- Cancer drug prices are so high that doctors will test cutting doses (washingtonpost.com)
A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness...they point to their pilot study involving a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount…Szmulewitz (University of Chicago oncologist) and others now want to run full trials to see whether the doses of other oral oncology drugs can be ratcheted back because of the “food effect,” which can alter how a medication is absorbed. They also plan to explore whether the duration of some prescriptions can be shortened and whether some cheaper non-cancer drugs can be substituted for expensive cancer ones. They recently created a nonprofit organization, the Value in Cancer Care consortium, to organize their work...
- FDA requests removal of Opana ER for risks related to abuse (fda.gov)FDA Seeks to Pull Pain Pill Off Market, Citing Risk of Abuse (bloomberg.com)
...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...
- Ohio sues five drug companies over opioid crisis (reuters.com)Ohio files suit against 5 drug companies over opioid addiction (americanthinker.com)
The state of Ohio...sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a sky-rocketing drug addiction epidemic...The suit, filed by Attorney General Mike DeWine, comes as a growing number of state and local governments are suing drugmakers and distributors, seeking to hold them accountable for a deadly and costly opioid crisis...The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc...The suit...seeks to halt deceptive practices, a declaration the companies acted illegally and unspecified damages to the state and consumers...
- Mylan May Have Overcharged Taxpayers by $1.27 Billion for EpiPen (bloomberg.com)
U.S. taxpayers may have overpaid for Mylan NV’s EpiPen shot by as much as $1.27 billion over the last decade, according to a U.S. government report...by classifying EpiPen as a generic drug rather than a brand-name product, shortchanged the Medicaid program...Under Medicaid, makers of brand-name drugs must provide deep discounts on their products. In October, Mylan said it reached a settlement with the U.S. to pay $465 million for misclassifying the drug as a generic product, which doesn’t require the same discounts...(Senator Charles Grassley)...has been critical of the...settlement, calling it too small...As part of bringing down drug costs, we have to make sure companies that take part in federal health care programs aren’t gaming the system...It’s Congress’s job...to ensure that taxpayers...don’t overpay for EpiPens or any other drugs in public health-care programs...Grassley has pushed for Mylan and the Centers for Medicare and Medicaid Services to explain why EpiPen was misclassified...
- Korea issues third set of punishments in Novartis bribery case (fiercepharma.com)
South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After a separate agency fined the drugmaker nearly $50 million over kickback payments in April, antitrust authorities in the country have just issued a new fine and complaint against the Swiss drug giant...South Korea’s Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint over payments the company offered doctors between March 2011 and August 2016, according to the Korea Times...The developments come shortly after the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won—approximately $50 million—and suspended reimbursement of Exelon and Zometa for three months, alleging the company’s employees provided approximately $2.3 million in unlawful kickbacks…
- Sandoval vetoes bill requiring advance notice of price hikes for diabetes-related drugs (reviewjournal.com)
Gov. Brian Sandoval...vetoed a bill that would have required drug manufacturers to notify the state in advance of planned price increases for diabetes-related drugs, among other provisions...Sandoval said that while Senate Bill 265 had well-intentioned provisions related to access to affordable health care, the measure also contained potentially detrimental consequences for Nevadans, “not the least of which is the possibility that access to critical care will become more expensive, more restricted, and less equitable.”...“SB 265 fails to account for market dynamics that are inextricably linked to health care delivery and access to prescription drugs,” Sandoval said. “This failure cannot be overlooked, and it could cause more harm than good for Nevada’s families.”...Sandoval also said there was insufficient evidence to support the notion that the measure would lead to lower drug costs…
- Suspected drug thefts persist at VA hospitals after ‘zero tolerance’ announced (abcnews.go.com)
Federal authorities are investigating dozens of new cases of possible opioid and other drug theft by employees at Veterans Affairs hospitals, a sign the problem isn't going away as more prescriptions disappear...Data...show 36 criminal investigations opened by the VA inspector general's office from Oct. 1 through May 19. It brings the total number of open criminal cases to 108 involving theft or unauthorized drug use. Most of those probes typically lead to criminal charges...Doctors, nurses or pharmacy staff in the VA's network of more than 160 medical centers and 1,000 clinics are suspected of siphoning away controlled substances for their own use or street sale — sometimes to the harm of patients — or drugs simply vanished without explanation...an IT specialist at the VA, says he's heard numerous employee complaints of faulty VA technical systems that track drug inventories, leading to errors and months of delays in identifying when drugs go missing. Prescription drug shipments aren't always fully inventoried when they arrive at a VA facility, he said, making it difficult to determine if a drug was missing upon arrival or stolen later...
