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Let’s be clear: Martine Rothblatt is just plain more of a lawyer than anybody else in this town.

The 60-year-old grandmother and CEO of United Therapeutics, the Silver Spring-based biotech she founded to help save her younger daughter’s life, banked $38 million last year. It made her the nation’s highest-paid female executive. It also made her the nation’s highest-paid transgendered person, as she had sex reassignment surgery in 1994.

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The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about. “Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency's FDA Voice blog.

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The world of technology is growing at a rapid pace, nothing new, but next year could involve some major cashing in for some health tech industries. With the help of some leading analyst firms, Business Insider put together a list of the trends that are predicted to be really booming next year.

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Evolva Holding SA (“Evolva”, SIX: EVE) today announced that Emergent BioSolutions Inc. (“Emergent”, NYSE: EBS) has acquired Evolva’s anti-bacterial programme, the EV-035 series. The lead compound in the EV-035 series is the broad-spectrum antibiotic GC-072, which is being developed with US government biodefense funding. For Evolva, this transaction is worth up to USD 70.5 million plus royalties.

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Healthcare workers treating Ebola victims are at a great danger of contracting the disease, as recent events in western Africa have shown. Currently available protective suits tend to require complicated procedures when putting on and taking off, are difficult to breathe in, and obscure the clinician’s face. A team at Johns Hopkins has developed, and just won a grant from the U.S. Agency for International Development (USAID) to further perfect, a new protective suit for use when treating highly infectious patients.

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Cathal Garvey used to work in cancer research. Now he is the scientific director of IndieBio, a biotech accelerator based in Cork, Ireland which is about to open a branch in San Francisco. Garvey originally studied genetics. "I got into genetics after seeing a documentary about it when it was quite young." he says."I had already decided that I was going to be a biologist at an even younger age. And then I thought ‘Oh my God, living things operate on a code.’"

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Maryland is not waiting for the new year or a new governor to start taking applications for a program intended to boost business development around colleges and universities.

The state is now taking applications for its new Regional Institution Strategic Enterprise Zone program(called the "Rise Zone" program for short). It requires two application stages.

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Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015. 

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NHLBI is soliciting applications from small businesses to develop and validate novel in vitro human cell-based tools for predicting the responses of individual patients to cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics for cystic fibrosis (CF) lung disease. Proposed research projects are expected to focus on the development of highly innovative cell-based systems that recapitulate a patient-specific CFTR phenotype to create a personalized study platform to examine response to CFTR-directed therapeutics. The models developed must be based on live cells from humans harboring CFTR mutations associated with CF. While the primary goal of this initiative is to promote precision medicine and optimization of treatment at the personal level, it may also yield as a secondary benefit the ability to select appropriate treatments for CF at an earlier age.

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Stem cell-derived blood and platelet products have the potential to meet critical medical needs. Remaining challenges exist in both the manufacturing process and additional discovery research. The manufacturing process needs to be made more efficient and cost-effective while assuring the effectiveness and safety of the blood products and enable their commercial viability. RFA-HL-15-022 supports R01 grants to address the basic or early translational research needs whereas RFA-HL-15-029 and RFA-HL-15-030 support small business awards to enable further advances in the manufacturing processes (tools and technologies) to take advantage of the existing knowledge and recent advances in the field to produce safe and functional blood and platelet products at reduced costs.

Barbara Mikulski

Chairwoman of the Senate Appropriations Committee and the Commerce, Justice, Science (CJS) Appropriations Subcommittee, today announced the Consolidated and Further Continuing Appropriations Act of 2015 provides increased funding to support American jobs and innovation, including funds for trade and economic development programs, and investment in scientific research and exploration.

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Building a biotechnology startup is a lot like getting a private university education: To make progress, you have to get past the high-cost barrier to entry.

First and foremost, biotech requires expensive clinical studies and the use of state-of-the-art manufacturing facilities.

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On October 9, 2014, the Investment Advisory Committee of the SEC issued its much awaited recommendations on the "Accredited Investor" definition of Regulation D of the '33 Act. This is in response to the SEC's Request for Comments on the definition of "Accredited Investor" in its release relating to Proposed Rules for Regulation D and Form D, which mainly related to general solicitation (for the full text of that release, see here).

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ATCC, the premier global biological materials resource and standards organization, and LGC, a leading global producer and distributor of reference materials and proficiency testing (PT) programs, announce a new agreement to provide high-quality proficiency testing programs supporting the food, beverage, animal feed, and pharmaceutical quality control markets in the United States.

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Bedsores, diabetic ulcers and other chronic wounds cost the U.S. health care system $30 billion a year. Why? At least in part because the primary tool doctors and nurses use to track wounds is a basic ruler.

A ruler can measure the size of a wound, but does little to track other important qualities, such as changes in shape and tissue color. Consider that patients are usually cared for by a rotating team of nurses, who may each interpret a wound's appearance differently, and it's easier to see how so much money is spent tending to preventable (or at least treatable) conditions.

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Pieris AG announced today the initiation of a Phase I clinical trial with PRS-080, an anti-hepcidin Anticalin® therapeutic protein designed to treat anemia. The trial is a placebo-controlled, single ascending dose evaluation of the compound's safety and tolerability in healthy volunteers. Conducted in Germany, the trial is underway and patients from the first cohort have been dosed.

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Hospitals are on the hunt for new ideas to transform health care, and some are looking to reality television for inspiration.

Several health care institutions recently have tested TV’s “Shark Tank” approach to seeking out innovation — gathering a panel of pros to hear invention ideas from startups.

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Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices:

  • Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • Reminder for the Extramural Scientific Community: Implementation of the Genomic Data Sharing Policy Begins January 25, 2015
  • Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns
  • NIH Modification to Guidance on Marking Changes in Resubmission Applications
  • Update: New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After May 25, 2015
  • Notice of NHGRI Participation in PA-14-015 "Ruth L. Kirschstein NRSA Institutional Research Training Grants (Parent T32)" and Establishment of New Training Program in the Ethical, Legal and Social Implications of Genetic and Genomic Research
  • Notice of Additional Due Date and Correction for RFA-HG-14-005 "Revisions to Add Biomedical Big Data Training to Active Institutional Training Grants (T32)"
  • Notice of Change to Instructions for Senior/Key Personnel in the Overall and Project Components of PAR-13-316 "NHLBI Program Project Applications (P01)" 
  • Request for Information (RFI): Challenges and Opportunities for Exploring and Understanding the Epitranscriptome

Requests for Applications:

  • Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (R41)
    • (RFA-HL-15-026)
    • National Heart, Lung, and Blood Institute
    • Application Receipt Date(s): February 9, 2015 and November 9, 2015
  • Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (R43/R44)
    • (RFA-HL-15-027)
    • National Heart, Lung, and Blood Institute
    • Application Receipt Date(s): February 9, 2015; November 9, 2015; and November 9, 2016