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Top Features
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
Updates on the Value of a Day of Delay in Drug Development
CEO Spotlight: Matthew Stober
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FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
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Evonik to Restructure Keto and Pharma Amino Acid Business
Application of QbD Approach for Tech Transfer and Process Characterization of Biologics
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Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
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Nipro Launches D2F Glass Vials Using Stevanato's EZ-fill Technology
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Lilly, insitro Enter Strategic Agreements for Metabolic Diseases
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Rottendorf Pharma Selects ValGenesis VLMS
FDA sIRB Mandate: A Chance to Reassess Site Performance
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Biosimilars
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Analytical Services
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Biologics, Proteins, Vaccines
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Drug Delivery
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Biosimilars
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Breaking News
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Industry News
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Regulatory Affairs
Tanvex BioPharma USA Achieves Dual U.S. Regulatory Milestones
FDA approves Nypozi and grants BLA acceptance of TX-05.
08.30.24
Biosimilars
|
Drug Development
Drug Patents, Exclusivity & Lessons from Humira: A Biosimilars Boom
Understand drug patents, FDA exclusivity and the future of intellectual property. See how Humira's exclusivity loss illustrates key pharma industry challenges.
Online Exclusives
Charles Sternberg, Associate Editor
07.31.24
Biosimilars
|
Breaking News
|
Drug Development
|
Drug Discovery
Piramal Pharma Solutions Reaches Innovation Benchmark
For the first time in the company’s history, the CDMO’s revenue earned on innovation programs surpassed that of generic projects.
07.30.24
Biosimilars
|
Breaking News
Boehringer Ingelheim, GoodRx Launch Patient Affordability Initiative
Will provide Boehringer's biosimilar to Humira at a low cash price available exclusively on GoodRx.
07.18.24
Biosimilars
|
Breaking News
|
Collaborations & Alliances
Evotec Expands Strategic Partnership with Sandoz
Solidifies Just – Evotec Biologics’ commitment to providing long-term commercial supply of biosimilars to Sandoz.
07.08.24
Biosimilars
|
Breaking News
Samsung Bioepis’ PYZCHIVA Approved by FDA as Biosimilar of Stelara
PYZCHIVA has been approved for the treatment of patients with moderate to severe plaque psoriasis.
07.02.24
Biosimilars
|
Breaking News
|
Industry News
Sun Pharma Merges Taro Pharma with Subsidiary
Taro is now a private company and wholly-owned by Sun Pharma.
06.24.24
Biosimilars
|
Breaking News
Sandoz’s Wyost and Jubbonti Granted EC Marketing Authorization
Become the first and only biosimilar versions of Amgen's medicines Xgeva and Prolia in Europe.
05.22.24
Biosimilars
|
Breaking News
|
Collaborations & Alliances
Boehringer Ingelheim Inks Deal to Expand Patient Access to adalimumab-adbm Injection
Will manufacture its Humira biosimilar for Quallent.
05.13.24
Biosimilars
|
Breaking News
|
Promotions & Moves
MAbxience Names New Chief Executive Officer
Jurgen Van Broeck brings experience and a proven track record in the pharmaceutical and biosimilar industries.
05.10.24
Biologics, Proteins, Vaccines
|
Biosimilars
Real-Time Kinetic Data in the Successful Dev of an Inhibition of Proliferation Potency Bioassay
The quantitative measurement of potency plays a critical role in biopharmaceutical development.
Biosimilars
|
Regulatory Affairs
Inflation Reduction Act and the Impact on Biosimilars
Exploring the IRA’s provisions and their impact to biosimilars.
Dinakaran (Dina) Balasubramanian, Dr. Reddy's Laboratories
04.10.24
Biologics, Proteins, Vaccines
|
Biosimilars
Underlying Economics of Unbranded Biologics
Unbranded biologics exist is to protect the gross list price of the branded variant.
Online Exclusives
Dinakaran Balasubramanian, Dr. Reddy’s Laboratories
04.05.24
Biosimilars
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
|
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
|
Breaking News
|
cGMP Manufacture
|
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
|
Biosimilars
|
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
|
Breaking News
|
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
|
Breaking News
|
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
|
Breaking News
|
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
Breaking News
FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
View Breaking News >
CURRENT ISSUE
September 2024
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
Updates on the Value of a Day of Delay in Drug Development
CEO Spotlight: Matthew Stober
CDMO Specialization
Post-COVID Trends in Biopharma Contract Manufacturing
Pharma’s Next Frontier: GLP-1s and Other New Therapies
CEO Spotlight: Prasad Raje
HPAPIs Soar Riding the Targeted Drugs Wave
View More >