Industry news

14 June 2018

Clearside Biomedical Announces Completion of Patient Enrollment in First of Two Phase 3 Clinical Trials of CLS-TA in Retinal Vein Occlusion

Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced completion of patient enrollment in a Phase 3 clinical trial (“SAPPHIRE”) of suprachoroidal CLS-TA used in combination with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) for the treatment of Retinal Vein Occlusion (“RVO”).

2 studies show CRISPR might drive up cancer risk in edited cells

Amirah Al Idrus / FierceBiotech

Off-target, or unintended, editing is a key safety concern of CRISPR-Cas9, as it can lead to cancer and other side effects. Two new studies show that CRISPR editing could raise the risk of targeted cells—those being edited to treat disease—developing tumors.

European Commission proposed a new research and innovation program

GMP News

For the next long-term EU budget 2021-2027, the Commission proposed €100 billion for research and innovation. The new programme – Horizon Europe – will build on the achievements and success of the previous research and innovation programme (Horizon 2020) and keep the EU at the forefront of global research and innovation.

Pfizer инвестирует в начинающие компании 600 млн дол

Илья Дугин / Фармацевтический вестник

Американская фармацевтическая компания Pfizer объявила о намерении инвестировать в начинающие биотехнологические компании 600 млн долл., из которых 25% пойдет на разработку лекарственных препаратов для лечения неврологических заболеваний, сообщает FirstWord Pharma.

Pfizer puts neuroscience at heart of new $600M VC fund

Nick Paul Taylor / FierceBiotech

Pfizer has committed $600 million to its VC fund. The Big Pharma is setting aside 25% of the money for investments in neuroscience startups, giving it a way to continue participating in the field despite its retreat from in-house R&D.

PIC/S approves new guidance on GMP inspections

GMP News

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced this month that it has adopted new guidance on good manufacturing practice (GMP) inspections, outlining a process for “desk-top assessment” of overseas facilities to identify instances when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections.

Women's hormone drug prices have climbed for years, but controversy hasn't ensued. Why?

Eric Sagonowsky / FiercePharma

Several drug pricing scandals have grabbed headlines in recent years in cases in which companies hiked the prices of old drugs or jacked up the cost of blockbuster drugs little by little year after year. Another case hasn't garnered the same attention—and maybe that's because people just don't like to talk about vaginas.

Russia amended procedure for state registration of some medicinal products

GMP News

Joint efforts to fight diabetes

GMP News

A tripartite Memorandum on Strategic Partnership in the Area of Non-Communicable Diseases (NCDs) was signed between Sanofi; Health of the Nation League, an All-Russian public organization; and Healthy Cities, Districts and Villages Association.

Why the Russian Pharmaceutical Market is Attractive for Foreign Generics, ARS PharmRussia Explains

Remedium

The overseas generic pharmaceutical industry from the ICH region (US, Japan, EU) and 'pharmerging' countries have good opportunities to gain profits in Russia, despite the strong governmental support of local drug manufacturers.