| Date | Title | Description |
| 04.06.2024 | FDA panel votes against MDMA for PTSD, setting up hurdle to approval | Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on... |
| 03.06.2024 | Health | Psychoactive drugs are having a moment. The FDA will soon weigh in | Proponents hope the efforts could yield the first major new therapies for mental illness since the introduction of modern antidepressants in the 1980s. But not all researchers are convinced that their benefits have been validated, or proper... |
| 03.06.2024 | Landmark review spotlights challenge of judging psychedelic therapies | figcaption>span]:font-sans">
The challenges of mainstreaming psychedelic therapies for conditions like PTSD, anxiety and major depression will be brought home this week when federal drug advisers scrutinize what could be the firs... |
| 28.05.2024 | Psychoactive drugs like ketamine and MDMA are having a moment. The FDA will soon weigh in. | Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives.
Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endure... |
| 14.05.2024 | Zerigo Health and Nextiva Partner to Expand Benefits for Employees with Chronic Skin Conditions | Connected Communications company now offers employees with psoriasis, eczema, and vitiligo a proven, at-home phototherapy treatment option
Offering Zerigo’s Skin Health Platform as part of our already robust benefit plans enables us to prov... |
| 13.05.2024 | Health | Breakthrough therapies are saving lives. Can we afford them? | The prices aren’t yet unmanageable, because so few people are currently treated. Patients must travel to designated treatment centers, and too few are referred by community physicians. But demand should increase as more treatments are intro... |
| 15.02.2024 | Weight-Loss Drugs: Cost and Cost-Effectiveness | Drugs like Wegovy and Zepbound are effective in helping people lose weight, but the high price tag keeps them out of reach for many. Our series on weight-loss drugs continues with a look at the drugs’ cost and whether they are cost-effectiv... |
| 07.02.2024 | House Budget's new math on weight-loss drugs | With one unanimous vote, the House Budget Committee this week may have significantly boosted the prospects for legislation to extend Medicare coverage to blockbuster weight-loss drugs.
The Preventive Health Savings Act, approved 30–0 Tuesda... |
| 11.12.2023 | The prices of 8 drugs were hiked without proof of new benefits, costing the U.S. $1.2 billion in 2022, report finds | During 2022, drugmakers substantially raised prices on eight widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $1.2 billion last year, a... |
| 13.11.2023 | AMA urges coverage of obesity treatments as payers balk at costs | WASHINGTON – The American Medical Association called on insurance companies, employers, and government programs to cover obesity treatments even as many remain reluctant to pay for them, fearing the costs of covering the drugs at a mass sca... |
| 03.11.2023 | State Prescription Drug Affordability Boards could end up limiting access to the life-saving cystic fibrosis medication Trikafta | I was living on the precipice of end-stage disease when I enrolled in the clinical trial that resulted in the historically fast Food and Drug Administration approval for the game-changing cystic fibrosis drug Trikafta. Five years later, the... |
| 10.10.2023 | Robert F. Kennedy is pitching centrism on health care, even on abortion | You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter in your inbox on Tuesdays and Thursdays. What RFK’s new lane means
Robert F. Kennedy is officially running for president as an independent. In a Monda... |
| 25.07.2023 | Rigorous Data Are Key to Convince Payers, Investors in the World of Digital Therapeutics | The most common and easiest way to take medicine is by swallowing a pill. For a new class of therapies, dosing is even easier—just a few finger taps on a touchscreen. The now-defunct Pear Therapeutics was a pioneer among companies developin... |
| 24.07.2023 | Drug pricing and the ‘impossible trinity’ for patients | You don’t have to be an economist to understand the law of demand: The higher the price, the less likely a customer is to buy a product. This, of course, limits how much companies can charge.
The law of demand applies to pharmaceuticals, bu... |
| 01.07.2023 | BioMarin’s Next Roctavian Challenge Is How To Successfully Commercialize Its Gene Therapy: Warranties May Be An Option | This photo provided by BioMarin in June 2023 shows a vial and packaging for their gene therapy, ... [+] Roctavian. On June 29th, the FDA approved Roctavian for hemophilia A. (BioMarin via AP)BioMarin |
| 16.06.2023 | The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab | Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured an unusual sentiment: optimism inflected with worry.
