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Reata Expands Options For Bardoxolone With New CKD Data

Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.

Clinical Trials Research & Development

Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers

In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.

Clinical Trials Research & Development

Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes

Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies. 

Approvals Blood & Coagulation Disorders

Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration

Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids, which are found in slime bacteria and have potent activity against serious bacterial pathogens.

 

Infectious Diseases Research and Development Strategies

Intercept Retakes The Lead In NASH

A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.

Clinical Trials Liver & Hepatic

Pioneering Gyroscope Therapeutics Aims To Develop One-Time Gene Therapy For AMD

Gyroscope Therapeutics, which aims to develop genetically defined therapies for a range of eye diseases, has begun dosing in a Phase I/II clinical trial in dry age-related macular degeneration using its lead candidate.

Clinical Trials Companies

Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA

Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.

Financing Infectious Diseases

Troubled Realm Therapeutics Selling Assets, Delisting From London AIM

US-based, UK-listed biotech says it is talking with 'interested parties' including those considering making an offer for the business.

Business Strategies Commercial

Shire Solid But Hemophilia Challenges Looming?

Shire puts in solid results in last full year before Takeda acquisition, with 4% sales growth and strong cash flow, but there was some weakness in hematology stemming from lower ex-US prices and rising competition.

Business Strategies Commercial
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