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India's largest drugmaker Sun Pharmaceutical Industries Ltd has been warned by U.S. health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year...Food and Drug Administration's "warning letter" to Sun Pharma indicates the agency is dissatisfied with the remedial measures the company has implemented since last September, when the FDA first notified the company of its concerns after an inspection...That inspection report highlighted nearly two dozen issues the FDA staff found, including problems with aseptic practices and water leaks in the ceiling of the manufacturing area...the agency could ban imports from the plant if the problems are not resolved...The Halol plant makes up about 15 percent of Sun Pharma's sales in its largest market, the United States.

U.S. deaths from drug overdoses hit a record high in 2014, propelled by abuse of prescription painkillers and heroin, the Centers for Disease Control and Prevention said on Friday...Drug overdoses increased 6.5 percent in 2014 from a year earlier, killing 47,055 people. The highest rates of death from overdose were seen in West Virginia, New Mexico, New Hampshire, Kentucky, and Ohio, the CDC report said...Deaths from opioids such as prescription pain killers and heroin accounted for 61 percent of overdose deaths and increased 14 percent in 2014, the CDC said...Lower heroin prices, wider availability and higher purity are causing more overdoses, the agency reported. It recommends stricter guidelines for prescribing pain killers, expanded availability and wider access to naloxone, an antidote for opioid-related overdoses.

Prices rose faster than inflation for 22% of top generic drugs reviewed between 2005 and 2014, according to a report released Thursday by HHS' Office of Inspector General....Had those generic drugs been subject to the same requirement that branded drugs face—where manufacturers pay additional rebates to Medicaid when the price of a drug increases faster than inflation—Medicaid would have pulled in $1.4 billion in rebates for the top 200 generic drugs, according to the report...The OIG produced the report in response to a request from Congress to examine recent increases in generic drug prices and the effects of those prices on Medicaid and Medicare drug spending...the OIG didn't make any recommendations, noting that that the two-year budget deal recently passed by Congress would extend the rebates to generics starting in 2017. In a previous, similar report, OIG had recommended CMS consider seeking legislative authority to broaden the rebate program.

China's drug regulator said on Thursday it will strengthen oversight of clinical trials of new drugs, where it said regulation was falling short despite a recent push to improve the quality of local drugs and compete better with international rivals...China Food and Drug Administration has rejected dozens of drug applications over the past few months due to false or incomplete trial data. A further 82 firms withdrew applications earlier this month...The drug regulator said in a statement...that while some regions had made progress in cracking down on poor drug trial data, many regions were still falling behind...The inspection work in some regions is not being taken seriously enough and the quality of inspection is too low...Global drugmakers in China are facing a tough challenge as local firms get increasingly competitive and as the central government looks to rein in drug prices to help curtail a wider medical bill expected to hit $1.3 trillion by around 2020...

Health-system pharmacists will inevitably face growing ethical challenges as their roles in patient care continue to evolve...ethical dilemmas embedded in health-system pharmacists’ everyday practice include competing interests, limited resources due to drug shortages, and an evolving health care delivery system that has shifted their role from dispensing medications to actively participating in direct patient care...One of the hot-button ethics issues in pharmacy currently is the trend of skyrocketing prescription costs and the lack of transparency in drug pricing decisions. Extremely high prices and lagging reimbursement may preclude health-systems from providing necessary medications to all patients who would otherwise benefit..."Patient welfare is at risk when the ethical perspective in health care is smothered by business and financial perspectives,"..."Patient well-being often hinges on the ability of health professionals to heed the ethical precepts of their calling."...Pharmacists are currently vying to gain support for an expanded role in patient care in the form of provider status, which will likely be more easily garnered if they are perceived as being on the side of patient care rather than the side of business interests.

Two months after a worker was found dead inside one of its cryochambers, a Henderson cryotherapy spa appears to be closed for good…On Dec. 10, a notice was posted on the front doors of Rejuvenice, 8846 S. Eastern Ave., saying the spa was more than $3,000 behind on its rent…Rejuvenice opened in July. And on Oct. 20, worker Chelsea Ake-Salvacion, 24, was found dead inside one of the spa's cryochambers… Ake-Salvacion's family hired the Las Vegas-based Richard Harris Law firm and the Bradley, Drendel & Jeanney law firm in Reno to investigate how she became trapped inside the chamber. Nevada's Occupational Safety and Health Administration office said it would not investigate because Ake-Salvacion died after business hours.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

SPECIALTY PHARMACEUTICALS featured prominently in the FDA’s new drug approval and expanded indications list once again in 2015. Below is the first of a 2-part summary of specialty pharmacy–related FDA approvals and expanded indications that took place this year...Part 2, which will be featured in the next issue of Specialty Pharmacy Times, will include oncology drugs and late-breaking FDA actions...

