Industry news

FDA Approves First Cannabidiol-based Drug

BioPrarm International

FDA announced on June 25, 2018 the approval of Epidiolex (cannabidiol) [CBD] oral solution, which contains a purified drug substance derived from marijuana, for the treatment of seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

BioPrarm International

Russian pharmaceutical manufacturers stake on prescription products

GMP News

In the first five months of 2018, Russia produced medicinal products worth 132.2 billion rubles (in ex works prices). Compared to the same period of the last year, the dynamics are still negative.

Deloitte’s recent survey reflects the increasing role of real-world evidence

GMP News

Deloitte’s real-world evidence (RWE) benchmarking survey studies how biopharma companies are using RWE, what they are investing in, areas of impact, and the hurdles to successful adoption. Many biopharma companies are increasingly using real-world evidence (RWE) – clinical evidence about a product’s usage, potential benefits, and risks derived from real-world data (RWD) – not only to demonstrate the value of their products but increasingly to address regulatory requirements, drive drug development, support outcomes-based contracts, and reduce products’ time to market.

Harvard researchers developed a new method to deliver insulin orally

GMP News

Scientists at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS, USA) have developed an oral delivery method that could dramatically transform the way in which diabetics keep their blood sugar levels in check.

02 July 2018

Mission critical. Biopharma companies are accelerating real-world evidence adoption, investment, and application

Deloitte Insight

What is real-world data (RWD) and real-world evidence (RWE)? Real-world data refers to health care data gathered from a variety of sources, outside of randomized controlled clinical trials. These data sources can include electronic medical records (EMRs), health insurance claims, genomic data, and data from health apps, wearables, and other biometric devices. Real-world evidence refers to the insights that are generated from these data.

Diversity in Biopharma Leadership Makes Dollars and Sense

Jim Greenwood / BIOtechNOW

A series of recent studies examining diversity and financial performance have fueled a growing insistence among big-name private equity firms, pension funds and money managers that their investees hire and promote more diverse talent up the ranks – or risk losing their clients’ capital.

FDA Clears Pathway for Off-Label Economic Communications

Jill Wechsler / PharmExec.com

After years of debate and discussion, FDA has finalized a more flexible policy for how biopharmaceutical companies may discuss payments, outcomes and healthcare economic data with payers, formulary committees and other audiences with expertise in drug prescribing and coverage. By clarifying a safe harbor for such communications, the policy is expected to encourage sponsors to conduct more studies that assess economic benefits of treatments, such as gains in quality-adjusted life years (QALYs) and reduced hospital stays and other procedures.

Output of Kaluga cluster may exceed 100 billion rubles by 2020

GMP News

By 2020, Kaluga pharmaceutical cluster will triple its output compared to 2017, announced Anatoly Sotnikov, Director of the regional Innovative Development Agency, during the visit of Svetlana Chupsheva, Head of the Agency for Strategic Initiatives (ASI), to Kaluga.

QVIA rolls out its Virtual Research Solutions suite

GMP News

Powered by the IQVIA CORE™, Virtual Research Solutions brings together unparalleled information assets, advanced analytics, technologies and critical domain expertise to design and execute trials and late-phase studies with people in mind. It starts with smart, connected devices and remote-monitoring systems that are linked to a dedicated virtual network of investigators and local healthcare providers.