Ethiopian quality control lab gains ISO testing accreditation
05-Dec-2011 By Nick Taylor
The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.
05-Dec-2011 By Nick Taylor
UBC & Medco are calling for personalised medicine developers to engage payers in Phase I to ensure necessary data is generated.
05-Dec-2011 By Gareth Macdonald
The global contract manufacturing market may be showing signs of recovery but careful investment and focusing on core activities is still the most sensible approach according to Sweden-based CDMO Recipharm.
Rise of Asian biopharm creates investment targets for Quintiles
01-Dec-2011 By Nick Taylor
Quintiles expects to make more investments in Asia-Pacific partnerships as the local biopharm sector grows.
AstraZeneca inks multi-year Cognizant biostatistics deal
30-Nov-2011 By Nick Taylor
AstraZeneca is outsourcing biostatistics and medical reporting work to Cognizant in a multi-year agreement.
China-focused USP committee to develop excipient standards
29-Nov-2011 By Nick Taylor
USP is creating a China-focused East Asia expert committee to develop quality standards for excipients.
UBC looking to ‘buy or build’ to serve strategic partnerships
29-Nov-2011 By Nick Taylor
UBC expects strategic outsourcing of outcomes and personalised medicine research to accelerate as biopharm cut fixed costs.
Russian rules on local trials blow for drug sector and boon for unethical CROs
28-Nov-2011 By Gareth Macdonald
The requirement for local clinical trials has been a ‘serious blow’ to Russia’s drug approval system and an opportunity for unethical CROs according to the Moscow-based Association of Clinical Trial Organisations (ACTO).
Indian trial compensation guidelines open to comment
28-Nov-2011 By Nick Taylor
India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.
FDA anti-adulteration efforts hindered by industry; GAO
28-Nov-2011 By Nick Taylor
Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
Forming CRO spin-outs can help big pharma; research
24-Nov-2011 By Nick Taylor
Spinning-out assets to form a CRO can help large biopharm commercialise knowledge and focus on core activities, research found.
Parexel adds imaging tech for early phase CNS research
24-Nov-2011 By Alexandria Pesic
Parexel has added functional magnetic resonance imaging technology (fMRI) to its early phase units to advance CNS research.
Take Solutions inks Mene deal for emerging market services
24-Nov-2011 By Alexandria Pesic
Take Solutions has partnered with Turkish CRO Mene Research to offer drug safety services in emerging markets.
EMA recalling oncology drugs manufactured by Ben Venue
23-Nov-2011 By Nick Taylor
The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
FDA sends Mylan Puerto Rico plant a GMP warning letter
23-Nov-2011 By Nick Taylor
The US FDA has sent Mylan a warning letter after inspectors found GMP testing failings at its Puerto Rico facility.
Schott strikes deal with Xinkang for joint venture in China
22-Nov-2011 By Alexandria Pesic
German technology giant Schott has signed an agreement with a Chinese firm to provide the fast-growing pharmaceutical market with a range of high-end glass packaging products.
ShangPharma opening facility dedicated to major customer
22-Nov-2011 By Nick Taylor
ShangPharma is opening a 100,000 sq ft facility dedicated to serving a big customer as it continues to strengthen ties to top clients.
CROs still seen as good investment says leading banker
22-Nov-2011 By Gareth Macdonald
The CRO industry is still considered a good long-term investment and the clinical services segment is set to continue its dominance thanks to sponsor R&D spending, says leading banker.
SeraCare posts Q4 loss after bioservice revenue halves
21-Nov-2011 By Nick Taylor
SeraCare slipped into the red in the fourth quarter as loss of government business halved bioservice revenues.
Aanjaneya’s profit soars as post-IPO expansion continues
17-Nov-2011 By Nick Taylor
Net profit at Indian API and formulation business Aanjaneya Lifecare jumped as it enacted post-IPO expansion plans to ‘dominate’ its markets.
UCB inks deal with Parexel & PRA to boost cost-effectiveness
16-Nov-2011 By Nick Taylor
UCB has inked a strategic deal with Parexel and PRA that an analyst believes has “very favourable” terms for the biopharm.
USP forges closer ties with Chilean drug standards group
15-Nov-2011 By Gareth Macdonald
The USP has forged closer bonds with the Chilean Pharmacopoeia Foundation (CPF) in the latest of a series of agreements with regional drug quality groups.
Trust in drug source may blind wholesalers to counterfeits
15-Nov-2011 By Nick Taylor
Wholesalers’ trust in the quality of products from some countries could decrease vigilance and allow counterfeits to reach pharmacies, research found.
15-Nov-2011 By Nick Taylor
To boost solubility pharma must develop, refine and improve existing methods as a “quantum leap” in formulation is unlikely, Pharmaterials' CEO said.
