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Top 30 New Medical Devices of 2024

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

FDA Approval

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Gene Therapy

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Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Trending Sources

Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. percent Roctavian has for its European Union (EU) approval. percent Roctavian has for its European Union (EU) approval. Roctavian, a $2.9

Gene Therapy

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Bridging Innovation & Patient Care: The Growing Role of AI

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Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

Gene Therapy

Gene Therapy Gene Dermatology FDA Approval

Pfizer’s New RSV Vaccine TV Commercial Calls for Protecting Moments

XTalks

NOVEMBER 15, 2024

You know how to protect against COVID and flu so ask your pharmacist or doctor about scheduling an RSV vaccine, too.” Pfizer’s RSV vaccine Abrysvo was approved in May 2023, along with GSK’s Arexvy, which was approved earlier that same month. The approval is pivotal as it opens up the vaccine to the under-60 adult population.

Vaccination

Vaccination Vaccine Gene Therapy RNA

Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

OCTOBER 21, 2021

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. Analysts meanwhile have suggested that Aduhelm may start to pick up momentum if that review is positive.

Sales

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Age-related macular degeneration market expected to grow to $22.8bn in 2031

Pharmaceutical Technology

JULY 28, 2022

Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year.

Marketing

Marketing Gene Therapy FDA Approval Development

The use of genomic profiling testing to improve oncology care

pharmaphorum

SEPTEMBER 12, 2022

Across LabCorp , we innovate through science and technology, with access to approximately 2,500 [doctors] and PhDs and over 700 patients. This reach allows us to support 82% of the novel drugs and therapeutic products approved by the US FDA, including 63% of those specific to oncology,” Reddy states.

Genome

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Advances in Rare Disease Drug Development: Disease Biology, Regulatory Support, Building Relationships and the Patient Voice

XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

Development

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Novartis’ $2 Million Gene Therapy Zolgensma Shows ‘Remarkable’ Results and Offers Hope for Children with SMA

XTalks

JUNE 8, 2021

Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. It was first approved in the US in 2019 to treat children below the age of two with SMA.

Gene Therapy

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FDA makes moves to advance ALS research ahead of upcoming Amylyx AdCom

Pharmaceutical Technology

AUGUST 12, 2022

We have patients calling us saying, ‘I want to get into this site, but they say [it will be] three months before they can see me,’ and it's not because the doctors don't want to do it. Thus, FDA funding could be what is needed on this front, says Cudkowicz. How far does the FDA’s plan go? They don't have the time for it.”

Research

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Race to the finish: pharma edges closer to approval with RSV vaccines

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. This would be preferable for patients as doctors must administer Synagis to patients five times per month during peak RSV season. per 100,000.

Vaccination

Vaccination Vaccine Antibody Development

T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

Eye on FDA

APRIL 15, 2020

Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. Why would COVID-19 affect a drug launch?

Medicine

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Improving Access to Cures Through Innovation

Pfizer

SEPTEMBER 27, 2022

Biosimilars are FDA approved, and often offer a lower-cost alternative to biologic therapies that treat challenging diseases like cancer, diabetes, and rheumatoid arthritis. on the policies of foreign governments — and could alter how doctors and patients access drugs. Leadership. 09.22.2022. Medicines, Research.

Medicine

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Top Life Science News and Trends in 2023 at Xtalks

XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. 6. GSK Canada chose Gretzky for his iconic status and the influence he has on the Canadian public, especially those over 60.

Life Science

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Top 30 New Medical Devices of 2024

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

Webinars

Trending Sources

Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod

Webinars

Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

Pfizer’s New RSV Vaccine TV Commercial Calls for Protecting Moments

Biogen’s Aduhelm rollout goes from bad to worse

Age-related macular degeneration market expected to grow to $22.8bn in 2031

The use of genomic profiling testing to improve oncology care

Advances in Rare Disease Drug Development: Disease Biology, Regulatory Support, Building Relationships and the Patient Voice

Novartis’ $2 Million Gene Therapy Zolgensma Shows ‘Remarkable’ Results and Offers Hope for Children with SMA

FDA makes moves to advance ALS research ahead of upcoming Amylyx AdCom

Race to the finish: pharma edges closer to approval with RSV vaccines

T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

Improving Access to Cures Through Innovation

Top Life Science News and Trends in 2023 at Xtalks

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