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. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

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World of DTC Marketing

SEPTEMBER 24, 2021

Physicians and insurers are rejecting Aduhelm because it should never have been approved in the first place. This drug was never about patients; it was about a company whose ego got too big and needed a savior in the form of a medicine that could bring in hundreds of millions of dollars. Can Biogen regain its momentum?

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Drugs Pharma Companies Doctors Doctor 222

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 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

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Gene Therapy Marketing Gene Drugs 263

World of DTC Marketing

JUNE 23, 2021

Source: Fierce Pharma If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. government.

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Drugs FDA Approval Doctors Doctor 218

Rethinking Clinical Trials

JANUARY 17, 2024

The first drug that used the new process was Remdesivir in May 2020. The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families.

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Clinical Trials Clinical Trials Antibody Trials 169

XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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Gene Therapy FDA Approval Gene In-Vivo 98

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. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD.

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Drugs FDA Approval Production Marketing 98

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

Drugs 52

Drugs Generic Drugs FDA Approval Trials 52

XTalks

FEBRUARY 8, 2024

Pharma commercials at Super Bowl 2024 will include ones for newly approved menopause drug Veozah and a unique partnership between antacid giant TUMS and sports betting company Draft Kings. This year’s kickoff will have the Kansas City Chiefs facing off against the San Francisco 49ers on Sunday, February 11, in Las Vegas.

Life Science 105

Life Science Marketing Branding Drugs 105

Rethinking Clinical Trials

JUNE 29, 2022

Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements. ? ? ? ? ? ? ? ? ?. Speaker.

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Big Data Clinical Trials Clinical Trials Drugs 130

pharmaphorum

OCTOBER 21, 2021

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. million in sales for the drug in the second quarter. Biogen reported $1.6

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Sales Doctors Doctor Gene Therapy 120

XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Hutchmed’s drug is also being paired with Tagrisso and AZ’s PD-L1 blocker Imfinzi (durvalumab) in global registrational trials.

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Antibody Drugs Protein Gene 109

pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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Antibody Marketing Drugs Medicine 98

XTalks

NOVEMBER 3, 2022

Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.

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Sales FDA Approval Production Insulin 98

pharmaphorum

NOVEMBER 16, 2021

NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini group company Arvelle Pharma’s Ontozry. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

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Drugs Medicine Clinical Trials Clinical Trials 98

Pharmaceutical Technology

FEBRUARY 22, 2023

The legal dispute is centered around rival cholesterol-lowering drugs produced by the two companies, which were approved in the summer of 2015. Developed by Sanofi and Regeneron, Praluent was approved by the FDA in July 2015. Both drugs are monoclonal antibodies that inhibit the protein PCSK9.

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Antibody Drugs Protein Sales 262

XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

JANUARY 9, 2023

First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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Gene Therapy Genetics Gene Clinical Trials 117

pharmaphorum

NOVEMBER 19, 2021

The cost-effectiveness agency had turned down Evrysdi (risdiplam) in draft guidance published in June, saying it was too expensive, but after negotiations with Roche has reached a deal that will make the drug available to around 1,500 people in England. million price tag make it is the most expensive treatment ever approved for NHS funding.

Drugs 98

Drugs Gene Therapy Genetic Disease Gene 98

Rethinking Clinical Trials

JULY 27, 2022

ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Given the history with other repurposed drugs, I was concerned people would not want to take Ivermectin. This was one of the reasons we gave people options about which drugs they were willing to take.

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Trials Pharmacy Medicine Clinical Trials 169

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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Gene Therapy Gene Engineer Production 147

XTalks

JUNE 9, 2021

Biogen has been working vigorously over the past couple of years to get its potentially disease-modifying drug Aduhelm (aducanumab) approved for Alzheimer’s disease, and it has finally happened. This Monday, the US Food and Drug Administration (FDA) granted accelerated approval to the drug for the treatment of the disease.

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Drugs Clinical Trials Clinical Trials Trials 98

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. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment. The median treatment time is about 23 weeks (or 5.3

FDA Approval 98

FDA Approval Development Licensing Licensing 98

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.

Drugs 98

Drugs Marketing FDA Approval Trials 98

Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Tags #pctGR, @Collaboratory1 The post Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC) appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials Cardiology 169

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion by 2028.

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Sales Medicine Drugs Marketing 109

pharmaphorum

APRIL 26, 2021

The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). The initiative was supported by grants from UCB and Pfizer and provided health information in the form of immersive experiences aimed at patients prescribed biologic drugs to treat the disease.

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Development Medicine Production Marketing 120

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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FDA Approval Marketing Drugs Clinical Development 62

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Antibody 52

Antibody Medicine Drugs Trials 52

Drug Discovery World

DECEMBER 20, 2022

The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug. million, making it the world’s most expensive drug. . Concerns about the high price tag have been raised in an article in Nature, particularly whether it will be affordable for low to middle-income countries. .

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

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. Safety data was also similar between the two groups.

Antibody 52

Antibody Sales FDA Approval Trials 52

Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. The drug was developed over eight years by Brian Bigger, Professor of Cell and Gene Therapy at The University of Manchester.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

pharmaphorum

MAY 10, 2022

The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA could result in an approval before the end of the year. The post Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go appeared first on.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

pharmaphorum

JUNE 12, 2022

By the end of the week, it was two for two, with both recommended for approval by a unanimous vote. 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.

Gene Therapy 57

Gene Therapy Gene Marketing Trials 57

pharmaphorum

APRIL 5, 2022

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour.

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Protein Sales Drugs Trials 52