Optimism because, after years of failed studies and the disastrous accelerated approv... |
| 02.06.2023 | New CMS Alzheimer's drug coverage plan raises questions around worth | A Medicare plan for covering new Alzheimer's drugs treatments is reviving thorny questions about whether pricey treatments with modest success slowing the disease's progression are worth the cost and safety concerns.
Driving the news: The C... |
| 25.05.2023 | Pfizer's Paxlovid still free, for now, after FDA grants full approval to COVID drug | The Biden administration will continue to manage the distribution of free courses of Pfizer's Paxlovid treatment for COVID-19 for at least another few months, the drugmaker said, even after the Food and Drug Administration granted Pfizer fu... |
| 12.05.2023 | FDA approves drug called Veozah to treat hot flashes resulting from menopause | The Food and Drug Administration announced Friday it has approved a new kind of drug to treat moderate to severe hot flashes caused by menopause, which could offer relief to millions of women who do not want to take hormone therapy to treat... |
| 25.04.2023 | Experts Raise New Questions About The Safety Of Anti-Alzheimer’s Drug Leqembi | Cells in an Alzheimer’s affected brain, with abnormal levels of the beta-amyloid protein clumping ... [+] together to form plaques that collect between neurons and disrupt cell function. (National Institute on Aging, NIH via AP)Associated P... |
| 18.04.2023 | What the recent failures of Mindstrong and Pear tell us about the future of digital mental health | Over the past five years, digital mental health has risen from a niche topic to a global health priority. Patients, researchers, regulators, and investors alike are thrilled by the potential of ubiquitous mobile technology like smartphones ... |
| 13.04.2023 | The lives at stake in the battle over Ozempic | Redeem now
Like millions of other Americans, Darrell desperately wants to lose weight.
The 76-year-old retiree from Aurora, Colorado, has severe obesity along with a number of other conditions, including high cholesterol, sleep apnea, and c... |
| 10.04.2023 | Don't Let Progressives Assign A Dollar Value To Human Life | WASHINGTON, DC - MARCH 23: Representative Cathy McMorris Rodgers (R-WA), chair of the House Energy ... [+] and Commerce Committee speaks to the media on March 23, 2023 in Washington, DC. (Photo by Tasos Katopodis/Getty Images)Getty Images |
| 22.03.2023 | The much-maligned ‘quality-adjusted life year’ is a vital tool for health care policy | Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year (QALY) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warn... |
| 11.03.2023 | Medicare Doesn’t Pay For Obesity Drugs: Lifting This Coverage Prohibition Faces Considerable Hurdles | Medicare does not reimburse weight-loss medications. It's possible this restriction will be lifted ... [+] soon.getty |
| 11.03.2023 | Covering new weight loss drugs could strain Medicare, policy experts warn | The emergence of highly effective obesity drugs has spurred renewed efforts to get Medicare to pay for weight loss medications, but a group of health policy experts is sounding caution.
Even a small amount of uptake would create significant... |
| 10.03.2023 | Вакцина от спинально-мышечной атрофии(СМА). Почему она такая дорогая? | СМА — спинально-мышечная атрофия. В организме из-за генетической мутации перестаёт работать ген SMN1, производящий SMN-белок. Недостаток белка в свою очередь приводит к гибели моторных нейронов, то есть нервных клеток, отвечающих за движени... |
| 02.03.2023 | Same patient, same drug, same insurer — coverage denied | Janice Morales-Ferrer is a planner. It’s helped her get ahead in her career and in raising three young kids. But it’s hard to plan when you’ve got a rare disease, especially one with no standard treatment regimen or predictable outcome.
