Pharmaceutical Industry

PPD seeing growth in Japan after J-GCP harmonization effort

Japanese trials sector heating up says PPD

By Gareth Macdonald

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.

Experts discuss the impact of M&A on CRO, sponsor partnerships

Dispatches from PCT US

Experts discuss the impact of M&A on CRO, sponsor partnerships

By Zachary Brennan

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.

Quintiles, Parexel, PPD lead all CROs in US trial totals, review finds

Quintiles, Parexel, PPD lead all CROs in US trial totals, review finds

By Zachary Brennan

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...

The Ministry of Health is working to provide accreditation to clinical trial centers, investigators and ethics committees

India taking further steps to reform clinical trial industry

By Zachary Brennan

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.

EMA management board meet in London, UK today

EMA urged to make trial data transparency policy crystal clear

By Gareth Macdonald

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.

All personal patient information and investigator names will be removed or redacted

TransCelerate recommends what to protect in trial transparency efforts

By Zachary Brennan

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...

ICH plans new guidance on multi-regional clinical trials

ICH plans new guidance on multi-regional clinical trials

By Zachary Brennan

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.

Ashland expands HPC production at VA plant

Ashland expands HPC production at VA plant

By Dan Stanton

Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.

Who's going places?

People on the Move

Who's going places?

By Fiona BARRY

Big changes in biologics in this week's column, as we round up the pharma industry's new scientific hires.

For big pharma, ten is the magic number of CMOs says ex-GSK Director

Dispatches from the GPCM Conference, London, UK

For big pharma, ten is the magic number of CMOs says ex-GSK Director

By Dan Stanton

Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.

Fight the Fakes campaign adds bevy of new partners

Fight the Fakes campaign adds bevy of new partners

By Zachary Brennan

The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).

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