Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
Temperature fluctuations during shipping have led to costly clinical data delays and product recalls, but such problems can be avoided through supply chain pre-planning say distribution firms.
PSC Biotech plans to enter the US sterile injectables contracting space after buying a plant originally set up by J&J unit Mentor Biologics to make a Botox rival.
As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.
EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.
US FDA approval of the inhaled corticosteroid (ICS) asthma drug Arnuity will help offset declining sales of the off-patent bestseller Advair, says GlaxoSmithKline.
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.
Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.
News of the discontinuation of the National Cancer Institute’s (NCI) Animal Production Program has led Charles River Laboratories rival Harlan to vie for the market of grantees that still need animal research models.
Clinverse, a provider of automated financial management tech solutions for clinical trials, has closed a $9.1m (€6.9m) round of funding led by New Jersey-based Edison Partners.
Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
A 3D printed human liver system could offer better informed risk-based decisions earlier in the drug development process than with current in vitro models, according to developers Organovo.
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.
Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.
A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.
Horizon Discovery says the gene editing tool CRISPR used to engineer its human cell lines is exploding the possibilities of screening for preclinical customers.
Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.
Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.
Eurofins Genomics has installed next generation DNA and RNA sequencing systems by Roche and Illumina, citing growing sponsor demand for high throughput services.
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.
UDG Healthcare has sold its share in a pre-wholesale supply chain JV to partner Alliance Boots and outlined plans to invest some of the €82m ($110m) proceeds in its packaging and marketing businesses.
All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.
A breakdown of trials run by the top contract research organizations (CROs) reveals that the big players are leaving little room for smaller firm to compete, according to a review by Outsourcing-Pharma.com of trials in clinicaltrials.gov.
With almost 20% year-over-year growth in its manufacturing services, Chinese CRO and CMO WuXi now expects its small molecule manufacturing and biologics to be the key drivers of growth for the next several years, Ge Li, chairman and CEO of WuXi, said.
GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
Recipharm AB will continue its spending spree of the past few years according to CEO Thomas Eldered, who reiterated the CMO’s plan to grow through takeovers in a results presentation earlier today.
Ranbaxy has reported a 14% drop year-on-year of overseas revenues attributed in part to the voluntary suspension of shipments from its Toansa and Dewas facilities API facilities.
Northern Ireland-based contractor Almac will create 348 jobs over the next five years in its pharma and clinical services business according to UK enterprise, trade and investment Minister, Arlene Foster.
Roche has tapped into its antibiotic stockpile to aid Red Cross relief efforts in Yunnan, China which was struck by a major earthquake earlier this month.
CRO Chiltern International has purchased a Gold Membership from non-profit standards consortium CDISC (Clinical Data Interchange Standards Consortium).
Over the next few months Sanofi and non-profit PATH are delivering the first large-scale batches of an artemisinin-based combination therapy to five African countries, which will for the first time be manufactured with semi-synthetic artesunate.
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.
Evotec has partnered with Shire to develop inhibitors against Fabry’s disease and says such collaborations will grow as Big Pharma increasingly looks towards rare diseases.
The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
Merck Millipore, the life science division of Merck KGaA, will invest €12m ($16m) at its Molsheim, France facility to expand its ready-to-use media manufacturing capabilities and capacity.
Pricks are a problem for the drug industry according to Prometheon Pharma, which has launched a crowdfunding campaign to help it develop a needle-free alternative delivery tech.
Chiasma says a scale-up manufacturing agreement with Capsugel will be unaffected despite Roche pulling out of a commercialisation contract for its oral peptide drug octreotide acetate.
