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June 26, 2017

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Today's Rundown

  1. Roche’s emicizumab cuts bleed rate by 87% in hemophilia A

  2. Langer’s Kala files for $86M IPO to bring eye drug to market

  3. Matinas BioPharma slumps on phase 2 flop despite positive PR

  4. [Sponsored] Getting cancer vaccines right: Key challenges and solutions for neoantigen identification

  5. Neothetics decimated by submental fat failure test

  6. Alnylam heads for phase 3 with acute porphyria program

  7. Philips unveils IntelliVue X3 to round out patient monitoring

Featured Story

Roche’s emicizumab cuts bleed rate by 87% in hemophilia A

Roche has released a closer look at the data it hopes will propel hemophilia A drug emicizumab to blockbuster status. Emicizumab cut the bleed rate by 87% in patients with inhibitors to factor VIII and aced all the secondary endpoints, leaving lingering concerns about side effects as the main barrier between Roche and big sales.

Top Stories

Langer’s Kala files for $86M IPO to bring eye drug to market

Kala Pharmaceuticals has filed to list on Nasdaq. The ophthalmic drug R&D shop has penciled in a fundraising goal of $86 million to equip itself to file for approvals of corticosteroid nanosuspension KPI-121 in two indications.

Matinas BioPharma slumps on phase 2 flop despite positive PR

Small cap biotech Matinas BioPharma was off by nearly 50% premarket on data coming out of its midstage vulvovaginal candidiasis candidate.

[Sponsored] Getting cancer vaccines right: Key challenges and solutions for neoantigen identification

Neoantigen-based cancer vaccines represent new, truly personalized therapeutic approaches to treating cancer.

Neothetics decimated by submental fat failure test

It was a short and bitter update out of San Diego’s Neothetics today after it said a phase 2 proof-of-concept study for its fat reduction therapy flopped.

Alnylam heads for phase 3 with acute porphyria program

RNA interference specialist Alnylam has hit the accelerator on its candidate drug for ultrarare porphyria diseases, prepping for phase 3 trials later this year after unveiling initial results in 12 patients.

Philips unveils IntelliVue X3 to round out patient monitoring

Philips is introducing its IntelliVue X3 patient monitoring system in Europe. The device is designed to monitor vitals at the bedside and when patients are being moved between locations to cut the risk of data loss.

News of Note

Verastem has posted new data from long-term follow-up of its phase 2 test of duvelisib on subsets of patients with follicular lymphoma or small lymphocytic lymphoma. Release

Former Vice President Joe Biden and Jill Biden launched the Biden Cancer Initiative, their new venture aimed at treating and preventing cancer in new and innovative ways. Statement

Synlogic says it has been handed a fast-track tag from the FDA for its lead product candidate, SYNB1020, for the rare disorder hyperammonemia. Release

Resources

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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

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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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