“I’... |
| 16.02.2023 | When Launched, Gene Therapy Roctavian Will Be Administered Mainly In 340B-Eligible Treatment Centers, Where It Will Be Substantially Discounted In Price | Gene editing in vitro.getty |
| 08.02.2023 | What the end of the COVID-19 emergency means for free vaccines, health data and more | The Biden administration is planning to end the COVID-19 emergency declarations on May 11, and expects to run out of government-bought vaccines and treatments as soon as this summer and fall.
Those moves could spell the end for a wide range... |
| 08.01.2023 | FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review | An Eisai drug that addresses an underlying mechanism associated with Alzheimer’s disease progression has won FDA approval, a regulatory decision that echoes a prior drug approval in the neurodegenerative disorder while also establishing new... |
| 02.01.2023 | With FDA Accelerated Approval Of Alzheimer’s Drug Lecanemab Likely January 6th, Discussion Turns To Price And Reimbursement | FILE - This file photo shows a closeup of a human brain affected by Alzheimer's Disease. Lecanemab, ... [+] a beta amyloid-directed monoclonal antibody, has demonstrated modest efficacy - slowing cognitive decline - in a Phase 3 study. (AP ... |
| 01.01.2023 | The Aduhelm Operetta: ‘I’ve got a little list’ | The Congressional report on the FDA’s approval of Aduhelm makes some good points. As regulatory science advances, so too must the FDA’s administrative procedures.
But this report mustn’t be seen as an excuse for the agency to hew to a 20th ... |
| 23.12.2022 | New Alzheimer’s Drug Could Be Priced Up to $20,000 a Year: Group | Essai and Biogen could price their new Alzheimer’s drug as high as $20,000 a year, according to a draft report from an influential group.
The Institute for Clinical and Economic Review, which issues recommendations on drug pricing, said tha... |
| 22.12.2022 | Eisai and Biogen’s latest Alzheimer’s drug needs to be cheaper than the last one, analysts say | The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.
The Institute for Clin... |
| 02.11.2022 | What causes hot flashes? Astellas ramps up educational campaign ahead of FDA decision | Astellas’ fezolinetant isn’t due for an FDA decision until February in vasomotor symptoms (VMS) associated with menopause — but the pharma company isn’t waiting until then to educate women about what’s causing their... |
| 11.10.2022 | New generation of weight loss medications offer promise — but at a price | Excitement is building about a new generation of drugs that tout the ability to help adults with excess weight shed more pounds than older drugs on the market.
Some patients, obesity medicine specialists say, are experiencing decreases in b... |
| 30.09.2022 | Cost of Amylyx ALS drug revives pricing debate for new meds in rare diseases | Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio will reach the market carrying a premium $158,000 a year price without a requirement that the company produce the clinical data to support it.
Approval of the Amylyx ... |
| 31.08.2022 | ICER reaffirms Qsymia as most cost-effective obesity treatment in final report | Last July, the cost-effectiveness drug watchdog ICER released a preliminary draft report that Vivus’ Qsymia was the most cost-effective option for weight loss. That decision has now been validated.
