- House Just Passed the Biggest Health Reform Bill Since Obamacare (fortune.com)
The House of Representatives on Wednesday night overwhelmingly passed wide-ranging legislation meant to overhaul the drug approval process, boost biomedical research, and many other significant health-related policies. The so-called 21st Century Cures Act was approved on a 392-26 vote and will head to the Senate for consideration next week...The bill aims to speed up the approval for drugs and medical devices through a variety of tweaks to the Food and Drug Administration. But it also encompasses a host of other big initiatives, including more than $5 billion in funding for the National Institutes of Health and money to help the FDA; $1 billion for tackling the opioid epidemic; and provisions that are meant to help pair Americans who suffer from serious mental illnesses with available psychiatric beds...
- Pharma-to-physician social media and app marketing will soar by 2018: report (fiercepharma.com)
Pharma companies’ marketing communications to their target audience of healthcare providers are increasingly digital. That's not terribly surprising, considering the uptake in digital channels among physicians for professional use...What is changing…is the way pharma reaches doctors...In 2016 in the U.S., brand promotional emails, healthcare provider portals and key opinion leader webinars are the top three ways pharma companies reach out...by 2018, KOL webinars, social media and mobile apps will top the list, with social media and mobile apps growing the fastest, by 50% and 27%, respectively...Social media is a very powerful channel that can help in understanding the end consumers. It’s easy to make marketing decisions like segmentation, course of patient education, and influence adherence through listening and analysis of the social behavior...
- 8 Things to Know About Biosimilars (medscape.com)
With the recent US Food and Drug Administration approval of a fourth biosimilar medication, these compounds remain a hot topic in many areas of medicine, including nephrology, oncology, endocrinology, gastroenterology, and rheumatology…Despite the growing body of knowledge about biosimilars—and despite their increasing coverage in peer-reviewed journals and presentations—a recent Biosimilars Forum press release reveals that more physician education is needed about these medications...
- What Are Biosimilar Medications?
- What Is the Approval Process of Biosimilars?
- How Many Are Approved, and for What Conditions?
- What Does 'Interchangeable' Mean?
- What Is Extrapolation?
- Are Biosimilars Safe, and Can They Be Trusted?
- Do Patients Know and Trust Biosimilars?
- How Do the Costs of Biosimilars Compare to Biologics?
- Juno says two more patients die in leukemia drug trial (reuters.com)
Juno Therapeutics Inc said two more patients had died after suffering brain swelling during a trial of its experimental genetically engineered leukemia drug, bringing the total up to five...Juno said...it had voluntarily put the mid-stage study on hold and informed the U.S. Food and Drug Administration earlier this week...The company is still evaluating the cause of the deaths and has not yet decided whether it will continue developing the drug...JCAR015 is an experimental chimeric antigen receptor T-Cell therapy...The FDA, which had imposed a hold on the trial after the first three deaths, lifted it soon after Juno agreed to revert to its original drug regimen that excluded fludarabine...The elimination of fludarabine reduced toxicity but has not proved to be the only contributing factor...
- Drug regulation: 27 medicines sold by top firms ‘fail’ quality tests in seven states (indianexpress.com)
In a major crackdown...the drug regulators of seven states have alleged that 27 medicines — sold by 18 major drug companies in India including Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma — are of "substandard" quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test...These include key drug brands of eight top-tier companies, which are the leaders in their respective molecule categories with a market share ranging from 47 per cent to 92 per cent. Of the 18 companies, only two said they had stopped sale of the affected drug batches and just one said the affected batch had been recalled from the market...Only eight companies responded to specific queries sent by The Indian Express on the findings of the regulators. Among the reasons they cited were: drug batches were picked up for testing from an "unofficial distributor"; no "labelling requirement" as drug batch was meant for the World Health Organisation; a batch of "counterfeit" drugs were picked up for testing; test conducted on the drug was "not necessary"; testing methodology "incorrect"; the company was doing contract manufacturing for someone else; "inappropriate storage" and "handling" in the marketplace (retailer).
- 21st Century Cures would require pharma to post policies on experimental drugs (statnews.com)21st Century Cures bill would weaken requirements for disclosing industry ties (statnews.com)Bernie Sanders attacks the 21st Century Cures Act and pharmaceutical industry ‘greed’ (statnews.com)
In a nod to patients clamoring for greater access to experimental medicines, the 21st Century Cures legislation would require companies to publicly disclose their policies for making such drugs available...The language in the bill, which is designed to jump start medical innovation, appeared after complaints that many drug makers make it difficult for patients and their physicians to sort out the process for gaining access to medicines that are not yet approved for use by the Food and Drug Administration...only 19 of 100 drug makers publicly post policies about their programs for obtaining experimental medicines...only one of those companies posted information about specific procedures for making requests, and this company did not list any contact information…the findings underscored arguments by patient advocacy groups and lawmakers that the process for gaining access to experimental medicines is unwieldy, which has also generated criticism of the FDA...
- GAO Releases Compounding Report (iacp.site-ym.com)
The U.S. Government Accountability Office has published a report...on compounding entitled “ Drug Compounding – FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges.”
- Teva inks trailblazing cannabis pact with Israel’s Syqe Medical (fiercepharma.com)
Teva has struck a new marketing agreement, and it’s one that’ll help the Israeli drugmaker blaze a new trail in the drug industry...The pharma has inked a pact that will make it the only distributor in Israel of local company Syqe Medical’s cannabis inhaler, the companies...without disclosing any financial data on the agreement. Teva will also help Syqe set up a support and instruction team of nurses for patients and healthcare providers...Israel boasted about 26,000 medical cannabis consumption licenses—a figure that’s expected to double by 2018...And with licensed patients spending an average $100 per month on cannabis, the revenue potential is there for Teva if the company can get the inhaler selling.
- Health-insurance commission cuts make it harder for consumers to get expert help (reviewjournal.com)
As insurance companies nationwide look for ways to cut costs, commissions for individual plans have been reduced and in some cases eliminated...That has led many of the hundreds of brokers and agents in Nevada to focus on other more-profitable sectors and made it harder for shoppers to find help navigating the complicated and confusing marketplaces for individual health insurance, either private or via the Affordable Care Act exchange...On the Silver State Health Insurance Exchange, the state’s official portal for so-called Obamacare plans, the number of brokers and agents registered to assist users declined from roughly 500 last year to about 150 this year…Nevada’s largest insurer, UnitedHealthCare, said that it will still pay commissions on renewals, though at a lower rate, but not on new policies...Our actions are consistent with our long-stated approach to continually evaluate the dynamics of the market as they evolve, and to refocus our resources as necessary so that we can provide consumers with access to quality care…
- Sandoz to donate up to $10 million in generics to Americares (drugstorenews.com)
Sandoz...announced that it would be donating up to $10 million in generic medicines annually to Americares, an organization that responds to those affected by poverty or disaster with health programs, medicine and medical supplies. The initial donation will include more than 25 Sandoz products for treatment of infections, cardiovascular condition, eyecare, skin conditions and musculoskeletal pain…Limited access to healthcare poses a significant barrier to long-term social and economic development around the world...Sandoz has partnered with Americares since 1989 and Novartis and Sandoz have donated more than $230 million worth of medicine to the organization since then...