FDA nixes Evoke Pharma’s gastro nasal spray

The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis.

The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.

Get the full story on our sister site, Drug Delivery Business.

Cigna lowers insulin price to $25 per month

Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients.

Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. Insulin list prices regularly increase by double digits annually, according to the FDA, which attributed the price hikes to a lack of competition.

Get the full story on our sister site, Drug Delivery Business.

FDA chief to big pharma: ‘End the shenanigans’

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prescription drugsFDA commissioner Dr. Scott Gottlieb yesterday scolded pharmaceutical companies that employ tactics to stifle generic drug competition, calling on them to “end the shenanigans.”

At this week’s Federal Trade Commission meeting on competition within the pharmaceutical industry, the FDA chief called out brand-name pharma companies for trying to extend negotiations over risk evaluation and mitigation strategies, or REMS, to stall generic companies from buying a product to run bioequivalence studies.

Get the full story at our sister site, Drug Delivery Business News.

Startup aims to disrupt asthma, COPD space with digital inhaler

  • How a versatile epoxy is enabling brain stimulation

    Rohit Ramnath, Senior Product Engineer, Master Bond In but another example of how useful and critical epoxies can be, researchers in Israel used a two-part epoxy to construct a magnetic coil to stimulate animal brain neurons via a magnetic field. Designers of medical electronics assemblies have many options to choose from when selecting one or […]

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    By Stewart Eisenhart, Emergo Group Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]

  • How middleware is changing medtech

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  • How have medtech launches and prototyping evolved with 3D printing?

    Here are three basic ways that 3D printing can help you get your medical device project off the ground. Jim Medsker, Keystone Solutions Group Additive manufacturing, commonly referred to as 3D printing, began to surface in the 1980s. Since then, the technology has quickly become a valuable tool for creating plastic prototype parts in a rapid […]

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  • Report: Q3 medical device recalls down 39%

    Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]

  • West Pharma posts Street-beating Q3 earnings, sales

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    Integer today posted third quarter earnings that beat expectations on Wall Street. The Frisco, Texas-based company posted profits of $13.7 million, of 43¢ per share, on sales of $363.3 million for the 3 months ended September 29, seeing bottom-line growth of 19.5% while sales grew 4.8% compared to the same period last year. Adjusted to […]

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    The expanding ecosystem of microbiome startups

    More funding and another powerful pharma backer have entered the microbiome space, showing that at least some investors and pharma execs believe the field can begin converting preclinical ideas into valid human therapies.

    Finch Therapeutics

    Somerville, Massachusetts-based Finch Therapeutics announced a new agreement with Takeda Pharmaceuticals on Wednesday, a solid endorsement of its sophisticated bioinformatics platform.

    Along with oncology and central nervous system disorders, gastrointestinal diseases are one of Takeda’s three therapeutic pillars. As part of the deal, Takeda will pay an upfront $10 million for exclusive worldwide rights to FIN-524, an investigational drug for ulcerative colitis, and any follow-on products for irritable bowel diseases (IBDs). Ulcerative colitis is a form of IBD in which the immune system attacks the lining of the large intestine.

    Finch’s science taps into the high-potential, highly-unpalatable concept of a fecal transplant. It involves transferring a microbiota rich stool sample from a healthy individual into someone with severe gut dysbiosis.

    It’s a smart approach, given how little we know about the many thousands of microbial strains that occupy our guts. Instead of adding them to a therapy one-by-one, scientists can take a sample ecosystem that is already known to work. Finch then has a feedback loop in place to determine how patients responded to the different donor cultures.

    “By working from clinically annotated datasets of donor and patient microbiota before and after fecal transplantation, we can look for the patterns in changes to the patients’ microbiota associated with targeted clinical outcomes,” said Finch CEO Mark Smith in an email forwarded by a company representative.

    It underscores how variable our microbiomes are, whether we’re healthy, sick, or somewhere in between.

    Smith cited a 70-patient randomized control trial of fecal transplants performed at McMaster University (Moayyedi et al, 2015). Five donors were used in the study, but just one, Donor B, had a demonstrably large therapeutic effect. Without Donor B, the study would have failed.

    Just how much Kombucha was Donor B drinking? And how do we learn from the strength of that participant’s microbiota? Finch is working to answer the latter.

