Supply chain, logistics

CMOs earn €8.4m in EU grants to help scale-up manufacturing of thermo-stable vaccines

20-Apr-2015 By Zachary Brennan

A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.

CRO CTI Clinical expands use of Medidata's cloud-based tools

15-Apr-2015 By Zachary Brennan

Full-service CRO (contract research organization) CTI Clinical Trial and Consulting Services is expanding its use of Medidata’s Clinical Cloud platform to improve operational efficiencies, data accessibility and decision-making processes for its clinical...

Dispatches from BPI 2015

Pfizer's vetting process sorts the strategic CMOs from the casual flings

15-Apr-2015 By Dan Stanton

Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.

Slow study start-ups tied to local IRB use, expert says

31-Mar-2015 By Zachary Brennan

As CROs (contract research organizations) and sponsors look to shave off time from their clinical trial start-up phase, which is where delays occur most frequently, companies may want to look away from local IRBs (institutional review boards), an expert...

Parexel audit reports come under scrutiny thanks to Ranbaxy’s FDA lawsuit

25-Mar-2015 By Zachary Brennan

Parexel’s audits of Ranbaxy’s deficient manufacturing operations in India were of specific interest to the FDA, though the CRO did not turn over the reports because of concerns that their release might damage the confidentiality of the company’s audit...

BioClinica looks to service more CROs with new RTP office

24-Mar-2015 By Zachary Brennan

Service provider BioClinica will open a Research Triangle Park (RTP) office in North Carolina in response to a rapidly expanding customer base of study sponsors and CROs (contract research organizations) with which it has strategic partnerships.   

Clinical Ink merges with CentrosHealth to create new trial tech platform

20-Mar-2015 By Zachary Brennan

eSource solution provider Clinical Ink is merging with CentrosHealth, a provider of mobile apps for clinical trial patient engagement and electronic patient reported outcomes (ePRO). 

Sanofi signs CRO Evotec to €250m, five-year research partnership

20-Mar-2015 By Zachary Brennan

The strategic partnership comes with Sanofi providing €250m to Evotec, including €40m upfront, as part of efforts to discover new drug candidates, including in the area of oncology, and specifically at Sanofi’s R&D site in Toulouse, France.

Sigma-Aldrich lands exclusive distribution deal with Roche

19-Mar-2015 By Zachary Brennan

Sigma-Aldrich has signed an exclusive agreement with Roche to distribute its biochemical reagents product portfolio via Sigma’s eCommerce and supply chain capabilities. The companies did not disclose any of the financial details of the deal.

Rise in outsourcing to lead to further CMO consolidation, DPx CEO says

18-Mar-2015 By Zachary Brennan

The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.

Distributing donated drugs a major challenge says UK neglected diseases group

13-Mar-2015 By Gareth Macdonald

More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).

EUCROF calls on EMA not to publish CRO inspection reports as part of transparency efforts

11-Mar-2015 By Zachary Brennan

The European CRO (contract research organization) Federation is calling on the EMA (European Medicines Agency) to not allow for the “unrestricted publication of inspection reports” as only “findings that are of relevance to the public should be made publicly...

CDMO Rottendorf signs five new projects with top biopharma companies

06-Mar-2015 By Zachary Brennan

Chicago-based Rottendorf Pharmaceuticals, a top 20 contract development and manufacturing organization (CDMO), has signed three formulation development projects and two commercial transfer projects with multiple top pharma and biotech companies in the...

Patheon: Irix deal about US and Canadian customer demand for local APIs; all staff to be retained

05-Mar-2015 By Gareth Macdonald

Irix Pharmaceuticals will cater for North American customers’ desire for local supply according to Patheon, which says it plans to retain the API firm’s 180 staff.

Apax's proposed Azelis takeover backed by unions

25-Feb-2015 By Gareth Macdonald

Apax Partners says workers' unions have backed its plan to buy a controlling stake in chemical distributor Azelis from fellow private equity firm 3i.

