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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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Pharma News for Amgen BioNTech and Gilead
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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Pharma News for Azurity, Sobi, and Sanofi
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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Pharma News for Aktis, Alcon and Takeda
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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Pharma News for Novartis and Gilead
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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Pharma News for Sarepta and Ionis
Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen

Bristol-Myers Squibb’s Opdivo and Yervoy Combo Fails in Phase III Trial Bristol-Myers Squibb has reported that their Opdivo and Yervoy checkpoint inhibitor combo failed a phase III trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most frequent type of kidney cancer. The CheckMate -914...

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Pharma News for AbbVie and Sobi
Novo Nordisk’s Concizumab for Hemophilia; AbbVie Ends its Alliance with Alector; ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal; BMS’ Opdivo Gets NHS Use; Merck to Acquire Seagen; FDA Priority Review to Roche’s Lunsumio; AstraZeneca to Acquire TeneoTwo; FDA Orphan Drug Designation to PBI-200

Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B Novo Nordisk has announced Phase III results for their concizumab drug for hemophilia A or B, demonstrating efficacy in preventing bleeding events and paving the way for regulatory filings later this year. Concizumab, an anti-tissue ...

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Pharma News and Updates for BMS, Mirati, Roche, Dermavant, Merck
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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Pharma News and Analysis for BMS, Sandoz, and Pfizer
BMS Sells NY Biologics Plant; FDA Approves Mitsubishi Tanabe’s Radicava, Love Pharma Acquires MicroDoz; Sandoz Launches Generic of Roche’s Esbriet; Pfizer to Acquire Biohaven Pharma; eureKARE’s Cell and Gene Therapy CDMO; Atamyo’s LGMD Gene Therapies; FDA approves Eli Lilly’s Type 2 Diabetes Treatment

Love Pharma Completes the Acquisition of MicroDoz Therapy LOVE Pharma Co. has announced the completion of its acquisition of MicroDoz Theraphy Inc. ("MicroDoz"). Love Pharma holds exclusive manufacturing, marketing, packaging, selling, and distribution licenses in Europe, the United Kingdom, and North America. U...

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Pharma News and Updates for GSK, BriaCell, Gilead, Lilly, Merck, Halozyme
GSK Acquires Sierra Oncology; BriaCell’s Targeted Breast Cancer Immunotherapy; Merck’s Tepmetko; Gilead’s Magrolimab for MDS and AML; Eli Lilly’s Retevmo; Merck’s Pneumococcal Vaccine; FDA Approves Bevacizumab Biosimilar; Halozyme to Acquire Antares Pharma

GSK Acquires Sierra Oncology for USD 1.9 Billion GlaxoSmithKline has agreed to buy Sierra Oncology and its lead drug assets, momelotinib, for anemia caused by the blood malignancy myelofibrosis. GSK is paying USD 55 per share in cash for Sierra, a 39% premium to the company's closing share price yesterday, valui...

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