- Amgen cannot stop imminent sale of Neupogen copycat: U.S. appeals court (reuters.com)
U.S. appeals court has cleared the way for Novartis AG to launch the first biosimilar drug in the United States as it declined on Wednesday to stop the sale of the company's copycat version of Amgen Inc's blockbuster cancer drug Neupogen (filgrastim)…. Novartis (Sandoz) could begin to market its biosimilar drug, to be sold under the name Zarxio…. a version of Neupogen, have been available in Europe since 2006...
- Las Vegas trial centers on diabetes drug Actos (reviewjournal.com)
Billions of dollars are at stake in a Las Vegas trial that centers on two men who were diagnosed with bladder cancer after taking the diabetes drug Actos… Robert Eglet… represents Mary Iorio, the widow of Maurice Iorio.. filed a product liability case… against Takeda Pharmaceutical Co… Thousands of plaintiffs across the country have filed product liability lawsuits against Takeda. The company is accused of failing to inform consumers and medical professionals about the risk of bladder cancer...
- Federal appeals court affirms FTC’s power to regulate cybersecurity (modernhealthcare.com)
..federal appeals court…affirmed the Federal Trade Commission's power to regulate cybersecurity—a decision that follows a number of massive healthcare data breaches over the past year… FTC alleges that Wyndham engaged in unfair cybersecurity practices that exposed consumers' personal data to unauthorized access and theft…FTC doesn't now get involved in many healthcare breach cases,..But it could.
- Report: A&P selling prescription files to Rite Aid (drugstorenews.com)
A&P is seeking approval to sell pharmacy assets for several of the stores it is immediately closing to Rite Aid in a transaction valued at $8.1 million, Rite Aid has agreed to buy the prescription files for 12 stores that are closing…"When a pharmacy is closing, the value of pharmacy related assets, particularly customer prescriptions, is unstable and the transactions must occur on an accelerated timeline to avoid permanent and significant diminution of value,"
- Settlement will make Narcan more affordable, Mass. AG says (bostonglobe.com)
Attorney General Maura Healey announced Monday that a manufacturer of a drug that can help reverse opioid overdoses will pay the state $325,000, resolving her concerns about a sharp price increase…. settlement with Amphastar Pharmaceuticals Inc. will help make the drug, naloxone (nasal administration),..more widely available for less money to cities and towns across the state…The $325,000 will go into the Municipal Naloxone Bulk Purchase Trust Fund, created in this year’s state budget. That fund is aimed at helping communities gain cheaper access to the drug.
- Illinois man denies cancer drug smuggling conspiracy charge (washingtonpost.com)CanadaDrugs.com Indictment Exposes Fake Drug Sales, PharmacyChecker Role (blog.legitscript.com)
Illinois man (Ram Kamath) pleaded not guilty..to conspiring with an online Canadian pharmacy to smuggle mislabeled, unapproved...counterfeit prescription drugs into the U.S...Federal prosecutors accuse Canadadrugs.com,..and its affiliated companies..selling $78 million in prescription drugs,..mislabeled by having text in a foreign language or missing the required "Rx only" symbol.
- Walgreens Settles Pharmacist Consultations Lawsuit (pharmacytimes.com)
Walgreens will pay a $500,000 settlement concerning a civil complaint that the retail pharmacy giant was not compliant with California regulations related to pharmacist consultations… noncompliant with rules requiring pharmacists to perform consultations with patients receiving new prescriptions or new dosages…
- Pharmacy Pays Settlement for Lack of Break Times (pharmacytimes.com)Point Reyes Station pharmacy settles claims by former workers for rest-break pay (marinij.com)
An independent pharmacy will pay a $46,000 settlement over an alleged lack of break times for its employees…Three former employees,..filed small claims lawsuits with California’s labor commissioner against Point Reyes Station-based West Marin Pharmacy…Deputy Labor Commissioner…ruled that the pharmacy owed the 3 ex-employees rest-period premium wages and waiting-time penalties.
- In huge victory for generics, court invalidates Takeda’s Velcade patent (biopharmadive.com)
…federal judge has ruled Takeda's patent on Velcade (bortezomib) invalid…Velcade's patent was challenged by Actavis, Sandoz, and Accord Healthcare…Takeda expected to have patent protection until 2022, but based on the latest court decision, generics could hit the market by 2017…Velcade,..is a big seller for Takeda, bringing in almost $2.9 billion in revenues in 2014.
- CanadaDrugs.com Indictment Exposes Fake Drug Sales, PharmacyChecker Role (blog.legitscript.com)
Money laundering. Customs forms falsifications. Conspiring with a supposedly "impartial"…certification program to sell fake cancer medicines to unsuspecting doctors and clinics — and then giving that certification program’s employee an all-expenses paid trip to a tropical island…disturbing federal indictment unsealed...Department of Justice against CanadaDrugs,..PharmacyChecker,... there are 10 important takeaways,..from the indictment.
- When they sell to US residents, Canadian Internet pharmacies aren’t really selling drugs from Canada
- The medicines were fake
- Cold-chain drugs were stored at too-warm temperatures, returned and then resold to other customers in their adulterated state
- CanadaDrugs was raking in the profits from the sale of drugs, including counterfeits, to US residents
- After it became aware of the FDA investigation, CanadaDrugs took steps to cover up its counterfeit drug sales, moving the drugs offshore, and continued selling illegal drugs to US residents
- CanadaDrugs knowingly engaged in illegal activity, putting patients at risk
- The Canadian International Pharmacy Association certifies Canadian online pharmacies — and is run, in part, by CanadaDrugs
- CanadaDrugs lied, and falsified US Customs records to smuggle illegal drugs into the USA
- PharmacyChecker employee helped store the counterfeit drugs in his garage
- PharmacyChecker approved CanadaDrugs as legitimate despite knowing that CanadaDrugs used an illegal and unsafe supply chain