LATEST NEWS
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    'Average Manufacturer Price' is now a mostly settled matter
    The blizzard that inundated Washington a week ago was not the only source of business paralysis: there was also the final Average Manufacturer Price (AMP) rule issued by CMS, which is targeted primarily at how drugs reimbursed under Medicaid are to be calculated, but which will have broader implications for state programs, other public health programs and some aspects of commercial insurance reimbursements. It's a big deal--federal and state spending on Medicaid drugs was $45 billion in 2014--and one that has been years in coming. However, unlike other federal-agency pronouncements that cause near-immediate reaction
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    Agency plans new guidance in traceability, REMS and biosimilarity, among others
    Just before the snows shut down Washington last weekend, FDA issued its annual list of intended guidance documents across the range of regulatory functions it oversees. Some of these come about through legislation; some are agency-generated when a gap in FDA policies is realized. The agency strives to meet its schedule--under transparency recommendations from former Administrator Margaret Hamburg--but the deadlines get missed, and the guidances that are issued are sometimes not quite what was expected. Guidances are not "law;" but FDA promulgates these documents with the expectation that
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    Sonoco ThermoSafe's device provides 120 hours of on-spec performance
    Sonoco ThermoSafe (Arlington Hts, IL) is offering a container, the Quarter PMC unit, with several innovations that cross the boundaries between the single-use and metal containers. ("Quarter PMC" is an air-transport term referring to the "LD7" spacing in a widebody aircraft for cargo; four quarter PMCs fit in the space of one LD7 container.) The quarter-PMC size allows for one European-sized pallet. The unit has composite walls engineered with interlocking "L" shapes to reduce edge leaks, and a so-called "universal" packout design, such that the same unit can be used in winter or summer, while generally achieving 120 hours of transit time at a minimum within either 2-8
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    Deal value soared above $300 billion in 2015, but will the dealmaking sustain Big Pharma companies?
    EY's annual Firepower report evaluates both the financial resources available to select pharma companies for M&As, and the future financial position of those companies, given their product portfolios. The result, EY hopes, is a quantitative perspective on how big pharma, big biotech and small specialty companies should position themselves for future growth. In 2015, the dealmaking volume soared above $300 billion, led by the proposed Pfizer-Allergan merger. The combination of Big Pharma's many acquisitions during the year (thus taking on debt and burdening stock prices) caused that sector's Firepower Index to decline by 6%
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    Controlled environment protects cold chain shipments in transit
    To accommodate its growing capacity for temperature-controlled air freight, United Cargo (Chicago) has opened a temperature-controlled storage facility at Newark Liberty International Airport. The facility has room for up to 48 RKN units (metal-walled, powered pallet containers), with electrical connections to power the RKN batteries. Temperature is kept at a steady 15-25C, the usual range for storing controlled room-temperature (CRT) products. Freight forwarders or pharma manufacturers can deliver product to the facility; it also serves as temporary storage for RKN units transiting from one aircraft t
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    HDMA's 2015-16 Factbook updates member financial, operational performance
    Late last year HDMA published its annual Factbook, a compilation of HDMA member survey data as well as relevant industry statistics. Given that 91.4% of US pharma products flow through these wholesale/distribution companies (up from 90.1% in 2013), even pharma executives not directly involved in distribution have important lessons in the Factbook data. For 2014 (the date of most of the financial and operational data; some survey data was collected for 2015), HDMA members were handling more product lines (average number of SKUs: 47,024, up 8.5% from 2013). By 2015
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    List includes 21 new orphan drugs, and of the 45, 15 are cold chain products
    It's a great way to start the New Year: FDA's Center for Drug Evaluation and Research (CDER) reports 45 "novel new drugs" were approved in 2015, up from 2014's 41, and representing a new high not seen since the mid-1990s. The drug-approvals count is fraught with conflicting perspectives: some feel that FDA puts too many obstacles n front of approvals; and some are concerned that the more streamlined orphan-drug pathway is being abused. Nevertheless, FDA uses the occasion for some chest-thumping: nearly two-thirds of the approvals (29 of the 45) were first-in-the-world
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    While FDA tries to referee the naming conventions for biosimilars, different factions of the healthcare system weigh in with conflicting priorities
    This past week, New Jersey joined a growing list of states that have codified rules on how pharmacists can substitute a biosimilar for the original, branded biologic; in general, the rules specify that when a substitution (for an "interchangeable" product--more about that later) has been made, the pharmacist needs to report that back to the prescribing physician; and physicians can forbid a substitution by writing "dispense as written" or other language to that effect. This action follows two other biosimilar-prescribing practices
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COLD CHAIN FOCUS
While temperature-controlled components advance, service providers are identifying innovative refinements to basic shipping services
 
INDUSTRY EVENTS
 
 
 
 
WHAT THEY'RE SAYING
Pharmaceutical Commerce sat down recently with Bill Roth, founder and president of Blue Fin Group. Here's what he had to say.
 
 
FEATURES
Good growth is occurring in the vaccine business, despite the hurdles of public perceptions and public-health funding shortfalls  continued >
 
A 'performance curve' chart for containers could simplify the design process  continued >
 
Observational research-evaluating outcomes in patients in a naturalistic rather than an experimental setting-has the potential to answer many research questions  continued >
 
Even with legislative incentives, pharma manufacturers struggle to cost-justify pediatric innovation  continued >
 
European experience to date indicates a changing perspective on biosimilar pricing  continued >
 
 
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SPECIAL FOCUS REPORT
Cold Chain 2015 Directory
 
 
CLINICAL OPERATIONS
Facility manages clinical trial supply, storage, packaging and distribution 
 
 
 
   
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