NSCLC
Jun 14, 2022
GSK’s RSV Vaccine Clears Phase III Test in Adults; Roche’s Tecentriq for Adjuvant NSCLC; Owkin Bags $ 180 million from BMS; EU Approves Roche’s Mosunetuzumab; Dostarlimab Elicits Clinical Complete Response in dMMR Rectal Cancer; FDA Backs Bluebird’s CALD Gene Therapy; Takeda’s Dengue Fever Vaccine TAK-003; FDA Approves Dupilumab
GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.&...
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May 31, 2022
Bristol-Myers Squibb’s Opdivo Approval; Mirati’s KRAS-inhibitor Adagrasib; J&J and Legend Biotech’s CAR-T Carvykti Approval; Roche’s Glofitamab; Arena Pharma’s Etrasimod Phase 3 Trials; FDA Approves Dermavant’s Vtama; FDA Approves Novartis’ Cell Therapy; NICE Approves Merck’s Keytruda
Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...
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Mar 29, 2022
Sanofi’s Rare Disease Drug Xenpozyme’ Approval; FDA Approves Novartis’ Pluvicto; AstraZeneca’s Imfinzi Trial Result; FDA’s Green Signal to Argenx’ Vyvgart; ViiV Healthcare and J&J’s HIV Treatment Cabenuva; UCB’s FINTEPLA Approval; Cullinan’s Update for CLN-081; MEI Pharma & Kyowa’s Zandelisib Approval
Sanofi’s Rare Disease Drug Xenpozyme Wins World’s First Approval in Japan Sanofi’s Xenpozyme, also known as olipudase alfa, the world's first therapy for the rare disease Niemann-Pick type A/B and B, has been approved for the treatment of children and adults with non-CNS manifestations of Acid Sphingomyelinase D...
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Mar 22, 2022
Bristol Myers’ Opdivo combo Opdualag for Melanoma; Biogen’s Aduhelm; Marinus’ Ztalmy for CDKL-5 Deficiency Disorder; Merck’s Keytruda + Lynparza; Vitaris’s Breyna; Moderna’s Second COVID-19 Booster Shot; Takeda’s Exkivity; BMS’s First LAG-3 Checkpoint Inhibitor
NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...
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Feb 15, 2022
Pfizer & Lilly’s JAK Inhibitors Drug; FDA Approves Lilly’s Bebtelovimab; GSK’s Benlysta; Daewon’s Non-steroidal Anti-inflammatory Drug; Lilly & Innovent’s Lung Cancer Drug; Bayer’s Asundexian
Pfizer and Lilly's JAK Inhibitors Safety Concerns Prompt Europe to Investigate the Drug Class The risk of heart problems associated with the use of JAK inhibitors has called the entire drug class into question. In September, the FDA announced that it would require safety warnings for drugs such as Pfizer's Xelja...
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Jan 14, 2022
Most Promising Oncological Drugs Expected to Launch in 2022
The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...
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Jan 11, 2022
Noxxon’s NOX-A12 clinical trial; Exact Sciences buys PreventionGenetics; Nuvalent’s clinical trails for NVL-520; Stryker acquires Vocera Communications
Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...
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Jan 05, 2022
Assessment of Key Products that Got FDA Approval in Second Half (H2) of 2021
Although COVID-19 continued to dominate headlines in 2021, pharmaceutical companies did not cease developing new treatments this year. The US Food and Drug Administration maintained a rapid rate of new drug approvals this year, all while managing the urgent examination of COVID-19 tests, treatments, and vaccines un...
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Dec 21, 2021
Edwards’ Sapien 3 with Alterra Prestent; Koios Medical’s breast, thyroid cancer-spotting AI; Lineage Collaborates with Genentech; Novartis, BeiGene ink deal
Edwards secures FDA approval for Sapien 3 with Alterra Prestent for Transcatheter Pulmonic Valve Replacement Edwards Lifesciences declared to receive approval from the U.S. Food and Drug Administration (FDA) to use the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra...
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Dec 06, 2021
T-cell Immunoglobulin and ITIM domain (TIGIT) Inhibitor: An Insight into the Pipeline Development Activities, Major Collaborations, and Advancements
T-cell immunoreceptor with Ig and ITIM domains (TIGIT) is a relatively new immunological checkpoint that has been studied as a potential immunotherapeutic target. TIGIT is a transmembrane glycoprotein receptor containing an Ig-like V-type domain in its cytoplasmic domain and an ITIM in its extracellular domain. It'...
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