Industry news

EMA Publishes Annual Report

BioPharm International

The European Medicines Agency (EMA) published its 2015 annual report on May 17, 2016. The report provides information on the agency’s market authorization approvals for the year, gives an update on the agency’s projects, and features interviews with industry representatives on topics such as data requirements and immunotherapies.

J&J commits $740M for its second cancer R&D pact with MacroGenics

John Carroll / FierceBiotech

Whatever Johnson & Johnson ($JNJ) learned about MacroGenics’ off-the-shelf approach to stirring a T cell attack against cancer since inking their first partnership deal 17 months ago seems to have only whetted the pharma giant’s appetite for more. 

Large-scale HIV vaccine trial to launch in South Africa

U.S. National Institute of Health

An early-stage HIV vaccine clinical trial in South Africa has determined that an investigational vaccine regimen is safe and generates comparable immune responses to those reported in a landmark 2009 study showing that a vaccine can protect people from HIV infection.

The Remarkable Rebirth of Cancer Immunotherapy

FierceBiotech

There’s reason for new hope in the ongoing battle against cancer. From standing-room-only presentations of provocative data at cancer conferences, to landmark publications and new drugs approvals, the signs are multiple and clear. Harnessing the immune system as an anti-cancer therapy--a strategy that has yet to fully deliver on its promise-- is now the most exciting area of oncology drug development. 

Any Chance for “Cures” Legislation This Year?

Jill Wechsler / BioPharm International

Is there any chance “Cures” legislation will pass in 2016? Probably not by summer, as election-year activities will prompt an early exit from Washington. Thus the only chance for action on legislation promoting biomedical innovation is in a “lame duck” session of Congress in November. Rep. Fred Upton (R-Mich), lead House sponsor of the 21^st Century Cures legislation, will no longer head the Energy & Commerce Committee next year due to House rules, and he is pressing hard for a final “Cures” bill to cap his tenure as chairman.

PhRMA member companies invested $58.8 billion in R&D in 2015

Stephen J. Ubl / PhRMA

For more than 30 years, the U.S. biopharmaceutical industry has been the world leader in the development of new medicines, driving innovation for patients. And PhRMA member companies continue to be at the forefront. According to the 2016 Biopharmaceutical Research Industry Profile and corresponding industry chart pack,Biopharmaceuticals In Perspective, released today, PhRMA member companies invested an estimated $58.8 billion in research and development (R&D) in 2015, up 10.3 percent from 2014.

Cross-country deals, new drug trials gain momentum in Asia

Richard Smart / BioWorld

George Yeh, president of Taiwan Liposome Co. Inc. (TLC), told BioWorld Asia that in the coming years more trials for new drugs would take place in Asia, and that cross-country collaborations will help train a new generation of doctors in how to detect the potency and effectivity of treatments yet to reach the market.

U.K.'s early access scheme working but challenges remain

Nuala Moran / BioWorld

Two years after it was instituted, the U.K.'s Early Access to Medicines Scheme (EAMS) has succeeded in getting drugs to patients in advance of a formal marketing approval, but the aim that therapies arrive a year beforehand has not been met, and the fact the scheme is not funded makes it hard for small biotechs to participate.

Another tycoon writes a big check for cancer R&D: So what?

John Carroll / FierceBiotech

A few weeks ago it was Sean Parker of Facebook fame and his $250 million contribution for an immuno-oncology network of top institutions and investigators. Today it’s Larry Ellison’s turn to write a big check, this time for $200 million to help erect an eponymous oncology research center: The Lawrence J. Ellison Institute for Transformative Medicine of USC. 

16 May 2016

Syndax Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Business Update Following IPO

Syndax Pharmaceuticals (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2016, and provided a pipeline update and review of upcoming milestones.  As of March 31, 2016, Syndax had $133.7 million in cash, cash equivalents and short-term investments.