Kite Pharma’s announcement of its new state-of-the-art cell manufacturing facility in Frederick County, Maryland, and the opening of the 32,000 square foot JLABS @ Washington, D.C. to Viela Bio’s $150M IPO and Paragon Bioservices $1.2B acquisition by Catalent, 2019 was an exciting year for so many companies and people in the region.

As the New Year begins, it’s time to turn the spotlight on 2020 and ask: Who will be the next big success story that could emerge in the new year?

To answer that question we dug into our databases, analyzed the news stories of the past year and asked around to get feedback from some of the region’s industry leaders.  There are many companies in this vibrant ecosystem that are advancing their pipelines and building momentum, but a few of them really stood out to be on the cusp of a break-out year.

Here are the five life science companies to keep an eye on in 2020 and beyond.

Click here to read more via BioBuzz.

Biotech firm, RoosterBio looks to expand

By | News | No Comments

FREDERICK COUNTY, Md. (WDVM) — 2020 is already shaping up to be a big year for RoosterBio, now that they are expanding.

The Frederick based, biotech company is expanding its home base for the second time. Mid-December of 2019, they announced they would be adding an additional 5,000 SF of space.

RoosterBio is focused on developing and manufacturing human adult stem cells and stem cell-based products. The company is the leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems. This expansion is a result of an increase in global need. They’ve been distributing in the U.S. market for about 5 years, and now they are moving into global markets like Asia and Europe.

Many of their products are used for research and clinical trials in humans. They can make these products much faster and cheaper than their competitors. Biotech companies like this are important for the future of innovation and medicine because they can help companies looking for a cure for aging stem cells and degenerative diseases, and gene therapy for cancer, therapeutics, etc.

Click here to read more via WDVM

GlycoMimetics and Apollomics Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Uproleselan and GMI-1687 in Greater China

By | News | No Comments

ROCKVILLE, Md. & FOSTER CITY, Calif. & HANGZHOU, China–(BUSINESS WIRE)–Jan. 6, 2020– GlycoMimetics, Inc. (NASDAQ: GLYC), a leader in the field of applied glycotechnology for cancer, and Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, announced today an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200106005583/en/

Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. The companies will also collaborate to advance the preclinical and clinical development of GMI-1687, a highly potent, subcutaneous E-selectin antagonist with broad clinical potential. Subject to the terms of the agreement, GlycoMimetics will receive an upfront cash payment of $9 million and will be eligible to receive potential milestone payments totaling approximately $180 million, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 in Greater China. GlycoMimetics will supply uproleselan and GMI-1687 to Apollomics via a clinical and commercial supply agreement. GlycoMimetics retains all rights for both compounds in the rest of the world.

“We believe Apollomics is the ideal long-term strategic partner for uproleselan and GMI-1687 in Greater China. The company has a highly experienced leadership team and drug development capabilities that complement our desire to bring these novel therapies to patients with AML and other hematologic malignancies,” said Rachel King, GlycoMimetics Chief Executive Officer. “We are excited about the opportunity to expand the reach of uproleselan and GMI-1687 with this agreement.”

Click here to read the entire press release.

Join our Mailing List