Supply chain, logistics

Aseptic manufacturers must invest in latest GMP compliance, says UK CMO

11-Nov-2014 By Dan Stanton

Investing in GMP compliance regulations is key to success in sterile manufacturing says UK-based Symbiosis which is looking to capitalise on gaps left by recent CMO pullouts.

Survey finds CROs far from going paperless with TMFs

30-Oct-2014 By Zachary Brennan

Although the barriers for going paperless are relatively low for CROs, the service providers have yet to fully adopt electronic TMFs (trial master files), a new survey says.

Dispatches from BioProcess International

Shift to single-use means end users ceding more control to suppliers, experts say

22-Oct-2014 By Zachary Brennan

As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.

Do mid-size CROs have business model problems? One CEO thinks so

21-Oct-2014 By Zachary Brennan

Squeezed by the pressure of shorter deadlines and higher quality expectations, as well as by competition from larger peers, mid-size CROs may need to think more about innovation to stay ahead, a CEO of a mid-size CRO told us.

Clinical trials driving consolidation in IMP distribution and logistics industry, says PCI

20-Oct-2014 By Dan Stanton

Consolidation in the healthcare logistics industry is inevitable, says PCI as it opens a US storage and distribution facility for clinical trial materials.

news from cphi

CDMO strategic deals 'the new standard,' say Catalent and DPx, but big and small pharma demands differ

16-Oct-2014 By Dan Stanton

Strategic relationships with contract manufacturers are becoming the standard, but big and small pharma demands differ considerably according to the two largest CDMOs, DPx and Catalent.

Marken expansion into Latin America continues with Chile, Peru depots

09-Oct-2014 By Zachary Brennan

Fresh off the near completion of its depot in Sau Paulo, Brazil, Marken has now also completed the construction of another depot in Santiago, Chile, in order to more easily handle the influx of clinical trial specimens coming from South America.

Parexel acquires RTSM service provider ClinIntel

06-Oct-2014 By Zachary Brennan

CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.

Pre CPhI Special

Complex regs and unknown markets top API shippers' logistics headaches

02-Oct-2014 By Gareth Macdonald

The world is getting larger, at least it is in terms of the pharmaceutical industry, according to execs who cite security concerns when shipping to new markets as the top logistics worry.

PPD increases stake in small molecule discovery company X-Chem citing Big Pharma relationships

29-Sep-2014 By Zachary Brennan

CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company with its entire existing staff and management team. 

Injectables demand helped drive PCI's latest acquisition of Welsh packaging and logistics firm Biotec

23-Sep-2014 By Dan Stanton

PCI has bought packaging and distribution firm Biotec Services International citing demand for cold chain services from a growing injectibles market.

US gov rallies industry to join mission to Indonesia and the Phillipines

18-Sep-2014 By Dan Stanton

Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.

US FDA warns patients off all products from Texas compounding pharmacy

17-Sep-2014 By Fiona BARRY

The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.

DHL and Octapharma open cold-chain logistics centre in Germany

16-Sep-2014 By Dan Stanton

In a venture with plasma products manufacturer Octapharma, DHL has opened a €3.4m ($4.4m) cold-chain logistics centre in Germany for the pharma and life sciences industries.

Parexel adds two clinical tech companies to partner program

16-Sep-2014 By Zachary Brennan

CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program. 

Marken’s Brazilian depot to receive first shipment this month

11-Sep-2014 By Gareth Macdonald

Marken expects the first batch of trial supplies to reach its new depot in Sao Paulo, Brazil later this month.

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 By Fiona BARRY

US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.

Dispatches from the NYSE

Catalent sees growth strengthened by international softgel markets

09-Sep-2014 By Zachary Brennan

CDMO (contract development and manufacturing organization) Catalent saw Q4 revenue rise 3% and income rise 66% thanks in part to an increase in its oral technologies segment.

Biologics trials: the ‘stretched’ global supply chain

08-Sep-2014 By Fiona Barry

The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.

Patheon: Expediting supply of Ph I trial drugs can cut pharma costs

01-Sep-2014 By Dan Stanton

Patheon has sliced four weeks off its Quick-to-Clinic service saying speedier supply of materials for first in human trials increases pharma’s return on investment.

If it’s an IATA certified cold chain, this must be Belgium

28-Aug-2014 By Gareth Macdonald

Brussels airport has become the first European shipping hub to adopt a cold-chain certification programme for pharmaceutical cargo that industry group IATA claims “goes beyond” GDP requirements.

DEA approves manufacture of GHB at Patheon Cincinnati plant

26-Aug-2014 By Dan Stanton

Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

Planning essential to ensure temperature control, say logistic firms

25-Aug-2014 By Dan Stanton

Temperature fluctuations during shipping have led to costly clinical data delays and product recalls, but such problems can be avoided through supply chain pre-planning say distribution firms.

