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Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club...While regulators warn of the risk of buying drugs online, the Amsterdam-based Social Medwork sees its network of trusted suppliers as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis...Now it is looking to raise its profile and expand, by signing up former EU Commissioner Neelie Kroes to its supervisory board and securing 1.5 million euros ($1.73 million) in new funding from the Social Impact Ventures capital fund...patients who cannot get the drugs they want through local healthcare systems are using the organization to self-import medicines from abroad...

AmerisourceBergen Corp...will pay $625 million to resolve civil fraud charges over the sale of syringes containing drugs for cancer patients, double billing, and providing kickbacks to doctors...The settlement...boosts AmerisourceBergen’s total payout to $885 million over its repackaging and distribution of pre-filled syringes that were not approved by the Food and Drug Administration...AmerisourceBergen admitted that from January 2001 to January 2014, its Medical Initiatives Inc pharmacy unit in Alabama shipped millions of syringes for patients undergoing chemotherapy that contained drugs prepared in an unsterile environment...Authorities said AmerisourceBergen would harvest “overfill” from the original vials of such drugs as Aloxi, Anzemet, Kytril and generic Kytril, Neupogen and Procrit...That enabled the company to create more doses than it bought, and generate at least $99.6 million of extra profit...

A judge from the 21st Federalist Court of Brasilia has ruled to invalidate US biopharma company Gilead’s exclusivity patent for Sovaldi (sofosbuvir)...Hepatitis C is a major public health issue in Brazil; it has been estimated by Brazilian academics that 1.5 million people in the country were chronically infected with the virus in 2014...A centre-left, environmentalist presidential candidate for the upcoming election, Marina Silva, filed a popular action analysis complaint to the court arguing that Gilead’s patent for Sovaldi should be overturned in order to reduce costs for patients...The patent was granted in 2015 by the National Institute of Industrial Property...Silva and her running mate Eduardo Jorge claim the INPI made the decision without the consent of the National Agency of Sanitary Surveillance, meaning Brazil’s national interest was not adequately recognised in the decision...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

CEOs from more than 700 hospitals sent a letter to congressional leaders...calling on them to protect the 340B drug discount program, among them Banner Desert Medical Center...The 340B program requires drugmakers to provide discounted drugs to hospitals, health centers, and other healthcare providers that serve disproportionate numbers of low-income and rural patients...But the program has been under increased scrutiny after enjoying years of bipartisan popularity, including three expansions in Congress. Critics argue that hospitals are taking advantage of the discounts to line their wallets and are snapping up oncology providers to boost the number of pricey specialty drugs they can prescribe under the program...the letter said the group is concerned cuts to the 340B program would increase the prices of need and existing drugs...In our larger disproportionate share hospitals, the program enables us to provide a wider range of comprehensive services to people who are uninsured and traditionally underserved—services that would need to be scaled back along with any 340B reductions...For our more rural critical access hospitals, cuts to 340B would threaten the only places for people in the communities to get their care in the first place...

The Food and Drug Administration last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors..."Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently,"...For small volume parenteral drugs and biologics, FDA recommends that strength per total volume be the primary and most prominent expression of strength, followed by strength per milliliter enclosed by parentheses...two recent MedWatch reports cited medication errors that led to patients overdosing on compounded injectables that featured strength per milliliter more prominently on the labels than the strength per total volume...Such mix-ups could be avoided...if compounders were to follow the same labeling conventions as traditional drugmakers, though FDA does not review the labels of compounded drugs before they are sold.

American James Allison and Japanese Tasuku Honjo won the 2018 Nobel Prize for Physiology or Medicine on Monday for game-changing discoveries about how to harness and manipulate the immune system to fight cancer...The seminal discoveries by the two Laureates constitute a landmark in our fight against cancer...Allison...worked on a protein known as CTLA-4 and realized that if this could be blocked, a brake would be released, unleashing immune cells to attack tumors...Honjo...separately discovered a second protein called PD-1 and found that it too acted as an immune system brake, but with a different mechanism...The discoveries led to the creation of a multibillion-dollar market for new cancer medicines. In particular, drugs targeting PD-1 blockade have proved a big commercial hit, offering new options for patients with melanoma, lung and bladder cancers...

Sunshine Law Will be Expanded to Include Nurse Practitioners, Physician Assistants, Nurse-Midwives, and Others...Congress is expected to finalize within days a new law to expand transparency surrounding payment to non-physician providers. Beginning in 2020, pharmaceutical and medical device companies must disclose payments made to those providers for speaking or consulting, as they must do now with physicians...In many states, nurse practitioners, physician assistants, and other non-physician health professionals account for a substantial number of prescriptions—often including prescription opioids.” The law also applies to clinical nurse specialists, nurse-anesthetists, and nurse-midwives...Without full transparency, pharmaceutical companies can operate under the cover of darkness, possibly using gifts and payments to influence the prescribing practices of medical professionals like nurse practitioners and physician assistants...

Biopharmaceuticals, a class of drugs comprising proteins such as antibodies and hormones, represent a fast-growing sector of the pharmaceutical industry. They’re increasingly important for “precision medicine” — drugs tailored toward the genetic or molecular profiles of particular groups of patients...Such drugs are normally manufactured at large facilities dedicated to a single product, using processes that are difficult to reconfigure. This rigidity means that manufacturers tend to focus on drugs needed by many patients, while drugs that could help smaller populations of patients may not be made...To help make more of these drugs available, MIT researchers have developed a new way to rapidly manufacture biopharmaceuticals on demand. Their system can be easily reconfigured to produce different drugs, enabling flexible switching between products as they are needed...Traditional biomanufacturing relies on unique processes for each new molecule that is produced...We’ve demonstrated a single hardware configuration that can produce different recombinant proteins in a fully automated, hands-free manner...

The FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS, for the first time...

• ….applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics…
• ….training be made available to health care providers who are involved in the management of patients with pain (e.g., nurses and pharmacists), and not only to prescribers.
• ...education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.
• ...new product labeling containing information about the health care provider education available through the new REMS.
• ,,,the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content.