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Primex Pharmaceuticals Plots Launch Plans For Oral Pediatric Sedative

With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.

 

Neurology Pediatrics

Mylan Head Of Biologics Chrys Kokino On Fulphila Launch And US Biosimilars

Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.

Biosimilars Strategy

"Impressive" HbA1c And Weight Reductions Spur Phase III Plans For Lilly's Dual Incretin Agonist

Heading into Phase III in 2019 is Lilly's dual agonist of GLP-1 and GIP, which has shown notable therapeutic effects on blood sugar and body weight in type 2 diabetics in a mid-stage clinical study. Meanwhile Lilly/Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, is being discussed with regulators with regard to its use in type 1 diabetics, an additional indication, following the release of full results from the EASE Phase III program.

Metabolic Disorders Clinical Trials

Momenta Is Exiting Biosimilars; Is That A Bellwether For Biosimilar Sentiment?

CEO Craig Wheeler talked to Scrip about the challenging biosimilar market dynamics and the company's decision to end most biosimilar drug development. The path to value creation in biosimilars is not clear, he said.

Biosimilars Business Strategies

Vertex Set To Dominate Cystic Fibrosis Market For The Next Decade

Vertex is set to reap huge benefits from its triple combination program for cystic fibrosis over the next 10 years, potentially becoming the biggest selling drug in this disease, according to a new report from Datamonitor Healthcare.

Respiratory Market Intelligence

Phase III Roxadustat ALPS Data Positive For New Class Of Anemia Therapies

Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease.

 

Clinical Trials Renal

Fix Antibiotic Payment Models To Spur R&D Investment, US FDA’s Gottlieb Says

Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.

Infectious Diseases Reimbursement

Medical Aesthetics: Sales Rise For Popular Products, But Unmet Needs Remain

Botox was a game-changer, which means challengers to Allergan's blockbuster are on the way. Dermal fillers and devices also have an important role, but dermatologists say innovation is needed to fill treatment gaps. Business development is ongoing to expand companies' product portfolios.

Aesthetics Business Strategies

Medical Aesthetics: Key Players In A Largely Untapped Market

Medical aesthetics is a growing, but largely untapped biopharma niche with unique consumer marketing and doctor relationship-building strategies where key players have honed their skills for many years. Allergan's blockbuster Botox dominates, but competitors are gaining ground.

Aesthetics Business Strategies
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