Category:

Alibaba Health Information Technology Ltd…the subsidiary of China’s biggest e-commerce operator is attempting to revive its fortunes by tapping new areas of growth -- like consumer safety...China...scrapped plans to implement a compulsory drug coding system intended to identify counterfeit medicines that would have used a platform developed by Ali Health. The Alibaba Group Holding Ltd. subsidiary says it is now using the same technology to build a commercial tracking platform that will have wider applications beyond medicines...Ali Health’s new system could be used to track the origins of products such as baby formula, farm produce and even wine for Chinese consumers concerned about food safety…Ali Health is currently talking to partners to expand use of the technology, and continues to run the existing drug tracking system for the government while awaiting a final decision. The China Food & Drug Administration suspended the electronic coding system earlier this year for use in the drug industry as it made draft amendments to existing rules, allowing the use of other methods to track medicines back to their origin...

...one drug maker has failed to provide the Food and Drug Administration with a required study about the effect its powerful painkiller might have on teenagers...At issue is Xartemis XR (oxycodone/acetaminophen), which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called post marketing study to determine its safety in youngsters between 12 and 17 years old…as of June 24, the company blew past a March 31 deadline for submitting its pediatric assessment. The drug maker also failed to respond to an April 25 "noncompliance" letter for which the FDA provided a new 45-day deadline to either submit the data or request an extension...The assessment was required under the Pediatric Research Equity Act...What happens if the company fails to comply and submit the data to the FDA? According to federal law, the agency could determine that Xartemis XR is misbranded. That would not lead to a product withdrawal, but the FDA could pursue an injunction or seizure proceedings...

Johnson & Johnson...was ordered...to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug....jury found that J&J failed to properly warn Risperdal could cause gynecomastia...also determined that the company "intentionally falsified, destroyed, or concealed records" that Risperdal could cause boys to develop breasts...J&J has a bad track record when it comes to marketing Risperdal...In 2013, the company paid more than $2.2 billion to resolve criminal and civil charges of illegally promoting the drug for unapproved uses...J&J reputation. The health care giant has portrayed itself as a trustworthy corporate brand, but has endured several episodes that have sullied its well-honed image...

CVS Pharmacy has agreed to pay $3.5 million to settle allegations that dozens of its Massachusetts pharmacies violated federal law by filling forged prescriptions for addictive painkillers and other controlled substances...Attorney Carmen Ortiz announced the settlement...CVS says it entered into the agreement to avoid the expense and uncertainty of further legal proceedings...settlement resolves two investigations by the Drug Enforcement Administration after reports of forged oxycodone prescriptions. One involved hundreds of forged prescriptions at 40 CVS stores in Massachusetts and New Hampshire. The other involved 120 forged prescriptions at 10 CVS stores in and around Boston.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

...World Health Organization wants to develop a fair pricing model for pharmaceuticals...the agency plans to convene governments, patient groups, and drug makers to fashion the notion into something realistic. The trick is to find the right balance between access to affordable medicines and enticing companies to develop new and improved medicines, while also ensuring lower-cost generics remain available. We spoke with Suzanne Hill, the secretary to the WHO Expert Committee on the Selection and Use of Essential Medicines, about how the agency hopes to get this done…

Pharmalot: This seems rather lofty or at least complicated. How is this supposed to get done?

Hill: We want to get evidence together that looks at the price drivers — how manufacturers set prices and what we know and don’t know about that. And we need to understand the questions surrounding R&D costs. We also want to understand the strategies that countries, payers, and health systems are using to manage prices and which ones may be effective and which aren’t. We also want to understand the return on investment that manufacturers need to ensure that supplies of medicines are continued...

A federal appeals court...that biosimilar makers must always notify their brand-name rivals six months before launching expensive biologic medicines. The decision may have a significant impact on near-term health care costs, because it will effectively delay competition for these pricey drugs...The stipulation is designed to give a brand-name company time to determine what, if any, patent challenges can be pursued before a biosimilar is launched. In a closely watched case last year, the federal appeals court already ruled that biosimilar companies must wait until they actually receive Food and Drug Administration approval before giving 180-day notice to a brand-name rival...today’s decision will answer an important policy question and serve as a broader benchmark for the entire pharmaceutical industry going forward...A great deal is at stake for patients and payers because biosimilars are estimated to save as much as $44 billion in US health care costs over the next decade. Many insurers and analysts forecast that biosimilars will cost 10 percent to 30 percent less than brand-name biologics, although the number is a moving target, given that companies raise biologics prices to anticipate competition...

Pfizer reached an agreement with the city of Chicago to follow a code of conduct for marketing opioids that officials hope will become standard practice for other companies...The drug maker agreed last week to disclose in all promotional materials that opioids carry a risk of addiction and not to promote them for any unapproved uses...Pfizer must make clear that there is insufficient research about the effectiveness of opioids if used beyond 12 weeks…Some industry watchers, meanwhile, said that the four-year agreement, which does not pertain to any other city or state, largely requires Pfizer to adhere to existing laws and regulations governing drug marketing. For this reason, they said the agreement breaks little new ground in the battle against inappropriate or overprescribing of opioids..."This landmark agreement is a big step in the right direction to help protect and educate the public about the true risks and benefits of highly potent and highly addictive painkillers," said Chicago Mayor Rahm Emanuel in a statement...It’s in Pfizer’s interest to highlight the addictive properties of opioids because they have a competing product under development (tanezumab)...When a company comes out slamming a particular class of drugs, it’s generally because they have a competitor in the wings. Think of this as prelaunch marketing, which can start long before the launch...

As part of a strategy to switch patients to newer HIV treatments, Gilead Sciences...raised prices on a pair of older HIV medications that face patent expiration...triggering still more criticism by AIDS activists of its overall pricing strategies...the company raised the wholesale acquisition cost...for the two older medicines — Complera (emtricitabine, rilpivirine,tenofovir) and Stribild (cobicistat, elvitegravir, emtricitabine,tenofovir) — by 7 percent, to $2,508 and $3,469 a month, respectively. This follows price hikes of 7 percent and 5 percent last January...Meanwhile, Gilead left intact prices for two much newer versions of these drugs — Odefsey (emtricitabine, rilpivirine, tenofovir) and Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) – which remain priced at $2,346 and $2,578 per month...By boosting prices for the older HIV treatments twice in just six months, Gilead is clearly hoping that doctors will prescribe its newer drugs. And physicians have an added impetus for doing so: the newest Gilead medications are more potent and studies have indicated they are likely to cause fewer side effects...price hikes has angered AIDS activists, who say the higher prices reflect indifference to the ability of payers to absorb higher drug costs...AIDS Healthcare Foundation believes the price hike is a good reason to push to invalidate Gilead patents...The small savings from the cheaper new drugs pales in comparison to how cheap they would be if they went generic...

Rio de Janeiro’s hospitals are running out of syringes and basic medications, and their staffs are running on little-to-no pay, with one month to go before the city hosts the 2016 Summer Olympics...Doctors in the city are warning tourists who are planning to visit Rio de Janeiro not to do so if they do not have health insurance, as service prices increase with demand...Rio de Janeiro’s medical system has been bordering collapse for months, though the situation has deteriorated as the city and state government’s have poured millions into Olympic facilities at the expense of public services.