Top News

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.

EMA Provides Update on Relocation Preparedness and Impact on Staff Retention

Sep 26, 2017

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

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

NJII and Rutgers University to Form the New Jersey Continuous Manufacturing Institute

Oct 18, 2017

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit

Oct 17, 2017

DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.

EMA Publishes Brexit Plan

Oct 17, 2017

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

Supplier News

DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit

DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.

Temperature-Controlled Shipping Service Solution

Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.

CordenPharma Invests in Small Molecule API Development Capacity

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

Bio/Pharma News

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.

FDA Expands Approval for J&J’s Psoriasis Biologic

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Standards/Regulations

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.

EMA Updates Guidelines on Excipients in Labeling

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

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.
 
View the special coverage

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

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.

Glythera Licenses Novel Payload Class from Cancer Research UK for ADC Development

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

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

Gerresheimer Presents Pharmaceutical Packaging Solutions at CPhI Worldwide

Gerresheimer is showcasing its range of Duma Pocket containers, which are available in different sizes and colors and come with various closures.

DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit

DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.

Temperature-Controlled Shipping Service Solution

Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.

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