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Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.

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GlaxoSmithKline’s experimental drug GSK095 is designed to work in tandem with checkpoint inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a preclinical trial of a related GSK drug suggest that the combo holds promise in treating pancreatic cancer—so much so that the company is launching a phase 1 study of the drug in combination with Merck’s blockbuster PD1 checkpoint inhibitor Keytruda.

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2018 was undoubtedly one of the most important years ever for biopharma, setting records for valuations and dealmaking. But a paper published in January called some of that exuberance into question, noting that many startups over the years have managed to become unicorns – with valuations of $1 billion or more – despite having little or no published, peer-reviewed data.

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Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced additional positive data from a Phase 2 extension study of its NasoVAX intranasal influenza vaccine candidate. Data from this study demonstrated that 100% of the evaluated subjects remained seroprotected, and the seroconversion rate was unchanged more than one year after vaccination.

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Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced that it has applied the CE mark to PGDx elio™ plasma resolve. It is the first kitted plasma-based NGS oncology test to have that certification, enabling greater access to genomic testing for cancer patients in Europe.

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Innovation is a principal driver of U.S. economic growth. In 2019, the U.S. will spend an estimated $581 billion on research and development — more than any other country in the world and about 25% of the world’s total — helping the nation rank No. 6 on the Global Innovation Index. According to the results of the ranking, knowledge and technology outputs are America’s particular strengths.

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It all begins at birth. That’s the starting point for Kurt Newman as he shares his poignant journey as a pediatric surgeon. Newman offers a new perspective for approaching the most chronic and debilitating health conditions. Against a backdrop of personal challenges and patients who overcame impossible odds, we learn to appreciate the importance of treating every child with early customized care, and an eye for the future.

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BioTalk Host Rich Bendis sits down with Anne Lindblad, Ph.D., President, and CEO of Emmes, to discuss her view of the region, her history with the company, and their mission, vision, and values.

Anne Lindblad, Ph.D., joined Emmes in 1982 as a Biostatistician and is currently the President and CEO. She has supported clinical research throughout her career, serving as Principal Investigator of projects spanning diverse disease areas, including neurology, ophthalmology, oncology, dialysis, transplantation, speech and hearing, and dentistry. Dr. Lindblad has been an NIH reviewer on multiple project applications for NINDS, NEI, NICHD, NIDCR, NIDDK, and NCCAM and has served as a member or chair of several Data and Safety Monitoring Committees for NEI, NIAAA, NIDDK, and NINDS. She was a member of an Advisory Committee charged with drafting policy to shape the appropriate planning and conduct of intramural studies at NIH. She was elected to the Board of Directors for the Society for Clinical Trials (2003-2006) and served as Program Chair (2002), as an Officer (2006-2014), and as President (2012-2013). Dr. Lindblad was selected to serve on NIH’s National Advisory Dental and Craniofacial Research Council from 2004 through 2008. She has taught courses in best practices in clinical trial design and conduct for ophthalmologists, neurologists, and immunologists. She has published and presented over 100 manuscripts in peer-reviewed journals and conferences. Dr. Lindblad joined the Board of BioHealth Innovation in 2018.  Emmes has grown from 15 employees in 1982 to over 650 globally. In 2019 Emmes announced a significant investment by Behrman Capital which will allow Emmes to gain access to new tools, talent, service offerings, and expanded footprint faster than what Emmes might otherwise have accomplished.

Listen now on iTunesGoogle Play, and TuneIn

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Eargo, a direct-to-consumer health technology company that is destigmatizing hearing loss through innovation, announced it raised $52 million in Series D funding from existing investors New Enterprise Associates (NEA), the Charles and Helen Schwab Foundation, Nan Fung Life Sciences, and Maveron. And new investor Future Fund also participated in this round.

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Alexandria Real Estate Equities, Inc. ("Alexandria" or the "Company") (NYSE: ARE) today announced that it has priced a public offering of $200,000,000 aggregate principal amount of 4.000% senior notes due 2024, $350,000,000 aggregate principal amount of 3.800% senior notes due 2026 and $300,000,000 aggregate principal amount of 4.850% senior notes due 2049. Goldman Sachs & Co. LLC, Citigroup Global Markets Inc., J.P. Morgan Securities LLC and SMBC Nikko Securities America, Inc. are acting as joint book-running managers in connection with the public offering and Barclays Capital Inc., BB&T Capital Markets, a division of BB&T Securities, LLC, BBVA Securities Inc., BNP Paribas Securities Corp., Capital One Securities, Inc., Evercore Group L.L.C., Fifth Third Securities, Inc., Mizuho Securities USA LLC, PNC Capital Markets LLC, RBC Capital Markets, LLC, Regions Securities LLC, Samuel A. Ramirez & Company, Inc., Scotia Capital (USA) Inc., SunTrust Robinson Humphrey, Inc., TD Securities (USA) LLC, U.S. Bancorp Investments, Inc. and Wells Fargo Securities, LLC are acting as co‑managers in connection with the public offering.

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Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health.

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  • PR and Marketing – What’s the difference?
  • How do you establish your brand?
  • Are their tips for marketing on a tight budget?
  • What should an effective marketing plan include?
  • How can a strong digital strategy build credibility?
  • How can I get press coverage for my product/service/technology?
  • What type of budget is realistic for marketing/public relations activities?

Learn the answers to these questions and more through the April 4th PathFinder Innovation Program. (There is no charge to attend in person or by videoconference, however, pre-registration by NOON, 4/2 is required).

8:15 a.m. Networking and Coffee
8:30 a.m.  – Issues Overview and Discussion (in person/by videoconference)

  • Pam Clark, Principal, Creative Director - Clark Concepts
  • Warren Ellis, VP of Marketing, Montgomery County Economic Development Corp.
  • Rachel Wojnilower, Digital Marketing Manager – Clark Concepts
  • Jennifer Owers, WebDesigner/Project Manager – Clark Concepts

9:45 a.m. – 1:1 Office Hours (in person/by videoconference)*

This program is cosponsored by BioHealth Innovation, Launch Workplaces, and TEDCO. It is open to anyone in the BioHealth Capital Region.  

To register/for more information, email:  BHI@BioHealthInnovation.   (Please include in your RSVP:  Your company name, your title and contact information, the type of product(s) services you are promoting, and your interest in a 1:1 meeting following the overview session.)

*Attendance at Overview in person/by videoconference is required to participate in 1:1 sessions.

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Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration for its EchoSure device to deliver definitive blood flow data on demand.