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.
FDA releases draft co-crystal guidance to support NDAs
05-Dec-2011 By Nick Taylor
The US FDA has published draft guidance to help companies submit marketing applications for API-excipient co-crystals.
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.
UK government make health data available in bid to boost R&D sector
01-Dec-2011 By Natalie Morrison
Pharma companies and contract research organisations will soon be able to view important UK health data.
Sepha sees growing demand for cost saving testing tech
01-Dec-2011 By Gareth Macdonald
The drug industry's need to improve product quality while reducing production costs is driving global demand for testing technologies according to Sepha.
Ranbaxy forms pact with Teva to launch generic Lipitor in US
01-Dec-2011
Ranbaxy has introduced generic Lipitor in the US after partnering with Teva and gaining FDA approval for manufacture at its US plant.
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.
Lonza to supply Elan with API for trials of candidate Alzheimer’s disease drug
30-Nov-2011 By Gareth Macdonald
Chemicals supplier Lonza will manufacture the API for a candidate Alzheimer’s disease drug being developed by Elan in an agreement announced yesterday.
Ideal Cures claims film coating tech is twice as quick as others
30-Nov-2011 By Natalie Morrison
Ideal Cures says its new Instacoat E Series film can cut tablet coating times in half and save manufacturers money.
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.
Virus catching filter helps Novo stop batch tests on live animals
30-Nov-2011 By Nick Taylor
Novo Nordisk has stopped using living animals in batch quality tests after developing a virus filtration tool for factor VII production.
Fire at Aurobindo API plant injures three, operations unaffected
30-Nov-2011 By Gareth Macdonald
Aurobindo Pharma says a fire that broke out at its manufacturing plant in India injuring three employees did not disrupt production operations.
Strategic deal visibility creating opportunities for small CROs
30-Nov-2011 By Nick Taylor
Online 24/7 news has accentuated big CROs’ ties to large pharma and created opportunities for smaller vendors, a CEO said.
30-Nov-2011 By Gareth Macdonald
Taste masking plays a vital role in treatment compliance according to Cargill, which has launched a new flavour technology that it claims can make drugs more pleasant to take and help manufacturers save money.
USPTO rejects MonoSol claims in delivery film patent fight with BDSI
29-Nov-2011 By Gareth Macdonald
The USPTO has rejected MonoSol RX’s claims that production methods for a cancer pain patch developed by BioDelivery Sciences (BDSI) infringe on manufacturing techniques it uses to make its own drug delivery films.
Analysts back CMO Arch’s IPO on CRAMS biz potential
29-Nov-2011 By Nick Taylor
An expanding CRAMS business and bulk drug strength makes Indian CMO Arch Pharmalabs’ IPO a solid investment, analysts report.
29-Nov-2011 By Natalie Morrison
High potency APIs are becoming a key focus of the pharmaceutical business, with drug makers from all areas racing to establish a foothold in the market.
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.
SOHM acquires Novatrend Medicament's product line in latest Indian forray
28-Nov-2011 By Natalie Morrison
Generic drugs manufacturer SOHM is continuing its expansion into the Indian market with the acquisition of Novatrend Medicament’s product line.
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.
Biotechs fear being overlooked by the big CROs; Covance
28-Nov-2011 By Nick Taylor
Fear of getting “lost in the shuffle” makes some biotechs nervous about outsourcing to big CROs, a Covance VP said.
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.
Biocon close to finalising partnership for development of oral insulin
24-Nov-2011 By Natalie Morrison
Biocon is close to signing an agreement with a partner willing to inject cash into its experimental insulin pill, said its MD.
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.
Pfizer gains 1st ISO 50001 energy accreditation at Ireland plant
24-Nov-2011
A Pfizer Ireland plant has become the first in its network to achieve ISO accreditation for cutting CO2 emissions and energy use.
EC seeks industry feedback to shape serialisation policy
24-Nov-2011 By Nick Taylor
The EC is seeking industry comments before implementing the serialisation aspect of the falsified medicines directive.
Hong Kong the latest regulator to recall drugs from Ben Venue
24-Nov-2011
The Hong Kong DH has become the latest regulator to take action against products manufactured by Ben Venue Laboratories.
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.
GSK urges FDA to consider absorption of nanomaterials in new guidance
23-Nov-2011 By Natalie Morrison
GlaxoSmithKline (GSK) has urged the US FDA consider the absorption of nanomaterials in the gastrointestinal (GI) tract within its proposal for new regulations on nanotechnology.
pSivida signs tech evaluation agreement for injectable implant
23-Nov-2011 By Natalie Morrison
pSivida has inked a technology evaluation agreement with an unnamed global pharma over its Durasert drug delivery technology.
Shire submits regulatory filings for Massachusetts Vpriv plant
23-Nov-2011
Shire has submitted EMA and FDA regulatory filings to add ‘substantial manufacturing capacity’ for Vpriv (velaglucerase alfa).
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.
Lifting bulk drug price controls could boost Indian clinical trials
23-Nov-2011 By Nick Taylor
India could enhance its status as a global player in clinical trials if plans to abandon bulk drug price controls go ahead.
23-Nov-2011 By Nick Taylor
Covance is adding mass spectrometry and other capabilities to meet growing demand for biosimilar comparability services.
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.
Biocon introduces insulin pen to Indian market
22-Nov-2011
Biocon has begun selling a reusable insulin pen, based on Haselmeier technology, to patients in India.
Novavax leasing cGMP plant to meet expected vaccine demand
22-Nov-2011 By Nick Taylor
Novavax is leasing a cGMP plant in Maryland under ‘very favourable terms’ to meet anticipated demand for its VLP vaccines.
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.
21-Nov-2011 By Natalie Morrison
Contract services providers which embed service personnel in pharma companies are becoming more prominent in the industry.
Shortages to worsen after Ben Venue suspends manufacture
21-Nov-2011 By Nick Taylor
Ben Venue Laboratories has voluntarily suspended manufacture at the Ohio plant linked to drug shortages.
IntraPac hiring 63 in NJ to IN packaging plant relocation
21-Nov-2011
IntraPac is creating 63 jobs by relocating operations from New Jersey to an 80,000 sq ft packaging plant in Indiana.
DaVita bringing jobs to Denver in early phase expansion
21-Nov-2011
DaVita is creating up to 200 jobs in Denver by opening an early phase clinical research unit and call centre.
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.
21-Nov-2011 By Nick Taylor
Real-time release testing can save money by cutting recalls but “fear of the unknown” is limiting use, a FDA official said.