Top News

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Dec 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Nov 21, 2017

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

FDA Approves Digital Pill

Nov 14, 2017

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

PharmTech eBook Series

 

Vaccines Development and Manufacturing 2017 eBook

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.  

View E-Book

 

Industry News

New Research into Old Antibiotic May Lead to New TB Treatments

Dec 15, 2017

Research into an old antibiotic might open the door for new drugs to treat tuberculosis and other related microbial diseases.

New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

Dec 14, 2017

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

FDA Releases Draft Guidance on Gluten in Drug Products

Dec 14, 2017

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

Supplier News

Abzena Secures ADC Manufacturing Contract with US Biotech Firm

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

Additional Size for Quaternary Diaphragm Pumps

The Quattroflow QF10k size pump from PSG, a Dover company, has been added to its line of quaternary, four-piston diaphragm pumps.

EMA Approves mAb Production at Samsung BioLogics Facility

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

Bio/Pharma News

Amicus Files NDA for Fabry Disease Drug

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

Novo Nordisk Expands Insulin Manufacturing Facility in India

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

Standards/Regulations

Approaches to USP OTC Monograph Modernization

The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.

Contract Manufacturing Raises Regulatory Concerns

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Drug Development

Amicus Files NDA for Fabry Disease Drug

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

What are the Ingredients for Bio/Pharma Career Advancement?

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Best Practices

Best Weighing Practices in the Pharmaceutical Industry

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Maintaining Thermal Fluid Systems

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

Treating Halogenated Hydrocarbon Emissions from Pharmaceutical Production

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

40 Years of PharmTech

PharmTech Reflects on Four Decades of Bio/Pharma Innovation
Pharmaceutical Technology marks 40 years of publishing for the bio/pharma industry reviewing advances and changes in technology, science, regulatory oversight, and patient care.
 
View the special coverage

Sponsored Videos

PharmTech Talk

Contract Manufacturing Raises Regulatory Concerns

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

New Report Stresses Importance of Affordable Drugs

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

Will Pharma Meet the Drug Tracking Deadline?

Manufacturers and trading partners struggle to meet drug tracking requirements

PharmTech Europe News

EMA Issues Drug Warnings and Review

During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

EMA Updates Brexit Guidance

The agency and the European Commission published updated guidance to answer questions about Brexit.

What are the Ingredients for Bio/Pharma Career Advancement?

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Peer-Review Research

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

How to Monitor HPMC Concentration Through Conductivity Measurement

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

More eBooks

 

CPhI Update

Ophthalmic Drug-Delivery Device Improves Patient Experience

Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.

CPhI Global Pharma Index Shows India’s Reputation Improving

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

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