ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

Driven entrepreneurs and savvy startup leaders participated in the recent “Fueling an Innovation Ecosystem for Startups to Thrive” webinar that featured prominent connectors and innovators from the BioHealth Capital Region (BHCR). The virtual event was sponsored by WorkForce Genetics and covered a wide range of topics including the pandemic, critical regional resources for startups, advice for approaching investors and a list of the biggest mistakes made by entrepreneurs when seeking funding.

Manassas, VA - On June 17, 2020, Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients. The Principal Investigator is Serpin Pharma’s collaborator,

Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, "SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection."

Deloitte has launched the Life Sciences Catalyst in Cambridge, a collaborative platform enabling organisations in the biotech, medtech, pharmaceutical and technology sectors, as well as prospective investors, to come together to tackle the biggest challenges facing their industries.

The Life Sciences Catalyst will facilitate connections between people, businesses and investors to support companies with their growth, regardless of their evolutionary stage.

ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

The proof-of-concept, randomized, multicenter, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

To limit the spread of Covid-19, the U.S. Centers for Disease Control and Prevention recommends that individuals practice social distancing. When local conditions allow for retail stores to open, they confront a variety of guidelines that vary by state. For example North Carolina places specific limits on the number of customers allowed per square foot, while Oregon generally advises that the number of customers in the store should be limited so that customers can remain six feet apart. Whether or not customers are required by law to wear masks in stores depends on the state. How retailers implement these guidelines also varies among types of retailers and even within store categories. Grocery stores, for example, have adopted a wide variety of specific methods to ensure that customers remain apart.

Virologist Andrew Pekosz has a team of 15 people working around the clock in his lab at the Johns Hopkins Bloomberg School of Public Health supporting work on a potential treatment for COVID-19. Pekosz’s lab is testing the blood of coronavirus survivors for plasma antibodies that researchers think might help treat critically ill coronavirus patients.

Image: Nekeshia Maloney, JHTV's director of contracts

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google https://bit.ly/3hz2jpU, Apple https://apple.co/3eYLiUs, Spotify https://spoti.fi/3f3cqBU, TuneIn https://bit.ly/302voUG, and YouTube (Audio Only) https://bit.ly/3f3cQZ0

Today, July 22nd, a virtual summit was hosted by KidneyX to announce the six winners of the Redesign Dialysis Phase 2 prize. The goal of the Redesign Dialysis prize is to provide prize money for novel ideas and innovations that will lead to better outcomes for people with kidney diseases and eventually to a truly artificial kidney. The eventual artificial kidney and innovations made along the way will lead to better outcomes for individuals with kidney diseases and improve their quality of life by bypassing in-center hemodialysis.

BALTIMORE, July 23, 2020 /PRNewswire/ -- Vita Therapeutics, Inc. announced today that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne's Muscular Dystrophy (DMD).

VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. The company plans to continue to progress this treatment towards clinical trials and plans to bring it forward for other congenital muscular dystrophy diseases as well. This therapy was exclusively licensed from technology originally invented at Johns Hopkins University and the Kennedy Krieger Institute in the labs of Dr. Kathryn Wagner and Dr. Gabsang Lee.

D.C. is requiring people making travel into Washington from 27 states to self-quarantine because of new surges in Covid-19 cases.

The order went into effect Monday.

Montgomery College announces several pop-up, remote classes which could be valuable for you and your teams: :

• Sustaining Resilience MGT632 (crn#16869), August 5, 2020, 
• Leading Through Change, MGT633 (crn#16870), August 14, 2020 
• Strengthening Effective Communication, MGT634 (crn#16871), August 19, 2020

All three classes are structured remote from 8:30 a.m. to 12:30 p.m. and cost only $129.

Course descriptions may be found on the Summer 2020 Popup Classes Flyer (PDF, Get Adobe Acrobat PDF Reader.-Link opens in new window.) .

Registration information may be found at WDCE Registration Options.

NEW YORK – Liquid biopsy firm Creatv MicroTech is developing a diagnostic platform that measures the amount and size of specific circulating stromal cells called cancer-associated macrophage-like cells (CAMLs) to identify traces of cancer in a patient’s bloodstream.

The Potomac, Maryland-based company initially plans to commercialize the method, called LifeTracDx, to predict immunotherapy response in stage II to III non-small cell lung cancer (NSCLC) cancer patients.

Researchers from AstraZeneca, the University of Oxford, and its spinout company Vaccitech today published preliminary Phase I/II data showing their closely-watched COVID-19 vaccine candidate AZD1222 (formerly ChAdOx1 nCoV-19) to have an acceptable safety profile, and favorable immunogenicity against the virus.

“A single dose elicited both humoral and cellular responses against SARS-CoV-2, with a booster immunization augmenting neutralizing antibody titres. The preliminary results of this first-in-human clinical trial supported clinical development progression into ongoing phase 2 and 3 trials,” the researchers concluded in Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial, published today in The Lancet.

“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features Sara Nayeem, M.D., a Partner at New Enterprise Associates (NEA)

Sixteen finalists are announced in the "Make Your Medical Device Pitch for Kids!” special COVID-19 edition competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in COVID-19-related pediatric medical devices, the finalists will compete in a virtual pitch event held on July 20,2020. Winners will receive grant awards of up to $50,000.

