Meanwhile, competitor CSafe Global broadens its containers' usability
    The active-powered unit-load device (ULD) for shipping temperature-controlled products was pioneered by Envirotainer (Upplands Vasby, Sweden) years ago, but its use by air carriers has been limited to flights originating outside the US because it lacked FAA approval. Now, the company has been granted FAA approval for its RKN unit, putting it in direct competition with CSafe Global (Dayton, OH), whose RKN unit has been approved by both FAA and the European Aviation Safety Agency. The wider use of the Envirotainer ULD won't be immediate; the company says that a technical-acceptance process
    Deloitte veteran is a board director of the company
    Deloitte LLP (New York) has announced the appointment of Homi Kapadia, a 28-year veteran at the company, as leader of its life sciences industry practice, which employs nearly 4,000 professionals serving biopharma, med device and consumer health industries in the US. He takes over from Terry Hisey, principal, Deloitte Consulting LLP, who has transitioned to a top client-service position for the practice, according to a company statement. Kapadia will guide the practice to deliver a "cross sector" viewpoint to clients in light of their growing interdependency on other sectors as the health system converges around population health and value-based incentives
    European consumers will eventually have a pan-European method of checking pharmacy legitimacy
    Following through on one element of its comprehensive Falsified Medicinal Products Directive (2011/62/EU), the European Commission has selected a logo design that will appear on online-pharmacy websites and other retailers, starting roughly a year from now. The logo (pictured) is a stripe with a cross appearing in outline; the box in the middle left of the logo will have the flag of the EU country where the pharmacy is established. Behind the logo--still to be finalized
    San Francisco bounces back as No. 2; NJ/NYC/Westchester moves up to No. 5
    One of the highlights of the BIO international convention each year is the release of a report from JLL, the international commercial real-estate management and consulting firm, of its ranking of life sciences "clusters"--regions where life sciences companies tend to concentrate. Life sciences (biopharma, medical devices and crop science--the latter in keeping with the BIO organization's interests there) have been a preeminent attractor of state and regional economic development funds, in part because the lively venture-capital investing (especially of late) takes small labs to big manufacturing/research organizations with high-paying jobs
    CRM, master-data and related businesses will be purchased for $520 million
    IMS Health, which has been fairly active over the past year in acquisitions, leading to its IPO in April, has announced the acquisition of parts of Cegedim, the Paris-based IT and healthcare-data company. "Cegedim's complementary offerings will accelerate the build-out of our strategic roadmap in information and technology services," said Ari Bousbib, chairman and CEO of IMS. "The global combination of product, technology, infrastructure and people capabilities will bring compelling, integrated solutions to our clients and allow for greater operational efficiency." The $520-million deal is expected to close in early 2015. Bousbib focused on two assets
    Agency okays correcting misinformation on third-party sites; sticks to the general principle of balanced information
    Ever so slowly, FDA's Office of Prescription Drug Promotion (OPDP) has been issuing a series of guidances for pharma marketers in dealing with new media in promoting their products. The new guidances address "correcting independent third-party misinformation" and "social media platforms with character space limitations" (i.e., Twitter, and paid search placements on search engines). These and prior guidances trace back to a 2009 meeting that FDA held to air out online-advertising and social-media issues; since then, the industry
    DaVita Rx offers enhanced adherence services, touts better outcomes for patients
    While specialty pharmacies are transforming prescription delivery to certain patients, another category of pharmacy that might be called "special services pharmacy" is emerging. One such example is DaVita Rx, which has just announced the delivery of its 15th million prescription to, mostly, renal disease patients, including those making use of DaVita's network of dialysis centers nationwide. The primarily mail-order pharmacy (it has three locations, in California, Texas and Florida) seeks to provide all prescriptions (not just those for kidney disease) to patients, and handles approximately 80,000
    Organization hires BSI Supply Chain Solutions to lead international joint audit program
    Rx-360, the industry consortium formed in the aftermath of the heparin scandal in 2008 (in which contaminated, raw heparin sourced from China entered finished products and caused multiple deaths in the US and Europe), chose the PDA/FDA Supply Chain Conference (Washington, DC; June 3-5) to celebrate its fifth birthday. While the organization's original goal--to both accelerate the auditing of suppliers to pharma manufacturers and reduce audit cost and complexity by pooling audit results--remains a driving force, the organization has expanded its scope by generating recommended guidances on many
    In the big swing to specialty pharmaceuticals and distribution, some manufacturers are looking for 'good enough' services
    Specialty pharmaceuticals, specialty distribution and specialty pharmacies are all the rage in the US biopharma industry today; the generally accepted notion is that specialties will represent half of industry revenue by the end of the decade, if not sooner. But in discussions with pharma clients and their distributors and service providers, a new twist to this is emerging, which might be called Alternative Specialty Lite or just Specialty Lite, according to Rob Brown, VP, business development at Omnicare Specialty Care Group (Cincinnati), which is one of the companies in the specialty-
    Physicians Sunshine Act, agg spend and OIG actions join PDMA Alliance's traditional focus on sample accountability
    The 2014 PDMA Sharing Conference, now in its 23rd year, will be held in Leesburg, VA on Sept. 14-17. This year's theme is "PDMA, Sunshine Act, OIG and Beyond;" as the nonprofit, industry-led organization's web page notes, "Today, pharmaceutical and medical device manufacturers are being challenged further"--beyond the sample-accountability requirements that led to the founding of the organization in early 1990s. Indeed, if all goes according to schedule, Health and Human Services will be releasing public information on pharmas', med devices' and others' spending on physicians just a couple weeks after the meeting--and the ripple effect that will have on healthcare businesses is looming large.
    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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Closer tracking of small-parcel shipments helps meet regulatory requirements
Pharmaceutical Commerce sat down with Angela Miccoli, president of Cegedin Relationship Management NA, to talk about sales force automation, customer relationship management and multichannel marketing. Here’s what she had to say.
The eye-popping price tag on the hepatitis C drug, from Gilead Sciences, has prompted unprecedented pushback from payers  continued >
How to prepare for reporting and utilizing published data for business and compliance purposes  continued >
Setting a foundation for long-term success: How the pharmaceutical industry can transform Big Data into actionable insight  continued >
Global industry will spend $8.36 billion on cold chain logistics this year  continued >
A rising flow of new, expensive therapies is transforming relationships among payers and providers. Manufacturers will have to react nimbly to the changes  continued >
US pharma layoffs do not reflect the industry's health
The perverse fascination that the business press has with pharma layoffs masks the industry's underlying strength
Veeva survey finds wide disparities among trial operators and sites in managing clinical data
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