LATEST NEWS
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    Payer trends dominate near-term outlook
    The IMS Health Institute for Healthcare Informatics has published a white paper, "Harbingers of Change in Healthcare: Implications for the role and use of medicines," that's worth a look. It is a little sketchy on how the 10 items were chosen (the report lists five IMS Health analysts as authors; and that's it), while noting that the list is "not intended to be exhaustive." On the other hand, the items are backed up by up-to-date market data (IMS Health's core service); for example, it notes that Medicare prescriptions for sofosburvir (Gilead Science's Sovaldi) and simeprivir (J&J's Olysio), for hepatitis C, jumped eightfold (to over 105,000 prescriptions
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    New study suspects Indian manufacturers 'differentiate drug quality according to the destination of consumption'
    A messy situation is getting messier for Indian manufacturers, in particular those producing generics for export. On Sept. 22, FDA added more drugs from Apotex' Bangalore, India, facility to ongoing "detention without physical examination" restrictions; in effect, these Apotex drugs are banned from importation. That action motivated Health Canada to do more or less the same, even though it had given Apotex an all-clear in an inspection earlier this year. "Health Canada last inspected the [Bangalore] facility in February 2014 with an international regulatory partner. The visit resulted in a compliant rating. The FDA had issued a compliant rating
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    DHL garners headlines with a 'parcelcopter' delivering daily drugs to remote North Sea island
    DHL Parcel (Bonn, Germany) has joined in the buzz generated by Amazon, and the entire unmanned aircraft movement, with a pilot (folks in this field will have to stop using that word!) program to deliver prescribed drugs to a pharmacy in Juist, an island in the North Sea. The device, flying at 18 meters/s, will make a run from the harbor in Norddeich to Juist, carrying a customized air-transport container. DHL Parcel straddles the "autonomous" aspect of this project; while insisting that the device is unpiloted, it will also have continuous monitoring from a station at Norddeich. Once the project "takes off" (DHL's phrase), vacationers and island residents can receive prescriptions several times a week, particularly "on times when such alternatives as ferries and flights are not available"
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    Regulatory compliance continues to exceed cost as a primary driver
    UPS' seventh global survey of supply chain managers in healthcare products finds a greater consensus of industry goals regarding supply chain management, but a lesser degree of actually following through on those goals. All this is occurring in a context of rapid change, driven by the desire to tap into global markets, adoption of new distribution channels, and the urgency to keep up with expanding regulatory compliance initiatives. "One of the values of this survey is the timeline it establishes for industry issues," notes John Menna, VP for healthcare strategy. "In past years, we've asked about global initiatives and found that 81% of healthcare executives planned
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    Emphasis placed on high-level security in data transfers
    A new round of IT platform development is gradually taking shape for enabling pharma manufacturers and distributors to comply with the dictates of the Drug Supply Chain Security Act (DSCSA), passed 10 months ago and specifying compliance deadlines as soon as January 1. The newest entrant is Axway (Phoenix)--a longtime player in pharma track-and-trace issues, and one with a significant installed base already among manufacturers and wholesalers. The new Axway Cloud Global Traceability and Compliance Service (let's call it Axway GTCS) joins other longtime players in this field, such as TraceLink (Woburn, MA) and rfXcel (San Ramon, CA), in providing a cloud-based system for acquiring serialization
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    Jon Giacomin replaces Kaufmann as CEO of Cardinal Pharmaceutical segment
    Following the previously announced retirement Jeffrey Henderson, Michael Kaufmann (photo), a 24-year veteran of the $91-billion/yr company, takes over as CFO. Kaufmann has been head of the Pharmaceutical segment (drug wholesaling, the predominant portion of Cardinal's business) since 2009. Kaufmann's "unique blend of financial acumen and extensive operational experience make him ideally suited to take the position of CFO," said George Barrett, chairman and CEO, in a statement
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    Vendor-managed system inventories and protects specialty pharmaceuticals in healthcare settings
    The ASD Healthcare unit of AmerisourceBergen (Frisco, TX) is a specialty distributor of oncology, nephrology and blood-derivative products for specialty pharmacies and clinics; for the past several years it has marketed a combined storage and inventory-management system called Cubixx. The Cubixx unit (see photo) is a refrigerator-sized, powered unit that employs RFID technology to track inventory, record additions and removals and provide security for the high-value products typically stored within it. Keeping the inventory under temperature-controlled (cold chain) conditions is also an important feature
