Top News

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

Oct 20, 2017

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

Oct 13, 2017

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

Pharma Gives Update on Puerto Rico Manufacturing Operations

Sep 28, 2017

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

PharmTech eBook Series

 

Biologics and Sterile Manufacturing 2017 eBook
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.
 
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Industry News

Europe Takes Action to Foster Advanced Therapy Development

Oct 20, 2017

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

IBD Reveals 2017 Biotech Innovator Awards Winners

Oct 19, 2017

The financial news and research organization has announced the winners of the first Biotech Innovator Awards.

Organizations Seek to Advance Industry Knowledge of Continuous Manufacturing

Oct 19, 2017

Rutgers University-based C-SOPS annual meeting described advances in continuous manufacturing understanding and future plans for broader education efforts.

Supplier News

Catapult, ANTRUK to Collaborate on Antimicrobial Research

The companies will embark on a joint antimicrobial research project, with the intent to discover antibiotic combinations that target resistance.

CiToxLAB Acquires Bioanalysis Facility in Montreal

The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.

SCHOTT Opens Facility in China

SCHOTT began production of glass ampoules, vials, and cartridges at a new facility at the SCHOTT Xinkang headquarters in Zhejiang, China.

Bio/Pharma News

Lilly and CureVac Partner on mRNA Cancer Vaccines in $2.73-Billion Deal

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

GSK’s Shingles Vaccine Approved in Canada

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

Standards/Regulations

Europe Takes Action to Foster Advanced Therapy Development

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

REMS Guidance Published

FDA published guidance on the format and content of REMS documents.

FDA Releases Guidance on Resolving Issues with the Agency

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

Drug Development

NIH Partners with Leading Biopharma Companies for Cancer Immunotherapy

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

The Maze of Drug Development—De-Risking the Journey

Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.

Best Practices

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.

Understanding the Potential of Artificial Intelligence Across the Pharmaceutical Lifecycle

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

Data Integrity Best Practices

Electronic systems allow biopharma manufacturing companies to meet data integrity requirements and optimize practices.

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.
 
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PharmTech Videos

USP Supply Chain Safety Videos

Sponsored Videos

PharmTech Talk

Storm Impact on Drug Supply

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

Will Interchangeability Boost Biosimilar Prescribing?

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Congress Unlikely to Act on Drug Pricing Legislation This Fall

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

PharmTech Europe News

Europe Takes Action to Foster Advanced Therapy Development

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

EMA Publishes Brexit Plan

The agency has published a continuity plan for its move from the United Kingdom.

EMA Updates Guidelines on Excipients in Labeling

Europe updates the guideline on excipients information in labeling and packaging.

Peer-Review Research

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.

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

Analysis of Total and Transferrin-Bound Iron from Serum Samples

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

Sponsored eBooks

 

Preparing to File Your IND
This eBook aims to help drug makers avoid common pitfalls in the IND application process, explain what’s needed to secure a successful IND approval, and break down the regulatory requirements for both IND filings and GMPs in early development.

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CPhI Update

The Technological Evolution Driving Pharma’s Future

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

CPhI Expert Comments on Role of Excipients

Pharma companies are responsible for excipient quality, but they face challenges, including a regulatory environment that discourages development of new, pharma-specific excipients.

Drug Revenue and Affordability

Girish Malhorta, CPhI expert and president of EPCOT International, discussed world revenues for pharmaceuticals and how companies may improve cost and availability of drugs in CPhI’s 2017 Annual Report.

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