Horizon says its £6m (€7.7m) purchase of Austrian biotech Haplogen Genomics means it can produce cell lines ten times faster than before using a haploid gene platform.
CROs are due to see an increasing workload in 2015, though the way they conduct trials with partners may continue to shift, according to the Tufts Center for the Study of Drug Development’s Outlook for 2015.
Japan was involved in fewer drug industry-sponsored multi-regional clinical trials (MRCT) in 2014 than any year since 2008 according to the Pharmaceuticals and Medical Devices Agency (PDMA).
Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social media sites to advertise their products, according to the MHRA.
Discovering a new antibiotic candidate and finding out how it kills superbugs without letting resistant mutants escape involved advanced chemistry according to the scientists who determined its structure.
German CRO Evotec AG and Padlock Therapeutics have successfully completed an initial goal in developing inhibitors of protein-arginine deiminases (PADs) and have further extended their collaboration through March 2017.
The Board of Directors of the Association of Clinical Research Organizations (ACRO) has elected Jamie Macdonald, CEO of INC Research, as its 2015 chairman and David Simmons, Chairman and CEO of PPD, as vice chairman.
Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk of generic competition in 2015 according to one industry analyst.
Sotio has selected local CRO Accord Research to carry out Phase I/II trials on its dendritic cell vaccines to treat patients with lung cancer in the Czech Republic.
India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
Cancer and infectious disease immunotherapy developer Argos Therapeutics is collaborating with Saint-Gobain’s Performance Plastics division, to design, integrate and scale production of a range of disposables for use in the manufacturing of Argos’ lead...
Certara subsidiary and regulatory and medical consultancy Synchrogenix has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Terms of deal were not disclosed.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of the new class of treatments for America’s three million Hepatitis C sufferers.
The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.
More than a year since its creation, India’s Apex Committee is now calling for developers of cancer treatments approved without trials in India to monitor the first 500 patients to assess the drugs’ safety and efficacy.
As the waiting period for LabCorp and Covance to proceed with their integration ended late last month, both companies are now turning to the logistics of the merger and hiring Deloitte consultants to help.
The US FDA will give drugmakers and distributors until May to comply with new track and trace laws in order to minimise disruptions in the supply chain.
Injectable-heavy drug pipelines and increased biotech funding are driving up US demand for sterile manufacturing, according to UK-based Symbiosis, which is looking to help fill the gap left by several high-profile exits from the space.
PPD and SNBL will set up a clinical services joint venture (JV) in Japan and collaborate on preclinical and Phase I bridging studies under a new agreement.
Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of the castration-resistant prostate cancer drug Xofigo (radium Ra 223 dichloride).
Contract drug developer Evotec AG has achieved multiple milestones resulting in €8m ($9.8m) in revenue thanks to its collaborations with Bayer and Janssen Pharmaceuticals.
It is likely Santa will be fit and healthy, if a little tipsy, this Christmas Eve as over 12,000 prescriptions were filled in the North Pole this year.
With PRA and INC Research joining Parexel, Quintiles, Covance and Icon in the land of public companies, 2014 was a year in which the top shelf of CROs filled out.
US package delivery giant UPS has announced it will buy Polish healthcare logistics firm Poltraf SP zoo from private equity fund Ortie Capital Investment.
Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.
British Airways and Iberia’s cargo division IAG has become the first airline to be awarded accreditation under new EU Good Distribution Practices (GDP) guidelines.
PPD’s biotech company X-Chem has licensed a second drug discovery program to Bayer Pharma, which follows on a multi-target collaboration the companies established in 2012.
Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.
The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
European CRO KCR has acquired a portfolio of clinical projects from the Ukrainian CRO Axis Group thereby making the country the most important location for KCR in the region of the Commonwealth of Independent States (CIS).
The holidays are fast upon us, so let’s put ‘business’ to one side and get into the festive mood. To keep in the spirit of things, we’ve got a ‘gift’ for you – enjoy. Happy Holidays!
