[1]Hello, everyone, and how are you today? We are just fine, thank you. Our outlook is brightened by the delightful combination of a shiny sun enveloping the leafy Pharmalot campus and a few cups of stimulation, which are as needed as ever. Feel free to join us. Remember, no prescription is required. And now, time to get cracking. We trust that you can relate. So here are a few items of interest to help you along. Have a great day and keep in touch…
Pfizer is increasing its financial assistance to patients, doubling the allowable income level for people to receive dozens of its medicines for free, the Associated Press [2] reports. Pfizer chief executive Ian Read insists the drug maker isn’t boosting assistance due to the heightened scrutiny of prices, but because more and more people can’t afford needed medicines as insurance plans shift more costs onto patients.
What does Martin Shkreli think of the US Senators investigating pricing practices at his company? “The senators have their facts wrong,” the Turing Pharmaceuticals chief executive told CNBC [3]. “They’re trying to make a tempest out of a teacup, and a mountain out of molehill. This is co-opting a headline to try to gain political capital, which is really unfortunate.” Shkreli was sent a letter asking him to appear at a hearing next month. Meanwhile, he may reportedly [4] lower the price of his controversial drug by 10 percent, which is not a lot.
Gilead Sciences’ blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out, reports, citing a letter published in The New England Journal of Medicine. The letter detailed episodes of a slowing heart rate that developed within the first 10 days of Sovaldi therapy in three of 415 patients treated in 2014.
OptumRx, one of the largest pharmacy benefits managers in the US, began halting payments to a mail-order pharmacy closely-linked to Valeant Pharmaceuticals more than a year ago after recognizing billing irregularities, Reuters [8] reports, citing former employees at the pharmacy and other sources. Philidor Rx Services persisted in efforts to secure reimbursement for Valeant drug sales even after receiving a cease-and-desist order from OptumRx.
Alexion Pharmaceuticals last month received a request from the US Department of Justice to produce documents and other information pertaining to compliance with the Foreign Corrupt Practices Act, according to a regulatory filing [9]. This follows a similar request last spring from the US Securities and Exchange Commission, which is also looking into recalls of the Soliris treatment for a rare blood disease and a serious kidney disorder.
Insys Therapeutics is pushing painkillers to the legal edge of aggressive medical marketing and its practices are being investigated by a raft of federal and state officials, NBC News [10] explains. The thrust of the story is already known, notably the investigations, but this provides more detail, especially from former employees who describe the various methods that were used to boost prescriptions.
An Indian court blocked Reliance Life Sciences from launching a copy of Herceptin, the cancer treatment sold by Roche, according to The Economic Times [11].
The US health care system saved a record $254 billion last year through the use of lower-cost generic drugs, Chain Drug Review [12] writes, citing data from the generic industry trade group.
Sanofi struck a licensing deal that could eventually be worth up to $3.5 billion with South Korea’s Hanmi Pharmaceutical in a bid to add investigational diabetes medicines to its portfolio, Bloomberg News [13] says.
China has launched a three-year pilot program to loosen approvals for new drugs in hopes of encouraging greater innovation, according to Reuters [14].
Johnson & Johnson entered into a definitive agreement to acquire Novira Therapeutics, which is working on a potential cure for patients with chronic hepatitis B virus infection, The Philadelphia Business Journal [15] reports.
American Family Pharmacy was issued a warning letter [16] by the FDA for producing tablets with inconsistent colors, among other issues.
AstraZeneca’s keenly awaited cancer immunotherapy drug durvalumab may not get to market as quickly as first hoped, according to Reuters [17].
GlaxoSmithKline’s Nucala therapy has been approved to treat patients with severe asthma attacks in combination with other drugs, The Wall Street Journal [18] writes.
AstraZeneca and Cephalon, a unit of Teva Pharmaceutical, reached a multi-state accord over civil charges they overbilled state Medicaid programs, Reuters [19] tells us.
Reckitt Benckiser is still hunting for a licensee to take over the K-Y personal lubricants brand in the UK, but has so far not found a suitable partner to help it meet regulatory demands, The Deal [20] tells us.