UK drug exporters shipping outside the EEA must seek MHRA approval

20-Aug-2014 By Gareth Macdonald

EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

UDG exits pre-wholesale JV; nets €70m for packaging and comms businesses

18-Aug-2014 By Dan Stanton

UDG Healthcare has sold its share in a pre-wholesale supply chain JV to partner Alliance Boots and outlined plans to invest some of the €82m ($110m) proceeds in its packaging and marketing businesses.

Almac announces Government backed recruitment drive

14-Aug-2014 By Gareth Macdonald

Northern Ireland-based contractor Almac will create 348 jobs over the next five years in its pharma and clinical services business according to UK enterprise, trade and investment Minister, Arlene Foster.

IMCD sees modest gains post IPO and plans to accelerate growth efforts

13-Aug-2014 By Staff reporter

IMCD has seen a modest increase in operating profit and revenue since going public in June according to first half results published earlier today.

Venn acquires part of French CRO for about €500k

12-Aug-2014 By Zachary Brennan

In its third acquisition in the past 10 months, European CRO (contract research organization) Venn Life Sciences has acquired Cardinal Systems, a France-based CRO specialising in data management and randomisation systems.

Marken opens clinical trials depot in trial haven of Brazil

11-Aug-2014 By Zachary Brennan

Supply chain specialist Marken announced last week the opening of their newest clinical trials depot in Sao Paulo, Brazil to help sponsors and CROs looking to conduct trials there and elsewhere.

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

11-Aug-2014 By Zachary Brennan

For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).

I’m sticking with you: McKesson and CVS JV solid for 3 more years

30-Jul-2014 By Fiona BARRY

McKesson Corporation, a healthcare services and information technology company, today announced a three-year extension to its pharmaceutical distribution agreement with CVS Caremark.

Medidata sees revenue growth in Q2 as new clients spike

30-Jul-2014 By Zachary Brennan

Cloud-based solutions provider Medidata saw its revenue increase 22% over Q2 last year to $83.2m as the company’s customer base saw steep growth.

AmerisourceBergen set to pass $100bn sales mark for FY 2014

28-Jul-2014 By Dan Stanton

AmerisourceBergen has reported “outstanding operational and financial performance” for the third quarter 2014, and is set to pass the $100bn revenue mark for the fiscal year. 

WIRB-Copernicus Group acquires biosafety consulting firm Alliance Biosciences

24-Jul-2014 By Zachary Brennan

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

Accovion continues expansions across Europe

23-Jul-2014 By Zachary Brennan

Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe. 

Biosimilar trials: the ‘under the radar’ sourcing race

23-Jul-2014 By Fiona Barry

Timescales and sourcing comparator biologics are the biggest challenges for biopharmas running biosimilars studies, says an expert.

UPDATE

Baxter Q2: Drop in demand hits CMO biz, despite overall sales growth

21-Jul-2014 By Dan Stanton

Baxter BioPharma Solutions dropped four percent year-on-year for the second quarter 2014 due to a fall in demand for contract manufacturing services.

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 By Gareth Macdonald

Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

West is East - Indian plant opens to serve Asian-Pacific customers

17-Jul-2014 By Dan Stanton

West’s new pharmaceutical packaging facility in India will reduce supply lead times for its Asia-Pacific customers, the company says.

CMO quality audits: necessary and beneficial to all, says consultant

10-Jul-2014 By Dan Stanton

A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.

US FDA to set more specific GMP regulations for outsourcing facilities

02-Jul-2014 By Zachary Brennan

Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.

Exporters rush to meet Chinese FDA serialisation requirements

26-Jun-2014 By Fiona BARRY

Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.

Big Pharma Insourcing replacing Asian suppliers as competition for western CMOs

23-Jun-2014 By Dan Stanton

Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant

Dispatches from DIA 2014

BioClinica taps risk-based monitoring with Blueprint Clinical acquisition

17-Jun-2014 By Zachary Brennan

CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address risk-based monitoring strategies for trials.

Complex manufacturing more likely kept in-house, says J&J post Ben Venue

05-Jun-2014 By Dan Stanton

Outsourcing is still a significant part of Janssen’s strategy, the firm says despite suffering shortages due to manufacturing and quality problems at now defunct CMO Ben Venue.

DHL acquires four worldwide logistics depots

03-Jun-2014 By Fiona BARRY

DHL has acquired or partnered with four GMP clinical trials supply depots in the Philippines, Egypt, Belarus and Turkey.

Adopt highest GMP/GDP standards for Asian clinical trials, says Almac

02-Jun-2014 By Dan Stanton

Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.

Hikma eyes Ben Venue's assets as part of $300m Bedford Labs acquistion

29-May-2014 By Dan Stanton

Hikma Pharmaceuticals says it is evaluating Ben Venue’s manufacturing facility as an option in its $300m (€220m) acquisition of Bedford Laboratories.

Relypsa selects DSM to manufacture API for hyperkalemia treatment

22-May-2014 By Zachary Brennan

California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...

Dispatches from the Biological Production Forum

Valeant puts head in the Cloud to manage over 800 CMOs

13-May-2014 By Dan Stanton

Managing over 800 CMOs could lead to quality and compliance nightmares but Valeant says it has come up with a unique cloud-based strategy.