2024, Biopharma, FDA and Pharma

Q1 Biopharma Recap

Zymewire

APRIL 22, 2024

Summary of funding events, FDA approvals, clinical trial stats, and upcoming research and development plans from the world of biotech and pharma in Q1 2024

Biopharma

Biopharma FDA Pharma

Novartis Kidney Disease Drug Hits First Goal of Study; 2024 FDA Filing Planned

MedCity News

OCTOBER 2, 2023

Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.

FDA

FDA Pharma Biopharma

With More 2024 FDA Filings Planned, Novartis Drug Starts Showing Blockbuster Potential

MedCity News

DECEMBER 11, 2023

Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations.

FDA

FDA Biopharma Pharma

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

MedCity News

OCTOBER 9, 2023

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.

FDA

FDA Pharmaceutical Biopharma Pharma

Organon Gets More Skin in the Game by Acquiring Roivant’s Dermatology Subsidiary

MedCity News

SEPTEMBER 18, 2024

An FDA decision for the topical cream in atopic dermatitis is expected by the end of 2024. By acquiring Dermavant, Organon gets Vtama, a drug approved for treating plaque psoriasis. The post Organon Gets More Skin in the Game by Acquiring Roivant’s Dermatology Subsidiary appeared first on MedCity News.

FDA

FDA Biopharma Pharma

Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. The post Chiesi expands rare disease portfolio with Amryt Pharma acquisition appeared first on. in an all-cash transaction at $14.50 per American Depositary Share (ADS). Each ADS represents five Amryt ordinary shares.

Pharma

Pharma Biopharma Management Medicine

First FDA Approval of an RSV Vaccine Goes to GSK

MedCity News

MAY 3, 2023

FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.

FDA

FDA Biopharma Pharma

Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission

MedCity News

MARCH 21, 2023

Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.

FDA

FDA Biopharma Pharma

After Data Miss in Lead Cancer Indication, Replimune Maps Path for Oncolytic Virus

MedCity News

DECEMBER 5, 2023

Replimune’s lead therapeutic candidate did not meet the two main goals of a study intended to support an FDA submission in cutaneous squamous cell carcinoma. But Replimune’s therapy, an oncolytic virus, has better data in melanoma, and the company plans a 2024 FDA submission in this skin cancer.

Leads

Leads FDA Biopharma Pharma

Kyowa Kirin Buys Into Gene Therapy With Orchard Therapeutics Acquisition

MedCity News

OCTOBER 5, 2023

The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.

FDA

FDA Marketing Biopharma Pharma

What sets the Drugs to Watch in 2024 apart

Clarivate

JANUARY 8, 2024

The annual Clarivate Drugs to Watch report for 2024 features 13 new therapeutics with standout commercial and/or clinical potential. FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. The post What sets the Drugs to Watch in 2024 apart appeared first on Clarivate.

Marketing

Marketing Patients Healthcare Healthcare

Novartis Drug From $3.2B Deal Succeeds in Phase 3, 2024 FDA Filing Is Planned

MedCity News

OCTOBER 30, 2023

Novartis drug candidate atrasentan met the main goal of a pivotal study in the chronic kidney disease IgA nepropathy. It’s one of two drugs added via the multi-billion dollar acquisition of Chinook Therapeutics; together with a homegrown therapeutic candidate, they give Novartis three different approaches to treat the rare disorder.

FDA

FDA Biopharma Pharma

Merck Missed on Seagen, But Comes Back With Potential $22B Daiichi ADC Deal

MedCity News

OCTOBER 20, 2023

The most advanced of them is on track for an FDA submission in 2024. After paying $4 billion up front, Merck will share in the development and commercialization of three Daiichi Sankyo cancer drugs in the red-hot field of antibody drug conjugates, or ADCs.

FDA

FDA Biopharma Pharma

Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

MedCity News

SEPTEMBER 26, 2023

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner.

