Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.
Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.
Swiss-based Sellas Life Sciences Group has signed a definitive master service agreement with CRO Pharmaceutical Product Development (PPD) to advance and expand clinical and regulatory development.
By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.
Squeezed by the pressure of shorter deadlines and higher quality expectations, as well as by competition from larger peers, mid-size CROs may need to think more about innovation to stay ahead, a CEO of a mid-size CRO told us.
Little more than a week after purchasing the UK RTSM provider ClinIntel, Parexel has secured new office space in Nottingham, UK and won grants totalling £1m ($1.6m).
Consolidation in the healthcare logistics industry is inevitable, says PCI as it opens a US storage and distribution facility for clinical trial materials.
Changing pills to a more user-friendly formulation can increase patient compliance, brand loyalty, and extend IP exclusivity, says CMO Hermes in an exclusive podcast.
Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.
Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.
Strategic relationships with contract manufacturers are becoming the standard, but big and small pharma demands differ considerably according to the two largest CDMOs, DPx and Catalent.
Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.
MedImmune’s neurodegenerative disease partnership with the University of Cambridge is about working with “great scientists with great brains” according to a spokeswoman for parent company, AstraZeneca.
AbbVie’s proposed £31bn ($50bn) takeover of Shire is very likely “dead” after the US biopharma's board changed its recommendation and advised shareholders not to back the bid.
The lack of an Ebola vaccine decades after the virus was discovered is due in part to IP protections in trade deals like TTIP that discourage innovation according to NGO, Health Action International (HAI).
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
Thermo Scientific is assessing its PK/PD data analysis software after a technical paper found discrepancies in results that may have affected drug approvals.
Aesica has turned its back on sterile injectables manufacturing and, in an exclusive interview, told Outsourcing-Pharma.com there is now limited steriles capability in the UK following the exit of other key players.
Gilead says its hepatitis C combination drug Harvoni will deliver significant healthcare savings in the long-term despite its $1,150 (€885) a pill price tag.
'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.
Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook.
The auditing company, SGS, recently certified that Capsugel’s manufacturing sites in Colmar, France and Bornem, Belgium meet Good Manufacturing Practice (GMP) standards set by EXCiPACT for pharmaceutical excipients manufacturing.
The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.
US academics have licensed a mobile clean room design from Xoma for a vaccine and medical countermeasure plant being built in Texas as part of an HHS-funded project.
Drugmakers will “inevitably” shift from batch to continuous production of tablets and, according to Freeman Technology, a quality by design (QbD) approach is a fundamental requirement.
The phrase “lean manufacturing” conjures up job cuts and not much more for many people, but managers can use the method to drastically simplify HPAPI (highly potent active pharmaceutical ingredients) production, says an expert.
Fresh off the near completion of its depot in Sau Paulo, Brazil, Marken has now also completed the construction of another depot in Santiago, Chile, in order to more easily handle the influx of clinical trial specimens coming from South America.
Almac has made a new investment alongside Hapa to expand its UK commercial packaging facility to provide a humidity controlled blister packaging suite, complete with off-line blister printing for two unnamed Japanese customers.
The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert the global decline in quality, according to Hovione’s CEO.
Consolidation in the pharma industry is driving the second-hand processing equipment market but despite attempts to regulate the industry, a glut of online vendors means illegal drugmakers can buy such systems.
Following pushes to go public by top peers, CRO INC Research has filed an S-1 with the SEC in preparation for an IPO (initial public offering) on the NASDAQ.
Making drugs generates a huge amount of waste but industry is showing signs of cleaning up its act according to Paul Anastas, the Yale scientist who coined the phrase "green chemistry."
Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.
Hospira has received a US FDA Warning Letter at an Australian injectables facility months after workers asked the firm not turn the site into “the new Rocky Mount.”
As US Congress considers the FAST (Fair Access for Safe and Timely Generics) bill to tackle “smokescreens” preventing competition, an expert tells in-Pharmatechnologist.com the problems behind marketing exclusivity run deeper and could be solved with...
