All
FDA Seeks Participants in DSCSA Pilot Program
Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.
Andrew Alliance, Sartorius to Collaborate on Pipettes
The companies will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.
Federal Court Enters Consent Decree Against Compounder
The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.
Micromotors Deliver Oral Vaccines
Researchers used magnesium particles as tiny motors to deliver an oral vaccine against the bacterial pathogen Staphylococcus aureus.
Virtual Docking Library to Aid Drug Discovery
A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.
Barrier Film Offers Clear and Opaque Options for Blister Packaging
Honeywell introduces Aclar Accel barrier film with faster production and delivery for pharma packaging.
Sartan Manufacturers Should Review Manufacturing Processes, Says EMA
The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.
PCI Pharma Services Expands Bottling Capacity
PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.
EMA Approves Two Biosimilars and Two Generic Drugs
The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.
Amprologix, Ingenza Get Funding for Antibiotic Development
The companies will develop Amprologix’s lead epidermicin-based antibiotic candidate.
Meissner Announces New Manufacturing Facility
The company will open its first European manufacturing facility in Castlebar, Ireland.
USP’s Generics Access Plan to Encourage Competition
The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.
Genentech, Xencor Partner on Cytokine Therapeutics
In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.
Lipid Excipient Targets Multiple Dose Forms
A solid lipid excipient from ABITEC is designed for multiple dosing forms.
New Reactor Flask Heating System Offers Safe Lab Option
A new reactor flask heating system now offered by Asynt allows the conduction of safe experiments in academic teaching and research labs.
A CDMO’s Perspective of Important Bio/Pharma Industry Trends
Keeping abreast of the latest industry trends and retaining flexibility are key to maintaining a strong market position.
Rebate Challenge Alters Drug Pricing Debate
New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.
IQVIA Launches IQVIA Biotech, Dedicated to Emerging Biotech and Biopharma Industry
Company launches new services dedicated to emerging biotech and biopharma companies.
Packaging Peril: ‘No-Deal’ Brexit May Lead to Missed Deadline
As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.
Spotlight on Assessing the Environmental Impact of Medicines
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
Stimulating Discussion
A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.
Pharmapack Report Forecasts a Rise in Innovation from Smaller Companies
Pharmapack Europe event organizers have released a report titled, ‘European drug delivery and packaging’ that forecasts an increase in innovation from smaller European companies.
ABPI Calls for Action to Plug Science Skills Gaps
The ABPI has released a statement calling for action to address skills shortages in science within the UK, which could jeopardize the country’s position for medicines and vaccines R&D.
Validair Monitoring Solutions Secures New Funding to Support Growth
Validair Monitoring Solutions has secured new funding that will be used to support the growth of the company across the UK.
ChargePoint Achieves HazLoc Certification, Allowing for North American Expansion
ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.
MHRA Signs MoU with Russian Counterpart for Regulatory Cooperation on Medicines
A Memorandum of Understanding (MoU) has been signed by the UK’s MHRA and the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.
TrakCel, WindMIL Therapeutics Partner to Develop Supply Chain Platform
TrakCel and WindMIL Therapeutics have formed a partnership to build a custom-configured cellular supply chain tracking and orchestration platform.
Sphere Fluidics Closes Latest Investment Round Raising $2 Million
Sphere Fluidics has closed its latest investment round in which it raised US$2 million (approximately £1.5 million).
Hitachi Chemical to Acquire apceth Biopharma
The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.
Janssen, MeiraGTx Partner on Eye-Focused Gene Therapy
Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.
