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June 01, 2018

Today's Rundown

Featured Story

Roche scraps €120M SMA drug after hitting ‘many difficulties’ 

Roche has stopped development of the spinal muscular atrophy drug it acquired for €120 million ($140 million) upfront three years ago. The Swiss pharma is walking away from olesoxime after running into “many difficulties in developing” the oral mitochondria-boosting drug. 

Top Stories

Right-to-try is designed to weaken the FDA, law’s author says

The author of right-to-try legislation is pressuring Scott Gottlieb, M.D., to implement the law in a way that weakens the FDA. “This law intends to diminish the FDA’s power over people’s lives, not increase it,” wrote Sen. Ron Johnson.

Immuno-oncology player Neon Therapeutics looks for $115M in IPO

Neon Therapeutics plans to use its IPO cash to push its lead candidate, a personalized neoantigen cancer vaccine, through phase 1 and to nudge its preclinical programs into the clinic.

Cortexyme gathers $76M to fund efficacy study of antibiotic for Alzheimer’s

Alzheimer’s disease startup Cortexyme was able to round up $76 million in funding for a potentially first-in-class treatment, while other companies are looking to move away from the field.

Amgen to ramp up early-stage immuno-oncology with 2 MD Anderson deals

Amgen and the University of Texas MD Anderson Cancer Center are teaming up to accelerate up to 16 preclinical and clinical programs in blood cancers, small-cell lung cancer and other small-cell cancers.

Xynomic preps broad push for HDAC cancer drug after series B

U.S.-China biotech Xynomic Pharma has raised additional funding to take an HDAC inhibitor in-licensed last year into seven new cancer trials.

Call for this year's Fierce 15 nominations

It’s that time of year again when we are looking for the best, the brightest and the fiercest for our annual Fierce 15 biotech awards.

EuroBiotech Report—Gilead-Galapagos, Nouscom hire, Prothena cuts, Crescendo-Zai and EMA

In this week's EuroBiotech Report, Gilead and Galapagos hail JAK1 success, Nouscom poaches a Pfizer executive, Prothena cuts deep into its workforce and more.

FiercePharmaAsia—Takeda investors’ fear, WuXi’s 6-fold stock jump, Gardasil-made billionaires

A group of 12 Takeda shareholders demand a vote on the Shire deal out of fear for "high risks"; WuXi AppTec becomes the largest-cap CRO after its stock jumped sixfold in three weeks since listing in Shanghai; Gardasil franchise's Chinese nods propelled two families into Bloomberg’s billionaires club.

Chutes & Ladders—Former Novartis oncology head jumps to metabolic startup

Novartis' ex-oncology head jumps to startup; Axovant poaches Allergan's CMO; and Biogen brings on Pfizer dealmaker—plus more hirings, firings and retirings throughout the industry.

Enrollment Showcase

SBMI Now Offering an Online Graduate Program in Bioinformatics

UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics.

Resources

[Whitepaper] Is the pharma business model ready for precision medicine?

Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare.

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] Compliance Certificate and Training for Life Sciences Professionals

4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics.

[Whitepaper] Choosing the Best Steriles Dosage Form for Your Phase I Clinical Supply Needs

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development.

[Whitepaper] Risk-based Approach to Change Management of GxP Systems

Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems.

[Whitepaper] Regulatory Transformation at UCB

UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off.

[Whitepaper] Five Tracking Spreadsheets it’s Time for Regulatory to Retire

Find out how to eliminate regulatory’s tracking spreadsheets for good.

[Whitepaper] A Simpler Approach to RBM in Clinical Trial Management

Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

Events

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