Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.
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.
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.
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.
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.
As more than half a dozen companies are now vying to help treat and vaccinate Ebola victims in West Africa, where nearly 3,000 people have died from the illness, GlaxoSmithKline is taking the lead in getting product manufactured.
The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”
CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company with its entire existing staff and management team.
At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated.
Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...
The market opportunity for each Indian drugmakers granted a license to manufacture Gilead’s hepatitis C drug Sovaldi could be worth over $600m, an analyst has calculated.
The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.
The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.
Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.
Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.
In a venture with plasma products manufacturer Octapharma, DHL has opened a €3.4m ($4.4m) cold-chain logistics centre in Germany for the pharma and life sciences industries.
Experts have predicted more CROs will go public as Private Equity looks to get a return on its investments, but such shifts are indicative of a booming market rather than waning interest.
Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.
Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
A little more than a year after it was acquired by private equity company KKR (Kohlberg Kravis Roberts & Co.) for $1.4bn, newly rebranded PRA Health Sciences is looking to go public with an IPO.
Protalix shares rocketed 18% then reversed in one weekend after the Israeli protein manufacturer clarified it is not in talks to produce Ebola drug ZMapp.
US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.
Strategic partnerships - always a hot-topic for CROs – are becoming almost exclusively a big issue for mid-sized biopharma, though small biopharma and large pharma companies are interested as well, Quintiles CEO Tom Pike said Monday at the Morgan Stanley...
The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.
Investors losing interest in CROS? Have your say in our poll
An under-attended investor day at Quintiles, the world’s largest CRO, is indicative of waning interest in the clinical sector according to a William Blair analyst.
CRO Pharmaceutical Product Development (PPD) announced today that it has acquired for an undisclosed sum RCT Logic’s exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison...
ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.
A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.
Drug developers should add their early-stage discoveries to an open-source database or pay a fine to cut wasted time duplicating results, say researchers.
G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.
Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
Access to portable and flexible technology could be one way of containing transmissible diseases says G-CON as it launches a more readily deployable version of its ‘POD’ manufacturing suite.
German jobs are safe despite a programme that will cut the cost of operations by 15%, Boehringer Ingelheim says as it reacts to international price reductions.