ICER made its final de... |
| 01.06.2022 | The Access to Rare Indications Act could be a game changer for millions of Americans | The term “medically necessary” is the yardstick by which insurance companies, including Medicare and Medicaid, decide if they will pay for a particular treatment. For the millions of Americans living with rare diseases, most of which do not... |
| 10.05.2022 | ICER: Merck's Covid-19 pill doesn't show 'net health benefit' but price is reasonable | The Institute for Clinical and Economic Review, a pharma drug pricing watchdog, recently dug into the data on three Covid-19 therapeutics, voting 11-2 that there is not enough evidence to demonstrate a “net health bene... |
| 03.02.2022 | A rarity for ICER: Cost watchdog says Covid-19 therapeutics appropriately priced in the US | Known as a fervent watchdog over the prices and cost-effectiveness of new pharmaceuticals, the Institute for Clinical and Economic Review (ICER) said in a report published early Thursday that all four Covid-19 outpatient treatments’ prices ... |
| 04.01.2022 | Multiple blockbusters from Gilead, Pfizer, Vertex see (list) price hikes to start 2022 | Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potenti... |
| 23.12.2021 | What’s Behind Biogen’s Move To Cut Prices On Its Controversial Alzheimer’s Drug Aduhelm? | CAMBRIDGE, MA- March 21, 2019: Biogen headquarters. (Staff photo By Nicolaus Czarnecki/MediaNews ... [+] Group/Boston Herald) (Photo by Nicolaus Czarnecki/MediaNews Group/Boston Herald via Getty Images)MediaNews Group via Getty Images |
| 23.12.2021 | FDA nod for Novartis sets up cholesterol drug showdown with Amgen, Regeneron | The FDA has approved a new cholesterol-lowering drug from Novartis that addresses the same target as two commercialized medicines from Amgen and Regeneron, but with a different approach and a key dosing advantage—just two injections per yea... |
| 20.12.2021 | Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms | Prescriptions and insurance coverage of Alzheimer’s disease drug Aduhelm have been slow, and drugmaker Biogen is slashing the therapy’s price in half in an effort to move the needle on sales. The price cut comes as a Center for Medicare and... |
| 24.11.2021 | Why Are Drug Prices So High? Because Asshole McKinsey Consultants Figure Out Ways To Re-Patent The Same Drugs Over And Over | The House Oversight Committee recently launched an investigation into the giant consulting firm McKinsey, and its role in inflating drug prices as well as pushing opioids at every opportunity. |
| 19.11.2021 | Connect Biopharma celebrates a mid-stage win for its Dupixent rival, but shares tank after investors clamor for data | A suite of drugmakers is looking to topple Dupixent in the eczema market — and on Thursday, China-based Connect Biopharma uncorked some mid-stage results it says will pave the way to a pivotal trial. But investors want hard ... |
| 19.11.2021 | FDA delays its decision on Bristol Myers' $13B heart drug another three months | Last week, Bristol Myers Squibb marched out long-term data for its heart drug mavacamten ahead of what execs had hoped would be a positive FDA decision in January. But regulators are saying they need a bit more time to think.... |
| 19.11.2021 | FDA opens up an ethical can of worms with accelerated approval for first drug for underlying genetic cause of dwarfism | The FDA on Friday signed off on an accelerated approval for BioMarin’s Voxzogo (vosoritide) injection, the first treatment to target the underlying genetics of dwarfism, which can increase the height of children five ye... |
| 16.11.2021 | The prices of 7 drugs were hiked without proof of new benefits, costing the U.S. $1.6 billion in 2020 | During 2020, drug makers raised prices on seven widely used medicines by substantial amounts without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $1.67 billion l... |
| 16.11.2021 | UPDATED: ICER finds unsubstantiated drug price increases cost US $1.67B in 2020, but overall net increases lower than years past | The Institute for Clinical and Economic Review on Tuesday morning released its latest on “unsupported” drug price increases for seven top treatments, and how even after rebates and other concessions, these increases... |
| 21.10.2021 | Exclusive: Athira CEO Leen Kawas resigns after investigation finds she manipulated data | The ink has barely dried on AstraZeneca’s $39 billion deal to swallow Alexion back in July. But independent drug watchdog ICER has been crunching the numbers, and it decided that the star of the deal — rare disease moneymaker Soliris — is g... |
| 14.10.2021 | The hidden cost of Covid-19: years of life lost among the young | Body counts appear to support the common perception that Covid-19 does its worst damage among the old and vulnerable. But body counts mask another reality, and focusing on them is skewing policy decisions and individual choices.
There’s no ... |
| 14.06.2021 | Doctors fear a controversial new Alzheimer's drug will get in the way of better treatments | The FDA recently approved a new Alzheimer's drug called Aduhelm, but it isn't clear that the treatment works. Skye Gould/Insider This story is available exclusively to Insider subscribers. Become an Insider and start reading now.
Sign up fo... |
| 30.05.2021 | If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it | Most visits to the memory center where I care for individuals living with Alzheimer’s disease end in disappointment.
