Industry news

FDA issues draft guidance on quality manufacturing metrics

Eric Palmer / FeircePharmaManufacturing

After years of dealing with avoidable manufacturing issues that led to questionable meds and drug shortages, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), initiated the Office of Pharmaceutical Quality last January. The idea is for it to work up guidelines that will push even reluctant drugmakers toward quality manufacturing and establish a risk-based method for setting inspections. The office is now providing an idea of how that will work.

Trans-Pacific Partnership impasse on data exclusivity for biologics softens

EJ Lane / FeircePharmaAsia

Negotiations in Hawaii to reach an agreement on the Trans-Pacific Partnershiptrade pact appear to have made some headway on the thorny issue of data exclusivity for biologics with Australia and other countries opposed to the United States' 12-year standard now willing to consider 8 years, Nikkei Asian Reviewreports.

No 'duh': Obvious answer to drug R&D is not so easy to implement

Mari Serebrov / BioWorld

The answer to reducing the cost and time of developing drugs for unmet needs seems pretty obvious – a better understanding of the disease, the patient and the molecule being developed.

Innovative drugmakers take note, China plans national serious illness insurance rollout this year

EJ Lane / FeircePharmaAsia

Last week, China approved the rollout of medical insurance on serious illness nationwide, said Liang Wannian, vice-director of the medical reform office under the State Council and a senior official with China's National Health and Family Planning Commission, at a July 24 policy briefing.

Foresite Capital reloads with a $450M biotech venture fund

Damian Garde / FierceCRO

Venture investor Foresite Capital closed a $450 million new fund, its largest ever, and is setting out to find the next generation of promising drug developers. Foresite's latest raise follows a $300 million fund put together last year and a $100 million close in 2013. Since its foundation in 2011, Foresite has made bets on public and private companies alike, searching for "transformative products" in biotech and med tech, CEO Jim Tananbaum said.

Cutting-edge research centers back Deerfield's $550M biotech venture fund

John Carroll / FierceBiotech

Some of the world's top research institutions are backing a new, $550 million biotech venture fund from Deerfield Management. The investment outfit reported today that it raised the money from the likes of Memorial Sloan Kettering, Seattle Children's and Princeton University to back new drugs related to genetic diseases, cancer and orphan diseases. And there will be an added focus on new drug development tech as well as healthcare delivery.

BDO Special Report: PE Deal Activity in Healthcare

BDO

With the U.S. Supreme Court’s recent decision upholding healthcare coverage of millions of Americans, private equity investment in the industry may regain some of the steam it lost in the first half of 2015. 

Google's Calico snags access to Ancestry.com data to find genetic causes of long life

Nick Paul Taylor / Fierce Biotech IT

Google's ($GOOG) life-extension biotech Calico has secured access to data held by Ancestry.com, a family tree business that sells DNA testing kits. Calico will pick through the genetic data and millions of family trees in search of contributors to long life spans and drug targets.

Biopharmaceutical Industry Strongly Committed to Responsible Clinical Trial Data Sharing to Improve Public Health

Jeff Francer PhRMA

The biopharmaceutical industry remains committed to enhancing public health through responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.

Study: Firms “underinvest” in long-term cancer research

Peter Dizikes / MIT News

Pharmaceutical firms “underinvest” in long-term research to develop new cancer-fighting drugs due to the greater time and cost required to conduct such research, according to a newly published study co-authored by MIT economists.