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Implementing an Automated DOE in Twin Screw Wet Granulation
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Parexel Announces CEO Transition
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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The High Five: Key Regulatory Topics for Drug Development in 2024
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Biosimilars
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Inflation Reduction Act and the Impact on Biosimilars
Exploring the IRA’s provisions and their impact to biosimilars.
Online Exclusives
Dinakaran Balasubramanian, Dr. Reddy’s Laboratories
03.15.24
Biosimilars
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Regulatory Affairs
Regulatory Affairs: The Generic Industry Faces External Challenges
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
03.04.24
Biosimilars
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cGMP Manufacture
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Solid Dosage/Creams/Ointments
JAMP Pharma Group Acquires Manufacturing Facility in Quebec
Strengthens the Canadian supply chain and contributes to addressing drug shortages.
03.01.24
Bio News
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Biosimilars
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Breaking News
Fresenius Kabi Introduces Cyclophosphamide for Injection, USP
Serves as a generic substitute for Cytoxan, for use in treating several forms of cancer.
02.28.24
Biosimilars
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Breaking News
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Collaborations & Alliances
FDA Approves First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira
Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
02.26.24
Biosimilars
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cGMP Manufacture
Chanelle Pharma Founder Sells Company to Private Equity Firm
Chanelle will remain an Irish managed company with the current management team remaining in place.
02.13.24
Biosimilars
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Breaking News
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Industry News
Sandoz to Acquire U.S. Biosimilar CIMERLI
Inclusive of biologics license application, product inventory, ophthalmology sales and field reimbursement talent.
01.24.24
Biosimilars
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Breaking News
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cGMP Manufacture
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Collaborations & Alliances
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Drug Development
Chime Biologics, Kings Pharm Partner to Accelerate Biosimilar Launch
Chime will provide cell line development, process development, global GMP manufacturing, commercialization, and regulatory filing support.
09.25.23
Biosimilars
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cGMP Manufacture
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Drug Development
Teva Pharmaceuticals, Alvotech Expand Strategic Biosimilars Pact
Teva gains exclusive commercialization of two new biosimilar candidates in the U.S. and line extensions of two current biosimilar candidates.
07.25.23
Biosimilars
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cGMP Manufacture
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Industry News
Samsung Biologics, Pfizer Partner to Manufacture Biosimilars Portfolio
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio.
06.08.23
Biosimilars
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cGMP Manufacture
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Drug Development
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Evotec Biologics, Sandoz Enter Biosimilars Development & Mfg. Pact
Partnership supports Sandoz pipeline expansion to 24 biosimilar assets.
05.11.23
Biosimilars
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04.13.23
Bio News
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Similis Bio Partners With Novel351k to Develop Multiple Biosimilar Programs
Novel351k will leverage its experience with regulatory and clinical strategies to accelerate the development of the programs toward commercialization.
02.15.23
Biosimilars
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Breaking News
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Industry News
Biocon Completes Acquisition of Viatris' Global Biosimilars Business
Creates an integrated, leading global biosimilars enterprise with eight commercialized products.
Videos
Biosimilars
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Biocon Completes Acquisition of Viatris' Global Biosimilars Business
Creates an integrated, leading global biosimilars enterprise with eight commercialized products.
11.29.22
Biosimilars
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Breaking News
FDA Approves First Biosimilar to Lucentis
Polpharma Biologics Group BV, Formycon AG and Bioeq AG win FDA approval of Cimerli for retinal diseases.
08.03.22
Biosimilars
Policy Reforms on Cards to Fast Track Biosimilars
More Indian firms in the fray vying for a “similar” pie.
S. Harachand, Contributing Writer
06.07.22
Bio News
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Biosimilars
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Breaking News
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cGMP Manufacture
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Industry News
OcyonBio, Biosimilar Solutions to Begin GMP Mfg. in Puerto Rico
The plant in Aguadilla will include more than 95,000 sq.-ft. of cleanroom and biomanufacturing space, with biosimilar production scheduled in 2022.
03.15.22
Biosimilars
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Breaking News
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Industry News
Biocon Biologics to Acquire Viatris’ Biosimilars Assets in $3.3B Deal
Gains global biosimilars business with revenues estimated to be $1 billion next year, along with its portfolio of in-licensed assets.
03.01.22
Bio News
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Biologics, Proteins, Vaccines
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Biosimilars
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Breaking News
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Industry News
Samsung Biologics Acquires Full Ownership of Samsung Bioepis
Buys out Biogen’s stake in the joint venture for $2.3 billion.
01.28.22
Breaking News
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
View Breaking News >
CURRENT ISSUE
March 2024
Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
Pre-filled Syringe Packaging Trends
Liquid Pharmaceutical Filling: Small, Smaller, Micro Batches
Newsmakers Q&A: BioVectra
Multi-particulate Formulations – Tablets or Capsules?
Manufacturing Equipment Trends
OSD Outsourcing: Savvy CMOs Hone Skills as Complex APIs Fuel Demand
Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
The Road Ahead for CDMOs in 2024
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