Orphan drugs are medicines used in the treatment of rare diseases with less than five lakh patients in a country, but are believed to be expensive. Published: 27th February 2019 07:48 AM | Last Updated: 27th February 2019 07:59 AM…
Indian biosimilar market to be worth $40 billion by 2030
The Confederation of Indian Industry (CII) & Sathguru Management Consultants released a position paper on Indian Biosimilars Industry. “Indian Biosimilars Industry: Roadmap to Actualize Global Leadership” at the 2nd National Biotechnology Conclave 2018 – Driving Inclusive Growth for Indian Bio-economy…
German Regulators: 1,300 Trials Imperiled by “Hard” Brexit
Some 1,300 trials in the UK may have to stop their work if the UK leaves the EU without some kind of new regulatory regime in place, officials at Germany’s Federal Institute for Drugs and Medical Devices say in a…
Three Reasons Why Mobile Technology Is A Secret Weapon For Patient Engagement And Study Success
The use of mobile technology in clinical trials is becoming increasingly prevalent, most notably in collecting electronic clinical outcome assessment (eCOA) data. Its role, however, in improving patient engagement throughout an entire study is a lesser known area, and an…
Patients Are Eager for Trials But Aren’t Getting the Word, Survey Finds
Patients are eager to participate in clinical trials, but they’re having trouble finding the information they need — not just on social media, but from their own doctors, a new survey suggests. Many respondents said they’d be interested in joining…
Keep Investigator’s Brochure Updates Clear, Concise and Timely, Experts Advise
Investigator’s brochures (IBs) are meant to be a living document, updated at least once a year to keep up with progress and developments in the trial. But scheduling and drafting updates can prove challenging, says Tiffany Guckin, associate director of…
CDER Drug Trials Report Shows Declining Enrolment
CDER released its fourth annual Drug Trials Snapshots report, which shows a significant drop in the number of participants in pivotal novel drug trials that led to agency approvals. The overall number of participants dropped by more than half from…
Doing More With Less: The Road To Success For Clinical Trials
Conducting a clinical trial can be both a time consuming and costly affair for pharmaceutical companies. If one is to be successful, they must have their affairs in order, from navigating protocols and regulations to the basic budgeting. As the…
Genentech Pulls Plug on Two Alzheimer’s Trials
Genentech has closed two large Phase III trials for its once-hyped anti-Alzheimer’s drug crenezumab after an independent data monitoring committee warned the company that crenezumab wasn’t likely to hit its primary endpoint. The CREAD 1 and CREAD 2 trials had…
Particle Sciences partners with Encube Ethicals to Develop Novel Vaginal Rings
Contract development and manufacturing organization (CDMO), Particle Sciences, a Lubrizol LifeSciences company, has announced its partnership with leading Indian contract manufacturing organization (CMO), Encube Ethicals. Under the partnership the two companies will develop innovative intravaginal rings with the intent to…
