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Robert Mulroy, Merrimack CEO, discusses the risk factors and...

AstraZeneca and Cephalon — have agreed to pay a total of $54 million to federal and state governments to settle allegations that they shortchanged Medicaid programs on rebates for drugs… The allegations involve rebates owed to Medicare which are negotiated with pharmaceutical companies, which are often touted as a main reason that the cost of any drug is actually less than the published price…in a lawsuit against the two drug companies claiming that they violated so-called “false claims acts” by manipulating how they reported the prices of drugs in order to decrease rebates owed to state Medicaid programs… lawsuit claimed that AstraZeneca and Cephalon falsely treated certain fees paid to wholesalers as “discounts,” improperly lowering the average prices reported and they amount they paid…

PATIENTS and taxpayers are set to save some cash as the federal government announces it'll no longer subsidise basic over-the-counter medicines like paracetamol and aspirin...17 common drugs that treat issues like headaches, heartburn and constipation will be removed from the Pharmaceutical Benefits Scheme from January 1, 2016…The move is expected to save taxpayers half a billion dollars over the next five years, which…says will instead be spent on listing new life-saving drugs…The Consumers Health Forum is concerned consumers will now be buying and taking medicines without a treatment plan and regular monitoring from their doctor... the move will have no impact on a patient's ability to speak to their doctor or pharmacist about over-the-counter medicines… Australian Medical Association…said doctors welcomed the announcement, which was based on advice from the independent Pharmaceutical Benefits Advisory Committee.

...Senate panel on Wednesday launched a bipartisan probe into pharmaceutical pricing, seeking documents from four drugmakers including Valeant Pharmaceuticals and Turing Pharmaceuticals, companies embroiled in controversy over price hikes on lifesaving drugs…Senate's Special Committee on Aging also requested information from Retrophin Inc and Rodelis Therapeutics…Drugmakers and their defenders say drugs are priced to help enable discovery and development of innovative new treatments…House...could authorize an investigation…

Pfizer is looking to help more patients afford medication, announcing… that it would be expanding eligibility for its RxPathways program, which offers services to help patients access medication. The change makes patients who earn up to four times the federal poverty level based on family size (up to $97,000 for a family of four) eligible for some of the 40 medicines offered for free by the program…“We have listened to patients and acted quickly to significantly expand the eligibility of our patient assistance programs. While patient assistance is not a permanent solution, it is a necessary step for helping to solve some of the high co-pay issues that some patients face,”…

...controversial HPV (human papillomavirus) vaccine does not cause chronic pain or dizziness, despite reports from patients’ families complaining of those side effects, European regulators said…after an extensive review…European Medicine Agency began its review in July after families complained that girls who were vaccinated suffered complex regional pain syndrome…a chronic pain that affects limbs. Other families said the vaccines caused postural orthostatic tachycardia syndrome…which causes dizziness and fainting…“The available evidence does not support a link” between the vaccines and the syndromes…“There is no reason to change the way the vaccines are used.”

Federal laws and regulations generally frown on hospitals providing Medicare patients with free or discounted medications, but a recent policy statement from the OIG appears to buck that trend. From now on, hospitals won’t face any administrative sanctions for waiving or discounting self-administered drugs (SADs) that are either administered or ingested in an outpatient setting and aren’t covered under Medicare Part B…policy statement was prompted by reports that some hospitals were charging Medicare patients for SADs, resulting in financial hardships for the patients. The hospitals believed that the anti-kickback statute required them to bill for the SADs, and at higher rates than patients would receive at retail pharmacies...Many hospitals are already waiving or discounting patient costs for SADs, as Medicare patients can end up paying more for the SADs than they would have if the drugs were dispensed at a retail pharmacy...

Caremark, a division of CVS Health, won an incentive package Tuesday from Orange County (FL) to bring a pharmaceutical operation here next year that could create as many as 500 jobs…County commissioners approved the company's request in a 6-1 vote…Caremark plans to establish a support operation here for its pharmacies in the southeastern U.S…The jobs, including 100 pharmacists and 350 pharmacy techs, will pay an average annual salary of about $49,000, qualifying it for a "high-wage jobs" tax break…The Caremark proposal also will boost the county's tax roll by $18.7 million…Caremark would add 275 jobs by the end of next year and another 225 jobs in 2017…The company would be in line for $1.5 million in tax refunds from the state, or about $3,000 per job. The county would kick in up to $300,000.

Insys Therapeutics CEO Michael Babich has stepped down, with company chairman Dr. John Kapoor taking over as CEO…The news comes as the company reported third quarter earnings…shortly after CNBC released an investigative piece…day on the company, which included allegations of fraud, kickbacks, and aggressive drug marketing…the…company…markets and sells an opioid painkiller called Subsys Fentanyl, which is administered by spray.

Drug was set to be dumped from UK’s list of approved medicines before deal was reached with pharmaceutical firm Roche...An expensive drug that could prolong the lives of women with advanced breast cancer by at least six months will remain on the list of medicines available on the NHS (National Health System) after the manufacturer agreed to lower the price…Roche’s Kadcyla was one of a number of drugs set to be dumped from the Cancer Drugs Fund list of medicines that the government pays for because the National Institute for Health and Care Excellence does not consider them to be cost-effective…In the case of Kadcyla, cost was the only issue. Nice and NHS England accept that the drug works well and can extend women’s lives significantly without severe side-effects. But Roche launched the drug at a reported £90,000 ($138,000) per patient per year, which is nearly double the limit for Nice approval…