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June 29, 2016

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Today's Rundown

  1. Tesaro’s PARP ovarian cancer drug hits PhIII goal; prepares to file

  2. Merck, Moderna tie up in $200M deal to develop mRNA-based ‘personalized’ cancer vaccines

  3. Galena plummets into micro-cap territory on Phase III breast cancer vaccine trial halt

  4. FDA’s Pazdur named acting head of new ‘Oncology Center of Excellence’

  5. New Gilead hep C combo Epclusa gains FDA approval

  6. Pfizer aces another pair of PCSK9 inhibitor trials

  7. From EuroBiotech Report: Prolific biotech entrepreneur commits cash to Evotec’s NASH program



Featured Story

Tesaro’s PARP ovarian cancer drug hits PhIII goal; prepares to file

Tesaro has posted positive top-line results for its experimental PARP inhibitor niraparib for patients who express BRCA--and those who don’t--as it looks to file later this year. Its shares jumped 106% on the news by 10 a.m. ET.



Top Stories

Merck, Moderna tie up in $200M deal to develop mRNA-based ‘personalized’ cancer vaccines

Wednesday, June 29, 2016

Merck will pay $200 million upfront to Moderna, which the company will use to lead all R&D efforts through proof of concept and to build out a suburban Boston manufacturing facility. The program will focus on several types of cancer and include combinations with Merck’s Keytruda (pembrolizumab).

Galena plummets into microcap territory on Phase III breast cancer vaccine trial halt

Wednesday, June 29, 2016

Galena Biopharma fell more than 80% in premarket trading on news that an Independent Data Monitoring Committee stopped a Phase III trial of its NeuVax in early stage breast cancer for futility.

FDA’s Pazdur named acting head of new ‘Oncology Center of Excellence’

Wednesday, June 29, 2016

Oncology drug czar Dr. Richard Pazdur--who earlier this month despaired at biopharma’s “me-too” approach to cancer development--has been named as the interim leader of a new Oncology Center of Excellence that will be run out of the FDA.

New Gilead hep C combo Epclusa gains FDA approval

Tuesday, June 28, 2016

Gilead has seen its new combo of sofosbuvir and velpatasvir gain FDA approval as the company now offers a new cocktail that can treat all 6 types of hep C.

Pfizer aces another pair of PCSK9 inhibitor trials

Wednesday, June 29, 2016

Pfizer has posted positive data from two more trials for its new experimental anti-cholesterol drug bococizumab as the three-way dual for the PCSK9 inhibitor market heats up.

Prolific biotech entrepreneur commits cash to Evotec’s NASH program

Wednesday, June 29, 2016

Herbert Stadler’s Ellersbrook has invested in Evotec’s in-house NASH drug discovery program. The deal sees Ellersbrook and Evotec agree to jointly bankroll the advance of NASH programs, with a view to spinning them off into an independent startup or partnering them with a biopharma company down the line.




News of Note

Lipocine has seen its shares tank as the FDA refused to approve its testosterone drug, saying there are problems with the treatment’s label and dosing algorithm. Release

Cambridge, MA-based Cyteir Therapeutics has been given a $2 million, 2-year grant from the NCI to support preclinical development of its RAD51 modulator for the treatment of cancers. Statement

Agilis Biotherapeutics has been given an Orphan Drug Designation by the FDA for the treatment of Aromatic L-amino Acid Decarboxylase Deficiency. Release

New York’s BeyondSpring has launched a Phase III NSCLC trial for its candidate plinabulin in China. Statement


Resources

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[Whitepaper] The Remarkable Rebirth of Cancer Immunotherapy

Sponsored by: Covance


Al Blunt, MD, Executive Medical Director, Oncology at Covance discusses how the lessons learned from the past decade of developing targeted therapies are relevant to the future development of cancer immunotherapy. Download today!

[Whitepaper] Complimentary IDMP Report from Gartner

Sponsored by: Veeva Systems


Gartner research on short- and long-term strategies for IDMP compliance.


Events

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