pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

FDA 72

FDA Chemotherapy 72

pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug. Many are still predicting multibillion-dollar sales for the drug, albeit with a longer runway, despite reservations about its clinical efficacy among doctors and payers.

Insurance 122

Insurance FDA 122

Pharmaceutical Technology

MAY 2, 2023

Oncolytic viruses, cytokines, and therapeutic vaccines currently play a very minimal role in oncology treatment, with substantial efficacy still to be demonstrated for these classes. Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category.

Immunization 52

Immunization Vaccines 52

Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. Despite its high price tag, bimagrumab’s unique features set it apart from currently marketed therapies.

Hospitals 52

Hospitals 52

pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

FDA 98

FDA Immunization 98

pharmaphorum

AUGUST 21, 2022

There’s no word yet on its pricing, but for comparison Spravato was launched with an annual price tag of around $32,400, which the Institute for Clinical and Economic Review (ICER) concluded was around 25% to 52% too high to be cost effective.

FDA 98

FDA Labelling 98

Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

52

52

pharmaphorum

JUNE 12, 2022

Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 million price tag, saying its ability to help patients reach sustained transfusion independence justified its high price. Eli-cel was also previously approved in Europe as Skysona.

FDA 59

FDA 59

pharmaphorum

DECEMBER 12, 2022

She told ASH that current therapies for ITP have limitations, including tolerability issues, lacklustre efficacy and a short duration of effect, as well as having a limited impact on quality of life.

Immunization 52

Immunization Labelling FDA 52

pharmaphorum

NOVEMBER 19, 2020

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

FDA 64

FDA Labelling 64

Pharmaceutical Technology

FEBRUARY 10, 2023

This is not the first treatment to come with a high price tag. Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

FDA 105

FDA 105

pharmaphorum

DECEMBER 23, 2022

But along with strong efficacy come some considerable risks and costs: cytokine release syndrome (CRS), where a patient’s immune system becomes dangerously over-stimulated, and neurotoxicity are potential side effects that need to be managed.

Immunization 52

Immunization Hospitals Vaccines 52

pharmaphorum

JANUARY 31, 2023

Another factor that impacts trust in pharmaceutical companies is the discrepancy between the efficacy of medications in controlled clinical trials and their effectiveness in real-world use. Given the high price tags placed on many medications, it’s easy to understand why patients often feel that they are being taken advantage of.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Vaccines Communication 52

pharmaphorum

JUNE 8, 2021

” “FDA approval closes the door on further placebo-controlled trials of aducanumab that might have helped to resolve disputes about efficacy quickly and cleanly,” he added. Though good luck taking the drug off the market if future data doesn't support the its efficacy.

FDA 98

FDA Labelling 98

European Pharmaceutical Review

AUGUST 24, 2022

tag ® , inspired by the unique features of microtubule biology and perfectly suited for DAR 2 and DAR 4 ADCs. Selective Generation of Efficacious Antibody–Drug Conjugates. Antibody-drug conjugates: challenges, solutions and future potential… Pushing the boundaries of ADC design. Tubulis’ second technology platform is called Tub?tag

Compounding 82

Compounding Pharmaceutical Companies Pharmaceutical Companies 82

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. These countries will have a smaller patient pool due to population size and will likely carry a price tag that is significantly below that of higher GDP countries.”.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies Hospitals 59

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

FDA 52

FDA 52

Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. Sickle cell disease is an inherited blood disorder that is caused by mutations in the HBB gene, which codes for the oxygen-carrying protein haemoglobin in red blood cells.

FDA 59

FDA 59

The Checkup by Singlecare

DECEMBER 5, 2023

The #ozempic tag on TikTok has amassed over 1 billion views to date. Ozempic became one of the most talked about drugs in 2023. Popular media outlets like Variety and Fortune caught onto this secret to celebrity weight loss and made this medication a viral sensation. Elon Musk posted his endorsement of Ozempic on X.

Insurance 105

Insurance Prescription Filling FDA Dosage 105

pharmaphorum

MAY 17, 2021

C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1

FDA 52

FDA Labelling Vaccines 52

pharmaphorum

FEBRUARY 22, 2021

Lentiviral vectors have become a popular alternative for some therapies because they can deliver larger gene sequences into target cells and are less likely to stimulate an immune response in the patient that could affect their safety and efficacy. million in Europe.

Immunization 52

Immunization 52

The Checkup by Singlecare

JANUARY 15, 2023

Greater efficacy is needed beyond the early stages of Alzheimer’s. Aduhelm carries a hefty price tag, and it is not appropriate for any other form of dementia, such as dementia with Lewy bodies and vascular dementia. In reality, both categories of medication have only modest benefits for cognitive function.

