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June 21, 2017

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Today's Rundown

  1. Gottlieb’s FDA to rethink targeted therapy regulation to speed development, drive down healthcare costs

  2. Cash-strapped ImmunoCellular halts brain cancer vaccine trial, eyes 'strategic alternatives'

  3. Flagship-backed Rubius raises $120M to take off-the-shelf red blood cell cancer therapeutics into the clinic

  4. [Sponsored] PAREXEL’s Connected Journey™ of Data-Driven Services

  5. Apple Tree helps Big Apple biotech Syntimmune in $50M series B

  6. Sarepta signs another Duchenne gene therapy pact as it aims for wider treatment

  7. Merck, Illumina back immune-mapper SerImmune in $8M round

  8. Faster patient enrollment gets Veristat long-term deal with AOBiome

  9. IBM grows Baheal deal to bring Watson genomics to China

Featured Story

Gottlieb’s FDA to rethink targeted therapy regulation to speed development, drive down healthcare costs

The FDA is working on a medical innovation development plan designed to lower healthcare costs by streamlining the path to market for targeted therapies and other novel drugs. Commissioner Scott Gottlieb, M.D., pitched the plan as a broad drive to ensure the FDA has the tools and policies to encourage and evaluate innovative therapies.

Top Stories

Cash-strapped ImmunoCellular halts brain cancer vaccine trial, eyes 'strategic alternatives'

ImmunoCellular Therapeutics has been forced to suspend a phase 3 trial of its lead cancer vaccine, ICT-107, after failing to raise the funds it needs to complete the study.

Flagship-backed Rubius raises $120M to take off-the-shelf red blood cell cancer therapeutics into the clinic

Rubius Therapeutics has raised $120 million to take two of its off-the-shelf red blood cell therapies into the clinic. The Flagship Pioneering-backed biotech is using its method for expressing proteins on allogeneic red blood cells to create candidates that hit multiple immuno-oncology targets.

[Sponsored] PAREXEL’s Connected Journey™ of Data-Driven Services

How PAREXEL's New Ecosystem of Technology, Processes and Expertise is Transforming Drug Development

Apple Tree helps Big Apple biotech Syntimmune in $50M series B

New York biotech Syntimmune has got off a beefy $50 million series B round as it looks to use the funds for its FcRn biology tests.

Sarepta signs another Duchenne gene therapy pact as it aims for wider treatment

Sarepta Therapeutics has penned its second DMD gene therapy pact this year as it announces a tie-up with France’s Genethon, a nonprofit R&D org.

Merck, Illumina back immune-mapper SerImmune in $8M round

SerImmune, whose technology maps the human antibody repertoire, rounded up $8 million from Merck, Illumina Ventures and unnamed investors. The funds will drive the expansion of the company’s immune mapping platform and antibody repertoire database.

Faster patient enrollment gets Veristat long-term deal with AOBiome

Microbiome startup AOBiome first tapped Veristat to help run a phase 2 study that tests its ammonia-oxidizing bacteria for the treatment of hypertension, and after Veristat finished enrollment earlier than expected, AOBiome decided to extend the collaboration.

IBM grows Baheal deal to bring Watson genomics to China

IBM and Baheal Pharmaceutical have moved quickly to expand their relationship. Weeks after IBM gave Baheal a starring role in selling its Watson for Oncology product in China, Big Blue has penned a similar deal covering its molecular data interpretation technology.

News of Note

Eisai says its study of lorcaserin will "continue as planned" after the DMC signed off on an interim safety review of the trial. Statement

Blood disease biotech Tolero Pharmaceuticals says it is adding European study centers to its ongoing midstage test for alvocidib in MCL-1-dependent relapsed/refractory acute myeloid leukemia. Release

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[Webinar] Going Digital: Connecting Submission Documents and Regulatory Data

Hear three innovative leaders explain how regulatory can “go digital” in their operations by leveraging the data-handling capabilities in their RIM systems.

[Webinar] Outsourcing complex microsurgeries – is it worth the risk?

Performing a sophisticated surgery to create a myocardial infarction model. Join us on June 7th at 11:00 AM EDT.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

[Webinar] Leveraging Medical Insights for Better Healthcare Engagement

Join this global webinar to learn a new approach for demonstrating medical affairs' impact with better metrics - beyond reach and frequency, enabling launch success and better engagement with strategic KOL insights, and increasing your organization's share of voice in the healthcare landscape.

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[Whitepaper] DocuSign Life Sciences eBook: Reducing Cycle Time with Digital Transaction Management

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[Whitepaper] Streamline Regulatory Compliance in Life Sciences with Digital Transaction Management

The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

Events

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