STAT

OCTOBER 6, 2022

And this is especially true for us, since we hit the proverbial pause button yesterday to observe ancient rituals. Please feel free to join us.  Even a drug-price watchdog, the Institute for Clinical and Economic Review, deemed the $2.8 Rise and shine, everyone, another busy day is on the way.

74

74

pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

FDA 111

FDA 111

STAT

AUGUST 2, 2023

The middle of the week is upon us. Meanwhile, do keep us in mind if you hear anything interesting. … So many people have turned to drugs used for weight loss that some employers are cutting off insurance coverage to head off climbing bills , The Wall Street Journal reports. could qualify to use the drug.

Insurance Coverage 73

Insurance Coverage Insurance 73

Pharmaceutical Technology

MAY 19, 2023

DMTs for MS have a high price tag, particularly in the US. According to GlobalData’s recent Multiple Sclerosis: Seven-Market Drug Forecast and Market Analysis to 2030 – Update report, which identified 19 DMTs marketed for MS in the US, the average annual cost of therapy increased by 9% between 2020 and 2022.

98

98

pharmaphorum

NOVEMBER 19, 2020

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

FDA 64

FDA Labelling 64

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. It said the drug was the first to treat the underlying mechanism in Alzheimer’s rather than addressing symptoms.

FDA 98

FDA Labelling 98

pharmaphorum

AUGUST 21, 2022

There is still a pressing need for antidepressant therapies that can start to work more quickly than current tricyclic or selective serotonin reuptake inhibitor drugs can take weeks to elevate mood, placing severely affected patients at risk of self harm before they kick in. Photo by Sydney Sims on Unsplash.

FDA 96

FDA Labelling 96

Pharmaceutical Technology

DECEMBER 15, 2022

In an expanded version of the sales forecast from GlobalData’s June 2022 publication, Cardiomyopathies: Global Drug Forecast and Market Analysis , the global cardiomyopathies market is expected to grow from $3.07bn last year to $9.63bn in 2031. of sales in 2021 and 2031 respectively. of global cardiomyopathies sales in 2021 and 31.2%

52

52

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

JANUARY 9, 2023

” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1 million in the US and just under €2 million in Europe, which the company says is justified by its dramatic benefits when given as a one-shot therapy to patients with SMA.

119

119

pharmaphorum

JUNE 2, 2022

R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. The price is right. It is estimated that between 3.5

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JUNE 12, 2022

The FDA still has to deliver its own verdict on the applications, and doesn’t always follow its advisors’ lead, but with two unanimous decisions bluebird looks set up for its first approvals in the US. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8

FDA 59

FDA 59

pharmaphorum

APRIL 14, 2022

US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel in June, by endorsing its proposed $2.1 million price tag. million if paid through an outcomes-based contract for patients with sustained transfusion independence.”

FDA 64

FDA 64

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour. ” Image by Pexels from Pixabay .

Labelling 52

Labelling Chemotherapy Immunization 52

Pharmaceutical Technology

FEBRUARY 22, 2023

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. The legal dispute is centered around rival cholesterol-lowering drugs produced by the two companies, which were approved in the summer of 2015. Both drugs come with a high price tag.

FDA 104

FDA 104

Pharmaceutical Technology

JULY 14, 2022

The commercial investment required to research and develop an innovative drug, prove its safety and efficacy, and bring it to market is staggering. Most famously, the US passed its Orphan Drug Act in 1983, providing innovators with financial motivation to develop orphan drugs and meet the needs of these forgotten patients.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies Hospitals 59

pharmaphorum

MAY 17, 2021

Empaveli’s label covers treatment-naïve PNH patients as well as those who want to switch from Soliris or Ultomiris, and is based on the phase 3 PEGASUS trial in 80 patients which compared the drug to Soliris over a 16-week period. The post Apellis set to take on Alexion as FDA clears PNH drug Empaveli appeared first on.

FDA 52

FDA Labelling Vaccines 52

pharmaphorum

NOVEMBER 24, 2022

Both drugs were given on top of standard antidepressants to patients wo had failed a least two earlier treatments. One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems.