Dosage 52

Dosage FDA Insurance 52

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. Currently, all approved CAR-T therapies are autologous, where T cells taken from patients are modified and then re-infused.

FDA 59

FDA Immunization 59

The Checkup by Singlecare

NOVEMBER 2, 2023

Weight loss Substantial evidence supports the efficacy of GLP-1 drugs for weight loss and weight management. The high price tag is a barrier for many people. Both GIP and GLP-1 hormones are involved in regulating hunger and food intake. Obesity is not consistently recognized as a medical condition across health insurance plans.

Insurance 52

Insurance FDA Adverse Reactions Hospitals 52

The Checkup by Singlecare

SEPTEMBER 7, 2023

Due to their efficacy in diabetes treatment and the significant weight loss experienced with this class of drugs, Moujaro, and other drugs are in high demand and sometimes hard to locate in stock at the pharmacy. GLP-1 receptor agonists are relatively new on the U.S. They are currently available as brand-name drugs only.

Insurance 52

Insurance Insurance Coverage FDA Dosage 52

Pharmaceutical Technology

JUNE 21, 2023

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. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

FDA 98

FDA 98

pharmaphorum

DECEMBER 2, 2020

It almost hadn’t made it through clinical development, facing problems with ineffective chiral isomers and limited efficacy in animal testing, but showed such impact in human trials that it blew the competition away. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

Compounding 128

Compounding Vaccines Pharmaceutical Companies Pharmaceutical Companies 128

The Checkup by Singlecare

MARCH 21, 2023

While opioids can be highly addictive, they are efficacious in providing immediate and adequate relief of severe pain , and there is often no substitute for granting satisfactory pain relief for one’s quality of life. However, one must be aware of the potential side effects and their drug-addicting properties. RELATED: Belbuca side effects 2.

Dosage 52

Dosage Controlled Substances Labelling Packaging 52

pharmaphorum

NOVEMBER 19, 2021

This is due to their first-to-market status, their efficacy and safety profiles and manufacturing success. Indeed, the price tags for Pfizer’s and Moderna’s jabs are substantial. However, Europe has decided not to renew AZ’s contract next year, preferring to focus on the slightly more efficacious mRNA jabs.

Vaccines 137

Vaccines Communication 137

Roots Analysis

SEPTEMBER 13, 2023

These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

Labelling 40

Labelling 40

European Pharmaceutical Review

NOVEMBER 10, 2022

With the new modalities used to treat disease and address previously undruggable targets, advanced drug delivery systems are critical to ensure targeted delivery, and to maximise safety and efficacy. Target engagement (efficacy) – cellular uptake and cytoplasmic/nuclear delivery of cargo is a major bottleneck for clinical translation.

Labelling 95

Labelling Compounding 95

European Pharmaceutical Review

JULY 11, 2022

We are delighted to be working with CEPI to further this nanoparticle technology with the goal of producing efficacious, low-cost, infrastructure-independent vaccine that will be accessible to low- and middle-income countries.” . How the novel coronavirus vaccine works. The innovative protein ?“glue”

Vaccines 92

Vaccines Immunization 92

pharmaphorum

FEBRUARY 26, 2021

The vaccine was pipped to the post in approval by Pfizer and AstraZeneca’s offerings, and showed lower efficacy in trials, but the company is hoping for an advantage with its single shot dosing, as opposed to the double shot approach of many of its key rivals, as well as its comparatively easier storage. .

Vaccines 126

Vaccines Labelling Communication 126

pharmaphorum

DECEMBER 7, 2021

That finding could provide some comfort to Biogen and Eisai, whose recently-approved amyloid-targeting drug Aduhelm (aducanumab) is struggling to gain traction in the market on the back of unconvincing efficacy data, safety concerns and a high price tag.

Compounding 52

Compounding Insurance FDA 52

European Pharmaceutical Review

DECEMBER 27, 2023

Currently CAR T-cell therapy is approved for three indications: acute lymphoblastic leukaemia (ALL), non-hodgkin lymphoma (NHL), and multiple myeloma (MM) – and the strongest correlation between CAR T-cell efficacy and persistence has been demonstrated in ALL. This is in addition to its considerable price tag.

Adverse Reactions 82

Adverse Reactions Immunization Medical Schools Chemotherapy 82

Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. Mounjaro is the first weight loss drug to show efficacy rates comparable to surgical procedures like sleeve gastrectomies. compared to a 5.1%

Insurance 105

Insurance Labelling Communication FDA 105

Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. Mounjaro is the first weight loss drug to show efficacy rates comparable to surgical procedures like sleeve gastrectomies. compared to a 5.1%

Insurance 98

Insurance Labelling Communication FDA 98