- ASCO 2017: What you missed (biopharmadive.com)
Loxo Oncology opened this past weekend's annual conference of the American Society for Clinical Oncology with compelling data showing its drug's efficacy across an array of 17 different cancers...the results were unquestionably positive for Loxo, larotrectinib's performance also marks another step forward in the lofty and still yet unrealized goal of precision oncology...Merck's flagship immunotherapy Keytruda (pembrolizumab) won a landmark approval from the Food and Drug Administraiton for tumors with a specific biomarker...Treating cancer based on solely on the genetic profile of a patient's cancer has been a long-talked about objective, and progress from Merck, Loxo and others show what's possible beyond the molecularly targeted therapies that have advanced clinical care in the past decades...improving precision could also be seen in data presented by Bluebird Bio and Nanjing Legend Biotech, which showed the broader potential for CAR-T therapy outside of leukemia and lymphoma. While checkpoint inhibitors have transformed oncology by broadly unlocking the immune system, CAR-Ts specifically engineer patient's T-cells to seek out specific targets expressed by different cancer types...for a round-up of some of the biggest developments from oncology's biggest conference.
- CAR-Ts steal the show - Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas.
- Roche's Perjeta cuts risk in Aphinity, but is it enough? - The large Phase 3 study has been closely watched as potentially practice changing but the modest benefit could limit its impact in adjuvant treatment of breast cancer.
- Loxo shows promise of biomarker approach to cancer - Clinical data presented Saturday showed treatment with Loxo Oncology's larotrectinib shrank tumors in three-quarters of patients with a range of 17 different advanced cancers.
- Juno marks progress with second-gen CAR-T - Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program.
- J&J seeks label expansion for Zytiga - The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.
- Incyte pads its IDO numbers - IDO inhibitors have been pegged as the next step in immuno-oncology combinations, but Incyte's rising market value prompts questions over what that's worth.
- Roche's Alecensa bests Xalkori in lung study - The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care.
- AstraZeneca's Lynparza stays step ahead of PARP rivals - Data showing a 42% risk reduction in disease worsening compared to chemo in breast cancer patients should help build Lynparza's profile outside of ovarian cancer.
- Merck touts Keytruda bladder benefit post Tecentriq failure - Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space.
- Chi-Med, Lilly tout cancer med's efficacy in the colorectal setting - Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.
- Evzio price hikes boosted Kaléo’s rebate bill but it hasn’t paid up, PBM lawsuit claims (fiercepharma.com)
Kaléo Pharma's price hikes on the lifesaving overdose med Evzio haven’t only angered lawmakers. A leading pharmacy benefit manager, Express Scripts, is going after the tiny drugmaker for unpaid rebates triggered by the exponential price increases...Express Scripts sued...claiming Kaléo owes it $14.5 million in unpaid rebates. The company’s coverage contract with Kaléo includes two types of rebates, a "formulary rebate" designed to secure coverage and a "price protection rebate" to limit exposure to dramatic price hikes….Kaléo faced Congressional heat earlier this year, when more than 30 senators wrote to the drugmaker seeking information about the drastic price hikes. According to the lawsuit, Kaléo took Evzio’s price from $718 per unit in September 2014 to $4,687 by November 2015...The senators wrote that they were "deeply concerned" about the price hikes that came amid an opioid-abuse epidemic...
- Philips in deals with U.S. hospitals on use of its gene data platform for cancer research (reuters.com)
Dutch healthcare technology company Philips said...it had reached deals with New York's Memorial Sloan Kettering Cancer Center and Utah-based Intermountain Healthcare for them to use its genomics platform for cancer research and treatment...MSK, the world's largest private cancer center, will work with Philips on new methods to use genetic data in the diagnosis of pancreatic cancer. Intermountain Healthcare, which runs 22 hospitals and 180 clinics, aims to make its medicine program, which offers individually targeted treatments, available to hospitals worldwide...Philips estimates the connected care and health informatics market will reach a total value of around 70 billion euros in 2019...