Counterfeiters target countries with weak laws says Antigua Pharma Society
24-Aug-2011
Drug counterfeiters are using the Caribbean as a transport hub to ship fake pharmaceutical around the world according to the Antigua Pharmaceutical Society.
New lab sees Aspex expand into analytical services
24-Aug-2011 By Nick Taylor
Aspex has expanded beyond equipment sales and into GMP analytical services after building, staffing and auditing a testing laboratory.
CRL names new regional heads of combined RMS-PCS units
24-Aug-2011 By Gareth Macdonald
US CRO Charles River Laboratories (CRL) has rejigged its upper management as part of a business realignment that unifies its regional research model and preclinical development businesses.
Foreign investment needed to boost UAE drug production
24-Aug-2011 By Nick Taylor
The UAE needs overseas investment to kick-start its pharmaceutical manufacturing sector and end reliance on foreign imports, the DCCI says.
MD adds west coast pharma logistics at Reno, NV site
24-Aug-2011 By Nick Taylor
MD Logistics has opened a 55,000 sq ft logistics facility in Nevada to expand its pharma distribution services to the west coast.
EU, OECD certify WuXi site GLP
24-Aug-2011
WuXi AppTec’s bioanalytical services unit has received GLP certification from the EU and OECD after inspection by Belgian authorities.
PBS Biotech buys Integrity to add manufacturing capacity
24-Aug-2011 By Gareth Macdonald
US bioreactor maker PBS Biotech has bought medical device focused CMO Integrity CMI to expand its manufacturing capacity
Needle-free drug delivery is the wave of the future, says Kalorama
23-Aug-2011 By Natalie Morrison
The worldwide market for needle-free drug delivery will double in value over the next five years, according to new market research by Kalorama.
Clinigene and Spaulding team up on pharmacology services
23-Aug-2011 By Gareth Macdonald
Biocon’s Indian unit Clinigene International has partnered with US counterpart Spaulding Clinical Research LLC to provide clinical pharmacology services.
Brazil & USP ink deals to up quality, harmonise standards
23-Aug-2011 By Nick Taylor
The USP is strengthening ties to the Brazilian pharmaceutical sector to improve quality and drive harmonisation of standards.
Rise of Chinese pharma helps ShangPharma grow in Q2
23-Aug-2011 By Nick Taylor
China-based clients now account for 10 per cent of ShangPharma revenues after successive quarters of triple-digit sales growth.
Strategic deals drive Catalent’s $410m move for Aptuit assets
23-Aug-2011 By Nick Taylor
Catalent is to buy clinical trial supply assets from Aptuit for $410m (€285m) as it adds scale to handle the shift to preferred provider relationships.
Chemspec to ‘go private’ after Halogen takeover
22-Aug-2011
Contract speciality chemical maker Chemspec International says it will ‘go private’ after being taken over by Halogen Limited, a holding company co-owned by members of its management board.
Boehringer Ingelheim's BVL plant to exit the CMO biz
UPDATE
22-Aug-2011 By Natalie Morrison
US-based contract manufacturer Ben Venue Laboratories (BVL) is to exit the CMO industry.
CMOs in India & China look to grow international business
22-Aug-2011
JB Chemicals and Asymchem Laboratories are expanding in response to interest in outsourcing manufacturing to India and China.
Silica-based cartridges boost metal removal at AstraZeneca
22-Aug-2011 By Nick Taylor
AstraZeneca has adopted and scaled-up silica-based cartridges for removal of metal impurities at its pilot plant.
EMA aims to spark debate on quality in clinical trials
22-Aug-2011 By Gareth Macdonald
The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
Ingredients & formulation research round up
22-Aug-2011 By Nick Taylor
in-PharmaTechnologist presents a roundup of recent ingredient and formulation research, including improved API impurity detection and a simple step to boost stability.
FDA and generic drug sector agree ‘epoch making’ plant inspection fee plan
18-Aug-2011 By Gareth Macdonald
The generic drug industry and the US FDA have reached an agreement that would see the former fund the latter’s overseas facility inspection programme to the tune of $299m a year, according to a number of reports.
18-Aug-2011 By Natalie Morrison
Companies looking to outsource patient recruitment need to think outside the box, says Cutting Edge Information’s director of research Eric Bolesh.
MakroCare teams with LSK Global for further Asian expansion
18-Aug-2011 By Gareth Macdonald
US-headquartered trial services firm MakroCare has continued its expansion in Asia with a new partnership with South Korea-based CRO LSK Global.
18-Aug-2011 By Nick Taylor
The US FDA has warned that rapid patient enrolment in emerging markets can overload sites that lack the staff to oversee data as it is generated.
Novel nasal implant from Intersect is winner for US FDA
17-Aug-2011 By Natalie Morrison
Intersect have received the FDA seal of approval of their targeted drug delivery technology for treatment in chronic sinusitis patients.
Russia's trial approval rate drops for second consecutive quarter; more resources needed says Synergy
17-Aug-2011 By Gareth Macdonald
Russian authorities need to dedicate more resources to reviewing trial applications ahead of new site accreditation rules due to come into effect later this year according to report on the country’s contract research sector.
