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Pharma News For Astellas, AnaMar, Biosyngen
4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016

4DMT Presents Positive Interim Data from Randomized Phase II PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD 4D Molecular Therapeutics, a prominent company in the field of genetic medicines with a focus on harnessing the full potential of geneti...

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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 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 for CG Oncology, Amgen, Elevar, and GSK
CG Oncology Teams Up With Merck & BMS; Parse Biosciences Partners With Molecular Diagnostics Korea; Amgen’s Olpasiran; Elevar Therapeutics Announces Results of Rivoceranib; FDA Approves GSK’s Measles Vaccine; Sage & Biogen Reveals Postpartum Depression Trial Result

FDA Gives Green Signal to First Measles Vaccine in Almost 50 Years GSK announced that the company's vaccine for protection against mumps, measles, and rubella (MMR) had been approved by the U.S. FDA. According to data from six clinical studies, the company filed a Biologics License Application in August 2021. ...

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Bladder Cancer Highlights ASCO
Seagen/Astellas plans to expand their Antibody Drug Conjugate (ADC), Padcev in additional bladder cancer settings?

Padcev (Enfortumab vedotin) for the treatment of locally advanced or metastatic urothelial cancer, Adcetris (Brentuximab vedotin) for the treatment of several types of CD30-expressing lymphomas, and Tivdak (Tisotumab vedotin) for the treatment of recurrent or metastatic cervical cancer are the three ADCs that Seage...

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Recent Pharma News
Roche’s Tecentriq combo proves effective in Bladder cancer

Roche’s Genentech has presented positive Phase III results from the IMvigor130 study aimed at studying Tecentriq (atezolizumab) tested in combination with platinum-based chemotherapy. The drug, Tecentriq, combined with Pt-based chemotherapy showed a noteworthy improvement in patients with untreated advanced bla...

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NASH
Notizia

FDA gives thumbs-up to Balversa The U.S. FDA has granted approval of Balversa (erdafitinib) to Belgium-based Janssen Pharmaceutica, for the treatment of advanced or metastatic bladder cancer. This drug is the first ever approved target-specific medication targeting susceptible FGFR genetic mutations, and for can...

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The risk of solid cancer after chemotherapy

Subsequent malignant neoplasms (SMNs) are one of the most serious and potentially lethal complications of cancer and its therapy. Radiotherapy has been known to be a human carcinogen, however, a growing body bolsters the selective contribution of chemotherapeutic agents to SMN risk. Cisplatin binds to and destructs ...

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Novo petitions FDA;J&J invests; Xarelto’s trial; Roche’s Tecentriq

Novo petitions FDA to require copies of Victoza to conduct clinical trials With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arg...

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FDA Approves; AZ nabs; Nordisk settles; Novartis pays

FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinas...

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