October, 2019 | PharmaShots

WHO Signs MoU with IGBA for Promoting the Access to Biosimilars and Generics

October 24, 2019October 24, 2019Shiwani Sharma

Shots: The memorandum of understanding signed between WHO and International Generic and Biosimilar Medicines Association to facilitates the approval of generics and biosimilars [Read More...]

Bausch Health In-Licenses Clearside’s Xipere (triamcinolone acetonide suprachoroidal injectable suspension) For Macular Edema Associated with Uveitis

October 24, 2019October 24, 2019Shiwani Sharma

Shots: Clearside to receive ~$20M prior to launch including an up front and is eligible to receive commercial & regulatory milestones on approval [Read More...]

GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in Women with Recurrent Ovarian Cancer

October 24, 2019October 24, 2019Shiwani Sharma

Shots: The approval for the expanded indication is based on P-II QUADRA study assessing Zejula (niraparib) in 463 patients relapsed, high-grade serous epithelial [Read More...]

Novartis Collaborates with Pliant Therapeutics to Develop Therapies for NASH and Fibrotic Diseases

October 24, 2019October 24, 2019Shiwani Sharma

Shots: Pliant to receive $80M including upfront & equity investment and eligible to receive development, regulatory and commercial milestones with royalties on sales. [Read More...]

Biomica Signs an Agreement with Weizmann Institute of Science to Develop a Selective Treatment Against Antibiotic-Resistant Bacteria

October 23, 2019October 23, 2019Shiwani Sharma

Shots: Biomica collaborated with Weizmann Institute of Science to develop a selective treatment against antibiotic-resistant strains of Staphylococcus aureus infection, targeting a specific [Read More...]

Brii Biosciences Collaborates with Qpex to Develop and Commercialize Antibiotics for Drug-Resistant Infections in China

October 23, 2019October 23, 2019Shiwani Sharma

Shots: Qpex Biopharm to receive up front, development, regulatory and commercial milestones with royalties on sales in the licensed territories. Brii Biosciences to [Read More...]

BerGenBio’s Bemcentinib Receives the US FDA’s Fast Track Designation for Relapsed Acute Myeloid Leukemia

October 23, 2019October 23, 2019Shiwani Sharma

Shots: The US FDA has approved FT designation for Bemcentinib to treat elderly patients with acute myeloid leukemia (AML) whose disease has relapsed [Read More...]

Biogen and Eisai Plan to File BLA to the US FDA for Aducanumab to Treat Alzheimer’s Disease

October 23, 2019October 23, 2019Shiwani Sharma

Shots: The BLA submission will be based on P-III EMERGE and ENGAGE studies that were discontinued in Mar’2019 following a futility analysis. The [Read More...]

Novo Nordisk’s Fiasp (insulin aspart injection) Receives the FDA’s Approval for use in Insulin Infusion Pumps to Treat Type 1 or Type 2 Diabetes

October 23, 2019October 23, 2019Shiwani Sharma

Shots: The US FDA has expanded the label for Fiasp (insulin aspart injection, 100 u/mL) to be used in insulin infusion pumps for [Read More...]

Alvogen Signs an Exclusive Commercialization Agreement with Three Pharma Companies for PF708 (biosimilar, teriparatide)

October 23, 2019October 23, 2019Shiwani Sharma

Shots: Alvogen collaborates with PharmBio, Kamada and Jamp to commercialize PF708 for the treatment of osteoporosis in South Korea, Israel and Canada respectively [Read More...]