Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
The FDA has issued an import alert against products manufactured at two Apotex facilities after the agency issued a warning letter, which raised several issues that the company is now working to resolve.
Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.
New multi-million dollar R&D contracts with top three pharma and biotech players go someway to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.
CMO Encap has expanded its colonic delivery offering and is combining the technology with liquid dosage forms to provide clients with a way to administer a wide range of therapeutics to the region.
Novavax’ VLP delivery system has been the subject of industry excitement this week after the US firm released Ph II data showing that a combination seasonal influenza vaccine based on the technology is effective and well tolerated.
Phlexglobal’s new contract with UCB will improve how the Belgian drug firm manages trials and is indicative of a wider industry move towards eTMF, according to CEO Nicola Murgatroyd.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Cytovance, MPI Research and UBC.
The global economic crisis has drastically reduced the growth of the North America API market, but brighter days are ahead according to new research by Global Markets Direct (GMD).
CRO Averion is planning to become a private company to reduce expenditure on auditor fees, which could realise savings of $805,000 (€561,000), and allow management to better focus on long-term goals.
Cloud Packaging Solutions has said the acquisition of Toll Packaging will boost its ability to meet the increased demand for shorter packing runs triggered by the current global economic crisis.
US CRO and central laboratory services provider Pacific Biometrics (PBI) has entered into a $4m (€2.7m) loan agreement that it says will help further the development of its contract biomarkers business.
CMO Avid Bioservices’ revenues rose by 74 per cent to $2.1m (€1.5m) in Q2, generating a further $7m from its parent company, and it has plans to boost output and become a leader in mammalian cell culture production.
in-PharmaTechnologist presents its latest round up of movements in the pharma space, including Merck’s post-merger management structure and a difference of opinion at LifeCycle Pharma.
US contract services firm PharmaForm has cut its workforce to 65 employees in a restructuring plan that parent company Akela Pharma said optimises its client support infrastructure.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
US investment group JLL has described Lonza’s rival offer for Patheon as “a hostile attempt to adversely impact [the Canadian contractor’s] competitive position.”
By acquiring a stake in India-based RSIPL Evotec believes it can offer clients quicker drug development services, an important aspect of coping with attrition, because larger teams of chemists are available in emerging markets.
AstraZeneca (AZ) has dramatically cut the time taken to initiate a Phase I oncology trial by working with its strategic partner to improve administrative processes and eliminate delays, according to research.
Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.
The biosimilars sector is predicted to be worth $19.4bn (€13.6bn) by 2014, by which time the US will have overtaken Asia as the dominant market, according to a report.
KV Pharmaceutical has begun rehiring employees to produce verification batches of certain products prior to resuming commercial manufacture, which appears to be on schedule after the FDA accepted the work plan.
Wyeth’s battles to protect the controlled-release (CR) version of its anti-depressant Effexor are a sign of things to come according to a new Espicom report identifying 30 CR drugs likely to face competition.
Facing “unparalleled” challenges MDS is seeking a buyer for its Pharma Services division, and claims to have begun discussions with two interested parties, to allow it to focus on its Nordion business.
Biotechnology firm Cel-Sci claims the “True Cold” low-temperature fill and finish service at its new manufacturing facility near Baltimore, Maryland is a first for the global contracting sector.
An “enormous leap in productivity” can be achieved by applying the principles of adaptive trials to broader operations, such as recruitment, according to a CEO that thinks CROs have to adopt the method.
The EMEA has issued US biotech firm Genzyme with a letter detailing “one major observation and several other observations” following an inspection of its Allston, Massachusetts manufacturing plant last month.
In the next week the Chinese SFDA is expected to approve licences for two locally produced H1N1 vaccines, which unlike some alternatives only require one dose to confer immunity.
Summit has sold Dextra, its analytical and manufacturing services division, to NZP but believes operating the contract business has been beneficial to its industry standing and R&D capabilities.
US firm PerkinElmer has opened a second plant to meet growing demand for radiolablled compounds for ADME and, it hopes, ultimately help drugmakers make go/no go development decisions earlier.
Synexus is meeting the rising demand for its services, which it says can dramatically increase recruitment rates, by acquiring clinical trial sites in Poland and is hoping to expand in India soon.
The Californian budget deficit presents a “real risk to future biotech investments”, according to the CEO of BayBio who explained to how the industry now has a difficult relationship with the state.
Sanofi-aventis is initiating the phased closing its manufacturing facility in Kansas, US, with complete shutdown expected to occur in 2012 and impact on 370 employees.
Pharmaceutical and cosmetics contract manufacturing organisations (CMOs) in India can now claim tax credit on their advertising spend following a recent appeal court victory for US beverage giant Coca-Cola.
Researchers believe they are a step closer to creating superefficient industrial catalysts after a team made platinum-on-gold bimetallic nanorods that are soluble in organic solvents.
CMO SynCo Bio Partners has entered the Japanese biologics production market, which it views as a growth opportunity, by signing its first contract with an emerging company based in the country.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Laxai, LabConnect, ERT and Avid Bioservices.
Drug development partnering site goBalto’s addition of Latin American clinical sites to its database in a deal with Chilean CRO Clinical Trials Support (CTS) is timely given the pharma and biotech industry’s focus on emerging markets.
Cobra Biomanufacturing’s new Adenovirus manufacturing and process services contract is further evidence of the health of EU biologicals market, according to business development manager Philip Ridley-Smith.
Sweden’s XSpray Microparticles says its new particle plant proves its RightSize tech can be scaled-up for industrial applications and will be a boost for its contract services offering.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Novartis’ former CEO joining Amylin’s board and an appointment at OctoPlus.
Demand for Cerep’s pharmacological profiling services picked up in the second quarter and it believes this, coupled to cost savings and commencement of delayed contracts, will help it improve in the second half of 2009.
Neuland Laboratories is building a facility to produce HPAPIs, which it predicts will contribute 20 per cent of its bottom line over the next two to three years, and has begun commercial peptide manufacture.
Chemicals firm Durect will supply drugmaker King Pharmaceuticals with two excipients used in the manufacture of the candidate anti-abuse painkiller Remoxy in an agreement signed last week.
US software group SourceSolution has signed a co-marketing deal with bioProcessUK they claim will help UK pharma contractors raise their global profiles and find new drug industry clients.
Ark Therapeutics is using its expertise and spare capacity to move into the contract manufacturing sector and is hoping to sign deals to produce the DNA-based medicine.
The number of registered clinical trials in Russia slipped in Q2, with the country attracting fewer international sponsors and regulatory inspections than in pervious years.
Dainippon Sumitomo Pharma has entered into a collaboration to develop Silence Therapeutics’ AtuRNAi delivery technology which improves stability, cut manufacturing costs and increase stability.