Top News
FDA Approves First Generics of Novartis’ Blockbuster MS Drug
Dec 06, 2019
The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.
Astellas to Acquire Audentes for $3 Billion
Dec 03, 2019
The acquisition aids in the expansion of the Astellas Focus Area approach, which involves the creation of medicines for diseases with high unmet medical needs by identifying combinations of biology, therapeutic modality and technology based on emerging science.
Novartis to Acquire The Medicines Company for $9.7 billion
Nov 25, 2019
The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.
Bio/Pharma News
FDA Approves First Generics of Novartis’ Blockbuster MS Drug
The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.
Horizon Discovery Partners with HPA to Expand Open Access Resource
Horizon Discovery has announced its partnership with the Human Protein Atlas, which will see the incorporation of Horizon’s CRISPR-edited knockout cell models into the Cell Atlas program.
Bioprocess Academy to be Established by GE Healthcare and Guangzhou Development District
GE Healthcare Life Sciences and Guangzhou Development District Investment Promotion Bureau have signed an agreement to jointly establish a training center for biopharmaceutical professionals.
Industry News
US Maintains Lead in Pharma Innovation
Dec 06, 2019
Expert poll highlights strength of US pharma sector and advances by emerging markets.
FDA Readies Modernized New Drug Review Operation
Dec 05, 2019
FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.
Horizon Discovery Partners with HPA to Expand Open Access Resource
Dec 05, 2019
Horizon Discovery has announced its partnership with the Human Protein Atlas, which will see the incorporation of Horizon’s CRISPR-edited knockout cell models into the Cell Atlas program.
Drug Development
CPI Partners with ImmunoBiology for Heat-Stabilized Formulation of Pneumococcal Vaccine
CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.
BioMed X Successfully Completes First Joint Project with Boehringer Ingelheim
BioMed X has announced the successful completion of its first joint research project in the fields of COPD and IPF that it had undertaken with Boehringer Ingelheim.
Catalent, Ethicann Partner on Fast-Dissolve Cannabinoid Treatment for MS Spasticity
Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.
Supplier News
GE Healthcare and ASLS Collaborate on Equipment for 3D Printed, Vascularized Tissue
GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.
Cambrex Sale to Premira Funds Affiliate Closes
Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.
GE Healthcare Life Sciences Launches New Software for Cell Therapy Workflow
The new software lets users choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.
Best Practices
Sharp Invests in Interactive Response Technology Solution
Sharp has invested US$650,000 into enhancing its Interactive Response Technology (IRT) solution.
Analysis of Sub-Visible Particles
Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
Ensuring Quality Control in Vendor Relationships
A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.
30th Anniversary
Standing the Test of Time
Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.
Farther Than the Eye Can See
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Analysis and Purification: Instrumental to BioPharma
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
PharmTech eBook Series
Regulatory Sourcebook and Reference, September 2019
Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.
Bio/Pharma and Brexit
‘Polling’ All the Way
As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.
The Cost of Brexit
Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.
Yourway Opens New Slovakia Location to Secure Client Trials in Case of No-Deal Brexit
The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.
Standards/Regulations
FDA Readies Modernized New Drug Review Operation
FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.
Investigating Combination Product Failures
Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Quality Issues Offset Biomedical Advances
Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
PharmTech Talk
FDA Readies Modernized New Drug Review Operation
FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.
Expert Panel Promotes Global Information Sharing
A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.
Biosimilars Struggle to Establish in US Market
Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.
Peer-Review Research
Optimizing Compression Coating for Pulsatile Release Tablets
Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
Optimizing Manufacturing Based on the Storage Stability of Pegylated Products
Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
Inhalation Drug Delivery: The Impact of Particle Size Reduction
Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
PharmTech Europe News
Horizon Discovery Partners with HPA to Expand Open Access Resource
Horizon Discovery has announced its partnership with the Human Protein Atlas, which will see the incorporation of Horizon’s CRISPR-edited knockout cell models into the Cell Atlas program.
Bioprocess Academy to be Established by GE Healthcare and Guangzhou Development District
GE Healthcare Life Sciences and Guangzhou Development District Investment Promotion Bureau have signed an agreement to jointly establish a training center for biopharmaceutical professionals.
Iontas, Adaptate Biotherapeutics Collaborate to Generate Optimized Antibodies for Cancer Targets
Iontas has entered into a collaboration agreement with Adaptate Biotherapeutics for the generation and optimization of antibodies for novel immune-oncology targets.
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.
Sponsored Videos
Current Issue
DOE Gains Ground in Biopharmaceutical Development
As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.
Mitigating Risk to Secure the Drug Supply Chain
Communications and planning are crucial to recovering from supply, operations, and facility disruptions.
Optimizing Compression Coating for Pulsatile Release Tablets
Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
Webcasts
Outsourcing
Cambrex Sale to Premira Funds Affiliate Closes
Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.
Catalent, Ethicann Partner on Fast-Dissolve Cannabinoid Treatment for MS Spasticity
Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.
Meeting E&L Expectations
As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
