Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]Read More
Shots: AbCellera to receive upfront, milestone, and royalties based on the development and commercialization of Abs, emerge under the collaboration The expanded collaboration will utilize AbCellera’s technology stack, which includes Trianni Mouse and OrthoMab protein engineering platform AbCellera will generate panels of Abs against up to 8 new targets across multiple indications, selected by Gilead […]Read More
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, […]Read More
Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new […]Read More
Shots: The companies will co-develop & co-commercialize the combination of Gilead’s Lenacapavir and Merck’s Islatravir in long-acting oral & injectable formulations for HIV. Gilead & Merck will share global development & commercialization costs (60%/40%) respectively For oral products, Gilead will lead commercialization in the US & Merck will lead in the EU & ROW while […]Read More
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, BioVectra, Support, Development, Commercialization, Bentracimab Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Published: Mar 12, 2021 | Tags: […]Read More
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available […]Read More
Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx. period (88% vs 17), low (150 mg/kg) and high dose […]Read More
Shots: The two OLE P-III 1489 and 1490 studies assessing Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) vs dolutegravir-containing triple for the treatment of HIV-1 in treatment naïve adults The study demonstrated the sustained efficacy & safety profile with no treatment-emergent resistance @144wks, >98% of treatment-naïve patients achieved and maintained undetectable viral load […]Read More
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the […]Read More
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