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GEN: NIH Invests $248.7 Million to Ramp up COVID-19 Testing

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Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.

The initiative is called NIH’s Rapid Acceleration of Diagnostics (RADx). “The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH director Francis S. Collins, MD, PhD. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”

The seven companies range in scope from small start-ups to large publicly-held organizations and their corresponding technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs.

Click here to read the entire article from GEN

BARDA upgrades Emergent pact with $258M option for anthrax vaccine stores

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Drugmakers around the world are scrambling to develop a COVID-19 shot, and Emergent BioSolutions has already signed on to help produce doses for some major players. Now, the Gaithersburg, Maryland-based biopharma has scored a contract update to deploy future vaccine doses for a wholly different kind of health crisis.

On Monday, Emergent BioSolutions said it received a contract modification from the Office of the Assistant Secretary for Preparedness and Response—part of the U.S. Department of Health and Human Services—to exercise an option valued at $258 million for extra doses of the company’s up-and-coming anthrax vaccine, NuThrax.

Emergent’s anthrax vaccine absorbed with adjuvant first scored a procurement contract from the Biomedical Advanced Research and Development Authority (BARDA) back in late 2016. The Monday update marks the first time BARDA has leveraged one of its options to lock down additional doses of the vaccine.

Click here to read more via FiecePharma

Emergent BioSolutions Receives EMA Agreement for Proposed Development Path of Investigational Chikungunya VLP Vaccine Candidate

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GAITHERSBURG, Md., Jan. 13, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide. We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial.”

Click here to read the entire press release.

GEN: 8 Biopharma Trends to Watch in 2020

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2019 saw a new record set for a list price of a prescription therapy—$2.1 million for the gene therapy Zolgensma® launched by AxeVis, a Novartis Company—and resulting renewed concerns over the price of treatments and whether politicos will ever be able to address the issue as the nation’s presidential election campaign season heats up.

Also renewed in 2019 was hope that a first treatment indicated for reducing clinical decline in people with Alzheimer’s disease may finally be approved, perhaps as soon as 2020—as well as the ongoing legal wrangle over who invented CRISPR-Cas9, thanks to a second interference proceeding now winding its way through the Patent Trial and Appeal Board.

Also “new” heading into 2020 is a wave of consolidation among gene therapy contract developers and manufacturers; and new concerns among investors as both mergers and acquisition activity and venture capital investment slow down (yet remain strong compared to some recent years), reflecting a cooling of financial markets also reflected in postponement of some IPOs, one of which was launched after being scaled down significantly.

Below is a list of eight biopharma-related trends cited by experts and others with a stake in the industry, as articulated in interviews with GEN, or in reports and other public statements.

Click here to read more via genengnews.com

BioBuzz: Kite Energizes Maryland’s Cell Therapy and Biomanufacturing Community Around Mission to Cure Cancer

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In May of 2018 Kite Pharma, a Gilead Company, announced the opening of a new Neo Antigen Facility in Gaithersburg, MD. Less than one year later in April of 2019, the company, announced that it was building a new biomanufacturing facility on a 20-acre site in Frederick, MD. Since then, Kite has been diligently working to build a world-class leadership team at both sites to achieve an important mission.

Those leaders are now onboard and are out sharing their important mission by engaging the regional community to recruit and hire the talent they need to fill more than 360 job openings across Maryland..

This November, in one of its first regional community events, Kite sponsored a BioBuzz ‘Meet and Greet’ networking event to get their message out to the local industry.  A few dozen of Kite’s employees, including Chris McDonald, VP of Manufacturing and Frederick Site Head, and Wayne Hardy, Senior Director of Manufacturing and Site Head at Kite’s Neo Antigen Facility, shared the powerful, patient-focused “why” behind Kite’s mission.

“Kite is pleased and happy to be part of this community. We’re here to make a difference. We’re on a mission to cure cancer,” stated Hardy.

“There are a lot of people out there who are suffering… there is probably not a single person in this room untouched by cancer. Think about 10 years from now. You could be telling your kids or grandkids ‘I was part of the team focused on the cure.’ That’s why we’re here in this room right now,” he added.

