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Gedeon Richter
News

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots:  The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab)  Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone  Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation   Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 20250Comments

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Akesobio
News

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…
April 25, 20250Comments

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Top 20 Biopharma 2025
TOP 20

Top 20 Biopharma Companies of 2025 

Shots:  Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones  With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
April 24, 20250Comments

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Repertoire Immune Medicines & Genentech
News

Repertoire Immune Medicines Collaborates with Genentech to Develop T cell-Targeted Therapies for an Autoimmune Disease

Shots: Repertoire & Genentech have entered into a collaboration & license agreement to identify & develop novel T cell-targeted therapies for an autoimmune disease, leveraging Repertoire’s DECODE platform As per the deal, Genentech will handle preclinical & clinical development along with global marketing in exchange for $35M upfront & ~$730M in development, regulatory & commercial…
April 24, 20250Comments

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Aclaris Therapeutics
News

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Shots: The US FDA has granted IND clearance to ATI-052 for the initiation of P-Ia/Ib trial The P-Ia/Ib trial assessing single & multiple ascending doses of ATI-052 followed by PoC portion in an undisclosed indication, is expected to begin in Q2’25 ATI-052 blocks upstream TSLP receptor signaling & downstream IL-4/IL-13 activation to inhibit a central…
April 24, 20250Comments

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Ipsen Pharmaceuticals
News

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Shots: Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively Elafibranor…
April 24, 20250Comments

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Sebela Pharmaceuticals
News

Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consists of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE) & non-erosive reflux disease (NERD); EE’s maintenance phase to end by Q3’25, with FDA’s NDA filing for both EE & NERD planned in Q4’25 EE study (vs lansoprazole) in 1250 pts (incl. 463 with LA Grade C/D)…
April 24, 20250Comments

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Mosaic Therapeutics & Astex Pharmaceutical
News

Mosaic Therapeutics In-Licenses ASTX029 & ASTX295 from Astex Pharmaceuticals for Combination Therapy Development for Oncology

Shots: Mosaic has in-licensed ASTX029 & ASTX295 from Astex (Otsuka Pharmaceutical’s subsidiary) to develop combination therapies using these assets, with the 1st combination study expected to begin in 2026 As per the deal, Astex granted Mosaic exclusive rights to develop combination products for pts with limited therapy options, receiving a 19% equity stake upfront &…
April 24, 20250Comments

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