    Azitra

    While gut bacteria and the microbiome are often used interchangeably, our microscopic citizens really populate our entire body, including the skin. That’s the target for Farmington, Connecticut-based Azitra.

    Azitra announced on Wednesday that it had closed a $2.9 million Series A venture round led by Bios Partners. With earlier seed funding, including from Peter Thiel’s Breakout Labs program, the startup has raised $3.75 million to date.

    Rather than brewing a complex bacterial concoction, Azitra has identified one key bacteria strain for its lead candidate, AZT-01, to be applied as a cream to affected skin. In its cross-hairs for treatment are eczema, rare genetic skin diseases, and more everyday cosmetic applications such as dry skin.

    In an email forwarded by a company representative, Azitra Cofounder and CSO Travis Whitfill said the microbial treatment isn’t just a band-aid — it could address an underlying cause.

    “Studies have repeatedly shown that these patients have an imbalanced microbiome, and in the case of eczema, they often have an overgrowth of Staph aureus. There is also evidence that our strain of bacteria can kill some strains of Staph aureus, which is one of the reasons we chose it as a chassis,” Whitfill said.

    Applied topically, the good bacteria can colonize the area and begin correcting the dysbiosis.

    Photo: spawns, Getty Images

    Five things we learned about FDA nominee Scott Gottlieb

    There’s no shortage of areas to debate when it comes to FDA policies, the need for reform and the argument against the erosion of safety standards.

    In fact, there were so many drug and device-related fields to cover, President Trump’s nominee for the top job at the Food and Drug Administration Scott Gottlieb didn’t get a chance to comment on food safety, supplements, and his other potential jurisdictions.

    In Tuesday’s nomination hearing, broadcast live, the Senate Health, Education, Labor and Pensions Committee pushed other major areas to the fore.

    They included Gottlieb’s “unprecedented” industry ties, drug and device approval speeds, science versus ideology, biosimilars and generics, and Gottlieb’s biggest concern of all: the opioid epidemic.

    Handling the boss

    Both sides of the aisle seemed concerned about President Trump’s hiring freeze in government departments, including FDA. Committee chair Sen. Lamar Alexander (R-TN) addressed it directly in his opening remarks, asking how Gottlieb would lead a strong agency incapable of hiring new talent.

    According to Alexander, former commissioner Robert Califf’s top priority with the passing of the 21st Century Cures Act was to be able to hire and pay the necessary talent to review investigational drugs and devices.

    Gottlieb reiterated the importance of FDA possessing a world-class workforce, armed with the resources and tools they need to do their job.

    The most direct sentence he could summon, however, was to note that he has been vocal about the need to maintain a strong FDA workforce in the past.

    “I will continue to make my opinions known on that issue,” he said.

    Others questioned how he could maintain a science-first, objective approach while working beneath an ideological president.

    “For those who have worked with me, I haven’t been shy about offering my unvarnished advice,” Gottlieb replied. “We mentioned 866 articles I’ve written where I’ve offered very clear thoughts. I’m going to continue to offer people my very clear thoughts on whatever issues I’m asked to opine on, including my boss’s.”

    Industry interests

    Unsurprisingly, the political parties returned to their respective corners when Gottlieb’s extensive industry ties were flagged. Democrat senators were concerned about his ability to remain impartial, while Republican’s viewed it as valuable experience in the field.

    Sen. Patty Murray (D-WA) began her address by expressing disappointment in the limited amount of time the committee had to review Gottlieb’s application papers, which chronicle his many connections. The full package was received on Friday, Murray said.

    “We’ve had just a handful of days to fully understand the extent of Dr. Gottlieb’s unprecedented financial entanglements with the industries he would regulate as FDA commissioner.”

    Murray repeated the term “unprecedented” several times, as Senator Alexander reminded the audience that the most recent FDA commissioner, Robert Califf, had extensive industry ties too.

    “I’m glad to know that you’ve got a background and experience in the issues before you,” Alexander told Gottlieb.

    For his part, the nominee promised to work with ethical experts throughout his tenure. He has already withdrawn from multiple compromising positions and has met the minimum impartiality requirements for the position.

    Part of the damage can’t be undone, however, in the eyes of the Democrats. It was pointed out that, if approved, he would likely oversee regulatory filings from some of the many companies that he has consulted for or financially invested in, including Cerecor and CRISPR Therapeutics.

