Fierce Pharma

JANUARY 18, 2024

AstraZeneca charts new course for Imfinzi in liver cancer, but FDA path remains uncertain aliu Thu, 01/18/2024 - 14:27

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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.

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Fierce Pharma

FEBRUARY 28, 2024

After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. The company is eying four new indications and potential peak sales of 4 billion euros.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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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.

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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.

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Fierce Pharma

FEBRUARY 7, 2024

were receiving the amyloid-busting antibody as of Jan. 26, Eisai explained in a third-quarter earnings presentation.

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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

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PM360

FEBRUARY 8, 2024

It’s open-source design meets FDA requirements for safety and protection. Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye.

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Fierce Pharma

JUNE 15, 2023

An approval now looks within reach for 2024. An approval now looks within reach for 2024. After acing a study for the induction treatment of ulcerative colitis, AbbVie’s Skyrizi has snatched another win in a maintenance trial.

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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.

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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.

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PM360

FEBRUARY 8, 2024

SYLVANT Can Open the Door SYLVANT is the only FDA-approved therapy for idiopathic multicentric Castleman disease (iMCD) that targets the underlying cytokine storm and can help deliver sustained symptomatic relief and durable tumor response. Silver Winner – Elevate Healthcare and Recordati Rare Diseases Inc.

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Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

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Sales FDA 246

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.

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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.

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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.

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pharmaphorum

JANUARY 9, 2023

is to acquire the 2015-established Amryt Pharma Plc. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50

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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.

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Pharmaceutical Technology

OCTOBER 2, 2023

The pharma company is seeking US approval of the drug for three bacterial diseases, with a PDUFA date of 3 April 2024.

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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.

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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.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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pharmaphorum

JANUARY 16, 2023

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. Analysts at GlobalData said last year that they expect LY03010 to launch in 2024 and bring in sales of around $64 million in 2030.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). GlobalData’s report showed LY03010 is expected to launch in the US in 2024. If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

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Pharma Leaders

JUNE 8, 2023

The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development, according to Kimberly Smith, RWE analyst in CDER’s Office of Medical Policy.

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Pharmaceutical Technology

JANUARY 8, 2023

Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Tezspire is being studied in a Phase II COPD study (NCT04039113) that is expected to complete in March 2024. Still, patients require an individual-led approach.

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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

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European Pharmaceutical Review

JUNE 27, 2023

For World Microbiome Day on 27 June 2023, EPR put questions to Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences, to find out how the field is progressing and what innovations could transform future microbiome-based therapies.

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PM360

DECEMBER 20, 2023

Learn more about why each company went with its respective strategy and the current outlook for each company in 2024 and beyond. The deal is expected to close in 2024. What is your outlook for 2024 and how do you believe companies can effectively differentiate themselves? and 10X Capital Venture Acquisition Corp.

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pharmaphorum

SEPTEMBER 8, 2022

Xevinapant, which is billed as a first-in-class antagonist of inhibitor of apoptosis protein (IAP), has been given breakthrough status by the FDA for HNSCC. The drug is already in a pair of phase 3 trials in HNSCC, with results due from 2024 onwards.

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pharmaphorum

JANUARY 23, 2023

Morphic Therapeutic has lost Johnson & Johnson’s Janssen Pharma as a partner, following the termination of an alliance to develop drugs targeting integrins first agreed in 2019. In a filing with the Securities and Exchange Commission (SEC). ” It was modified again in the middle of 2021.

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pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. A recent Science 37 survey noted that nearly three-quarters (73%) of respondents from the pharma industry were planning a hybrid or DCT, up from 49% in 2021. Novel digital endpoints. Source: Landers et al.,

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pharmaphorum

OCTOBER 10, 2022

Immutep claimed fast-track status from the FDA for efti last week as a combination therapy alongside Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) for previously-untreated non-small cell lung cancer (NSCLC), based on the results of the phase 2 TACTI-002 study. Also in its favour is that LAG-3 is now a tried and tested target.

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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.

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PM360

APRIL 22, 2024

TAP INTO TRUST AND MAKE IT RELEVANT Many HCPs report approaching pharma-created content with suspicion of promotional agendas and bias.

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PM360

SEPTEMBER 21, 2023

In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market. The product, manufactured by ARS Pharma and Neurelis Pharma, would be the first needle-free epinephrine alternative to autoinjectors, such as the EpiPen.

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