CRO Covance is looking to help its biopharmaceutical and medical device clients manage their contract terms and associated payments better as some companies are losing almost 5% of US revenue from insufficient processes and contract management systems.
inVentiv Health and Oncobiologics are employing a unique risk-sharing partnership to bring a number of the biggest blockbuster biologics to market as biosimilars.
ScinoPharm and Sundia MediTech have teamed up to try and win business from international drugmakers that - they say - want to simplify outsourcing to China.
Lonza has granted access to its potency boosting expression system to antibody developer Sorrento Therapeutics just days after a signing a similar deal with Pfizer.
A lack of understanding and commentary on proceedings may be putting some pharma firms off opting into the UK’s Patent Box scheme, according to a legal expert.
AMRI (Albany Molecular Research Inc.) saw its revenue increase 19% in Q2 compared to the same quarter last year as its discovery services and large scale manufacturing contract revenue spiked by over 20%.
Enteris has acquired an oral drug delivery platform from Unigene Laboratories and says the excipients used can increase solubility and absorption for both peptides and small molecules.
US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.
Strides Arcolab received a US FDA Form 483 for an injectables facility that provides for about 25% of subsidiary Agila’s revenues, which is currently in the process of being acquired by Mylan.
CRO INC Research opened two new locations in Osaka and Tokyo, Japan, to further expand the company’s reach to conduct trials in the highly sought-after Asian region.
The Supreme Court of India late last week ordered all state government health secretaries to meet with the national Secretary of the Ministry of Health to discuss ways to strengthen the framework for regulating clinical trials.
CRO Quintiles last week announced its fourth consecutive quarter of at least $1B in net new business, as well as 13% growth in the second quarter of this year, though analysts said the company did not meet bookings expectations.
EMD Millipore says while voluntary excipient quality schemes are step in the right direction, formal GMP and enforcement would create a level playing field.
Piramal is upgrading its ADC (antibody drug conjugate) manufacturing capacity in response to demand from clients in late phase trials looking to ramp up production.
Ireland-based commercialization services firm United Drug has announced plans to buy Spanish contract pharmaceutical sales group Expansis for €12m ($15m).
Hospira linked its improved Q2 results to progress made in efforts to address quality problems at various manufacturing plants, but the 483s and Warning Letters are still coming.
Delays are annoying. Whether you are a journalist trying to ask a few quick questions without involving teams of public relations people or a driver stuck in a traffic jam, delays are normally a bad thing.
Building on similar European documents, Australia’s TGA (Therapeutic Goods Administration) released guidance Tuesday to help assist drugmakers looking to win approval for their biosimilars.
Covance reported 10% revenue growth between the second quarter of this year and the same quarter last year, mostly due to central laboratories and late-stage development growth.
PRA CEO Colin Shannon tells Outsourcing-pharma.com merger with RPS will provide geographic and client base growth. Analysts say it is a positive move for two mid-sized CROs.
Private equity firm KKR announced today it will acquire RPS (ReSearch Pharmaceutical Services) from Warburg Pincus and will merge the company with PRA International.
The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.
The latest survey of clinical trial investigators found almost half most prefer to work with Covance’s central laboratories while nearly a quarter said they preferred Quintiles.
Management and staff involved in manipulating quality data during an FDA inspection have been sacked by Fresenius Kabi as part of remediation actions at its Indian API facility.
US CRO Crown BioSciences has acquired Precos citing the UK contractor’s preclinical oncology services and presence in the European market as the key drivers.
The California Institute of Regenerative Medicine’s board signed off on the allocation of $70M to begin setting up clinics and to bring a number of developing stem cell therapies into clinical trials.
inVentiv Health’s medical communications business is opening two new offices in Tokyo and New York City to be closer to clients and integrate further with the company’s clinical teams.
NovaMedica and the Russian Government are to build an $85m (€64m) facility as part of a joint venture encouraging local manufacturing, the company says.
