Category Archives: drug manufacturers

Breaking News: CVS Caremark and Cardinal Health Form Generic Drug Sourcing Entity

CVS Caremark (NYSE: CVS) and Cardinal Health (NYSE: CAH) today announced the signing of an agreement to form the largest generic sourcing entity in the U.S., which is the world’s largest generic drug market. Both companies are contributing their sourcing and supply chain expertise to this 50/50 joint venture and are committing to source generic drugs through it. The companies separately announced a three-year extension through June 2019 of Cardinal Health’s existing pharmaceutical distribution agreements with CVS Caremark. The U.S.-based joint venture is expected to be operational as soon as July 1, 2014, and will have an initial term of 10 years. Under this arrangement, [...]

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Logistics –The Other Half of the Healthcare Supply Chain Management Equation

A new white paper commissioned by Exel, a  North American leader in contract logistics, and its sister company DHL Supply Chain, argues that global life sciences and healthcare (LSH) companies must reevaluate and revolutionize their approach to supply chain management in order to survive the challenges threatening major disruption to the industry. Frankly, I think the point is understated when talking about the provider side of healthcare, where supply chains are already extending and reform isn’t “threatening” disruption, but causing it. In the good old days, provider supply chains were far more vertical and easier to manage –at worse organized around a product/at best organized [...]

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Biosimilars: Implications For Health System Pharmacists

Health systems professionals should prepare now for the introduction of biosimilars, a new category of pharmaceuticals intended to offer lower cost alternatives for some of the most expensive medications purchased by health care organizations.  This insight comes from newly published research co-authored by Novation, one of the nation’s largest GPOs. The primer, “Biosimilars: Implications for health-system pharmacists,” appears in the Nov. 15 issue of the American Journal of Health-System Pharmacy (AJHP).  The peer-reviewed article provides an update on the scientific, regulatory, and clinical practice considerations that are continuing to shape the developing market of biosimilars in the United States. Unlike generic small molecules, biosimilars represent a [...]

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JNJ’s Last Two Weeks: $5 Billion in Settlements and Stock Hits 52 Week High!

Late yesterday, Johnson & Johnson (JNJ) announced that it reached a multi-billion dollar settlement for victims of the company’s flawed all metal hip implant –the ASR XL metal hip implant system by JNJ’s DePuy Orthopedics Division. This $2.4 billion settlement comes just two weeks after another $2.2 billion settlement reached with the Department of Justice (DOJ) over alleged kickbacks and off label marketing schemes related to the company’s psychiatric drug Risperdal. And yes, JNJ’s stock price is up, as always seems to be the case when these issues settle, trading at its 52 week high. In a rare display of understatement [...]

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FDA Taking Back Seat to European Medicines Agency (EMA)?

The FDA continues to make news. Just yesterday, the US Congress passed a bill that increased the FDA’s regulatory powers over the US compounding pharmacy industry (in response to the NECC meningitis disaster of a year ago). While the new bill, entitled the “Drug Quality and Security Act,” is generally viewed as a step in the right direction, the phrase “tastes great less filling” seems to describe the way most industry stakeholders perceive it. It seems the FDA either doesn’t do enough or goes way overboard. Indeed today, one of GlobalData’s senior healthcare analysts made news amplifying what has become [...]

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NECC Disaster Spawns the Drug Quality and Security Act

Late yesterday, Congress passed the Drug Quality and Security Act. The bi-partisan bill was passed unanimously, as Congressional lawmakers did not want to be seen on the wrong side of the circumstances that led to the deadly meningitis outbreak that killed 64 people about a year ago (a.k.a. -the “New England Compounding Center (NECC) disaster”). The bill is designed to reel-in the largest compounders –the mass producers– not the companies that mix medicines for individual patients based on a prescription order or may produce limited quantities, again based on a prescription. However, the bill actually falls short of forcing these [...]

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JNJ Settles Risperdal False Claims Act Violations –Whistleblowers Get Record Pay Day

Johnson & Johnson (NYSE: JNJ) and its subsidiaries, Janssen Pharmaceuticals, Inc. and Scios Inc., will pay $2.2 billion –another healthcare record– to settle charges involving False Claims Act violations and  kick-backs paid to doctors to promote and prescribe the drug Risperdal. Risperdal was approved by the FDA to treat schizophrenia, but it was also aggressively and apparently, illegally marketed to doctors and nursing homes as a treatment for elderly patients with dementia and other serious mental illnesses. According to AG Eric Holder, “although consultant pharmacists (paid by JNJ) purported to provide ‘independent’ recommendations based on their clinical judgment, J&J viewed the pharmacists as [...]

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Drug Discovery and Repurposing: NuMedii and Thomson Reuters Announce Big Data Partnership

The IP & Science business of Thomson Reuters today announced a strategic initiative with NuMedii, a biotech company dedicated to changing the game in drug discovery. The partnership, which pairs NuMedii’s technology with the drug and disease information and systems biology expertise of Thomson Reuters, will create a repository of content and methodologies to identify new applications for existing drug compounds. NuMedii will use Thomson Reuters MetaCore and Integrity content, as well as Thomson Reuters Life Sciences Professional Services expertise to find FDA-approved drugs or discontinued development compounds that are appropriate for repurposing. “NuMedii is blending various innovative technologies and life science data to create a next [...]