Encap offers feasibility package for colonic delivery technology
17-Aug-2011 By Natalie Morrison
Encap Drug Delivery now offers a ‘feasibility package’ to assess the potential of its Phoral coating technology as a vehicle for therapy in colonic diseases.
LatAm investigators prefer pharma, not CRO, run trials
17-Aug-2011 By Nick Taylor
Latin American investigators prefer pharma companies, as opposed to CROs, to handle day-to-day clinical trials operations, according to a survey.
16-Aug-2011 By Natalie Morrison
Outsourcing should play a vital role in any patient recruitment strategy, says Cutting Edge Information’s director of research Eric Bolesh.
West to expand US packaging and device R&D centre
16-Aug-2011 By Gareth Macdonald
West Pharmaceutical Services says new R&D centre will focus on elastomer formulations and process development for its packaging and delivery tech businesses.
Private equity firm in talks to buy PPD in $4bn deal; reports
16-Aug-2011 By Nick Taylor
Carlyle Group is in exclusive talks to buy PPD in a deal valuing the CRO at around $4bn (€2.8bn), according to reports.
Unilife to ramp up Unifill sales and marketing campaign
16-Aug-2011 By Gareth Macdonald
Unilife says it will ramp up sales and marketing efforts for its Unifill prefilled syringe range after securing additional funding.
Ampac posts loss as volume shortfall offsets sales gains
16-Aug-2011 By Nick Taylor
Surging anti-viral sales drove fine chemical growth at Ampac in Q3, but the unit posted a loss after missing efficiency and throughput targets.
WuXi adding clinical services to open China to clients
16-Aug-2011 By Nick Taylor
WuXi is entering the Chinese clinical trial services sector to help international clients introduce products in the high-growth country.
Multivac packaging technology allows for broader scale production
11-Aug-2011 By Natalie Morrison
Multivac is developing a new packaging solution for sterile medical products that it says will solve issues in packaging diversity and batch size, as well as speeding up line clearance.
Excipient interaction review paper gets nod from IPEC
11-Aug-2011
A new review paper warning manufacturers about the dangers of under-estimating the effects of excipients has received the thumbs up from IPEC.
FDA issues with CRO-run trial in Argentina set back Adventrx
11-Aug-2011 By Nick Taylor
Adventrx faces having to redo its pivotal bioequivalence study after the FDA raised concerns about its CRO-managed trial in Argentina.
US drives contract packaging growth at United Drug
11-Aug-2011 By Nick Taylor
Contract packaging profit at United Drug rose in its latest results as strong US sales offset weak performance in Europe.
Biopharm turning to 3PL & global suppliers for savings
11-Aug-2011 By Nick Taylor
Close to two-thirds of biopharm companies plan to increase reliance on 3PL providers and global manufacturers in coming years, a survey found.
Operating profits drop for Parexel thanks to restructuring costs
10-Aug-2011 By Natalie Morrison
Restructuring costs for Parexel have caused a dramatic drop in GAAP operating income, reveal the company’s Q4 results.
Tereos Syral to add injectable glucose to range
10-Aug-2011
Tereos Syral plans to add pyrogen-controlled glucose monohydrate production capacity to expand into pharmaceutical starch derivatives.
Akela plans CMO buys after exiting development project
10-Aug-2011 By Nick Taylor
Akela Pharma is focusing on its CMO and expanding it through acquisitions after its partner exited their drug development programme.
eClinical results round-up
10-Aug-2011 By Nick Taylor
Outsourcing-Pharma presents a round-up of eClinical quarterly results, including financials from Medidata, Perceptive Informatics, ERT and BioClinica.
Pfizer “aggressively” pursuing cost saving real-time release
10-Aug-2011 By Nick Taylor
Pfizer is “aggressively” moving toward real-time release (RTR) and believes return on investment can be realised in a year.
apceth gets the go-ahead for somatic cell line production
09-Aug-2011 By Natalie Morrison
Contract manufacturing of somatic cell line therapies is to begin at apceth after the German company received a license.
Hyaluron buy a “money pit” for AMRI, analyst warns
09-Aug-2011 By Nick Taylor
FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said.
GSK signs packaging deal in Iraq
09-Aug-2011 By Natalie Morrison
GlaxoSmithKline (GSK) has won its four-year battle to start packaging drugs in Iraq by outsourcing production to a local company.
Outsourcing brings Neovacs to cusp of Ph III partnership
09-Aug-2011 By Nick Taylor
Neovacs is looking to partner for late stage development after using its outsourced model to bring multiple products to Phase II.
AstraZeneca looks to printers for personalised medicines
09-Aug-2011 By Nick Taylor
AstraZeneca has collaborated to research a scalable system based on inkjet printing for formulating personalised medicines.
ICIG takes Roche Colorado in bid to flex contract peptide manufacturing muscle
08-Aug-2011 By Natalie Morrison
International Chemical Investors Group (ICIG) will take over Roche’s Colorado API plant in a bid to gain footing in the peptide manufacturing industry.
EC revises stability testing
08-Aug-2011 By Nick Taylor
The EC has updated stability testing guidance to cover procedures for variations, such as change in batch size, to marketing authorisations.
First-to-file race slowing QbD adoption in generics
08-Aug-2011 By Nick Taylor
Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.