The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
After much discussion and some confusion, the ICH’s (International Conference on Harmonization) Q3D guideline, which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.
Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza following its commercialisation partnership last month.
Ireland once was a drug making nexus,Making meds sold from Cairo to Texas.But with key patents gone,Firms are keen to move on,And a new Limerick tech hub reflects this, says director.
Novo Nordisk has bought a biomanufacturing facility earmarked for closure by Olympus Biotech and begun rehiring staff in order to support its haemophilia product pipeline.
Poppies will continue to be the main source of industrial opiates long-term according to GSK, despite a recent breakthrough in efforts to produce it in GM yeast.
EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
Codexis has felt the impact of Gilead’s Sovaldi with product revenues tumbling almost 60% due to the reduction in its hepatitis C biocatalyst and intermediate business.
The Health Products Regulatory Authority (HPRA) of Ireland has published a list of 12 active substances contained in medicines that could potentially be switched from prescription-only to over the counter sale.
Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.
As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.
Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.
Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...
Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.
The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry powder delivery technology used to get it deep into the lungs is effective.
Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.
Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development partnering.
The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.
Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
A US presidential report on plans to improve chemical facility safety and security has incorporated a number of recommendations from the Society of Chemical Manufacturers and Affiliates (SOCMA).
Merck & Co. says the $3.85bn (€2.8bn) acquisition of Idenix will springboard its oral hepatitis C programme but according to an analyst is unlikely to threaten Gilead’s $1,000 pill Sovaldi.
Scientists are scouring the seas for novel bioactive compounds as part of PharmaSea, a four-year project which has already turned up interesting compounds from samples of mud, sediment and sea life.
Aesica has secured a Technology Strategy Board grant to fund a high-value chemical manufacturing process with the winning process set to improve the sustainability of an active pharmaceutical Ingredient (API).
Colorcon today opened an expanded facility in Goa, India to scale up production of tablet coatings and excipients for pharmaceutical manufacturers in South Asia.
Experts have predicted emerging Indian and Chinese markets will outpace Western markets as the $2.3bn oral solid dosage form (OSDF) excipients global market grows at a sustainable rate.
Researchers in Switzerland have devised a form of gold nanoparticle that shows promise as a weapon against tumours and as a delivery vehicle for drugs.
The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.
The amines market will grow 5% over the next decade according to BASF, which cited rising drugmaker demand as a key driver for its investment in a new German plant.
Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.
Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.
IPEC Americas has released a standardized letter and template that pharmaceutical companies can use to collect available information from their suppliers regarding elemental impurities in excipients.
Fungi have no place in an API facility, but soon enzymes derived from them may be commonplace say scientists developing oxidoreductases for cost and time saving industrial applications.
A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.
The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.
Drug excipient makers in India and those serving the market have a dedicated IPEC chapter after the delayed fifth branch of the industry group was finally formally incorporated at the end of January.