Industry news

Small European study highlights promise of gene therapy for rare immune disease

John Carroll / FierceBiotechResearch

A biotech with deep roots in the European gene therapy field has successfully tested a new approach to creating a personalized gene therapy for a rare disorder of the immune system.

FDA issues new guidelines on acceptance of data from overseas clinical trials

Varun Saxena / FierceMedicalDevices

The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both U.S. and foreign regulators."

FDA, industry scrambling to clarify or design new regs covering lab-developed tests

Varun Saxena / FierceDiagnostics

Science is rapidly shaping the landscape of the diagnostics industry, from the research into genetics and new materials like graphene, to the regulatory science practiced at the FDA.

No country for pharma firms

Neha Bothra / The Financial Express

Grappling with regulatory delays, several Indian pharma companies are looking to set up manufacturing facilities outside the country.

China steps up decentralized drug industry regulation, market prices push

EJ Lane / FeircePharmaAsia

China authorities at the highest level are acting on legislation that would, among other things, decentralize drug industry regulation and free some price controls.

22 April 2015

Clearside Biomedical, Inc. Announces Purchase of iScience Patent Portfolio for Suprachoroidal Space Drug Delivery

Сlearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced the purchase and acquisition of iScience Interventional Corporation’s patent portfolio covering drug delivery to the suprachoroidal space (SCS). 

Australia's Brandon Capital stakes a claim as Asian biotech booster with A$200M fund

EJ Lane / FeircePharmaAsia

The buzz around biotech in Asia has centered on friends and family bootstrap operations in China, local investor support in Taiwan and onto more formal state-backed incubation efforts in Japan, South Korea and Singapore along with boutique venture capital firms and investment arms of multinationals, such as Eli Lilly Ventures.

WHO calls for easy linking of bibliographic databases to trial registries

Nick Paul Taylor / Fierce Biotech IT

The World Health Organization (WHO) has updated its position on the disclosure of clinical trial data. Having advocated greater use of registries back in 2005, the WHO now wants to see the establishment of a more integrated IT system that includes data from new and old clinical trials.

Biopharma puts better use of existing data at top of R&D wish list

Nick Paul Taylor / Fierce Biotech IT

A survey by analysts at William Blair has found that biopharma R&D staffers think making better use of existing data is their best hope of improving productivity. Almost half of the 133 respondents said the topic was the biggest remaining opportunity to improve R&D.

Global pandemic of fake medicines poses urgent risk, scientists say

U.S. National Institute of Health

Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis, according to the editors of a collection of journal articles published today. Scientists report up to 41 percent of specimens failed to meet quality standards in global studies of about 17,000 drug samples.