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September 28, 2017

Today's Rundown

  1. Novartis, UC Berkeley join forces for ‘undruggable’ targets

  2. Zynerba soars on Fragile X data

  3. Cancer, gene therapy biotechs raise $303M in IPO bonanza

  4. [Sponsored] Mindful Clinical Trials: What’s Risk-Based Monitoring Got to Do With It?

  5. RNA biotech Arcturus backs onto Nasdaq in Alcobra deal

  6. Biotech researchers chart progress in fighting substance abuse

  7. The thinking process behind biopharma companies’ outsourcing management

  8. Senators jump on Allergan's 'blatantly anti-competitive' Restasis licensing deal

Featured Story

Novartis, UC Berkeley join forces for ‘undruggable’ targets

Novartis and UC Berkeley have formed a new pact aimed at unlocking difficult drug targets and boosting development of new meds in infectious diseases and cancer.

Top Stories

Zynerba soars on Fragile X data 

A phase 2 trial of Zynerba Pharmaceuticals’ Fragile X syndrome drug met its primary endpoint. The beleaguered biotech’s stock doubled on news of the route to redemption, despite the study’s lack of a control arm leaving reason to question how big an effect the drug had on the patients.

Cancer, gene therapy biotechs raise $303M in IPO bonanza

Three biotech companies focusing on cancer and eye diseases have collectively raised more than $300 million.

[Sponsored] Mindful Clinical Trials: What’s Risk-Based Monitoring Got to Do With It?

RBM shouldn’t be a point of concern, but rather a point of validation of what matters. It’s, above all, an opportunity to practice mindfulness in collecting clinical trial data within the site-and patient-centric environment.

RNA biotech Arcturus backs onto Nasdaq in Alcobra deal

Arcturus Therapeutics is set to gain a Nasdaq listing through a reverse merger with Alcobra. The deal will give Arcturus a route to public investors at a time when interest in RNA therapies is flying high on the back of Alnylam’s phase 3 success.

Biotech researchers chart progress in fighting substance abuse

As the opioid crisis broadens by the day, the biotech community is doubling down on its efforts to solve the mystery of addiction—and find new ways to combat it. Toward that end, two sets of researchers announced progress this week advancing research aimed at targeting addiction centers in the brain.

The thinking process behind biopharma companies’ outsourcing management

Through this brief summary of some presentations made by biopharma executives at this year’s Drug Development Forum, we offer some practical advice for sponsors on how to manage a smooth outsourcing relationship, and, for CROs, a peek into sponsors’ decision-making processes.

Senators jump on Allergan's 'blatantly anti-competitive' Restasis licensing deal

It didn't take long for Congress to push back at Allergan's first-of-a-kind patent deal with the Saint Regis Mohawk Tribe. Four senators are demanding an investigation, saying the move to protect Restasis is another example of pharma "putting profits before patients."

Resources

[Whitepaper] Industry Report: Clinical Operations Leaders Reveal Need for Change

The 2017 Unified Clinical Operations Survey finds that 99% of respondents report the need to unify their clinical applications, including CTMS, EDC, eTMF, and study start-up.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Five ways to make your patient support program a success

Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods.

[Whitepaper] The Impact of Contraceptive Requirements on Pediatric Clinical Trials

Children participating in pediatric clinical trials are included in the contraceptive requirements applied to women of child-bearing potential, creating significant challenges for sponsors, parents, investigators and study staff.

[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.

Events

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