LabCorp to operate under two segments following $5.7bn Covance merger

24-Feb-2015 By Zachary Brennan

The integration of Covance and LabCorp is beginning with the announcement that LabCorp will operate under two distinct segments: LabCorp Diagnostics and Covance Drug Development, LabCorp CEO Dave King said in a conference call last week.

Parexel expands its clinical trial site network to speed drug development

19-Feb-2015 By Zachary Brennan

CRO Parexel on Wednesday announced the expansion of its clinical trial site alliance network, which includes investigator sites and Site Management Organizations (SMOs) that help the company quickly access and enroll patient populations for clients’ clinical...

Penn is mightily pleased with safety record

10-Feb-2015 By Gareth Macdonald

Banishing kettles, 'Gemba walks' and encouraging employees to report near misses have helped Penn Pharma to remain accident free at its high potency compound manufacturing facility in Wales.

Cambrex: ‘Either we invest now or turn away API business”

09-Feb-2015 By Dan Stanton

Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.

Think you’re on track for 2018 EU serialisation? No you’re not

04-Feb-2015 By Fiona BARRY

Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.

CRO genae acquires e-novex EDC technology

04-Feb-2015 By Zachary Brennan

Belgian medical device CRO genae associates has acquired e-novex, a provider of electronic data tools for medical research.

Icon, PPD expand further into Ireland with more jobs, warehousing space

30-Jan-2015 By Zachary Brennan

While Icon is adding 200 new jobs at a new innovation center in Ireland, PPD is looking to double its packaging warehousing capabilities and quadruple its distribution services on the island.

HCV drugs Sovaldi and Olysio boost Q1 sales for AmeriSourceBergen

29-Jan-2015 By Dan Stanton

New hepatitis C drugs produced by Gilead, Janssen and AbbVie contributed to a first quarter spike in revenue for AmeriSourceBergen’s Pharmaceutical Distribution business.

Supply chain delays expected as Juno hits Northeast US

28-Jan-2015 By Dan Stanton

US Pharma firms are prepared for delays in the supply chain caused by Winter Storm Juno thanks to advanced planning and backup generators, says a logistics expert.

Catalent to offer integrated services in Germany through softgel expansion

27-Jan-2015 By Dan Stanton

A coating and packaging expansion at a facility in Germany will feed the demand for end-to-end softgel services, Catalent Pharma Solutions says.

PCI company expands temp-controlled trial supply services

23-Jan-2015 By Fiona BARRY

Biotec Services International, daughter company of clinical trial suppliers Packaging Coordinators Inc (PCI), has expanded its cold-chain storage and distribution capacity in response to client demand for a “one-stop shop”.

One-stop-shop CMOs could fall into pharma's over-capacity curse, say experts

16-Jan-2015 By Dan Stanton

CMO consolidation is resurrecting the ‘all-under-one-roof’ manufacturing model, but will firms fall into the same inefficiency pitfalls that drove pharma to outsource in the first place?

Ocean rises for drug transportation due to cost and cold chain concerns

15-Jan-2015 By Dan Stanton

AstraZeneca and Baxter are opting to transport pharmaceuticals by ocean and land routes as costs and cold chain security drive a drop in air freight.

AMRI to develop and manufacture parenteral generics for Genovi

13-Jan-2015 By Dan Stanton

AMRI has won a contract to develop and manufacture five parenteral generic products for Genovi Pharmaceuticals.

CROs plan to increase use of ePRO tech

13-Jan-2015 By Zachary Brennan

CROs, as well as sponsors, are receptive to, and plan to increase their use of ePRO (electronic patient reported outcomes), according to a survey published Monday from the Tufts Center for the Study of Drug Development.

US FDA lifts import alert at Hospira device plant in Costa Rica

09-Jan-2015 By Dan Stanton

Hospira will resume the sale of infusion pumps from its troubled Costa Rica facility following the lifting of a US FDA import alert.

