XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 After billions of dollars of investment, the company’s market valuation nosediving from nearly $10 billion in 2018 to just above $250 million currently and FDA delays, Zynteglo’s approval is the much-needed vote of confidence for bluebird. “Any

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Medical Xpress

NOVEMBER 23, 2022

million price tag. People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5

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XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia.

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year. The median treatment time is about 23 weeks (or 5.3

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XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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pharmaphorum

JUNE 8, 2021

Dementia specialist Prof Robert Howard of University College London (UCL) was also damning in his assessment of the decision, saying that the FDA has “sidestepped available clinical trial outcomes data that indicate the drug probably doesn’t work.”

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pharmaphorum

OCTOBER 29, 2021

Merck is the obvious partner for that ambition as Keytruda is in the ascendency among checkpoint inhibitors for TNBC, having also recently also picked up an FDA approval pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring.

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pharmaphorum

JANUARY 5, 2021

Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

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pharmaphorum

AUGUST 18, 2022

million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 price for gene therapy Zynteglo on FDA approval appeared first on. bluebird has opted to launch it at a cost of $2.8 million, which compares to the $1.7 Image by Ahmad Ardity from Pixabay .

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pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm.

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Delveinsight

FEBRUARY 9, 2021

Breyanzi will come with a price tag of USD 410,300 wholesale price, said the company, justifying it after taking into consideration several factors including medical and clinical value, patient value, and societal value.

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Pharmaceutical Technology

JUNE 29, 2022

In a series of data-driven deep dives, we will examine how the development of orphan drug therapies has evolved over the years, and use the FDA’s orphan drug program as a barometer of these advances. An orphan drug designation does not automatically translate into approval.

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Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 This is not the first treatment to come with a high price tag.

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XTalks

NOVEMBER 30, 2022

In this episode, Ayesha shared news about the FDA approval of the first gene therapy for the rare blood disorder Hemophilia B. Hear more about the therapy and how the high price tag of the new drug is actually lower than the cost of treating Hemophilia B patients over their lifetimes with current conventional treatments.

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XTalks

APRIL 29, 2022

Novo introduced a higher-dose version of Saxenda called Wegovy, which won FDA approval in 2021 for chronic weight management. Novo Nordisk’s oral semaglutide formulation Rybelsus , the first GLP-1 drug in pill format, received FDA approval in 2019 for the treatment of type 2 diabetes.

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XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication.

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. After the vote, the FDA extended the decision date by one month due to concerns it raised in briefing documents before the committee meeting.

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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. If approved, exa-cel would be the first FDA-approved gene therapy based on CRISPR editing.

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XTalks

NOVEMBER 24, 2022

The FDA approval was based on results of two studies with adult men, including the HOPE-B trial, which had 54 participants, the greatest number of patients in a gene therapy trial. Conventional treatment for hemophilia B involves prophylactic infusions of factor IX replacement therapy.

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World of DTC Marketing

JUNE 23, 2021

Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39 Not to mention the $56,000 annual price tag. According to STAT News “Patrizia Cavazzoni, director of the FDA’s drug division, in an interview with STAT on Tuesday. “We

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pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator.

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pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug. Biogen stumped up $1.525 billion upfront for rights to the drug and another Sage candidate for neurological diseases last year, when the expectation was that Aduhelm was unlikely to get FDA approval.

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Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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XTalks

FEBRUARY 8, 2024

Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla. Bayer is preparing to file for FDA approval based on strong Phase III data it shared last month.

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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.

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pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug.

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The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. —- End —-.

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XTalks

APRIL 18, 2024

Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). It also nabbed FDA approvals for two pairs of Elecsys in vitro diagnostics for the analysis of amyloid and tau in CSF.

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XTalks

DECEMBER 21, 2022

Gene Therapy Approvals. Bluebird bio is a notable mention as it secured FDA approvals for two of its gene therapies, Zynteglo and Skysona. And almost every time a new gene therapy approval was awarded, it would more often than not break the previous ‘world’s most expensive drug’ record.

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The Pharma Data

DECEMBER 3, 2020

Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag © Technology. Trimer-Tag © is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

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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.

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pharmaphorum

MAY 10, 2022

If lecanemab is approved it could be after the departure of Biogen chief executive Michel Vounatsos, who is leaving the company in the wake of a tumultuous few months following the approval of Aduhelm by the FDA last year.

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pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1

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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.

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XTalks

JUNE 8, 2021

With a price tag of over $2.5 It was first approved in the US in 2019 to treat children below the age of two with SMA. Related: Is $2 Million Too Much For FDA-Approved SMA Gene Therapy? million, Zolgensma is currently the world’s most expensive drug. Why is Zolgensma So Expensive?

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World of DTC Marketing

DECEMBER 13, 2021

As cancer survival rates rise, so do the price tags of life-saving treatments. Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials. billion included out-of-pocket costs of $16.22 ScienceNews.com.

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XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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