Industry news

As regulations tighten, China health care sector draws global interest

Carmen Ho / BioWorld

Biotech companies worldwide are gearing up to expand into the China market even as the CFDA toughens up its health care market through a series of reforms.

EMA updates first-in-human trial guidance to tighten volunteer safety

Phil Taylor / Fierce Pharma

The European Medicines Agency has followed through on plans to update its guidance on first-in-human clinical trials in light of a fatality in a French study earlier this year.

Analysts to Wall Street: Don't celebrate yet. The drug-pricing brouhaha is far from over

Arlene Weintraub / FiercePharma

When presidential candidate Hillary Clinton blasted Martin Shkreli on Twitter for hiking the price of an old drug called Daraprim by 5,000% in September 2015, biotech stocks plummeted. Clinton tweeted that such price hikes in the drug market were “outrageous” and that she planned to “take it on.”

ATM: Pharma fails to make drugs affordable to those who need them most

Nuala Moran / BioWorld

The pharmaceutical industry has made no progress over the past two years in making drugs more affordable in low and middle income countries. In addition, companies need to do more to develop access plans when products are in development, to ensure new drugs are more swiftly registered and made widely available once the first approval is granted, according to the fifth Access to Medicines (ATM) Index, published on Monday.

Expanding on Supreme Court patent decisions harmful to U.S. innovation

Mari Serebrov / BioWorld

Too many U.S. patent examiners aren’t “getting the memo” on how to apply recent court rulings on laws of nature and abstract ideas to patent applications covering drugs and diagnostics to software and financial management tools.

Antibiotic prescribing falling fast, finds analysis

Selina McKee / PharmaTimes

Antibiotic prescribing in England is "decreasing faster than ever", according to a new analysis of NHS Digital data. The reasearch, by Antibiotic Research UK and EXASOL, also found that seasonal variation in prescribing rates has been slashed by a half in just a year, indicating that campaigns designed to cut the number handed out for viral winter colds are bearing fruit.

Drugmakers to FDA: Let us share off-label study data with payers

Carly Helfand / FiercePharma

Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA to relax its regulations—and drugmakers believe the first step should involve sharing info with payers.

EU drug agency head fears loss of expert staff after Brexit

Ben Hirschler / Reuters

The head of Europe's drugs regulator is braced for disruption following Britain's vote to leave the European Union (EU) and said he feared losing expert staff if, as widely expected, the regulator is forced to decamp from London.

16 November 2016

Epic Sciences Validates Single CTC Sequencing, Identifies Clonal Heterogeneity in Metastatic Cancer

Epic Sciences, in collaboration with pharma co-authors, published an analytic validation of their sequencing assay in single circulating tumor cells (CTC) and demonstrated clinical feasibility in metastatic prostate cancer patients (mCRPC).  In addition to profiling genome wide copy number variation (CNV) from single cells, the authors also validated the ability to characterize the extent of genomic instability within individual CTCs.

Tech billionaire starts late-stage life science VC fund

Nick Paul Taylor / FIerce Pharma

An entrepreneur who made his fortune building a $14 billion tech company is setting up a life science venture capital fund. The Israel-focused fund will target maturing life science startups with a view to helping companies grow into the next Teva ($TEVA) rather than sell up or outlicense their programs, Reuters reports.