Pall sets up Singapore processing COE
14-Nov-2011
Processing technology maker Pall has opened a new centre of excellence in Singapore in a bid to capture a share of the country’s growing biomanufacturing sector.
inVentiv sets up in Korea as outsourcing demand grows
14-Nov-2011 By Nick Taylor
inVentiv Health has set up in Korea to meet growing demand for clinical and commercial services in the country.
14-Nov-2011 By Nick Taylor
Patheon is considering buying unique drug delivery technologies to expand its development service capabilities.
PDI operating profit falls as DCA buy drags on performance
10-Nov-2011 By Nick Taylor
Operating profit at PDI fell 90 per cent in the third quarter after the acquired digital communications unit again dragged on performance.
K-V prompts FDA investigation into compounding pharmacies
09-Nov-2011 By Nick Taylor
The FDA is investigating compounding pharmacies’ Makena after K-V Pharmaceutical said they differ from approved forms.
Globalised supply chain drives EMA to rethink batch release
09-Nov-2011 By Nick Taylor
The EMA plans to update guidance on certification and batch release in response to globalisation of the pharma supply chain.
Medidata plans acquisitions to continue strong profit growth
09-Nov-2011 By Nick Taylor
Medidata posted double-digit third quarter operating profit growth and is looking for acquisitions to continue the upward trend.
Pharma CSR reporting up 39% in 2011 according to KPMG
09-Nov-2011
Pharma sector corporate social responsibility (CSR) reporting has increased dramatically in recent years according to a new report that argues such activity enhances financial value.
Cyprotex invests to meet demand for cell-based preclinical tox
08-Nov-2011 By Gareth Macdonald
Cyprotex says increasing demand for cell-based preclinical toxicology services in North America prompted facility expansion plan.
Chinese FDA should hire CMC staff to boost QbD; Pfizer exec
08-Nov-2011 By Nick Taylor
The Chinese FDA should hire more CMC reviewers to encourage QbD applications, a Pfizer executive said.
Decline in Russian trial approvals slows in Q3
07-Nov-2011 By Gareth Macdonald
New data suggests the Russian MoH is getting faster at reviewing and approving clinical trials.
Greater FDA inspection role increased drug recalls in Q3, study
07-Nov-2011 By Gareth Macdonald
Greater FDA oversight of US manufacturing plants increased the number of drug recalls in Q3 in a trend that is likely to continue according to a new report.
07-Nov-2011 By Nick Taylor
Catalent is considering acquisitions as it adds scale, drug delivery technologies and capacity in emerging markets.
ViiV teams with Russian manufacturer
03-Nov-2011 By Gareth Macdonald
ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.
Innovation needed to kick-start eClinical sector; goBalto
03-Nov-2011 By Nick Taylor
A “tectonic shift” will kick-start eClinical innovation and move the sector beyond “clunky” systems currently available, the goBalto CEO said.
Lonza’s CMO biz gains pegged back by higher raw materials costs for ingredients unit
02-Nov-2011 By Gareth Macdonald
Gains made in manufacturing, particularly in biologics, were pegged back by the impact raw materials costs and the strong Franc had on its ingredients division says Lonza.
Gentronix partners to add cell health assays for early research
02-Nov-2011 By Nick Taylor
Gentronix has added cell health assays through a partnership with BioQuanta to detect toxicity earlier in development.
31-Oct-2011 By Gareth Macdonald
CMO Aenova says demand for contract manufacturing capacity in Europe is increasing.
31-Oct-2011 By Gareth Macdonald
BASF says solubility and bioavailability will be key focus for its pharmaceutical excipient product development efforts in the next few years.
Pii eyes gelatin shell evolution to enhance oral drug delivery
26-Oct-2011 By Nick Taylor
Pii is developing small intestine targeting drug delivery technologies as part of a focus on gelatin shell materials.
Effective outsourcers will have competitive edge in 2020; KPMG
26-Oct-2011 By Nick Taylor
Effectively outsourcing a significant portion of work will give biopharm a competitive advantage in 2020, KPMG said.
Quintiles says payers driving demand for market access offering
25-Oct-2011 By Gareth Macdonald
US CRO Quintiles says healthcare payer influence is driving pharmaceutical industry demand for market access services.
Merck plans $250m Singapore manufacturing expansion
24-Oct-2011 By Nick Taylor
Merck & Co is investing $250m (€180m) in its Singapore manufacturing capabilities as part of an expansion push.
Quintiles makes acquisitions in observational research and market access space
20-Oct-2011 By Gareth Macdonald
Quintiles has bought its way into the observational research space with the acquisition of Outcome Sciences and strengthened its market access standing with the purchase of VCG & Associates.
Avantor to add tamper-evident seals to raw material containers
20-Oct-2011 By Nick Taylor
Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.
JSS & Venn partner to offer transatlantic clinical services
19-Oct-2011
JSS Medical Research has bought Canadian assets from Venn Life Sciences as part of a joint-venture spanning North America and Europe.
