Top Pharma Rep Focus FDA Biopharma Content for April, 2024

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

MedCity News

APRIL 2, 2024

Ipsen is acquiring global rights to a Sutro Biopharma antibody drug conjugate for a target that is not yet hit by any FDA-approved drugs. Merck is among the companies pursuing this target, but Sutro claims its ADC could be first and best in this class.

Biopharma

Biopharma FDA Pharma

Accord BioPharma’s HERCESSI secures FDA approval

Pharmaceutical Technology

APRIL 30, 2024

Accord BioPharma, the division of Intas Pharmaceuticals, has secured approval from the US FDA for HERCESSI, a biosimilar to Herceptin.

FDA

FDA Biopharma Pharmaceutical

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

FDA

FDA Patients Biopharma Pharma

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

FDA

FDA Medical Pharmaceutical Biopharma

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

MedCity News

APRIL 1, 2024

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

FDA

FDA Biopharma Pharma

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

FDA

FDA Patients Marketing Biopharma

AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

MedCity News

APRIL 8, 2024

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.

FDA

FDA Medical Biopharma Pharma

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

FDA

FDA Patients Biopharma Pharma

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

MedCity News

APRIL 29, 2024

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

FDA

FDA Pharmaceutical Biopharma Pharma

Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

MedCity News

APRIL 26, 2024

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder.

FDA

FDA Biopharma Pharma

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

Safety

Safety FDA Leads Biopharma

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.

FDA

FDA Medical Pharmaceutical Biopharma

From viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape

European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

Manufacturing

Manufacturing Food and Drug Administration Biopharma Marketing

Pharma Rep Focus

April, 2024

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

Accord BioPharma’s HERCESSI secures FDA approval

Trending Sources

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

From viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape

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