A new trial model is needed to encourage cardiovascular disease drug development say researchers who claim the large, lengthly studies used to prove safety and efficacy of such drugs are a disincentive.
CRO Pharmaceutical Product Development (PPD) has established a five-year partnership with Anthem subsidiary HealthCore to help sponsors more quickly and effectively demonstrate how their products will perform in the real world.
Competition among the top CROs, many of which are conglomerations of smaller peers, is “ferocious” right now on nearly every level, Parexel CEO Josef von Rickenbach told Outsourcing-Pharma.com at the 51st annual DIA conference.
Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
Akebia Therapeutics has signed a master services agreement with CRO Quintiles in connection with its planned Phase III studies for Akebia’s lead product candidate for the treatment of anemia secondary to chronic kidney disease in non-dialysis patients.
The US spends billions on preclinical research that cannot be replicated due to errors in design, problems with lab protocols and mistakes during data analysis according to new research.
A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
As the hype continues to hover around the promise of gene and cell therapies, the latest guidance from the FDA will help sponsors, CROs and investigators design early-phase clinical trials for the products, which may pose substantial risks to patients.
An expansion at Vetter, a contract win for Dalton and a pre-approval inspection at LSNE – welcome to Outsourcing-Pharma’s round-up of sterile manufacturing news.
Ongoing research on two new drug delivery systems could help clinicians more accurately understand how certain tumors react to different treatments, according to the Journal of the American Medical Association.
Minerals used to manufacture two of Charles River Laboratories’ products may be derived from questionable sources in Africa, though following a review of suppliers, the company has yet to fully understand where exactly they’re coming from, according to...
Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.
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.
Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).
As biotech cash continues to flood the coffers of CROs (contract research organizations), large pharma R&D is still relatively flat, which means CROs will see about 6% growth annually, Brendan Brennan, CFO of Icon, told investors last week at the...
Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.
A capsule inspired by the porous structure of seashells has been developed to protect drugs from extreme temperatures and could be used in controlled delivery.
Research and clinical diagnostic tool provider Bio-Techne has agreed to acquire Cliniqa, which specializes in the manufacturing and commercialization of quality controls and calibrators as well as bulk reagents used in the clinical diagnostic market....
The 21st Century Cures Act may actually offer the FDA too much discretion to approve drugs without conventional clinical trials, and in some cases “on the basis of less rigorous data,” two medicine professors from Harvard write in an editorial in the...
US-based contract development and manufacturing organization (CDMO) Patheon has registered with the SEC as part of plans to go public with an IPO that could be worth as much as $100m.
Teva has refuted accusations of “meddling” with Mylan’s business in the latest chapter of what one analyst says is a far from friendly, if not hostile takeover attempt.
GlaxoSmithKline is unconcerned about losing its position in the respiratory market as Mylan launches the first generic version of blockbuster asthma product Seretide in the UK.
Johnson Matthey saw revenue from (active pharmaceutical ingredients) APIs increase in fiscal 2015 despite competition from generic manufacturers and the relocation of a key customer.
Unchained Labs has acquired Avia Biosystems and its characterization tool, the Isothermal Chemical Denaturation (ICD) system, to support the growing demand for biologics stability testing.
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.
Last week, a new chapter of PhRMA’s Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results went into effect, detailing efforts to raise awareness around expanded access programs, which provide investigational drugs for...
AstraZeneca has partnered with two Algerian companies, AHT Health and Hasnaoui Finance, to create a joint venture with the aim of building a new $125m manufacturing facility in Algeria.
Intertek will open an immunochemistry lab in Manchester, UK to cater for growing demand for specialised analytical services from biologics and biosimilars developers.
WuXi NextCODE and Fudan University have partnered to bring WuXi’s population human genomics database system and integrated research and clinical tools to the Fudan-led Collaborative Innovation Center of Genetics and Development (CICGD).
European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.
Replacing animal studies in drug development is impossible according to the European Commission, which has rejected a petition calling for a ban signed by 1.2m people.