Click here to read more via BioBuzz

Maryland VC totals ‘rebound’ with $226M raised in Q2

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Venture funding raised by Maryland companies took a big jump in the second quarter of the year, as companies in the state raised a total of $226 million.

That’s a 180% increase over the first quarter total of $80 million, according to data from a PwC/CB Insights MoneyTree report. The number of deals also increased, from 19 in the first quarter to 21.

When it comes to overall totals, it marked a “a significant rebound for the state,”  said Brad Phillips, a director in PwC’s Emerging Company Services practice. It came after totals dipped in Q1 coming off a year in 2018 that saw the highest VC haul since 2001.

It also followed an overall trend that makes judging a single quarter difficult, as Maryland consistently sees up-and-down totals from quarter to quarter in the region.

Phillips also noted that three of the top five deals in the region were for Maryland-based companies, as well as 62% of the funding and more than half the number of deals within the DMV region. Those three biggest deals all came from Gaithersburg-based companies in the form of a $75 million Series B investment in biotech company Viela Bio, a $50 million Series B for on-demand manufacturing marketplace Xometry and a $22 million Series C for biopharmaceutical company Sirnaomics. Overall, the state ranked 12th in the U.S. for number of dollars invested and 11th for number of deals.

Read more via Technical.ly Baltimore.

Viela Bio Closes $75 Million Series B Financing

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Funding to support regulatory filing and pre-commercial planning for lead product candidate, inebilizumab, and to advance development of additional clinical candidates targeting autoimmune and inflammatory diseases

Financing led by HBM Healthcare Investments

Gaithersburg, MD—June 17, 2019 – Viela Bio today announced the successful completion of a $75 million private placement of its Series B preferred stock, bringing the total capital raised since the Company’s launch in February 2018 to more than $300 million. The financing round was led by HBM Healthcare Investments, and additional new investors participating included Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs, and Barer & Son Capital. Existing investors participating included Temasek.

“We are pleased that our ongoing development of our clinical programs continues to attract capital from leading healthcare investors. This financing will support our upcoming regulatory milestone—the anticipated filing of our Biologics License Application with the U.S. FDA for our lead product candidate, inebilizumab, for the treatment of neuromyelitis optica spectrum disorder, or NMOSD,” said Bing Yao, Ph.D. Executive Chairman and Chief Executive Officer. “NMOSD is a severe, debilitating, and sometimes fatal neurological disease for which there is currently no approved treatment. While our priority is to serve this patient population through the successful approval and launch of inebilizumab, we believe this financing also puts us in a strong position to pursue additional new indications with inebilizumab. Furthermore, we believe this financing will allow us to advance the entirety of our clinical pipeline, which is comprised of several additional clinical candidates for a range of rare autoimmune and inflammatory diseases.”

Click here to read more via Viela Bio.

Emmes-Supported Study Results in the First Pediatric Drug Labeling Change for 2019

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ROCKVILLE, Md.April 2, 2019 /PRNewswire/ — Emmes today announced that it provided the data management support for a study, funded by the National Institutes of Health (NIH) and approved by the Food and Drug Administration (FDA), to safely use Acyclovir to treat infants infected with the Herpes Simplex Virus. Acyclovir, known by the brand name Zovirax, now includes recommended usage and dosage for newborns and infants up to three months of age on its label.

The Best Pharmaceuticals for Children Act (BPCA) mandates that NIH prioritize therapeutic areas in critical need for pediatric labeling, sponsor pediatric clinical trials, and submit the data to the FDA for consideration for labeling changes. The clinical trials are sponsored by the National Institute of Child Health and Human Development (NICHD), with the labeling reviews and approvals administered by the FDA.

In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: “With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients.”

Newborns can become infected with the virus during pregnancy, labor and delivery, or shortly after birth if the mother develops genital herpes near the end of her pregnancy. The Herpes Simplex Virus in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.

Emmes has served as a data coordinating center for the BPCA contract since August 2009. This entails study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses.

Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This is one of our  largest contracts and one that our Emmes team is extremely proud to support. Our role as a data coordinating center is a critical step in the process to study drugs and therapies used for infants and children and determine whether drug labeling updates are needed.”

Click here to read the entire release.

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