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Shortage of Accord’s phenytoin sodium expected until May
The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
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GSK halts Excedrin production due to manufacturing inconsistencies
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
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Strengthened regulatory systems are needed to improve drug safety, says report
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
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FDA issues warning letter to Health Pharma for cGMP violations
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
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Global neoantigen cancer vaccine market to generate $1,826.1m revenue by 2030
A study suggests the global neoantigen cancer vaccine market will grow exponentially due to expected drug launches, new technology reducing costs and currently unmet needs of the market.
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Novartis and NHS partner to improve manufacture of oligonucleotides
A partnership between Novartis and NHS England includes a proposal to investigate processes that can increase the scale and efficacy of oligonucleotide manufacture.
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Governor of California proposes state-run drug label
In a bid to lower the costs of medicines, California's governor has suggested contracting generic drug manufacturers to make pharmaceutical products for the state to sell, according to reports.
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Supply chain and drug pricing reform required to lower US healthcare costs
Price caps and government regulations will not lower US healthcare costs, instead supply chain and drug pricing reforms are required, says a brief by medical economist.
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Funding for AI in drug development, clinical trials and information synthesis hits $5.2bn
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
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First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
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FDA issues warning letter which highlights the importance of a quality unit
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
Whitepapers/App Notes/Posters
Whitepaper: Product characterisation: reveal your molecule earlier, faster and with accuracy
Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.
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New steps taken to lower US prescription drug prices
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
Whitepapers/App Notes/Posters
Application note: Cost review of water for injection systems
The following excerpt is the introduction from MECO’s whitepaper titled, A Cost Review of WFI Systems. You can download the full version of this whitepaper at MECO’s website.