    Drug approvals

    As a prolific writer and speaker, Gottlieb has an established track record indicating he would like to streamline the approval process. Some committee members, particularly Sen. Elizabeth Warren (D-MA) were particularly concerned about this pro-industry approach.

    Gottlieb’s biggest message here was that it doesn’t need to be a trade-off.

    “We should reject the false dichotomy that it all boils down to a choice between speed and safety,” he said.

    The approval process can be improved from many angles, he argued, such as through adapted clinical trials that don’t infringe on the scientific rigor applied.

    “We should be reminded always that we save lives by allowing good things to happen,” Gottlieb told the committee. “But we also save lives when we keep bad things from happening.”

    Biosimilars and generics

    Sen. Mike Enzi (R-WY) floated the issue of biosimilars in question session. Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologics patents will expire, creating a major opportunity for healthcare savings.

    Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologic patents will expire, creating a major opportunity for healthcare savings.

    “I think many of us have been disappointed by the economic savings we’ve seen from biosimilars so far,” Gottlieb said. 

    His answer was concise but touched on one of the major issues; FDA giving guidelines to biologics manufacturers in a timely fashion. Uncertainty has clouded the field until now.

    He also stated that the FDA needs to answer specific questions, such as whether or not biosimilars can be used interchangeably.

    The discussion moved on, returning later to generic drugs with a question by Sen. Todd Young (R-IN) that played right into one of Gottlieb’s top priorities.

    “There are literally billions of dollars worth of drugs each year that are sold as branded drugs at high prices but should be subject to generic competition,” the nominee said in agreement.

    A huge part of the problem, Gottlieb said, was the inability of current FDA guidelines to handle new complex drugs. The standard measures for bioequivalence and bioavailability no longer suffice. That confusion prolongs the exclusivity period of the drug, as generics struggle to break into the market.

    “This is an area I want to work on,” he said.

    Opioids

    The committee and Gottlieb all agreed on the urgency of the opioid epidemic.

    “The opioid epidemic in this country is having staggering human consequences,” Gottlieb said in response to a question by Alexander. “I think this is the biggest crisis facing the agency.”

    While he said an “all of the above” approach is needed, he singled out opioid alternatives as one of the greatest opportunities to turn the tide on the crisis.

    That could include new pain relieving drugs and devices that can administer them in a more localized way. He also mentioned the need for medical options that help patients maintain sobriety.

    Photo: VladimirSorokin, Getty Images

    Have we finally turned a corner with drug pricing?

    Drug developers, economists, and politicians are smart people. But maybe a four-year-old could have predicted this one: What goes up, must come down.

    Are drug prices finally on the way down?

    Looking at some of the major 2017 approvals thus far, there is some evidence to suggest the culture is slowly shifting.

    Even Teva Pharmaceuticals appears to have turned a new leaf. On Tuesday, the Israeli company announced that its Huntington’s disease therapy Austedo (deutetrabenazine) had received an FDA nod. Rather than altering the course of the disease, it helps treat patients’ involuntary movements.

    Leerink analyst Jason Gerberry reported that Austedo will be priced at around $60,000 a year. That compares to an older version of the drug called Xenazine (tetrabenazine), which sells for $152,000 per year. A generic version goes for $96,000.

    Austedo caps off a progressive few weeks.

    In late March, Roche subsidiary Genentech got the green light to market Ocrevus (ocrelizumab) for relapsing-remitting and primary-progressive multiple sclerosis (the latter being an industry first).

    Genentech announced an intended list price of $65,000 — pretty reasonable given the drug delivered a 47 percent reduction in annualized relapse rates compared to Rebif, a first-generation MS therapy that sells for around $86,000.

    On the same day, Regeneron Pharmaceuticals’ Dupixent (dupilumab) was approved for moderate-to-severe eczema. It got stamped with a list price of $37,000 a year, a significant discount on older drugs that sell for around $50,000 per year.

    Based on EvaluatePharma’s predictions, Ocrevus and Dupixent will be the highest grossing drugs to enter the market in 2017. The pricing on those drugs matters.

    Also in March, Newron Pharmaceuticals finally earned U.S. marketing authorization for Xadago (safinamide), an iterative MAO-B inhibitor for the treatment of Parkinson’s disease. The drug was already approved for sale in Europe.

