Rare disease therapies need to be administered in a way that suit the patient according to Shire CEO Flemming Ørnskov, who says smart, flexible delivery devices are core to the firm's product development strategy.
The People for the Ethical Treatment of Animals (PETA) is looking to send a researcher to learn about non-animal test methods – adoption of which it says is slowed by regulatory agency acceptance.
Ergomed is bolstering its orphan drug development services with its acquisition of PSR Group BV in a deal worth up to €5.7m ($6.69m) – which will position the company to be a “global player” in the area, says CEO.
The US FDA has finalised guidance supporting new technologies which look to modernise pharmaceutical manufacturing, such as 3D printing and continuous processing.
AmerisourceBergen (ABSG) has pleaded guilty to distributing misbranded injectable cancer drugs processed at an unregistered facility in Alabama and agreed to pay $260m (€220m).
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.
Lack of trust has become less of a barrier to clinical trial participation, though more work needs to be done as information access and service levels receive low marks in a recent survey.
The US FDA has warned that people with decreased liver function who taker higher than recommended doses of Intercept Pharma’s drug Ocaliva are at increased risk of liver injury and death.
Implementing ‘aggregation’ – the term used to describe pharmaceutical product unit-to-case hierarchy – is not mandatory in Europe, however industry delegates say there is incentive to push its adoption.
Post-Brexit relocation will, at best, delay approvals and, at worst, limit drug availability and put European patients at greater risk of side effects and death according to the EMA.
Communication difficulties are hampering drug industry efforts to assess damage to manufacturing operations caused by the hurricane that struck Puerto Rico last week.
BASF has announced plans for a specialty amines plant at its site on the Nanjing Chemical Industry Park in China, citing increasing demand from customers in Asia.
The EMA has asked the European Ombudsman for concrete details of its probe of pre-submission activities, warning that Brexit preparations have limited its capacity to respond.
Pharma and diagnostic partners will gain access to a human cancer biospecimens and clinical data from patients to power clinical and translational research, says CRO.
According to industry delegates, smaller contract services firms struggling to meet track & trace implementation costs will look to consolidate with competitors in light of impending serialisation deadlines.
Better trial designs mean fewer failed studies, says a tech industry veteran who has set his sights on improving the clinical trial process with artificial intelligence.
The use of snake venom protein-inspired candidate PseudoXa in patients taking anticoagulants, could combat severe bleeding in emergency surgery, says VarmX.
mProve Health has partnered with Greenphire to provide payment solutions on its patient engagement app – bringing it one step closer to creating a mobile hub for all study services, says CEO.
The Switzerland-headquartered contract research organization (CRO) has opened offices in Taiwan following a string of investments in the Asia Pacific region.
Pharma needs to include patient engagement solutions in marketing strategies as the patient’s role in decision-making continues to increase, says UDG COO, following MicroMass acquisition.
The US Food and Drug Administration (FDA) has issued warning letters to Korean company Firson Co. and Chinese firm Wuxi Medical Instrument Factory, citing sterilisation violations.
Recipharm has acquired a Spanish manufacturing plant and signed a supply deal with former owner Roche for a range of solid dose products worth €35m a year.
Ajinomoto Althea, Inc. has opened a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility in San Diego, CA.