Medicine

Medicine FDA Pharmaceutical Biopharma

Early diagnosis in Alzheimer’s disease: A first step towards better care

Clarivate

SEPTEMBER 11, 2024

Though there is no cure for the disease, people with Alzheimer’s can receive personalized, multimodal care and support to delay deterioration of their functional status and quality of life and alleviate the burden imposed on their care partners (Emblad, 2021; Bayly, 2021; Xiang, 2024). Food and Drug Administration, 2023 and 2024).

Food and Drug Administration

Food and Drug Administration Pharmacology Food FDA

Scorpion inks deal with Pierre Fabre for next-gen EGFR inhibitors

Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. According to GlobalData’s Pharma Intelligence Centre, Tagrisso is forecasted to have global sales of $8.19

Food and Drug Administration

Food and Drug Administration Biopharma FDA Pharmaceutical

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? Sticking to the cell and gene therapy space, what’s your main prediction for 2024?

Manufacturing

Manufacturing Food and Drug Administration Biopharma Marketing

FOCUS ON – Crowdsource/Adherence and Compliance

PM360

OCTOBER 22, 2024

DANNY SIGURDSON CEO and Founder Courier Health To effectively engage patients and prescribers to improve overall adherence to prescribed medication regimens, biopharma companies first need the visibility and full context of where a patient stands in their treatment journey. The axiom “you can’t manage what you can’t measure” applies here.

Education

Education Side effects Medical Patients

Beyond animal testing: the rise of organs-on-chips technology

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Online] Available at: [link] [Accessed 1 10 2024]. Back in December 2022, President Biden signed a new law stating that novel medicines no longer needed to be tested on animals to receive U.S. Works cited Anon., Nature, 631(8021). Barrile, R.,

Food and Drug Administration

Food and Drug Administration Pharmacology Food Engineering

CMS enters drug price negotiation arena in sea change for industry

Clarivate

AUGUST 20, 2024

Announced on August 15, 2024, this first batch of Maximum Fair Prices (MFPs) were mandated by the Inflation Reduction Act of 2022 , which allowed CMS to negotiate what it describes as the maximum fair price for therapies representing the greatest cost to Medicare. Initial MFPs released show sharp discounts Set to take effect Jan.

Manufacturing

Manufacturing Government Prescription Pharmaceutical manufacturing

How the U.S. election could impact the healthcare industries

Clarivate

OCTOBER 17, 2024

Congressional Democrats introduced legislation to make the subsidies permanent in September 2024, but the legislation has no chance of passage so close to the election. 31, 2024, and providers and payers are pushing for an extension. 31, 2024, and providers and payers are pushing for an extension. As of Aug.

Healthcare

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Pharma Rep Focus

Q1 Biopharma Recap

Novartis Kidney Disease Drug Hits First Goal of Study; 2024 FDA Filing Planned

Webinars

Trending Sources

With More 2024 FDA Filings Planned, Novartis Drug Starts Showing Blockbuster Potential

Webinars

FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Organon Gets More Skin in the Game by Acquiring Roivant’s Dermatology Subsidiary

Chiesi expands rare disease portfolio with Amryt Pharma acquisition

First FDA Approval of an RSV Vaccine Goes to GSK

Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission

After Data Miss in Lead Cancer Indication, Replimune Maps Path for Oncolytic Virus

Kyowa Kirin Buys Into Gene Therapy With Orchard Therapeutics Acquisition

What sets the Drugs to Watch in 2024 apart

Novartis Drug From $3.2B Deal Succeeds in Phase 3, 2024 FDA Filing Is Planned

Merck Missed on Seagen, But Comes Back With Potential $22B Daiichi ADC Deal

Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

Early diagnosis in Alzheimer’s disease: A first step towards better care

Scorpion inks deal with Pierre Fabre for next-gen EGFR inhibitors

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

FOCUS ON – Crowdsource/Adherence and Compliance

Beyond animal testing: the rise of organs-on-chips technology

CMS enters drug price negotiation arena in sea change for industry

How the U.S. election could impact the healthcare industries

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