Industry news

Oncology trials in China may see pilot program for 60-day IND decision

EJ Lane / FeircePharmaAsia

Investigational new drug applications for oncology in China may see a 60-day deadline for a thumbs up, or down, placing the country on a path already followed by Singapore, Taiwan and South Korea in Asia for quick early-stage decisions.

Slow down on the quality metrics push, drugmakers advise the FDA

Mari Serebrov / BioWorld

The FDA needs to apply the brakes on its headlong rush to adopt quality metrics for the manufacturing of drugs, the agency was told Monday. Industry groups speaking at a public meeting on a draft quality metrics guidance released last month were unanimous in urging the FDA to "start small, learn and revise" before dashing into a full-blown metrics program that could drive drugmakers and the agency itself into a sinkhole of data with no clear methodology for how it would be used.

Finding Cures in Early Research

Peter Winter / Thomson Reuters BioWorld

The pace of biotechnology innovation is accelerating, which is having a major impact on drug research and development productivity. There are a number of factors driving this exciting new era including significant progress being made in our genomic understanding of a range of diseases, the molecular pathways and the discovery of technologies that allow for the development of safer targeted and personalized therapies.

NIH launches human RSV study

U.S. National Institute of Health

A new study will expose healthy adult volunteers to respiratory syncytial virus (RSV), a virus that causes cold-like symptoms in adults. Better understanding of how adults develop RSV infection and immune system responses to infection will assist researchers in developing and testing future antivirals and vaccines to combat the virus. The research is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

27 August 2015

EPIC's Daniel Houston to Speak on Insurance and Risk Management Issues for Cyber, Technology, Media and Privacy at CFO Risk Management Summit

Cyber threats are one of the most significant risks businesses and individuals face today, says EPIC Insurance Brokers and Consultants. High profile breaches in the past few years have highlighted the substantial impact and significant costs associated with these attacks. And the breaches we hear about are just the tip of the iceberg, since information about an attack may not be revealed to the public if no personal data is stolen.

Analysts fret as market turbulence threatens biotech IPO market

John Carroll / FierceBiotech

The tremors reverberating through the stock market on Monday left a score of biotechs big and small shaken, alarmed and bruised by the end of the day. But the avalanche of share prices that started early retreated later in the day as the experts weighed in on the long-term implications.

Want to make the big bucks in R&D? Join the industry

Nick Paul Taylor / Fierce Biotech

When George Yancopoulos walked away from Columbia University to join Regeneron in 1989, the decision to leave academia for industry was at least partly motivated by the pay differential. The move paid off and then some, with Yancopoulos becoming the first billionaire biopharma R&D head at a time when the best-paid research institute chiefs are pulling in just north of $1 million a year.

26 August 2015

Epic Sciences Appoints Dave Henderson as Chief Information Officer

Epic Sciences, Inc. (“Epic Sciences”), announced today the appointment of Dave Henderson as Epic Sciences’ chief information officer (CIO). Mr. Henderson has more than 20 years of experience in information technologies at companies including Sequenom, Inc., CBS Corporation, and Paramount Pictures Corporation. 

WSJ: Debate roils over new radiation technique for breast cancer

Emily Wasserman / FierceMedicalDevices

As med tech companies roll out innovative radiation devices to treat breast cancer, medical experts are debating the pros and cons of a new technique that could be less expensive and more convenient than traditional therapy for the disease.

China slowdown for pharma shouldn't be ignored, WSJ says

EJ Lane / FeircePharmaAsia

The widely reported slowdown in sales in China noted across most multinational pharma companies deserves a harder look, the Wall Street Journal says. The WSJ said that overall emerging-market sales for the biggest firms tracked by Sanford C. Bernstein increased by about 5.5% for the year ended the second quarter well below a 9% average in the previous four quarters.