- CMS reportedly proposes 2-year ban of Theranos founder Holmes, revocation of lab’s license (biopharmadive.com)Walgreens Is Reportedly Taking Steps to Dump Theranos (fortune.com)
Centers for Medicare and Medicare Services is reportedly proposing to ban Theranos founder Elizabeth Holmes from owning or operating a laboratory for two years, along with revoking the license of Theranos' Newark, CA lab...Theranos had ten calendar days from receiving the notice to explain to CMS why the sanctions should not be imposed on Holmes and the company...The proposed sanctions stem from a number of key deficiencies CMS found in inspections last fall. Theranos had sent in a correction plan for the deficiencies but the regulator found it to be not credible.
- Biosimilars gain momentum — and pharma leaders are noticing (biopharmadive.com)
Biosimilar development in the U.S. appears to be gathering momentum, following the approval of Celltrion and Pfizer’s Remicade copy by the Food and Drug Administration in early April...The drug, marketed as Inflectra, is only the second biosimilar to clear regulatory review in the U.S., after Sandoz’s Zarxio in March 2015. But there are a number of other biosims entering late-stage development or with applications filed at the FDA... And with several blockbuster biologics nearing patent expiry, competition is likely to increase...Biosimilars promise to increase competition and lower prices across a number of other blockbuster biologics. They also represent new avenues of growth for companies seeking to enter previously protected markets...There is still a long way to go before biosimilars have anywhere near the market impact of generic drugs in the U.S...Biosimilars are still very much in early stages domestically...biosimilars look set to present a number of important opportunities and challenges to the U.S. biopharma landscape...
- Cashing In on Opioid War: Alkermes and Its $1,300-a-Month Shot (bloomberg.com)
A decade-old drug that was once seen as a commercial flop is getting a second chance to thrive as the fight against the opioid abuse epidemic shifts toward medical treatment in the U.S...Alkermes Plc’s Vivitrol, a $1,300-a-month shot that helps kill the high from painkillers and heroin, is poised to get a sales boost after President Barack Obama’s recent push to give millions of Americans better access to addiction medicines through expanded Medicaid coverage and extra budget funding...Alkermes is getting support from governors, police chiefs and judges who helped start more than 100 programs offering Vivitrol with counseling across 30 states...Nobody steals Vivitrol. Nobody traffics it unless they want to get sober...Vivitrol’s sales revival 10 years after its introduction is unusual in the pharmaceutical industry...The active ingredient in Vivitrol, naltrexone, binds to the same receptors in the brain as opioids and blocks the pleasurable feelings associated with taking narcotics...Designing drugs for addicts comes with thorny challenges: How do you prevent addicts from becoming addicted to the addiction treatment, and how do you prevent them from selling it to other addicts?
- Investor group launches campaign to curb antibiotic use in food (reuters.com)
Fifty four large investors managing 1 trillion pounds ($1.41 trillion) in assets have launched a campaign to curb the use of antibiotics in the meat and poultry used by ten large U.S. and British restaurant groups...McDonalds and JD Wetherspoon were among those to receive a...letter from institutions including Aviva Investors asking them to set a timeline to stop the use of medically important antibiotics in their supply chains...The other eight approached were Domino's Pizza Group, Brinker International, Darden Restaurants, Mitchells & Butlers, Restaurant Brands International, Restaurant Group, The Wendy's Company and Yum! Brands...The move follows warnings from the World Health Organization that the world is moving towards a post-antibiotic era in which many infections would no longer be treatable because of the overuse of antibiotics...Drug-resistant infections could cost the world about $100 trillion in lost output by 2050...
- Medicare ‘hospital star rating’ may correspond to patient outcomes (reuters.com)
The Centers for Medicare and Medicaid Services has been letting patients grade their hospital experiences, and those "patient experience scores" may give some insight into a hospital’s health outcomes...Some people have been concerned that patient experience isn’t the most important factor to measure...Medicare has been putting a lot of data out for a long time, but the broad consensus has been it’s very hard for consumers to use this info...CMS responded by giving out star ratings that consumers can understand easily...The five-star rating system is based on patients’ answers to 27 questions about a recent hospital stay...If you use the star rating you’re more likely to end up at a high quality hospital...But I wouldn’t use only the star rating to choose a hospital...
