Industry news

Tweet up? Twitter move to 280 characters opens new frontiers for pharma, agency says

Beth Snyder Bulik / FiercePharma

Will pharma learn to love Twitter now that it’s doubled its character limit to 280? Last week, the popular social media platform announced it would offer all users twice as much space, and at least one pharma ad agency says industry marketers should be glad.

Biosimilars Raise Analytical and Policy Challenges

BioPharm International

FDA Overhauls Inspection Process and Field Operations

Jill Wechsler / BioPharm Inertnational

To ensure the quality and safety of drugs, biologics, and medical products more efficiently and effectively, FDA is making significant changes in its plant inspection program, including more attention to imports and to foreign producers of drugs for American consumers. An aim is to target manufacturing oversight to more high-risk operations and free up resources for greater scrutiny of foreign facilities in the process.

EMA and EUnetHTA published a new joint work plan

GMP News

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration for the next three years.

U.S. approves digital pill that tracks when patients take it

Reuters

U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

MIT scientists propose a safer way to edit genes with CRISPR

Arlene Weintraub / FiercwBiotech

The gene editing system CRISPR-Cas9 has generated excitement for its potential use in eliminating disease-causing irregularities in DNA. But most CRISPR systems rely on viruses to carry Cas9 components into cells, where they then go to work cutting DNA.

NANOLEK will cover the needs for inactivated polio vaccine in Russia

GMP News

Polymilex®, an inactivated polio vaccine, is the first IPV fully manufactured in Russia. Nanolek is implementing the project to manufacture this vaccine since 2012.

Drug sales in Russia steadily grow this year

Remedium

Drug sales in Russia are steadily growing this year, according to latest data of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. For the 9 months of the current year drug sales in Russia grew by 13.7% on year-on-year basis to 3.3 billion packs in value terms.

Russian State Duma approves the drug labeling bill in the first reading

GMP News

Russia introduces total control over the quality of drugs. This is the goal of the bill submitted by the Ministry of Health and approved by the State Duma in the first reading. The amendments include the introduction of a federal state information system for monitoring the circulation of medicines in Russia. The system will track the circulation of drugs from the manufacturers to the end consumers. To ensure this, the bill proposes to use special labeling.

13 November 2017

Clearside Biomedical’s Phase 1/2 Open Label Clinical Trial of CLS-TA With and Without Eylea in Diabetic Macular Edema Presented at the American Academy of Ophthalmology 2017 Annual Meeting

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced that, on Friday, November 10, 2017, during the Retina Subspecialty Day of the American Academy of Ophthalmology  2017 Annual Meeting in New Orleans Charles C. Wykoff presented preliminary results from an exploratory clinical trial of CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration with and without intravitreally injected EYLEA® (aflibercept) for the treatment of diabetic macular edema.