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.
Cancer drug developer CEL-SCI announced Tuesday that since dropping CRO inVentiv Clinical back in 2013, patient enrollment in the trial run by its two new CRO partners – Aptiv Solutions and Ergomed -- has increased more than eight fold.
The implementation of track and trace will drive the outsourcing of drug packaging and UDG Healthcare is well-placed to benefit, according to a UK broking firm.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the US Food and Drug Administration (FDA) decides whether to approve the new drug.
Expert advice was key to persuading AstraZeneca to build a £120m ($188m) manufacturing plant in the UK according to the MHRA, which says the same help is available to all drugmakers free of charge.
Mylan will manufacture and distribute Gilead's antiretroviral HIV drugs, following a tech transfer, in order to increase access in developing countries.
Aid agencies in countries hardest hit by Ebola rely on manual, paper-based data collection according to one expert who says CDISC templates and mobile data capture would help.
The pace of recruitment is the biggest challenge in carrying out trials in Eastern Europe, says Mabion which has extended an agreement with local CRO Altiora for its biosimilar study.
Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
Aurobindo Pharma has recalled one lot of Gabapentin for the treatment of epilepsy and postherpetic neuralgia (pain after shingles), after it was found to contain empty capsules.
Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies.
Veeva Systems has reported a robust Q3 strengthened by increasing interest in its cloud-based clinical trial management software and a deal with inVentiv Health.
Bipartisan bills introduced in the US House of Representatives and the Senate would give manufacturers of Ebola therapies vouchers to speed up review of a drug of their choice.
As small biotech companies continue to cash in on new investments, IPOs and increasing approval rates of orphan and rare disease drugs, CROs are cashing in too and helping the companies navigate the regulatory and clinical landscape.
With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.
The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.
The lack of women on pharma boards is well-known, so why are companies still slow to balance the genders? A recruiter tells us the problem is “demand, not supply” and why quotas aren't a simple fix.
The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.
The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.
The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.
Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.
As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.
As part of a major transparency effort, the NIH (National Institutes of Health) and FDA are proposing to require the release of summary results of clinical trials for products that are unapproved or unlicensed.
Lachman Consultants has revealed more of the story behind the decline of the now bankrupt CRO Cetero/PRACS, which even though it’s shuttered, is still dealing with the fallout from its data integrity issues.
Dispatches from the FT Global Healthcare and Biotech Conference
The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.
A preclinical biotech backed by Bristol-Myers Squibb is forming a strategic alliance with Synergy Partners R&D Solutions to boost academic discoveries.
UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is key for Big Pharma and patients.
The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.
Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections.
An analysis of clinical trial data by Medidata and industry group TransCelerate BioPharma has found that the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring is minimal.
Dispatches from FT Global Pharmaceutical and Biotechnology conference, London
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
UK researchers working with GSK say a newly identified immune cell communication mechanism could explain why some drugs don’t work and drive development of smaller, large molecule meds.
The US Government has asked drugmakers and fine chemicals firms if laws designed to stop the proliferation of chemical weapons are hurting legitimate business.
As questions continue to be raised over why Ricerca was on the brink of closure and laying off all of its employees, as well as how the company’s new owners and CEO plan to turn it around, one thing is certain: new CEO Clifford Croley is confident.