As we embark on our third fund at LionBird, we believe that proactively thinking deeply about what will drive the next decade of healthcare will help us both filter through the noise of digital health, and quickly identify the right investment opportunities. We believe that 2020 represents an unprecedented inflection point in digital health (due to both the COVID-19 global pandemic, as well as many other factors) and we aim to define the trends for the coming decade and their implications for our investment strategy.

Facial temperature detection, campus heatmaps: They’re among the tools in a collection of apps created by teams from within the University System of Maryland over the last month to help limit the spread of COVID-19 — and navigate a society that has changed quickly in the pandemic.

In all, six apps were selected as winners of the USM COVID App Challenge, which was issued at the end of May to galvanize the creation of new tools to respond to the pandemic.

Image: AnTech, developed by Andrew Karam of University of Maryland College Park. (Screenshot via YouTube/AnTech)

Altimmune Inc. is making progress on its Covid-19 vaccine more than four months after jumping into that arena.

The Gaithersburg biopharma said Monday it has emerged from preclinical trials with positive results, positioning the clinical-stage company to start manufacturing the candidate, called AdCovid, in the third quarter of this year and start a phase 1 clinical trial in the fourth quarter.

Image: Dr. Vipin Garg is president and CEO of Altimmune. COURTESY ALTIMMUNE

The search for a cure for Covid-19 is lining the pockets of some landlords.

While the pandemic wreaks financial havoc on hotels and retailers, landlords who cater to biotech and pharmaceutical tenants are seeing increased demand as companies research treatments for the coronavirus, according to the Wall Street Journal. The work of those tenants, too, is more difficult to replicate in a work-from-home setup than the typical office employee.

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. 

Image: Emergent launched a phase 3 trial on NuThrax in March last year; that study is on track to finish by the year's end. (FiercePharma)  - https://www.fiercepharma.com

NEW YORK — The US House of Representatives Appropriations Committee on Monday approved a roughly $5.5 billion increase in funding for the National Institutes of Health in fiscal 2021, with budget increases for every institute and center.

The committee recommended a total of $46.96 billion in NIH funding for FY 2021, representing a nearly 13 percent increase over its current $41.68 billion budget. Earlier this year, President Donald Trump called for trimming the NIH's FY 2021 budget to $38.37 billion.

A lively discussion between our region’s top innovators and connectors to hear about their efforts to help grow the innovation ecosystem and the pipeline of successful startups across the BioHealth Capital Region.

https://www.youtube.com/watch?v=Dn51Ga8jLrI&feature=youtu.be

Fourteen businesses in New Jersey’s technology, life sciences, and clean energy sectors received a combined $12.3 million from 50 investments approved through the state’s Angel Investor Tax Credit Program during the first half of 2020, the New Jersey Economic Development Authority (NJEDA) announced yesterday. Two of the approved companies benefited from legislation signed by Gov. Phil Murphy last year expanding the program.

The theme of the 25th CBA Annual (Virtual) Conference is "Innovations amid Crisis: A Productive Year of Biopharma Industry". We will invite biopharmaceutical industry leaders, regulatory and scientific experts from US, China, and Canada to discuss recent research advances on COVID-19, and new trends in biopharma industry. The detailed conference program will be available at www.cba-usa.org shortly.

Time:

Day 1: 8 am – 11 am (EST), August 29th, 2020 (Saturday)

Day 2: 8 am – 11 am (EST), August 30th, 2020 (Sunday)

Registration link: https://bit.ly/2WfpRrR

The finalists are sourced from nominations and editorial coverage, and selected by the DC Inno team.

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the appointment of Dr. Joyson Karakunnel as Executive Vice President and Chief Medical Officer (CMO). Dr. Pierre Dodion, CMO since 2014, is retiring from this position.

Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. As CMO, he will be responsible for advancing Innate’s clinical pipeline and will lead a global team focused on clinical strategy, patient safety, regulatory and medical affairs.

Emergent BioSolutions revealed this week plans to expand its viral vector and gene therapy capabilities.

The company announced it will invest $75 million in its Canton, Mass., facility, which is focused on the contract development and manufacturing (CDMO) of drug substances for live viral vaccines, including the company’s smallpox vaccine

Healthcare stakeholders can no longer lag on digital transformation, and tapping into innovation can sate convenience-hungry consumers and tackle some massive challenges compressing their bottom lines.

Personalization and convenience have become table stakes in nearly every industry, and consumers are extending demands for these digital-powered experiences to healthcare — US consumers have expressed a willingness to jump ship to care services that can provide them with better digital experiences. 

Image: Business Insider Intelligence

The raise is one of the biggest in the Triangle since last year.

Scientists have responded to COVID-19 with unprecedented speed. Just months after the outbreak of the novel coronavirus, clinical trials are already underway for nearly 200 vaccines and therapies.  

But while the pace of COVID-19 innovation may be extraordinary, the research infrastructure allowing this remarkable work is hardly new. In fact, it was cemented into place nearly two generations ago when Congress passed the Bayh-Dole Act of 1980.

This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

ROCKVILLE, Md., July 13, 2020 /PRNewswire via COMTEX/ -- ROCKVILLE, Md., July 13, 2020 /PRNewswire/ -- ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy.