BioPharma Drive: Drug Pricing

DECEMBER 6, 2023

The funds are meant to boost Fujifilm’s capacity to manufacture cell therapies, a market it expects to grow substantially in the coming years.

Therapies 173

Therapies Production Marketing 173

BioPharma Drive: Drug Pricing

JULY 3, 2024

Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.

FDA 315

FDA Therapies Disease Marketing 315

Conversations in Drug Development Trends

NOVEMBER 12, 2024

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.

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Therapies Clinical Supply Clinical Trials Trials 72

BioPharma Drive: Drug Pricing

OCTOBER 10, 2024

Data readouts over the next six months could set expectations for how the highly lucrative market for weight loss therapies will look in the future.

Trials 270

Trials Therapies Marketing 270

BioPharma Drive: Drug Pricing

MARCH 20, 2024

million list price, the highest of any genetic medicine to come to market. Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25

Therapies 202

Therapies Marketing 202

Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Read it on our website here. Illustration by David S. Fast forward to 2023.

Therapies 128

Therapies Virus DNA Clinical Trials 128

BioPharma Drive: Drug Pricing

MAY 6, 2024

One analyst thinks the collaboration “bodes well” for Gossamer, which has had trouble convincing investors its drug seralutinib can compete on the market.

Therapies 173

Therapies Drugs Marketing 173

Drug Target Review

NOVEMBER 8, 2023

Problem w/ CTs and foundational understanding of Vittoria: can you explore the current limitations of cell therapies and the challenges faced by patients and providers? Currently, only a small percentage of cancers can be effectively treated with cell therapies, and there is little diversity in the currently approved products.

Therapies 116

Therapies Engineering Treatment Molecular Biology 116

Drug Target Review

JANUARY 4, 2024

What distinguishes Alder Therapeutics’ approach to regenerative cell therapy development from traditional methods, and how does it aim to reduce risks in the preclinical phase? Traditional approaches to regenerative cell therapy development are defined by several challenges. For manufacturing, it’s no different.

Therapies 98

Therapies Small Molecule Production Disease 98

PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

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Therapies Clinical Trials Clinical Research Trials 97

BioPharma Drive: Drug Pricing

OCTOBER 23, 2024

Elsewhere, Sangamo plotted a much faster path to market for its Fabry gene therapy. Yale spinout Modifi agreed to sell to Merck for $30 million upfront.

Therapies 187

Therapies Marketing Drugs 187

BioPharma Drive: Drug Pricing

DECEMBER 10, 2023

While new gene therapies for the blood disease grabbed headlines at ASH, Pfizer presented fresh data for an oral drug meant to build on its marketed therapy Oxbryta.

Therapies 187

Therapies Drugs Disease Marketing 187

Drug Patent Watch

DECEMBER 17, 2024

Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. Responding to Market Demands The pharmaceutical market is notoriously unpredictable. Flexibility has become more than just a buzzword it’s a necessity.

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Pharmaceuticals Therapies Production Pharmaceutical Companies 90

BioPharma Drive: Drug Pricing

JULY 3, 2024

Elsewhere, Vertex got an FDA decision date for its “vanza triple” and Dupixent won a marketing green light in Europe for COPD. Forbion led the startup’s Series B round.

Therapies 148

Therapies FDA Marketing 148

Fierce BioTech

MAY 19, 2023

Commercializing Gene Therapies, Part 4 – Market Entry This paper outlines three basic market archetypes for gene therapies and the key considerations leaders must address when prioritizing new potential markets.

Marketing 52

Marketing Therapies Science Research 52

PLOS: DNA Science

MARCH 21, 2024

The Food and Drug Administration just announced approval of Lenmeldy (atidarsagene autotemcel), a gene therapy to treat the neurological condition metachromatic leukodystrophy (MLD). The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. She passed away in 2013.

Therapies 98

Therapies Clinical Trials DNA Trials 98

BioPharma Drive: Drug Pricing

SEPTEMBER 24, 2024

The announced job cuts are the latest in a series of steps Bluebird has taken to preserve cash and break even financially amid slow uptake of its marketed gene therapies.

Therapies 164

Therapies Marketing 164

Drug Channels

MARCH 28, 2024

Bill discusses specialty therapy access barriers, including payer utilization management techniques and “no coverage” policies. Today’s guest post comes from Bill Dupere, SVP of Product Development & Partnerships at Mercalis. Contact Mercalis to learn about their Patient Support Services. Read on for Bill’s insights.

Marketing 98

Marketing Science Therapies Production 98

ASPET

OCTOBER 20, 2023

However, Pramlintide an adjunct to insulin therapy, enhances glucagon suppression and thereby offers improved glycaemic control. Although clinical benefits of Pramlintide are well reported, there still exists a high patient resistance for the therapy as separate injections for Pramlintide and insulin are required to be administered.

Therapies 100

Therapies Pharmacokinetics Treatment Marketing 100

PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. billion in 2023 to 1.2 billion in 2035.

Drug Development 97

Drug Development Clinical Trials Drugs Small Molecule 97

BioPharma Drive: Drug Pricing

SEPTEMBER 18, 2024

The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.

FDA 143

FDA Therapies Marketing 143

BioPharma Drive: Drug Pricing

JANUARY 31, 2024

The gene therapy developer’s demise has given Tectonic Therapeutic, a GPCR-focused startup founded by the prolific biotech entrepreneur, an alternate path to the public markets.

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Therapies Marketing 154

Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Fierce BioTech

SEPTEMBER 24, 2024

Unlocking European market access for rare disease therapies The European orphan drug market presents a significant opportunity for biotech firms. Learn more about early access programs (EAPs), and how they are emerging as a critical strategy for successfully launching rare disease therapies in this complex and diverse market.

Marketing 40

Marketing Therapies Disease Drugs 40

PPD

JANUARY 15, 2025

Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time. As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

PPD

MARCH 11, 2025

MDT helps bridge the gap in preference heterogeneity to ensure that rare disease therapies are developed with the diverse needs of patients in mind. Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region.

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Drug Development Clinical Trials Disease Trials 52

Fierce BioTech

MARCH 15, 2024

Oncology Market Outlook 2024 This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation.

Targeted Protein Degradation 52

Targeted Protein Degradation Marketing Therapies Science 52

LifeSciVC

NOVEMBER 28, 2023

Market conditions like this are demoralizing in the worst way. Furthermore, to make matters even more complicated, that same summer, markets had already turned sour, and the sentiment was darkening by the day. The biotech equity markets had effectively shut off the idea of an IPO (which was one of several paths we had mapped out).

Marketing 87

Marketing FDA Pharma Companies Government 87

BioPharma Drive: Drug Pricing

AUGUST 14, 2023

The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.

Vaccine 130

Vaccine FDA Therapies Marketing 130

Drug Target Review

AUGUST 6, 2024

Liver Fibrosis : Targeted therapies using ADCs could help reduce liver fibrosis and prevent the progression to cirrhosis. Expedited programs like the FDA’s Breakthrough Therapy Designation and Fast Track can shorten development timelines and reduce risk. Oncology drugs often command high prices, potentially leading to higher ROI.

Therapies 119

Therapies Pharmaceutical Companies Disease Treatment 119

PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. Nearly 39% of sponsors cite these costs as primarily driven by complex protocols.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Drug Target Review

SEPTEMBER 6, 2024

What trends are driving the increased use of in vivo delivery methods in gene therapy? How is the market demand for lentiviral vectors evolving, and what factors are influencing this growth? There is a very significant increased market demand for lentiviral vectors. New therapeutic areas are emerging in a powerful way.

Therapies 59

Therapies Vaccine Marketing Disease 59

ASPET

OCTOBER 12, 2023

The CET RAIDR program conserves both time-to-market and funds by leveraging previous conventional development work as a launch point for repurposing efforts. CBRN MCMs).

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Therapies Licensing Licensing FDA Approval 100

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

Clinical Trials 119

Clinical Trials Trials Therapies Marketing 119

ASPET

SEPTEMBER 7, 2023

Avalglucosidase alfa has received marketing authorization in several countries for infantile-onset and/or late-onset Pompe disease. This recently approved enzyme replacement therapy (ERT) was glycoengineered to maximize CIMPR binding through high-affinity interactions with ~7 bis-M6P moieties.

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Small Molecule Therapies Disease Treatment 100

Fierce BioTech

JUNE 13, 2024

Discover how this innovative digital design system is helping increase patient medication adherence and the length of therapies, by moving beyond segmentation to truly personalized experiences. Listing Image AllazoHealth_ListingLogo_250x190.png On Demand Start Date Wed, 08/07/2024 - 12:00

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Marketing Therapies 52

Conversations in Drug Development Trends

OCTOBER 14, 2024

Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. These therapies represent a significant shift from traditional treatments, offering patients a higher chance of long-term symptom relief and improved quality of life.

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Research Clinical Trials Therapies Immune Response 52