Ovarian Cancer

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AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data

Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin AstraZeneca and Daiichi Sankyo's drug Enhertu (trastuzumab deruxtecan) has gained approval in the United States for treating adult patients with inoperable or metastatic HER2-positive (IHC 3+) so...

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Pharma News for AskBio, Merck, SELLAS, RemeGen
Bayer’s AskBio Initiates Phase II GenePHIT Trial; FDA Approves Merck’s KEYTRUDA Plus Chemoradiotherapy as Treatment for Stage III-IVA Cervical Cancer; FDA Fast Track Designation to SELLAS Life Sciences R/R AML; RemeGen’s RC88; Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer; Tonix Pharma’s TNX-102 SL for Fibromyalgia

Bayer’s AskBio initiates Phase II GenePHIT trial in Congestive Heart Failure Merck, also recognized as MSD in regions beyond the United States and Canada, has officially announced that the FDA has approved for the use of KEYTRUDA, Merck's anti-PD-1 therapy, in conjunction with chemoradiotherapy (CRT) for treatin...

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Pharma News for AbbVie, Novartis, Avenge Bio, Eli Lilly
AbbVie Presents Phase III CANOVA Study Results; Novartis’ Iptacopan Shows Promise in Phase III Study; Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer; FDA Issues Complete Response Letter for Lebrikizumab; Nedosiran Approveed for Primary Hyperoxaluria Type 1; Orphan Drug Designation to BDC-1001 for Gastric Cancers

AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...

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Pharma News Updates Merck, Regeneron, Provention, Ardelyx, AbbVie
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 ...

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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 and Updates for AstraZeneca, Supernus, and BMS
VBL Therapeutics’ VB-111 (ofranergene obadenovec); BMS’s mavacamten (Camzyos); Merck’s KEYTRUDA; AstraZeneca and Daiichi’s Enhertu; Pfizer/Biohaven’s VYDURA (rimegepant); AstraZeneca’s Ultomiris; Supernus’s Viloxazine (Qlebree); AbbVie’s Rinvoq

FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer The FDA has given VBL Therapeutics’ VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer. VB...

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Pharma News and Updates Precigen, Biogen, Cerevance, Sanofi, Clovis
Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval

FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...

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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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Latest pharma happenings for Roche and Secura Bio
FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy  The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in muscle atrophy, in adults and...

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Pharma News | COVID-19 News | Cancer News
Merck, Dewpoint’s HIV Pipeline; Pfizer, BioNTech ‘s COVID-19 Vaccines; Roche’s Tecentriq- Avastin Duo Failure in Ovarian Cancer

Merck Collaborates with Dewpoint Therapeutics to Cure HIV with Condensates   Merck has forged a collaboration with Boston-based Dewpoint Therapeutics to treat HIV using Dewpoint’s proprietary platform for condensate-based drug discovery.Under the terms of the agreement, Dewpoint is eligible for receiving ...

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