As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.
The fanfare that accompanies Big Pharma strategic partnerships with CROs is rarely followed by progress reports according to an industry consultant, who warns the lack of feedback means mistakes are repeated.
In another setback for Alzheimer’s drug developers, European CRO/biotech Evotec and partner Roche have announced that their candidate did not meet its primary endpoint after 52 weeks treatment in a Phase IIb study.
Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.
Drug companies will continue to supply Greece for the time being, but mounting debts make it hard to predict what will happen in the longer term according to industry group EFPIA.
Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.
Western CROs with a presence in Japan are benefiting from growing demand from international pharma and local drugmakers interested contractors with global reach says PPD.
As M&A continues to ramp up for the pharma and biotech industry, communication and agility are two of the major keys for CROs to adapt to an acquisition, experts said Thursday at the Partnerships in Clinical Trials Conference in Boston.
Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.
With the closing of the acquisition of QSI (Quantum Solutions India), Parexel is looking to help serve its clients further in the pharmacovigilance space.
CROs (contract research organizations) continue to collaborate with sponsors on more clinical trials in the US, though the largest companies, such as Quintiles, Parexel and PPD, are working on a much larger share of the research as collaborators than...
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
With a small pipeline of clinical candidates, as well as R&D partnerships with top Big Pharma companies paying for those partnerships, Evotec could be in a position to re-define what it means to be an outsourcing partner.
NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.
CRO Icon has launched a new medical device and diagnostics research group following the combination of recently acquired Aptiv Solutions’ expertise with its own experts.
Fluctuations in regulations over the past few years have reduced the number of clinical trials run on the subcontinent, but now governing bodies are looking at new ways to attract trials and further control the industry.
The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.
Charles River Laboratories is nearing the acquisition of an early-stage drug discovery company, CEO James Foster told attendees at the Leerink Swann Global Healthcare Conference last week.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
US Pharma firms are prepared for delays in the supply chain caused by Winter Storm Juno thanks to advanced planning and backup generators, says a logistics expert.
BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
Novartis will close an OTC plant in Puerto Rico by 2019 and transfer manufacturing and packaging actives to sites in the US and facilities operated by Eli Lilly and Virbac.
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.
Drugmakers including China in multi-regional trials would need to submit dossiers filed elsewhere for CFDA review, open up non-Chinese sites to inspections and conduct local studies under draft guidelines proposed by Beijing regulators.
Evotec and Sanofi have entered into exclusive negotiations for a major strategic partnership that will include a €250m ($310m) minimum guaranteed commitment from Sanofi over the next five years.
Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference
2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.
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.
Campaigning group Alltrials has reiterated its call for the EMA to prevent "excessive redaction" and to let researchers print clinical trial data without fear of litigation ahead of the Agency’s vote on its access policy later today.
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.
Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration...
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.
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.