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AnHeart Therapeutics and Innovent Announce China’s NMPA Has Accepted a New Drug Application for Taletrectinib (ROS1 Inhibitor)
11/22/2023
AnHeart Therapeutics and Innovent Biologics, Inc. today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI).
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Apotex Corp. Launches Teriparatide Injectable for Osteoporosis Treatment in the United States
11/21/2023
Apotex Corp. announced the launch of Teriparatide Injection, a single-patient-use pre-filled pen used for the treatment of osteoporosis in the United States.
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Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care
11/21/2023
Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Hyrimoz® citrate-free high concentration formulation in Europe.
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Biosimilar Monoclonal Antibody Market Size to Surpass USD 69 Billion By 2032
11/21/2023
The global biosimilar monoclonal antibody market size was valued at USD 8.6 billion in 2022 and is projected to surpass around USD 69 billion by 2032, expanding at a healthy CAGR of 23.2% from 2023 to 2032.
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Organon To Present at the Piper Sandler 35th Annual Healthcare Conference
11/21/2023
Organon announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.
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Alvotech to Report Financial Results for the First Nine Months of 2023 on November 28, 2023, and Host Business Update Conference Call on November 29, 2023, at 8:00 am ET
11/21/2023
Alvotech announced today that it will release financial results for the first nine months of 2023, after U.S. markets close on Tuesday, November 28, 2023.
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New Capital Strengthens ProtaGene's Advanced Analytical Leadership in the Biologics and Cell and Gene Therapy Markets
11/20/2023
ProtaGene, a leading global contract research organization dedicated to advanced analytics for biologics and cell and gene therapies, announced additional investment from Ampersand Capital Partners.
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Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S.
11/17/2023
Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States. Market availability of the product in the U.S. is expected in the coming weeks.
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Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
11/17/2023
Astellas Pharma Inc. and Pfizer Inc. announced that the companies received an approval by the U.S. Food and Drug Administration of a supplemental New Drug Application for XTANDI®, following FDA expedited development and review programs, based on results from the Phase 3 EMBARK trial.
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Henlius Reported Financial Results for the First Three Quarters of 2023: Total Revenue Exceeded RMB3.9 billion, Profitability Further Improved
11/15/2023
Henlius(2696.HK)announced its financial results and business update for the first three quarters of 2023.
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UCB Announces U.S. Availability of BIMZELX® for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis
11/14/2023
UCB announced that BIMZELX® is commercially available for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
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Alvotech and JAMP Pharma announce receipt of marketing authorization for PrJamtekiTM (AVT04), the first biosimilar of Stelara® (ustekinumab)
11/14/2023
Alvotech and JAMP Pharma Group announced that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® developed by Alvotech.
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Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki™ (AVT04), the First Biosimilar of Stelara® (ustekinumab)
11/14/2023
Alvotech and JAMP Pharma Group announced that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® developed by Alvotech.
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Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance
11/13/2023
Kamada Ltd. announced financial results for the three and nine months ended September 30, 2023.
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IO Biotech Appoints Helen Collins, MD, to its Board of Directors
11/13/2023
IO Biotech announced the appointment of Helen Collins, MD, to its board of directors.
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Biosimilar Monoclonal Antibodies Market Size, Share, Report 2023 To 2032
11/13/2023
According to Vision Research Reports, the global biosimilar monoclonal antibodies market size was estimated at USD 8.75 billion in 2022 and it is projected to hit around USD 65.29 billion by 2032, growing at a CAGR of 22.26% from 2023 to 2032.
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Teva and Royalty Pharma Collaborate to Further Accelerate Olanzapine LAI Program
11/13/2023
Teva Pharmaceuticals International GmbH and Royalty Pharma plc (Nasdaq: RPRX), announced today a collaboration to further accelerate the clinical research program for Teva’s olanzapine LAI (TEV-‘749) by entering into a funding agreement of up to $125 million to offset program costs.
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Post Hoc Analysis Showed CIMZIA® (Certolizumab Pegol) Resulted in Meaningful Efficacy for RA Patients with High Levels of Rheumatoid Factor (RF)
11/11/2023
UCB, a global biopharmaceutical company, will present a post hoc analysis of the EXXELERATE trial examining the efficacy of CIMZIA® and adalimumab in patients with rheumatoid arthritis with high rheumatoid factor levels.
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STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
11/10/2023
Partners STADA and Alvotech announced that the Committee for Medicinal Products for Human Use within the European Medicines Agency has adopted a positive opinion for Uzpruvo, a biosimilar candidate to Stelara®.
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UCB Presents New Five-Year Data on BIMZELX® (bimekizumab-bkzx) in Ankylosing Spondylitis at ACR Convergence 2023
11/10/2023
UCB, a global biopharmaceutical company, announced new long-term data from the BIMZELX® Phase 2b study BE AGILE and its open-label extension.