Tags : Development

Roche and Prothena to Advance Prasinezumab in P-IIb Study for

Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients […]Read More

Boehringer Ingelheim and Pharmaxis Halt the Development of BI 1467335

Shots: The companies discontinue the P-IIa study assessing BI 1467335 vs PBO in 79 patients with moderately severe to severe NPDR without CIDME for 12wks. treatment period with an additional 12wks. follow-up period afterward. The study met its 1EPs in ocular safety with the treatment being well-tolerated The discontinuation is due to a lack of […]Read More

Janssen Halts the Development of Pimodivir for Influenza

Shots: The discontinuation is based on pre-planned interim analyses of P-III studies assessing Pimodivir + SOC vs SOC as monothx. in hospitalized & non-hospitalized patients with influenza A The therapy is unlikely to add benefits in hospitalized patients with influenza A. The company will halt both the studies, after consulting with BARDA In 2014, Janssen […]Read More

AstraZeneca Expands the Development of AZD1222 into P-III Study in

Shots: AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess its safety, efficacy, and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. […]Read More

Sarepta Therapeutics Collaborates with University of Florida to Accelerate the

Shots: Sarepta to fund four research programs at the UF and will get an exclusive option to develop any new therapeutic compounds resulting from the funded research programs. The projects include exploratory research in novel gene therapy vectors, next-generation capsids, and gene editing technologies along with new therapeutic areas in degenerative genetic diseases The focus […]Read More

Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the

Shots: Ovid will collaborate with UConn’s Stormy J. Chamberlain and secures exclusive access to identified genetic sequences for shRNA-based therapy. Ovid plans to leverage its translational medicine capabilities and drug development expertise in Angelman syndrome to advance OV101 into clinical Ovid is developing OV101 for Angelman syndrome to restore tonic inhibition addressing several core symptoms […]Read More

Otsuka Signs a Development and Commercialization Agreement with Esperion for

Shots: Esperion to receive $60M up front, $450M as development & commercial milestone and is eligible to receive 15-30% royalties in the sale of products in Japan. Otsuka will get exclusive rights to Nexletol and Nexlizet and will fund Japan-specific development costs associated with the products The collaboration leverages Esperion’s expertise in lipid management and […]Read More

Samsung Biologics Signs Multi-Product Development and Manufacturing Agreement with ImmuneOncia

Shots: The two companies expand their 2018 agreement to develop and manufacture five candidates from ImmuneOncia’s pipeline. The partners expand the collaboration to bring new treatments such as IMC-002 for cancer patients Samsung Biologics to provide CDO services from cell line development, process development, non-clinical/clinical material manufacturing, to IND submission supporting the global clinical trials […]Read More