Sanofi looks east with €300m Innovent cancer alliance
Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as […]
Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as […]
The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, […]
Shots: The P-Ib clinical trial evaluates the safety & tolerability of IBI302 multi-intravitreal injection in 18 patients with nAMD The results showed an improvement in […]
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
Shots: The companies collaborated to evaluate the safety, PK, PD & preliminary efficacy of the combination therapy of Innovent’s sintilimab + NeoCura’s NEO_PLIN2101 in patients […]
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, […]
Eli Lilly made a late entry into the checkpoint inhibitor market when it licensed ex-China rights to Innovent’s sintilimab last year, and a new trial […]
Shots: The P-III ORIENT-31 study evaluates sintilimab with/out Byvasda + CT vs CT in a ratio (1:1:1) in patients with EGFR-mutated LA or metastatic nonsq. […]
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, […]
Shots: Union to receive $20M up front and is eligible to receive ~$247M in milestone along with royalties on sales of orismilast in China & […]
Shots: The P-II TRUST trial evaluates taletrectinib (AB-106, ROS1/NTRK inhibitor) in 37 TKI-naïve or pre-treated patients with ROS1-positive NSCLC As of June 16, 2021 cut […]
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
Shots: The first patient has been dosed in P-II CIBI112A201 clinical trial evaluating IBI112 (SC, anti-IL-23p19 mAb) in patients with moderate-to-severe PsO The primary objective […]
Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, […]
Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, […]
Shots: The P-III ORIENT-11 study evaluates the efficacy & safety of sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT in 397 patients […]
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | […]
Shots: The first patient has been dosed in a P-I CIBI323A101 study evaluating IBI323 (anti-LAG-3/PD-L1 bispecific Ab) in patients with advanced solid tumors. The trial […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, […]
Shots: The first patient has been dosed in a P-II clinical trial evaluating the efficacy and safety of IBI362 (GLP-1R and GCGR dual agonist) in […]
Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: […]
Shots: The approval is based on P-III ORIENT-12 trial evaluating Tyvyt (sintilimab injection) or PBO + Gemzar (gemcitabine) & platinum CT in 357 patients in […]
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
The FDA has accepted Eli Lilly and China’s Innovent filing for their latecomer immunotherapy sintilimab, which is expected to compete on price with rivals such […]
Shots: The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L […]
Shots: The first patient has been dosed in the P-II trial assessing IBI302 in patients with active subfoveal or parafoveal choroidal neovascularization secondary to nAMD. […]
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting […]
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal […]
Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as […]
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, […]
Shots: Innovent to receive milestones for development and commercialization along with royalties on net sales of the therapy in the licensed territory. Etana is committed […]
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, […]
Shots: The NMPA has approved Byvasda for the treatment of adult recurrent Glioblastoma which is the third approved indication of Byvasda in China The launch […]
Shots: The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval […]
Shots: The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) […]
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Shots: The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer […]
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, […]
Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some […]
Shots: Innovent to receive $200M up front, $825M as development and commercial milestones along with royalties on net sales of the therapy. Both the companies […]
Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA […]
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