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Top 25 Biotech Companies of 2018

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While several biopharma giants (including Amgen, Novartis, and Merck & Co.) reported third-quarter earnings that beat expectations in recent days, biotechs appear to have been caught up in the past month’s stock market swoon. As of October 26, according to Zacks Equity Research, the stock prices of companies in its “medical-biomedical and genetics” sector, which includes smaller as well as larger biotechs, had fallen 10.3% over the previous six months, compared with a 1.6% increase for the overall S&P 500.

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2018’s Fiercest Women in Life Sciences – FiercePharma

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Things are looking up for women—or so they seem. In the era of #MeToo, more and more women are speaking up about workplace harassment and discrimination, and the perpetrators are increasingly held accountable. Industry groups, like the Biotechnology Innovation Organization (BIO), and states, such as California, are implementing rules to increase the proportion of women on corporate boards.

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Getting Paid for Your BioHealth Innovation – Reimbursement Planning (11/14)

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  • bhi-updated-logo-2017How do you obtain coverage and payment for your technology?
  • Is the process different for medical devices from diagnostics or therapeutics?
  • Can digital apps be reimbursed?
  • How do I work with bundled payments?
  • What is the process for securing reimbursement codes?  Do I need different strategies based upon the point of care?
  • How much do I need to budget for a reimbursement strategy?  When do I need one?
  • How to I talk to investors about my reimbursement strategy? 

Learn the answers to these questions and more through the November 14th PathFinder Innovation Program. (There is no charge to attend in person or by videoconference, however, pre-registration by NOON, 11/13 is required).

  • 8:15 a.m. Networking and Coffee
  • 8:30 a.m.  – Issues Overview (in person/by videoconference)
    • Speakers:  Brian Abraham, Founder, Lara Reimbursement Advisory
    • Luis Gutierrez, Entrepreneur-in-Residence, NHLBI and BioHealth Innovation
  • 9:30 a.m. – 1:1 Office Hours (in person/by videoconference)*

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

To register/For more information, email:  BHI@BioHealthInnovation.  (In person 1:1 scheduling:  www.tinyurl.com/BHIappointments.)

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

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Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations

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A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now. The transition to FORMS-E allows NIH to track SBIR Direct-to-Phase II applications using a new check-box on the SBIR/STTR Information Form for Direct Phase II

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Cerecor Announces Submission of Three Orphan Drug Designation Requests for Substrate Replacement Therapies to treat Congenital Disorders of Glycosylation

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Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) three Orphan Drug Designation (ODD) Requests for substrate replacement therapies to treat ultra-rare inherited metabolic disorders known as Congenital Disorders of Glycosylation (CDGs).

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How the Biopharmaceutical Industry Contributes to Open Scientific Knowledge – ITIF

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Price controls under consideration by the administration would reduce the biopharmaceutical industry’s investment in R&D, which would slow the pace of drug discovery. It would also damage the life science innovation ecosystem because biopharma firms contribute to knowledge sharing, including through university research in all 50 states, scientific publications (over 12,500 in 2017 alone), and other activities designed to develop and disseminate discoveries.

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