Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.
Rebuilding 'problem' sterile manufacturing plants to modern specifications may be a better option than spending money trying to fix them according to an ex-GSK expert.
US scientists claim their combination of a novel nanoparticle production platform and innovative spray coating technology paves the way for improved drug, biologic and vaccine targeting.
Intertek has acquired Melbourn Scientific, citing its capabilities in delivery device testing and formulation services as the key drivers for the deal.
Saltigo has won a manufacturing contract with Daiichi Sankyo under it which it will provide custom synthesis services for one of the Japanese drugmaker’s pipeline candidates.
Avanir Pharmaceuticals has bought North American rights to OptiNose’s novel intranasal delivery system to treat acute migraines, which is expected to be filed for US FDA approval by early 2014.
Programming errors in a vendor's EDC system meant some patients were mistakenly given placebo during a trial of an ALS (amyotrophic lateral sclerosis) drug candidate being developed by Cytokinetics.
A consortium of European vaccine experts, including the Swiss CRO Preclin Biosystems, has received almost €5.5m ($7.1m) from the EU to develop a vaccine against the deadly MRSA bacteria.
US drugmakers must stop ‘doing the minimum’ and put patient safety at the heart of their audit plans according to excipient industry expert Chris Moreton from FinnBrit Consulting.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.
AstraZeneca has selected the Sarah Cannon Research Institute (SCRI) to help develop oncology compounds using molecular profiling to more accurately predict a patient's response.
Rutgers New Jersey Medical School’s designation as an alliance site by Parexel will give the school access to trial opportunities from Parexel’s clients.
A new high-intensity sweetener-based reformulation approach could improve compliance among Alzheimer’s patients and make dose adjustment easier says Tokyo drugmaker, Eisai.
Drugmakers struggling with new EU API import rules now have details of the risk assessments that could solve their problems thanks to the Heads of Medicines Agencies (HMA).
Collaboration and intelligence sharing has seen pharmaceutical cargo theft decline heavily since Lilly fell prey to an $80m heist in 2010, says industry expert.
IPPT has announced plans to buy tablet press maker Kilian for €21m from IMA citing the German firm’s patent portfolio and Asian reach as the key drivers.
Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
Pharma firms are returning to European and North American manufacturers as quality issues and rising costs have lost India and China some of its ‘Eastern promise,’ according to industry experts.
CRO Novotech has added two new clinical research sites in Hong Kong and the Philippines earlier than expected as demand from sponsors, particularly US biotech companies, has spiked.
Academia and early-stage biotech companies are more frequently looking to fill holes in their expertise and preclinical capacities through the use of CROs, according to a commentary in Nature Reviews Drug Discovery.
India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
The Aspen Group, a generic pharmaceutical company, is moving further into the manufacturing business with the purchase of Merck’s API manufacturing sites in the Netherlands and Iowa.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.
Critical Pharmaceuticals says its protein and peptide delivery technologies offer long acting injectables and greater compliance, saving money and easing patient administration.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
With small companies and biotechs increasingly discovering new products, there are big opportunities for contract development and manufacturing organisations (CDMO), says ex-GSK expert.
Parexel’s growth rate has slowed recently to a pace that the company can more easily keep up with than in years past, CEO Josef von Rickenbach told us at DIA’s annual meeting in Boston on Monday.
Kohlberg Kravis Roberts (KKR) has purchased PRA International for $1.3B, which is about $500M more than previous private equity owner Genstar paid in 2007.
Cost of freight, customer service and regulatory compliance offer Western CMOs advantages over their Eastern Counterparts, according to US CMO Pharma Tech Industries (PTI).
CRO TKL Research is constructing a new clinical research facility that will include a 30-bed, Phase I unit as well as multiple, outpatient clinical examination rooms.
Roselabs Bioscience has invested $67M into a pre-filled syringe facility in India and is exploring the option of exporting the products to 35 countries in unregulated markets in southeast Asia, Latin America and Africa.