Tags : Two

Jazz Collaborates with Redx Pharma to Develop Two Targeted Cancer

Shots: Redx to receive $10M as up front followed by another $10M in year two and will receive up to $400M as milestones along with royalties on sales of the therapies. The first milestone is payable following IND submission Following a successful IND submission, Jazz will be responsible for further development, manufacturing, regulatory activities, and […]Read More

Merck Reports Results of Gefapixant (45mg) in Two P-III Studies

Shots: The two P-III studies (COUGH-1 & -2) involves assessing of gefapixant (45/15mg, bid) vs PBO in 2,044 patients with refractory or unexplained chronic cough for 12 & 24wks. respectively In both the studies, gefapixant (45 mg) resulted in reduction of objectively measured 24hrs.-cough frequency @12 & 24wks. (18.45% & 14.64%), reduction in cough frequency […]Read More

Pfizer with its Partner BioNTech Receives the US FDA’s Fast

Shots: The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul 01, 2020. Additionally, the early results of German trial evaluating BNT162b1 are expected in Jul 2020 The companies BNT162 mRNA-based vaccine program involves the evaluation of 4 investigational candidates developed to target […]Read More

EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s

Shots: The CHMP has adopted the positive opinion recommending the approval of Theramex’s  Livogiva (biosimilar, teriparatide) intended for the treatment of osteoporosis and will be available as a solution for injection (20 micrograms/80 microliters) The CHMP has also recommend marketing authorization to EuroGenerics’ Qutavina (biosimilar, teriparatide) to treat osteoporosis, also available as a solution for […]Read More

Merck Collaborates with Yumanity to Accelerate the Development of Two

Shots: Yumanity will receive $500M upfront and milestones along with royalties on net sales of therapies, in exchange Merck to get an exclusive right to two novels Yumanity’s pipeline programs for the treatment of ALS and FTLD The collaboration integrates Yumanity’s drug discovery platform with Merck’s development and commercialization expertise in neuroscience    Yumanity and […]Read More

Tolmar’s Fensolvi Received the US FDA’s Approval to Treat Pediatric

Shots: The approval is based on P-III study which involves assessing of leuprolide acetate (LA,45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics The study achieved its 1E i.e. 87% of children achieved a serum luteinizing hormone concentration of <4 IU/L at six months post injection with most common […]Read More

Janssen Reports Submission of Two sBLA to the US FDA

Shots:::spohSththShots: The submissions are based on P-III GO-VIVA study involves assessing of SIMPONI ARIA in 127 patients aged 2-17yrs. with active pJIA having arthritis in 5or more joints, despite current treatment with methotrexate for at least two mos. The focus of the study is to evaluate PK safety & efficacy of the therapy in pediatric […]Read More

Global Pharmaceuticals and the University of Cambridge Collaborate to Launch

Shots: GSK, AstraZeneca and the University of Cambridge have formed a collaboration, supporting the UK’s government five-pillar plan to boost testing for COVID-19 A new testing laboratory will be set up in the University’s Anne McLaren laboratory and will explore the use of alternative chemical reagents for high throughput screening for COVID-19 testing for overcoming […]Read More