Pancreatic Cancer

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Ipsen’s Onivyde Combo Ends a Decade-Long Dry Spell in Newly Diagnosed Pancreatic Cancer

It marks the awaited green light for Ipsen following its acquisition of Onivyde in 2017. The FDA has given its nod to the supplemental new drug application for Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a primary treatment for adults with met...

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Pharma News for Amylyx, Sellas, Apnimed, Ocelot
ImPact Biotech’s IND Application for Padeliporfin VTP; Orphan Drug Designation to Ocelot Bio’s OCE-205 for Ascites; Amylyx’s Phase 3 ORION Study of AMX0035 for PSP; SELLAS Receives FDA Orphan Drug Designation for SLS009 for PTCL Treatment; Apnimed Updated on Second Phase 3 Clinical Study of AD109 for OSA

ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer ImPact Biotech, a biotechnology company in its clinical stage dedicated to advancing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for various solid tumors, announced on December 20, 2023, that the U.S....

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Pharma News for Pfizer, UCB, BioMarin
FDA Approves PENBRAYA for Most Common Serogroups Causing Meningococcal Disease; BIMZELX Approved Moderate to Severe Plaque Psoriasis; FDA Approves BioMarin’s VOXZOGO; FDA Fast Track Designation to ANPD001 for Parkinson’s Disease; UCB Announces FDA Approval of ZILBRYSQ; EMA Granted Orphan Drug Designation to Lisata’s LSTA1

UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...

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Pharma News for Gilead, Incannex, Avidity
Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5

Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...

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Pharma News for AbbVie, Oculis, AstraZeneca, Krystal Biotech, Alligator Biosciences
FDA Approves RINVOQ for Crohn’s Disease; FDA Approves Krystal Biotech’s Gene Therapy Vyjuvek; FDA Approves EPKINLY to Treat R/R DLBCL; FDA Orphan Drug Designation to Mitazalimab; Phase 3 Trial Result of OCS-01 Eye Drops; TAGRISSO® + Chemotherapy for the EGFR-mutated Advanced Lung Cancer

FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...

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Pharma News and Updates for Cingulate, Merck, Transcenta, Ipsen, Nuance
Ipsen’s Cabometyx Rejected by NICE; Vertex and CRISPR Therapeutics’s Submit BLA to the FDA for exa-cel; Orphan Drug Designation to Osemitamab for Pancreatic Cancer; FDA Clears Keytruda/Padcev for Bladder and Urothelial Cancer; Cingulate Completes Trial of CTx-1301 for ADHD; Nuance Pharma Announces Dosing of First Patient in ENHANCE Trial

FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer Transcenta Holding Limited has announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Osemitamab (TST001), a highly potent humanized monoclonal antibody that enhances ADCC (antibody-dependent cell-me...

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Pharma News and Updates for Akero Chiesi Pfizer
AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa

AstraZeneca’s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment f...

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Pancreatic Cancer Therapeutics Market Outlook
Treatment to Clinical Development – A Bumpy Journey for Pancreatic Cancer

Treatment for pancreatic cancer patients is challenging and not well defined, especially for patients with disease progression or adverse events seen after initial treatment. Studies suggest that, after diagnosis, about 22% of pancreatic cancer patients, regardless of their clinical stage of cancer, receive no trea...

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Venclexta full approval; PBP1510 Orphan Status; Roche/ Genesis collab; Immunomodulators for COVID-19

Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia   The US FDA has granted its full approval to Venclexta (venetoclax) for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older who are unfit for intensive induction chemotherapies.  The approval is based on the res...

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Lassen’s anti-IL-11 antibody; PTC’s COVID-19 trial; Lenzilumab’s result; Orca raises $192M

Lassen Therapeutics to create anti-IL-11 antibody for cancer and fibrosis Lassen Therapeutics is revealing USD 31 million from Frazier Healthcare Partners, Alta Venture and Longwood Fund and has an aim to create antibodies for cancer and fibrosis treatment. IL-11, a cytokine that plays a role in both disease are...

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