pharma news
Dec 08, 2022
Olympus Launches New Gynecologic Power Morcellator; Journey Biosciences Launched NaviDKD; GE Board Approves Separation of GE HealthCare; FDA Approval to Enovis’s STAR Ankle; FDA Clearance to Deep Blue Medical’s T-Line Hernia Mesh; NeuroOne Completed Feasibility Study with its OneRF Ablation System
Olympus Launches New Gynecologic Power Morcellator for Its Contained Tissue Extraction System On November 30, 2022, Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, launched the moresolution™ Power Morcellator, manufactured by TROKAM...
Read More...
Dec 06, 2022
Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Therapy, NKX019; Eisai Presents Results of lecanemab for Alzheimer’s Disease; EQRx’s Aumolertinib for EGFR-Mutated NSCLC; FDA Approves Olutasidenib for IDH1-Mutated R/R AML; FDA Orphan Drug Designation to AUM302 for Neuroblastoma; X4 Pharma Announces Results for WHIM Syndrome Drug
FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma A global clinical-stage biotech company, AUM Biosciences, focused on discovering and developing precision oncology therapeutics, declared that the U.S. FDA has permitted Orphan Drug Designation for AUM302. For the treatment of neuroblastoma, AUM302 i...
Read More...
Nov 29, 2022
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...
Read More...
Nov 22, 2022
FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes; FDA Backs Ardelyx’s CKD Therapy Xphozah; Merck to Acquire Imago BioSciences; Accelerated Approval to ImmunoGen’s ELAHERE; Regeneron and CytomX Announces Research Collaboration; FDA Grants Priority Review to Epcoritamab R/R LBCL
Merck to Acquire Imago BioSciences, Inc. for USD 1.35 Billion While its rumored acquisition of Seagen has yet to materialize, Merck & Co has continued to bolster its pipeline with smaller transactions, the most recent of which was a USD 1.35 billion agreement to acquire Imago BioSciences and its bomedemstat ...
Read More...
Nov 15, 2022
Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027
Genentech’s gantenerumab Fails in Phase III Trial for Alzheimer’s Disease In yet another setback for an amyloid-targeting drug, Roche's Genentech division has reported disappointing top-line results from its highly anticipated phase III trial of gantenerumab in early Alzheimer's disease. The failure is entirely ...
Read More...
Nov 08, 2022
Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma
Amgen Reports Promising Mid-stage Results for its Olpasiran Candidate Amgen has reported encouraging mid-stage results for its olpasiran candidate for lowering lipoprotein(a) - a risk factor for atherosclerotic cardiovascular disease - and now plans to move forward with a phase III program as soon as possi...
Read More...
Nov 01, 2022
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC
Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...
Read More...
Oct 25, 2022
Sumitomo to Purchase Myovant; AstraZeneca’s Tremelimumab Plus Imfinzi Approved in the US; AbbVie Acquires DJS Antibodies; Roche and Hookipa Pharma Signs USD 25 Million Deal; FDA Accepts BMS’s New Drug Application for CAMZYOS; Jazz and Zymeworks Sign Exclusive Licencing Agreement
FDA Accepts Bristol Myers Squibb’s Supplemental New Drug Application for CAMZYOS Bristol Myers Squibb declared that the U.S. FDA had accepted its supplemental new drug application for CAMZYOS for an expanded indication to reduce the need for septal reduction therapy. CAMYZOS is currently FDA-approved for treatin...
Read More...
Oct 18, 2022
CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat
CHMP Gives Positive Opinion on Takeda’s Qdenga The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH’s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product ...
Read More...
Oct 11, 2022
Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio
Merck’s Sotatercept Clears Phase III Trial Merck’s USD 11.5 billion acquisition of Acceleron last year was based on the promise of pulmonary arterial hypertension (PAH) candidate sotatercept, which has recently met the mark in a much-anticipated phase III trial. The STELLAR trial found that adding the activin re...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