People on the Move

Who's going places at CROs and services companies?

08-Jan-2015 By Fiona Barry

Outsourcing-Pharma.com's weekly round-up of senior changes in the contract and services world.

WuXi offers new mobile app for organic compound synthesis requests

08-Jan-2015 By Zachary Brennan

Chinese CRO WuXi PharmaTech has launched WuXi V-Lab, a mobile app to help researchers and chemists in need of small-molecule compound synthesis. 

Shareholder nod for Medtronic and Covidien's $43bn 'strategic' merger

07-Jan-2015 By Dan Stanton

The $43bn (€36bn) megamerger between Medtronic and Covidien is one step closer after shareholders voted to approval the deal yesterday.

Synchrogenix acquires AI-assisted medical writing company ClinGenuity

07-Jan-2015 By Zachary Brennan

Certara subsidiary and regulatory and medical consultancy Synchrogenix has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Terms of deal were not disclosed.

Symbiosis looks to US as pipelines and CMO exits drive injectables demand

05-Jan-2015 By Dan Stanton

Injectable-heavy drug pipelines and increased biotech funding are driving up US demand for sterile manufacturing, according to UK-based Symbiosis, which is looking to help fill the gap left by several high-profile exits from the space.

IAG Cargo receives EU GDP accreditation... and Igs might fly!

19-Dec-2014 By Dan Stanton

British Airways and Iberia’s cargo division IAG has become the first airline to be awarded accreditation under new EU Good Distribution Practices (GDP) guidelines.

AstraZeneca will outsource Crestor API following UK plant closure

19-Dec-2014 By Dan Stanton

The closure of an API plant in the UK will lead to opportunities for third party manufacturers, AstraZeneca has said.

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 By Dan Stanton

The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

Peregrine expanding own CMO to make mAb candidate rather than outsource

11-Dec-2014 By Dan Stanton

Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.

USFDA issues track and trace draft guidance for third-party logistic firms

11-Dec-2014 By Dan Stanton

Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.

Meda cuts Recipharm contract: Swedish plant and jobs under threat

04-Dec-2014 By Dan Stanton

Meda has terminated a manufacturing contract with Recipharm which says a facility in Sweden and up to 60 jobs could be at threat.

Track and trace regulation will drive outsourcing, says investment firm

02-Dec-2014 By Dan Stanton

The implementation of track and trace will drive the outsourcing of drug packaging and UDG Healthcare is well-placed to benefit, according to a UK broking firm. 

CMO use to grow despite Big Biopharma's in-house spend, say experts

02-Dec-2014 By Dan Stanton

Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”

Mylan in tech transfer to make Gilead's HIV drugs for developing world

01-Dec-2014 By Dan Stanton

Mylan will manufacture and distribute Gilead's antiretroviral HIV drugs, following a tech transfer, in order to increase access in developing countries.

Recipharm adds French plant and drug delivery tech in strategic deal with Flamel

27-Nov-2014 By Dan Stanton

Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies. 

German CMO looks to grow US biz through rise in SMEs and virtual pharma

24-Nov-2014 By Dan Stanton

Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.

Parexel makes strategic moves in EU, South America

13-Nov-2014 By Zachary Brennan

CRO Parexel is opening a new European Coordination Hub and Distribution Center in Berlin-Schönefeld, Germany, as well as new full-service clinical trial supply depots in Buenos Aires, Argentina, and São Paulo, Brazil.

Sanofi wearable injectable supply deal could net Unilife over $1bn per year

12-Nov-2014 By Dan Stanton

Unilife says its 15 year-wearable injector supply deal with Sanofi is “unprecendented” and could result in over $1bn of sales annually for the delivery device maker. 

ERT moves into trial management software with eClinical Insights acquisition

11-Nov-2014 By Zachary Brennan

Patient safety and efficacy endpoint data collector ERT has acquired eClinical Insights (eCI), a provider of cloud-based clinical trials management software, for an undisclosed sum.