June 24th 2025
mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.
May 7th 2025
FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.
March 25th 2025
Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.
February 17th 2025
The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.
February 8th 2025
European biopharma companies are looking beyond GLP-1s.
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
GPhA Issues Statement on Generic Drug Costs
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.
Eliminating Tablet Spots and Specks
Although the source of spots and specks on tablets is sometimes difficult to identify, following good maintenance and manufacturing practices can help solve or even prevent the problem.
FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper
A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.
Pfizer and Merck KGaA Announce Strategic Alliance
Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.
Grand River Aseptic Manufacturing Secures Two Contracts
Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.
Roche's Avastin Gains Ovarian Cancer Indication
Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.
FDA Approves Lemtrada for the Treatment of Multiple Sclerosis
After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.
The Challenge of Finding the Unknown
Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.
Seven Steps to Solving Tabletting and Tooling Problems---Step 3: Repair
Carrying on from our weekly column to help you eliminate a number of tablet manufacturing problems and tablet tooling failures with a simple seven-step tool-care process, we look at the third step, Repair.
Catalent Acquires Micron Technologies, Adds Particle Engineering Capabilities to Portfolio
Catalent has acquired Micron Technologies, a provider of particle size engineering technologies.
Seven Steps to Solving Tabletting and Tooling Problems---Step 2: Assess
As the second part of this series, we look at the importance of ?assessing? the punches and dies to check their condition and how this step may help avoid any problems that may occur during tablet manufacture.
Catalent Expands Highly Potent Drug Packaging Capabilities
Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.
Capsugel Expands User Program for Enteric Capsule Technology
Capsugel gives lead users access to intrinsically enteric capsule technology and support services.
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Parenterals, Particulates, and Quality by Design
The parenteral manufacturing industry is taking action to address particulate contamination issues.
Continuous Solid-Dosage Manufacturing Platform Nears Prototype Installation
A G-CON, GEA, and Pfizer collaboration developed a PCMM (portable, continuous, miniature, and modular) system to produce oral solid-dosage drugs.
Considerations in Developing Sublingual Tablets—An Overview
This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.
WHO Promotes International Collaboration for Generic Drug Approvals
The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.
First Biosimilar Application Kicks Off Legal Battle
Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.
SAFC Introduces New Protein Quality Supplement for Optimized Biologics Production
Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.
Seven Steps to Solving Tabletting and Tooling Problems—Step 1: Clean
Many factors can contribute to tablet manufacturing problems. Tablet tooling failures are generally the result of one, or a combination of issues.
Novartis Sells Influenza Vaccine Business to CSL for $275 Million
The divestment will create the number two player in the global influenza vaccine industry.
GSK Accelerates Ebola Vaccine Development
GSK's investigational Ebola vaccine is in Phase I safety trials.
J&J Speeds Ebola Vaccine Development and Expands Production
Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.
Drug Repackaging Company Recalls Tablets Due to Packaging Mix-Up
Contract Packaging Resources issued a voluntary recall of naproxen sodium tablets because some cartons contain bottles of ibuprofen.
EMA Works to Speed Up Ebola Treatment
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
External Lubrication System Enhances Tablet Press Performance
PharmaSpray delivers a consistent, validatable amount of dry lubricant.
Evaluating Cross-Contamination Risk of Highly Potent APIs
Manufacturers using highly potent APIs must examine cross-contamination routes and determine acceptable limits.
IDT Biologika Certifies Facility to Fill and Lyophilize Biologics and Vaccines
IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.
Focus on Biosimilars
The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.