Labelling 52

Labelling Hospitals 52

pharmaphorum

JANUARY 11, 2021

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. The gene therapy firm will be focused on its most important therapies in beta-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the US And Europe.

FDA 60

FDA 60

pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one.

FDA 52

FDA 52

pharmaphorum

DECEMBER 2, 2020

Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital. The company’s first product, a palatable anti-parasitic drug, made to taste like toffee, united Pfizer’s skills as a chemist with Erhart’s training as a confectioner.

Compounding 128

Compounding Vaccines Pharmaceutical Companies Pharmaceutical Companies 128

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

FDA 59

FDA Immunization 59

pharmaphorum

NOVEMBER 16, 2022

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. However, alongside this progress, Ben Hargreaves finds that there is also a conundrum over how to price these therapies.

130

130

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.

FDA 111

FDA 111

Pharmaceutical Technology

JUNE 21, 2023

per dose, it is the most expensive single-use gene therapy in the US. The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Haemophilia B is a rare condition.

FDA 98

FDA 98

pharmaphorum

MARCH 27, 2022

Both CAR-Ts are directed at BCMA, a biomarker for multiple myeloma also targeted by GlaxoSmithKline’s approved antibody-drug conjugate Blenrep (belantamab mafodotin) and J&J’s experimental bispecific antibody teclistamab, which was submitted for approval in Europe last month.

Labelling 91

Labelling Immunization FDA 91

pharmaphorum

NOVEMBER 28, 2022

Substra is the software that powered the MELLODDY platform, a collaboration in which Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Merck, Novartis, and Servier all agreed to share drug discovery data — but not with each other directly, nor with Owkin.

Hospitals 72

Hospitals 72

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). But Spinraza costs $750,000 in the first year of treatment and about half that price annually from then on. The post Roche takes on pricey rivals as FDA approves SMA drug appeared first on.

FDA 59

FDA Specialty Pharmacies 59

The Spirit Pharmacist

DECEMBER 2, 2021

However, psychedelic assisted therapy is resource intensive and will likely come with a price tag putting it out of reach of many persons that could benefit from such therapies. MoPoTsyo ran what is a called a 'Revolving Drug Fund' (RDF) which was seeded with grant funding.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage Insurance Patient Care 52

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. People simply can’t afford them. And governments struggle to manage costs.

Vaccines 90

Vaccines 90

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. 1 This is assuming a $1M price tag for all gene therapies. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach.

FDA 70

FDA 70

pharmaphorum

DECEMBER 7, 2021

Scientists in the US have found that people who use Viagra for erectile dysfunction seem to have a lower risk of developing Alzheimer’s disease – a link that they say should be examined more closely in clinical trials.

Compounding 52

Compounding Insurance FDA 52

The Physician Pharmacist

SEPTEMBER 14, 2023

And then kind of using that your pharmacy knowledge and background to kind of take that level of care to the next step is, you know, super important as well. So additionally, you know, let's kind of look into your medical school application period because we you know, both of us went through this at the same time. One is science.

Medical Schools 52

Medical Schools Hospitals Communication Patient Care 52

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house. US Food and Drug Administration.

Adverse Reactions 83

Adverse Reactions Immunization Medical Schools Chemotherapy 83

Pharmaceutical Technology

MARCH 17, 2023

These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs. Thus, a higher risk score reflects a more hostile market access environment and drug launch in a geographical area.

Pharmaceutical Companies 102

Pharmaceutical Companies Pharmaceutical Companies Communication 102

Pharma Marketing Network

JUNE 8, 2020

Thanks for coming on the podcast and if you wouldn’t mind, could tell us a little bit about yourself. We are now in a 20-yearlong economic depression for the working and middle class as a result of health care prices inflating, prices not cost. Good morning, Dave. Dave (HR): Sure. Thanks for having me on.

Health and Personal Care Stores 40

Health and Personal Care Stores Hospitals Mayo Clinic Specialty Pharmacies 40