    Xadago doesn’t represent a huge therapeutic gain and Newron – to its credit –priced it that way. Without insurance, a 30-day supply of the drug will cost $670, to be marketed in the United States by US WorldMeds.

    This all comes in stark contrast to Marathon Pharmaceuticals, the outlier in the conservative pricing trend. But the public, political and industry reaction to its proposed list price speak volumes too.

    After receiving marketing approval for its Duchenne muscular dystrophy drug, Marathon slapped an $89,000 price tag on what is essentially a decades-old corticosteroid, available overseas for around $0.60 per dose.

    Marathon eventually backed down after much outcry from the media and a harshly worded letter courtesy of Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings, (D-Md.). Marathon has since sold the franchise to PTC Therapeutics.

    It seems there’s no longer any tolerance for the ‘how far can we push this’ approach. The smart players are instead asking ‘what is reasonable and sustainable in our current healthcare climate?’

    But it’s early days. A handful of good examples doesn’t signal an industry shift. That will take many more years and wider changes to the healthcare system.

    Photo: TAW4, Getty Images

    The DNA of depression: Australia launches 20,000-person genomics study

    Why do some people respond to antidepressant medications, while others gain no symptom relief at all?

    That’s just one of many million-dollar questions that confound drug developers and healthcare providers working in the field of mental health. The unknowns complicate clinical trials, treatment decisions, and of course, greatly impact patients.

    In an effort to shine some light into the gray skies of depression, Australia has launched a 20,000-person genomics study, funded by the government’s National Health and Medical Research Council.

    The resulting data and findings will feed into an international study of 200,000 individuals with depression, the largest-ever undertaking in the field.

    It’s just what the doctor ordered.

    According to a recent report by the World Health Organization (WHO), depression is now the leading cause of disability worldwide. As of 2015, some 322 million individuals were afflicted — roughly the population of the United States. Global prevalence has soared close to 20 percent in the last decade alone.

    In a 2014 Nature article, Steve Hyman, director of the Stanley Center for Psychiatric Research at the Broad Institute, called for a large-scale genomics study of over 100,000 patients to bring the field up to speed.

    “Progress in other disorders, such as autism and schizophrenia, suggest that the best hope for insights is to identify specific genetic variants associated with the disease,” Hyman wrote. “However, success in depression will require studies of much larger collections of human DNA samples than in other diseases if statistically significant signals are to come through.”

    As part of the Australian study, volunteers 18-years and older will be asked to complete a 15-minute online survey. Based on their responses, they may then be asked to submit a saliva sample for genomic analysis. The sample will be sequenced and screened for hundreds of DNA variants through a process known as ‘genome-wide association scans’ (GWAS). The investigators are particularly interested in patients who have taken medications for the disease.

    Genomic studies could unlock information about why some individuals – and families – have a greater likelihood of developing depression. The data could inform new drug development and ensure the right patients are recruited into the right trials.

    It could also help explain the variable response individuals have to antidepressant medications — a burgeoning field known as pharmacogenomics. Such tests help guide what therapies and doses may work best.

    Mayo Clinic startup OneOme has a panel that includes information on what psychotropic drugs, including antidepressants, could be well-tolerated based on the individual’s genetic makeup. Several genes relate to antidepressant efficacy, including HTR2A/GRIK4 and SLC6A4.

    “There is a clear need in the psychiatric space for objective biomarkers that allow healthcare providers to tailor treatment – and that’s where pharmacogenomics comes in,” said OneOme CEO Paul Owens in an email forwarded by a company representative. “Since genetic factors account for up to 95 percent of drug-response variability, pharmacogenomics can help physicians identify which psychiatric drugs may work best for individual patients, before they even take them.”

    While pharmacogenomics holds wide potential, a lot more information is needed to effectively treat mental illnesses the first time around. Owen also noted that the medical community has been slow to capitalize on the knowledge that does exist.

    “Unfortunately, the education and understanding of genomics – let alone pharmacogenomics in routine medical practice – is still in its infancy stage,” he said.

    There is a long way to go, but a 200,000-person genomics study is a good place to start. As Hyman wrote in nature, a basic understanding of the biology is still lacking.

    “Failures to improve efficacy reflect continued ignorance of the molecular mechanisms of depression,” he said, then noted later on; “The investments will be well worth it.”

    Photo: phototechno, Getty Images