- Four Takeaways From The National Rx Drug Abuse And Heroin Summit (forbes.com)
At the end of March, over 1,900 people convened in Atlanta, Georgia, at the National Prescription Drug Abuse and Heroin Summit, with attendees including advocates, clinicians, treatment providers, law enforcement officers and government officials…first time heroin was included in the conversation...The conference was put on by Operation UNITE…Of the many discussions held at the summit, the primary takeaways in continuing the fight against opioid addiction include:
- Reduce Demand
- Clinician Education
- Holistic Approach
- Collaboration
- 9 Drugs That Cost Medicare a Fortune (fool.com)
...Medicare is in trouble...The program -- designed to protect our nation's senior citizens by covering some of the eligible costs tied to their hospitalization and outpatient care -- is on an unsustainable course...the Hospital Insurance Trust Fund stands just an estimated 14 years away from burning through its excess cash reserves...2030 would be the year Medicare's HI Trust exhausts its cash reserves...Once the cash reserves...are exhausted, hospitals would only be reimbursed at a rate commensurate to what the program brings in via payroll tax revenue...Medicare's prescription drug problem...prescription drug costs that Medicare Part B covers...include injections given on an outpatient basis by a physician...the real culprits the GAO report identified for rising Medicare Part B expenses are new Part B prescription drugs...between 2007 and 2013, new prescription drug introductions...83 in total, added $5.4 billion in costs to Part B...almost two-thirds of Part B new drug treatments are for ophthalmologic or cancer-based diseases...these are not inexpensive indications...Nine drugs wreaking havoc on Medicare's bottom line (total expenditures in 2013)...
- Lucentis: $1.37 billion
- Eylea: $1.09 billion
- Prolia: $665 million
- Treanda: $332 million
- Lexiscan: $257 million
- Yervoy: $224 million
- Privigen: $184 million
- Provenge: $183 million
- Soliris: $150 million
- WADA makes meldonium U-turn, could affect Sharapova ban (reuters.com)
Athletes who tested positive for meldonium before March 1 could have bans overturned less than four months before the Rio de Janeiro Olympics after WADA said it was unable to establish how quickly the drug...cleared the human body...The World Anti-Doping Agency's notice to national anti-doping bodies is expected to have a major impact on many of the 172 athletes who have tested positive for the performance-boosting drug since January...They include five-times grand slam tennis champion Maria Sharapova, who was among 40 Russian athletes to test positive for the drug after it was added to WADA's list of banned substances in January...In these circumstances, WADA considers that there may be grounds for no fault or negligence on the part of the athlete...adding that the presence of less than one microgram of meldonium in the samples was acceptable...The fact that WADA felt compelled to issue this unusual statement now is proof of how poorly they handled issues relating to meldonium...The Russian Sports Ministry supports and welcomes the decision made by WADA because it has shown a willingness to understand the situation, rather than stick to the rulebook...WADA has demonstrated impartiality and being objective in the fight against doping...
- California bill would require drug makers to report 10 percent price hikes (statnews.com)Pharmaceutical Cost Transparency Act - AB 463 (leginfo.ca.gov)
In the latest effort to push back against drug costs, the California legislature will hold a hearing on Wednesday to review a bill that would require companies to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would have to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move...The legislation, which would also require insurers to provide regulators with spending data on prescription medicines...The...bill "will bring prescription drugs in line with the rest of the health care sector by shedding light, for the first time, on those drugs that are having the greatest impact on our health care dollar," said state Senator Ed Hernandez...The Pharmaceutical Research and Manufacturers of America...in its own letter opposing the bill, argued that the reporting requirements are "extraordinarily broad" and would potentially apply to many drugs for which the impact of a price hike on insurance premiums would be "essentially" minimal and "would reflect an imperceptible change in the total cost of care."...BioCom maintained that the bill fails to require payers and pharmacy benefits to similarly disclose their reasons for increasing copayments, deductibles, and out-of-pocket expenses for consumers...
- CRISPR Dispute Raises Bigger Patent Issues That We’re Not Talking About (realclearhealth.com)
The worlds of science, technology and patent law eagerly await the...government’s decision on who deserves patents on what many have referred to as the biotechnology invention of the century: the CRISPR/Cas9 gene-editing technique...Scientists hail CRISPR/Cas9 as more accurate and efficient than other, now-traditional genetic engineering methods...CRISPR has generated worldwide debate about how it could accelerate the manipulation of plants, animals and even human beings at the molecular level. That some DNA modifications can be passed on to future generations raises particular concern...But the patent dispute, focusing on whether scientists at the Broad Institute of MIT and Harvard or those at University of California, Berkeley invented the technology, seems far from these ethical concerns...the...Patent and Trademark Office, which will make a decision in the next few months...But amid all the breathless anticipation, we’ve been ignoring two important lessons from the CRISPR/Cas9 patent dispute: patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.
- Do we need patents to stimulate innovation?
- Power of patents, in absence of regulations
- CRISPR’s future use in one institution’s hands