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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.
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.
The Great Divide? Implications of the SPC Waiver
Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.
Fujifilm Extends Regional Presence Through Danish Acquisition
Fujifilm has bought Biogen ApS’ Copenhagen facility for US$890 million.
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
CPhI to Host Korea Conference, Expand Korea Pharmaceutical Hub
CPhI will host the CPhI Korea Conference to focus on the international nature of South Korea’s growth in exports.
Alizé Pharma 3 Completes €67 Million Series A Financing Round for Boost in Portfolio
Alizé Pharma 3 completed a €67 million Series A financing round led by LSP to boost its product portfolio in rare endocrine and metabolic diseases.
New Gas Filters and Traps to Reduce GC System Downtime
Phenomenex’s Zebron Gas Management filters and click-on inline gas traps can reduce gas chromatography (GC) system downtime and column damage.
NIIMBL and FDA Partner in Biopharmaceutical Manufacturing
NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
Fixed-Dose Combination Tablet Significantly Reduces Cholesterol, Notes Study
Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.
European Specialty Pharmaceutical Company Launches First Products in UK
Neuraxpharm Group has announced it is launching its first products in the United Kingdom.
CHMP, CMDh Recommend a Change in Names of Liposomal Medicines to Avoid Errors
CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
Finnish Company Gains FDA Approval for Prostate Cancer Treatment
Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Cannuba Supports UK’s First National Pilot Study on Medical Cannabis
Cannuba has announced its support of the first national pilot study in the United Kingdom aimed at assessing patients on prescription medical cannabis.
Cambrex Announces Expansion of Scottish Solid-Form Screening Facility
Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
EMA Recommends Gilenya Not be Used in Pregnancy
EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Olon Constructs Fermentation Facility in Italy
Olon began construction of a GMP facility for biologic APIs in Capua, Italy.
CURE Pharmaceutical Receives Patent for Oral Thin Film Technology
Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.
Hikma and Civica Rx Sign Long-Term Agreement to Reduce US Generic Drug Shortages
Hikma will supply 14 essential medicines to US hospitals and patients.
High-Recovery Workflow Solutions for Biological Products
The new ready-to-use, packaging and production workflow solutions from DWK Life Sciences feature NextGen V and E-Z Ex-Traction vials to enhance security and minimize waste.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
Jubilant Cadista Pharmaceuticals Recalls One Lot of Drospirenone and Ethinyl Estradiol Tablets
Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.
FDA Approves Nine Generic Versions of Lyrica
The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.
AQbD, the Evolution of Pharmacopoeial Standards?
MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
Safe and Sound with Radio-Frequency
As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?
Clinical Review Leads to Discontinuation of Investigation into BACE Inhibitor for Alzheimer’s Prevention
Novartis, Amgen, and Banner have announced their decision to discontinue the investigation into the BACE1 inhibitor CNP520 (umibecestat) as a preventative therapy for Alzheimer’s disease.
Partnership Addresses Rift Valley Fever Vaccine
The Coalition for Epidemic Preparedness Innovations is partnering with Colorado State University to develop a single-dose vaccine candidate against Rift Valley Fever.