“Are there any new treatments, Dr. Karlawish?” patients or family members hopefully ask.
I shake my head and say, “No.”
adv... |
| 07.05.2021 | Rather than turning its back on the QALY, pharma should collaborate on efforts to improve it | A key element in the long-simmering debate on reining in drug prices in the United States is how to ensure that prices are affordable, represent a sufficient reward to industry for the innovation it provides, and reflect the benefit that pa... |
| 13.04.2021 | 3 changes coming to drug pricing | The time is right for new thinking. Thanks to the development of Covid-19 vaccines in record time, pharma’s image among consumers — and the political leaders representing them — has earned a well-deserved boost.
No matter if Democrats or Re... |
| 13.02.2021 | Another Keytruda combo tops standard of care in advanced kidney cancer, posing new test for Bristol's I/O med | In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.
Price i... |
| 31.01.2021 | The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work | Remdesivir in a syringe.getty |
| 20.01.2021 | Drug price hikes without new evidence upped spending by $1.2B, ICER says | “These are not cherry-picked niche drugs, or some sort of outlier situation,” ICER spokesman David Whitrap said in a phone interview. “These are the costliest price increases for our country and of those ten, seven of them have no evidence ... |
| - | A biotech CEO plans to charge up to $3 million for a gene therapy — but he'll offer a money-back guarantee if it doesn't work | Jean-Jacques Bienaimé, the CEO of BioMarin Pharmaceutical. BioMarin Pharmaceutical This story is available exclusively to Insider subscribers. Become an Insider and start reading now.
The biotech BioMarin is preparing to launch its hemophil... |
| - | Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms | Prescriptions and insurance coverage of Alzheimer’s disease drug Aduhelm have been slow, and drugmaker Biogen is slashing the therapy’s price in half in an effort to move the needle on sales. The price cut comes as a Center for Medicare and... |
| - | Trending in gene therapy, independent organization highlights value and cost effectiveness | Gene therapy — a medical approach that treats diseases by addressing the underlying genetic problem — is ushering in a new era of medicine. With a one-time treatment, gene therapy has the potential to dramatically impact the lives of people... |
| - | Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease | A Bristol Myers Squibb drug that the pharmaceutical giant added to its pipeline via a multi-billion dollar acquisition now has FDA approval, a decision that makes it the first authorized treatment for a rare inherited heart disorder that ca... |
| - | FDA nod for Novartis sets up cholesterol drug showdown with Amgen, Regeneron | The FDA has approved a new cholesterol-lowering drug from Novartis that addresses the same target as two commercialized medicines from Amgen and Regeneron, but with a different approach and a key dosing advantage—just two injections per yea... |
| - | 3 changes coming to drug pricing | Pounded by both sides of the political aisle, pharmaceutical companies know what it feels like to be whipsawed by opposite ends of the American reimbursement system.
Two weeks after the November election, President Trump announced a new mod... |
| - | Drug price hikes without new evidence upped spending by $1.2B, ICER says | BMS
The Institute for Clinical and Economic Review (ICER) published its second-ever report on Unsupported Price Increases (UPI) last week, compiled from data supplied by SSR Health, which is part of the investment research firm SSR.
While t... |
| - | Aduhelm’s loss is a win for value-based drug pricing | The latest–and perhaps final–blow to the once-promising Alzheimer’s Disease medication Aduhelm came when its maker, Biogen, said it will stop collecting data on patients who are using it. Biogen said this was a result of Medicare and Medica... |
| - | Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi | The new Alzheimer’s treatment Leqembi will cost an estimated $26,500 per year, according to Eisai, the company that led the drug’s development.
Most seniors who are eligible for Leqembi will have to pay out of pocket because Medicare has li... |
| - | Value creators or financial destroyers? The potential of gene therapies to transform healthcare | Transforming lives
A college student able to fully participate in class and sports without worrying about joint bleeds, bruising, and sticking out as he sticks himself with his self-administered medicine. A thriving baby whose genetics woul... |