Biopharma

Modern tools to advance generic drug development and review

In news releases issued by the U.S. Food and Drug Administration (FDA), “firsts” always catch the eye. Because the majority of prescriptions in the U.S. are dispensed with generic medications, announcements of new “first generics” are especially noteworthy. These products are the first approval by the FDA that permits a manufacturer to market a generic […]

Life sciences licensing deals in the fourth quarter of 2017: updates and trends

During the fourth quarter of 2017, Cortellis Competitive Intelligence registered 1,107 new deals (excluding mergers & acquisitions) as part of its ongoing coverage of licensing activity in the life sciences sector compared to 1,043 in the third quarter and 1,035 in the fourth quarter of 2016.   High-value deals: worth $0.5 billion or more We […]

Steps taken to streamline regulatory processes in the Middle East

When the DIA’s Middle East Regulatory Conference convened in Kuwait late last year, an array of hot topics drew considerable discussion. The gathering, which brings together multiple stakeholders from multinational companies, local manufacturers and agents/distributors with representatives of health authorities from across the region, focused on verification/reliance procedures, lifecycle management, harmonization initiatives, pharmacovigilance, barcoding, serialization […]

Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis was gathered from Clarivate Analytics Cortellis. According to the latest National Survey on Drug Use and Health […]

Predictive analytics yield better disease forecasting: the example of MS

The possibilities Disease forecasts are market analytics, aimed at understanding and predicting a product’s market potential. Prediction modelling usually involves a prediction profile (algorithm) from past studies. The model is then “deployed” so that a new individual can get a prediction instantly for whatever the need be, such as an epidemiological endpoint. Predictions can range from […]

Green light to market Hemlibra for hemophilia A with inhibitors in the US

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry.   Roche Holding’s Hemlibra (emicizumab-kxvh) has been approved in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding […]

Notable licensing deals in the biopharma industry in Q3 2017

Introduction During the third quarter of 2017, Cortellis Competitive Intelligence registered 949 new deals (excluding mergers & acquisitions) added as part of its ongoing coverage of pharmaceutical licensing activity compared to 1,007 in Q2 this year and 1,023 in Q3 the previous year. High-value deals: potentially worth $0.5 billion or more Approximately 40 high-value new […]

CAR T-cell gene therapies enter the U.S. market

Ground-breaking anti-cancer immunotherapy Novartis and the University of Pennsylvania’s anti-cancer chimeric antigen receptor (CAR) T-cell therapy Kymriah has become the first ever gene-modified therapy approved in the U.S. The therapy takes the patient’s own T cells, engineers them to express a receptor that binds to the B-cell blood cancer marker CD19, and then re-infuses them […]