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Drug Shortages –A Manufactured Problem or a Manufacturing Problem?

Not too long ago, I did a post about Physicians Against Drug Shortages (PADS), a relatively new group organized to blame GPOs for drug shortages. I put it that way because these docs just don’t like GPOs. In fact, they are calling for the federal government to repeal the industry’s anti-kickback safe harbor provision. “We are convinced that the anticompetitive contracting and pricing practices, kickbacks and self-dealing of hospital GPOs are the root cause of this public health emergency,” said anesthesiologist Robert A. Campbell, MD, co-chair of PADS. “We’re launching a national campaign to build public awareness of these anticompetitive [...]

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Securing the US Pharmaceutical Supply Chain: Pharmacy Association Wants to Close Regulatory Loopholes

In a white paper released yesterday, the National Association of Boards of Pharmacy (NABP) stressed that closing several remaining and vulnerable regulatory gaps is paramount in preventing counterfeit or diverted drugs from infiltrating the US prescription drug supply chain. In “Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply,” NABP points to the roles of unscrupulous wholesalers in distributing counterfeit drugs and unapproved foreign-sourced drugs that have endangered US patients. To help safeguard the distribution chain, NABP has implemented updated criteria for the Association’s Verified-Accredited Wholesale Distributors (VAWD) accreditation program, including revised criteria allowing virtual wholesale distributors to qualify for VAWD. Further, the [...]

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Definition of “Purpose-Built Company” Evolving –Water Street Healthcare Partners Provides Smart Money Example

Investment bankers seem to be getting smarter, especially those focused on the seed capital needs of early stage companies. No longer content to hit .05 (one in twenty), you’re starting to hear the phrase “purpose-built” bandied about. What is a purpose-built company? The traditional definition talks about the decided advantage and enduring success that companies who remain true to their core values and purpose tend to have over those that don’t. Naturally, these companies learn how to adapt their strategies and tactics to a changing world, but they don’t abandon their core purpose and the values that got them there [...]

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Johnson & Johnson Fined in China For “Monopolistic Practices”

Apparently, even the largest monopoly in the world has its limits. China continues to prosecute foreign companies for “monopolistic practices” –which has become a catch phrase for most any multi-national business activity that exceeds the thresholds of the Foreign Corrupt Business Practices Act (FCBPA). Johnson & Johnson (JNJ) has become the latest foreign company to be accused of misconduct in China. A ruling by a Shanghai court ordered JNJ to pay $85,000 to a local distributor for violating its anti-monopoly laws. Specifically, two subsidiaries of the company were accused of setting a minimum price for the sale of surgical instruments. [...]

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Blame Gamers Now Targeting GPOs for Injectible Drug Shortages

Physicians Against Drug Shortages (PADS) is a relatively new group that has organized to blame GPOs for drug shortages. I’m putting it that way because being against drug shortages –by no means a controversial stance– seems secondary to this group’s raison d’etre. Apparently, these docs just don’t like GPOs. In fact, they are calling for the federal government to repeal the industry’s anti-kickback safe harbor provision. There is nothing new about the rhetoric. “We are convinced that the anticompetitive contracting and pricing practices, kickbacks and self-dealing of hospital GPOs are the root cause of this public health emergency,” said anesthesiologist [...]

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IMS Study Says $200 Billion in Healthcare Costs “Avoidable”

According to a new study released today the IMS Institute, nearly 8% of the nation’s (U.S.) total annual healthcare expenditures are avoidable. Specifically, more than $200 billion could be saved each year if just medicines were prescribed and used more responsibly by patients and healthcare professionals. The report – Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly – examines six areas that contribute to unnecessary costs: medication nonadherence, delayed evidence-based treatment practice, misuse of antibiotics, medication errors, suboptimal use of generics and mismanaged polypharmacy in older adults. Together, these areas lead to unnecessary utilization [...]

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US Pharma Spending Declines for First Time in 60 years

Despite the fact that overall healthcare spending (direct and indirect costs, revenues), are at all time highs, U.S. spending on pharmaceuticals is reaching an all time low –if you are willing to count the last 60 years an adequate measuring stick. It’s simple: the market’s acceptance of widely used, inexpensive, generic substitutes has succeeded in driving the decline. And the generic manufacturing industries’ adept maneuvering –when a big drug hits its patent cliff— is darn near optimized.  Not only do employers and insurers “get it,” but according to lots of related survey data, consumers understand the drill too. “The largest [...]

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Just in Time for Mother’s Day: New FDA Warnings for Moms-to-be

The FDA is now warning doctors and putting out the message to women of child-bearing age that half-a-dozen medications commonly prescribed to treat migraine headaches have been found to decrease a child’s intelligence, if taken while their mothers are pregnant. In fact, just yesterday, the FDA said that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches. These drugs all contain the ingredient valproate sodium which already carries a boxed warning about the risk of birth defects. But the FDA said that it is now adding this new warning based [...]

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