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    Among the various 'metal' health plans, coverage increases as premiums go up, says HealthPocket.com
    It wouldn't be unexpected: higher-premium plans should have better coverage of more or higher-cost medical services, but it's nice to see that confirmed by a study by HealthPocket.com, a two-year-old consumer-health service that allows comparison shopping of plans. Its just-released study finds that across five commonly prescribed specialty products (Humira, Copaxone, Gleevec, Atripla, and Norditropin used to treat inflammation, multiple sclerosis, cancer, HIV, and growth deficiency respectively), out-of-pocket (OOP) costs for patients on platinum plans were 64% lower than gold plans, 74% lower than silver plans, and 78% lower
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    Airport will organize client carriers to meet new IATA standards
    The International Air Transport Assn. (Montreal) has "welcomed" the Brussels Airport "to become the first to become the first European hub for pharmaceutical freight using IATA's global certification program for shipping cold-chain pharmaceuticals," according to a statement. Over the past year, IATA, which represents the majority of air transport (passenger and cargo) capacity globally, established a certification specific to pharmaceutical transport, run by its Center of Excellence for Independent Validators (CEIV)
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    MolecularHealth's RxAssistance evaluates patient access to commercial therapeutics and clinical trials
    It sounds a little gimmicky, but there is real science and informatics behind a new service from MolecularHealth (Woodlands, TX) called RxAssistance. MolecularHealth has already commercialized TreatmentMAP, what it claims to be the largest single panel genetic test, looking for over 500 genetic markers in a patient's tumor. Until now, the physician ordering the $5,000 test would receive an "actionable" report summarizing the genetic findings, and recommending up to three treatment options, based on efficacy and
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    Meanwhile, a scramble to accelerate vaccine testing ramps up
    Direct Relief, Inc., one of a number of public health nonprofits that responds to disasters and other healthcare crises, is organizing a shipment of more than 40 tons of essential medicines and supplies to support healthcare workers trying to manage the Ebola outbreak, now affecting several countries in West Africa. The death toll has passed 1,000 (and is thought to be significantly undercounted) and the latest reports from the World Health Organisation say that it could last months. This latest shipment from Direct Relief (there has been at least one prior delivery) includes 2.3 million gloves, 65,000 masks, 92,000 gowns, and 185,000 tabs of antibiotics
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    Three times as many manufacturers expect more 3PL use as expect less; 38% see no change
    A survey conducted by Sonoco ThermoSafe, one of the leading providers of passive packaging for life sciences products, shows that industry managers place performance above cost as a container-selection qualification, are looking to increase their usage of third-party logistics (3PLs) providers, and are increasingly factoring in environmental concerns with recyclability and reuse of the containers. Preliminary results are based on 165 respondents both who were both personally interviewed and who filled out an online survey. Pharmaceutical Commerce's editor in chief, Nick Basta, was part of
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    Pharmaceutical Commerce's latest report finds continued growth in these specialized logistics services
    The 5th edition of the Biopharma Cold Chain Sourcebook analyzes economic, regulatory and technological trends in a vital part of today's industry: the shipment of temperature-controlled products. The just-published report calculates that current (2014) expenditures for commercial shipments will be $8.36 billion, rising to $10.28 billion in 2018. By comparison, last year's Sourcebook estimated the 2013 cold-chain business to be $7.5 billion, rising
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COLD CHAIN FOCUS
Family of GTS Carry Packs handles drugs that patients self-administer
 
INDUSTRY EVENTS
 
 
 
 
WHAT THEY'RE SAYING
Pharmaceutical Commerce sat down with Mr. Mortazavi recently; here's what he had to say
 
 
FEATURES
The drive for lower costs, safer products  continued >
 
True 'market access' should involve coordinated approaches to patients and their healthcare providers  continued >
 
MDM practices are moving far beyond compliance concerns  continued >
 
The eye-popping price tag on the hepatitis C drug, from Gilead Sciences, has prompted unprecedented pushback from payers  continued >
 
 
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SPECIAL FOCUS REPORT
2014 Cold Chain Directory
 
Our annual compilation of key vendors and service providers in this vital component of pharmaceutical distribution, together with a preview of the IQPC Cold Chain Forum and more late-breaking news
 
CLINICAL OPERATIONS
 
 
 
   
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