recent pharma news
Sep 20, 2022
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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Sep 13, 2022
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial
Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...
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Sep 06, 2022
AstraZeneca’s Imfinzi for Biliary Tract Cancer; FDA Clears Boehringer’s Spesolimab; Novo Nordisk to Acquire Forma Therapeutics; Sanofi’s Xenpozyme Approved for ASMD; Another FDA Approval to Azurity’s Konvomep; Amgen’s Lumakras Trial Results; FDA Grants Priority Review to Sanofi & Sobi’s efanesoctocog alfa; Neurocrine Bio to Takeover UK Biotech Diurnal
FDA Approves AstraZeneca’s Imfinzi for Biliary Tract Cancer Imfinzi, a checkpoint inhibitor developed by AstraZeneca, has been approved by the FDA as the first immunotherapy for biliary tract cancer (BTC), a rare and aggressive form of cancer with few treatment options. Imfinzi (durvalumab) has been approved by ...
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Aug 30, 2022
Aktis’s Novel Targeted Alpha Radiopharmaceuticals; Koye Partners with Sonde Health; Novartis to Spin Off Sandoz Business; Alcon to Buy Aerie Pharma; Fast Track Designation to Merck’s MK-2060; FDA Approves Ibrutinib for Chronic GvHD; French Authorities Clears BrainVectis’s Clinical Trial; Takeda’s Dengue Vaccine TAK-003 Gets Approval in Indonesia
Aktis Oncology Raises USD 84 Million To Advance Novel Targeted Alpha Radiopharmaceuticals Aktis Oncology has raised an additional USD 84 million in its Series A round, adding to the USD 72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round included Merck's...
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Aug 16, 2022
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC
Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...
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Aug 10, 2021
Merck’s Keytruda Approval; Abbvie’s Venetoclax; Aprea’s Eprenetapopt; CRL to Incyte’s Retifanlimab; Keytruda/Lenvima for Endometrial Cancer
FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC In July 2021, the US FDA approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as...
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Jul 15, 2021
Hepion aces mid-stage study; Bicycle Therapeutics-Ionis collaboration; Nimbus raises $105M; Regeneron to support ISA Pharma
Hepion Pharma's NASH drug is set for Phase 2b after clearing the safety bar Hepion Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic drugs for the liver disease treatment arising from non-alcoholic steatohepatitis (NASH), declaring positive topline results from...
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Jul 08, 2021
Unity’s advanced vascular eye disease trial; Rallybio raises $100 M; Sanofi bets over $1B for Eureka’s candidate; Lilly invests in MiNA;
UNITY Biotechnology declares positive data from phase 1 clinical trial of UBX1325 in Advanced Vascular Eye Disease patients UNITY Biotechnology, Inc., a biotechnology company developing therapeutics to decrease, impede, or reverse diseases of aging, declared positive data from its Phase 1 safety study of U...
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Jun 24, 2021
Insilico Medicine raises $255M; Sanofi & Translate Bio initiate trial; Medtronic gains expanded FDA approval; Blackstone, Cellex & Intellia form CAR-T startup
Insilico Medicine raises USD 255 Million for AI drug discovery Insilico Medicine, a Hong Kong-based global leader in end-to-end artificial intelligence for target discovery, small molecule chemistry, and clinical development, closed a USD 255 Million Series C financing. Warburg Pincus led the round with parti...
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Jun 17, 2021
Mallinckrodt earns FDA nod for skin therapy; RayzeBio secures $108M; VectorY raises $38M; Umoja banks $210M
Mallinckrodt earns FDA nod for regenerative skin therapy for burns Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. The company said regenerative skin tissue therapy could lessen or eliminate the requirement of autografting of healthy skin to treat burn wounds. ...
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