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September 12, 2017

Today's Rundown

  1. FDA commissioner: We need to talk about drug development costs

  2. Phase 3 hepatocellular carcinoma fail crushes Onxeo

  3. Alexion cost cutting is 'all about building pipeline'

  4. [Sponsored] Leveraging Social Listening to Advance Alzheimer's Disease Research

  5. Erytech mulls first-line use for pivotal pancreatic cancer trial

  6. Sage sags on phase 3 epilepsy med failure

  7. Bristol-Myers advances new LAG-3 med relatlimab to fight PD-1 resistance

  8. After conjunctivitis flop, Aldeyra plays on positives for dry eye disease

  9. Alexion plots hundreds of layoffs, HQ move in sweeping corporate revamp

Featured Story

FDA commissioner: We need to talk about drug development costs

New FDA Commissioner Scott Gottlieb wants to target drug development costs as yet another study asks how much it really costs to make a medicine.

Top Stories

Phase 3 hepatocellular carcinoma fail crushes Onxeo

Onxeo’s Livatag has failed to beat the active control in a phase 3 hepatocellular carcinoma (HCC) trial. The setback wiped about 50% off Onxeo’s share price as investors adjusted to the diminished expectations for the doxorubicin-loaded nanoparticle candidate.

Alexion cost cutting is 'all about building pipeline'

Alexion is slashing its workforce by around 20% and closing sites in a bid to save $250 million a year, with R&D bearing the brunt and accounting for around two-thirds of the cost cutting.

[Sponsored] Leveraging Social Listening to Advance Alzheimer's Disease Research

When it comes to healthcare we know that consumers actively participate in social media to seek information and find support. More than 40% say that information from social media affects how they cope with a chronic condition, their approach to diet and exercise, the physician they select and even their decision to seek a second opinion1.

Erytech mulls first-line use for pivotal pancreatic cancer trial

Erytech is preparing to move eryaspase into a pivotal trial after full data from a phase 2b affirmed earlier top-line results. The red-blood-cell-encapsulated L-asparaginase improved overall survival and other outcomes in metastatic pancreatic cancer patients, emboldening Erytech to consider swinging for first-line use in phase 3.

Sage sags on phase 3 epilepsy med failure

After M&A hype and a small win for a midstage major depressive disorder test earlier this year, Sage Therapeutics has seen its shares soar. But today it was brought down to earth with a late-stage failure for brexanolone.

Bristol-Myers advances new LAG-3 med relatlimab to fight PD-1 resistance

Though immuno-oncology treatments have transformed the standard of care, many patients don’t respond to PD-1 therapies, and those who do can develop resistance. Hoping to combat that, Bristol-Myers is moving a new LAG-3 drug, relatlimab, into late-stage testing.

After conjunctivitis flop, Aldeyra plays on positives for dry eye disease

Tiny Aldeyra Therapeutics says it has seen “statistically and clinically significant improvements” in a midstage trial for its experimental eye med ADX-102, although not all data points were positive.

Alexion plots hundreds of layoffs, HQ move in sweeping corporate revamp

Following a sales fraud investigation that led to major executive changes, Alexion’s new management is rolling out its first corporate overhaul. The rare disease biotech on Tuesday announced a restructuring that includes cutting 20% of its staff and moving its headquarters to the Boston biopharma hub.

Resources

[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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