Industry news

08 January 2015

Epic Sciences Receives CLIA Certification for its Cancer Diagnostics Laboratory

Epic Sciences announced today that the company has received certification under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the “deemed status” provision of the U.S. Department of Health and Human Services’ (HHS) Center for Medicare and Medicaid Services (CMS), the state of California has granted the company’s initial CLIA clinical laboratory license.

08 January 2015

Kyowa Hakko Kirin and Syndax Announce an Exclusive License Agreement to Develop and Commercialize Entinostat in Japan and Korea

Kyowa Hakko Kirin Co., Ltd. and Syndax Pharmaceuticals, Inc., today jointly announced that the companies have entered into a license agreement for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Entinostat is a Class I selective histone deacetylase (HDAC) inhibitor being developed by Syndax in the United States and Europe in combination with hormone therapy for advanced breast cancer and immune therapy combinations in solid tumors.

07 January 2015

Marinus Pharmaceuticals Hires Dr. Albena Patroneva as Chief Medical Officer

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that it has retained Albena Patroneva, MD as Chief Medical Officer. Dr. Patroneva brings close to 20 years of experience spanning across research, drug development, clinical, regulatory and commercialization activities focused in neurology with large pharmaceutical companies, including AstraZeneca, Wyeth and Takeda. As Chief Medical Officer, Dr. Patroneva will oversee Marinus's clinical programs in epilepsy and pediatric orphan indications with its neurosteroid, ganaxolone.

Med tech exits pick up in 2014, momentum to continue into 2015

Stacy Lawrence, FierceMedicalDevices

Venture-backed medical device and diagnostics companies are benefiting from a groundswell of investor interest in life sciences that has been spearheaded by great biotech returns for the last several years.

A record year for biotech inspires some great expectations for 2015

John Carroll, FierceBiotech

Life science-related IPOs rocketed from an anemic 11 in 2012 to 37 in 2013 and a red-hot 79 in 2014, reports Jonathan Norris, a managing director at Silicon Valley Bank, in his annual assessment of the life sciences industry's appetite for new deals. 

Biopharma posts a chart-topping 41 new drug approvals in 2014

John Carroll, FireceBiotech

A burst of new drug approvals at the FDA just before Christmas pushed the total to 41 for 2014, the fastest pace in the past 18 years and a fresh sign that at least a few of the lead players have learned how to efficiently target new therapies for development.

NHS England picks 100,000 Genomes Project sites ahead of February start date

Nick Paul Taylor, FierceBiotechIT

NHS England has selected the 11 centers that will form the backbone of the 100,000 Genomes Project. Each of the centers will begin recruiting patients with cancer and rare diseases on Feb. 2 and send the samples they gather to Illumina ($ILMN) for sequencing and analysis.

Analytics and Big Data investments spur bumper year for digital health funding

Nick Paul Taylor, FierceBiotethIT

The likelihood of 2014 being another high-water mark for digital health was clear from the first few months of the year. When digital health seed funder Rock Health tallied up the total last week, it found digital health companies raised $4.1 billion in 2014, almost as much as they pulled in across the three prior years combined.

FDA hits the highest level of drug approvals in 18 years

Joe Barber, FirstWord Pharma

The FDA cleared 41 new medications in 2014, the highest level for the agency since 1996, when a record 53 new products were approved. The total was also 14 more than the number of drugs the agency approved in 2013.

Digital Health Funding Tops $4.1B: 2014 Year in Review

Teresa Wang, Rock Health

2014 was an incredible year for the digital health ecosystem, particularly for the 258 companies that had their coffers filled by investors. The year was a record-breaker from the start and by its close venture funding for digital health companies surpassed $4.1B, nearly the total of all three prior years combined. This represents a 125% YoY growth in funding compared to 2013.