Industry news

24 October 2017

Clearside Biomedical Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CLS-TA Used Together with Eylea in Patients with Diabetic Macular Edema

Clearside Biomedical, Inc.  (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced completion of patient enrollment in the Phase 2 clinical trial (“TYBEE”) of CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration (“suprachoroidal CLS-TA”), used together with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) for the treatment of diabetic macular edema (“DME”).  Patient follow-up in the TYBEE trial is 6 months. 

Russian-Finnish Life Sciences Center was presented in Saint Petersburg

GMP News

The official presentation of the joint Russian-Finnish Life Sciences Center established in close cooperation of 5 partners (of which 3 are from Finland), including Saint Petersburg Chemical Pharmaceutical Academy, University of Turku, Åbo Akademi, Turku Science Park, and the Union “Medical and Pharmaceutical Projects: 21st Century,” was held during the 4th annual Russian-Finnish Symposium “The Experience of Cooperation of Universities and Pharmaceutical Companies: from Research to Practice.”

Can cancer charity efforts from Roche, Bristol-Myers Squibb, AbbVie and more boost pharma's reputation?

Beth Snyder Bulik / FiercePharma

Big pharma companies signed on to two big-name cancer efforts—the NIH’s Cancer Moonshot and celebrity-heavy charity Stand Up 2 Cancer—that just might help burnish their industry’s standing.

FDA releases flurry of new, revised drug-specific guidance documents

Zachary Brennan / Endpoint News

In an effort to provide support for abbreviated new drug applications, the FDA on Thursday issued a flurry of product-specific recommendations, providing guidance for companies looking to develop generic versions of a number of popular medicines, including Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

Russian drug labeling system is ready to operate at its full capacity

GMP News

The drug labeling system was finalized in accordance with the functional requirements of the Russian Ministry of Health and Roszdravnadzor. This work took into account the proposals and comments made by the largest organizations in the pharmaceutical industry that were the first participants in the labeling of drugs.

CDMO Pfizer CentreOne opens new manufacturing facility in Japan

GMP News

Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, announced that it is now offering services in Nagoya, Japan.

Advice for pharma in payer marketing? Ramp up digital, study finds

Beth Snyder Bulik / FiercePharma

It’s time for pharma to get digital in payer marketing. The most important audience in that field—the people making decisions about formulary placement—are digital-savvy researchers who prefer to find and receive information online, new research has found.

Joint projects may increase exports of medicines from Russia to Uzbekistan

GMP News

In 2018, the Russian pharmaceutical manufacturers intend to increase their exports to Uzbekistan up to more than $60 million. “According to our trade mission, the total volume of Uzbek imports of these products last year was $525 million, while the supplies from Russia amounted to about $50 million. Based on positive growth dynamics in this area over the recent years, Russian exports of medicinal products are projected to reach $56 million in 2017 and, in 2018, they will be worth more than $60 million,” said a source in the Russian trade mission.

Kaluga Pharmaceutical Cluster will become an entry point for German companies

GMP News

An agreement on cooperation between the Association of Kaluga Pharmaceutical Cluster and Steinbeis Global Institute Tübingen at the Steinbeis University Berlin was signed on October 16 by Irina Novikova, the Executive Director of the Association, and Prof. Dr. Bertram Lohmüller, Director of the Institute.

A big step forward in linking the genome to disease risk

Arlene Weintraub / FierceBiotech

The human genome was first mapped about 15 years ago, but scientists have yet to gain a complete understanding of how genes maintain health—and how they govern the emergence of certain diseases. Now, a team of researchers led by Princeton University has taken a big step towards reaching that goal, publishing data related to 44 different human tissue types that they believe will help unlock the relationships between genetics and hard-to-treat diseases.