Bleeding Disorders

• Ixinity (coagulation factor IX (recombinant), Emergent BioSolutions Inc)
• Nuwiq (coagulation factor VIII (recombinant), Octapharma)
• Coagadex (coagulation factor X (human), Bio Products Laboratory Ltd)
• Adynovate (antihemophilic factor [recombinant] pegylated, Baxalta Inc)

Inflammatory Conditions

• Cosentyx (secukinumab, Novartis Pharmaceutical Corp.)
• Humira (adalimumab, AbbVie)

Cystic Fibrosis

• Kalydeco (ivacaftor, Vertex Pharmaceuticals)
• Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals )

HIV

• Evotaz (atazanvir/cobicistat, Bristol-Myers Squibb Co)
• Prezcobix (darunavir/cobicistat, Janssen Therapeutics)
• Genvoya (cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide, Gilead Sciences, Inc)

Hepatitis C

• Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie Inc)
• Daklinza (daclatasvir, Bristol-Myers Squibb)
• Harvoni (ledipasvir/sofosbuvir, Gilead Sciences, Inc.)

• Glatopa (glatiramer acetate injection, Sandoz, Inc.)
• Betaconnect (Bayer HealthCare’s electronic auto injector - Betaseron (interferon beta-1b)

Specialty Ophthalmics

• Lucentis (ranibizumab, Genentech)
• Eylea (aflibercept, Regeneron Pharm)

Hypercholesterolemia

• Praluent (alirocumab, Sanofi-Aventis)
• Repatha (evolocumab, Amgen Inc)

Miscellaneous Specialty Approvals

• Natpara (parathyroid hormone, NPS Pharmaceuticals, Inc)
• Cresemba (isavuconazonium sulfate, Astellas Pharma US, Inc)
• Cholbam (cholic acid, Asklepion Pharmaceuticals LLC)
• Jadenu (deferasirox, Novartis Pharmaceuticals)
• Anthrasil (anthrax immune globulin intravenous [Human], Cangene Corp)
• Rapamune (sirolimus, Wyeth Pharmaceuticals)
• Promacta (eltrombopag, GlaxoSmithKline and Novartis Pharmaceuticals)
• Envarsus XR (tacrolimus extended-release tablets, Veloxis Pharmaceuticals A/S)
• Dysport (abobotulinumtoxinA, Medicis and Ipsen)
• Keveyis (dichlorphenamide, Taro Pharmaceutical Industries Ltd)
• Procysbi (cysteamine bitartrate, Raptor Pharmaceutical)
• Xuriden (uridine triacetate, Wellstat Therapeutics Corporation)

Martin Shkreli, the pharmaceuticals entrepreneur vilified for jacking up the price of a life-saving AIDS drug, said on Saturday that unrelated securities fraud allegations that resulted in his arrest this week were "baseless and without merit."…Federal prosecutors have alleged that Shkreli was running a Ponzi-like scheme at his former hedge fund and a company he headed before he took the helm of Turing Pharmaceuticals Inc, where he created an uproar in September when the company raised the price of the drug Daraprim from $13.50 to $750 a tablet…"I am confident I will prevail," Shkreli wrote on Twitter on Saturday… The allegations have amplified the public outrage over the brash, boyish-looking Shkreli, who has become the poster child for the issue of soaring prices for prescription medications.

...more physician groups are making the case that stringent regulations and suboptimal technology have left physicians spending too much time grappling with their electronic health records...It's not that physicians are against health IT. In fact, most have adopted technology "at a blistering pace,"...But unrealistic and uncoordinated requirements are overburdening physicians' time and affecting the quality of patient care...AMA published a list titled "How EHRs tied up physician time in 2015."...EHR technology continues to underwhelm...Meaningful use is outliving its usefulness...Physicians are talking back -- and being heard...the Association of American Physicians and Surgeons also put out a strongly worded complaint this week, charging that EHRs could "crash" the U.S. healthcare system..."EHRs are supposed to be a cure-all for inefficiency and medical errors,"..."But the costly, clunky systems the government demands are worsening the problems and even driving some software experts back to paper."..."It's a major distraction from face-to-face patient care and interaction, thereby increasing the chance of missing important information, and in the end, increasing the probability of clinical and treatment errors,"..."The federal government should have no role in telling how physicians how to keep their records,"...