Tue.Jun 11, 2024

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Ipsen drug for rare liver disease approved by FDA

Bio Pharma Dive

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

Drugs 278
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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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ADCs are in focus. Here’s where AstraZeneca, AbbVie hope to take the field next.

Bio Pharma Dive

Newer components and drug combinations could expand use of the targeted cancer medicines, according to company executives.

Medicine 269
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June 11, 2024: Many Older Participants in Acupuncture Research Have Prior Acupuncture Experience, BackInAction Data Suggest

Rethinking Clinical Trials

Dr. Andrea Cook and Dr. Lynn DeBar, principal investigators of BackInAction Many older adults who participate in acupuncture research may have prior experience with acupuncture, according to an analysis of data from the BackInAction trial. The finding has implications for the design and conduct of future pragmatic clinical trials involving acupuncture.

Research 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Donanemab approval would fuel growth of amyloid-blocking Alzheimer’s drugs, analysts say

Bio Pharma Dive

After an FDA panel backed the experimental Lilly drug, Wall Street analysts see its likely clearance as benefiting Eisai and Biogen’s rival Leqembi.

Drugs 169
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Amphastar Pharmaceuticals gets grant for medication container assembly with cap and hold down members

Pharmaceutical Technology

Discover how Amphastar Pharmaceuticals' patented medication delivery system prevents premature discharge during storage. Secure, moisture-controlled storage for medication devices.

More Trending

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Purdue Pharma gets grant for tamper resistant opioid analgesic extended release dosage form

Pharmaceutical Technology

Discover Purdue Pharma's innovative tamper-resistant opioid analgesic dosage form with extended release properties. Learn about the patented solid oral form designed for controlled drug release and enhanced safety in medication administration.

Drugs 130
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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

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Kineta gets grant for compounds for treating proteostasis dysfunction

Pharmaceutical Technology

Discover Kineta Inc's groundbreaking patent for compounds targeting proteostasis dysfunction. Learn about the specific chemical structures, pharmaceutical compositions, and methods for treating various conditions, including cancer symptoms. US Patent Publication Number: US11958873B2.

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FDA wants to make the home a healthcare hub

pharmaphorum

The FDA is exploring ways to transform the home into a healthcare hub, bringing healthcare services closer to individuals. This article discusses the potential impact of this trend on the future of healthcare.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Eurofins Scientific gets grant for detection of DNA from specific cells for medical conditions

Pharmaceutical Technology

Detect cell-free DNA from specific cell types in biological samples with Eurofins' patented technology. Diagnostic applications for conditions like preeclampsia and cancer, including detecting chromosomal abnormalities in fetuses. Explore the innovative method now!

DNA 130
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After M&A stretch, Pfizer CEO says company needs 'breathing period' from large deals

Fierce Pharma

Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.

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United Laboratories International gets grant for method for removing contaminant material from oil and gas equipment

Pharmaceutical Technology

Discover a patented method for removing contaminant material from oil and gas industrial equipment using a unique solvent composition. Learn more about this innovative approach in the recently granted patent US11946021B2.

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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

Drugs 115
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Silence Therapeutics gets grant for compound for rna interference therapy in treating liver disease

Pharmaceutical Technology

Discover the groundbreaking patent by Silence Therapeutics Plc for a compound revolutionizing RNA interference therapy. Learn how formula (II) is paving the way for targeted treatment of liver disease and genetic disorders.

RNA 130
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3rd to 7th June – This week in clinical trials

pharmaphorum

Get the latest updates on clinical trials from 3rd to 7th June involving companies like uniQure, Takeda, Otsuka, CatalYm, Agios, and Transgene. Stay informed on the latest developments in the field.

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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using avpal variant

Pharmaceutical Technology

Reduce blood phenylalanine levels in adolescents with PKU using AvPAL variants. A detailed patent outlines a method involving weekly doses over 50 weeks for subjects aged 12-17, with dosage adjustments for optimal results.

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Ipsen, Genfit’s Elafibranor Wins FDA Approval for Primary Biliary Cholangitis

BioSpace

Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Piramal Enterprises gets grant for pharmaceutical kit for cancer treatment with CDK and antioxidant

Pharmaceutical Technology

Discover the groundbreaking patent by Piramal Enterprises Ltd for a pharmaceutical kit combining CDK and antioxidant enzyme inhibitors to revolutionize cancer treatment. Learn more about this innovative therapy now!

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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

Drugs 113
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Kyowa Kirin invests $530m in new US biologics manufacturing facility

Pharmaceutical Technology

Kyowa Kirin has received approval from its board of directors to invest $530m to establish a new biologics plant in Sanford, NC, US.

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Lilly Sees More Zepbound Out-of-Pocket Payments as Obesity Pill Nears Phase III Readout

BioSpace

More patients are having to pay out-of-pocket for Eli Lilly’s weight-loss medication Zepbound than they did for type 2 diabetes drug Mounjaro, according to Lilly USA President Patrik Jonsson.

Drugs 107
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Ultragenyx Pharmaceutical gets grant for method of protecting aav viral particles during heat inactivation

Pharmaceutical Technology

Protect AAV viral particles with Ultragenyx's patented heat inactivation method. Learn how specific buffers preserve genomic integrity and biological activity.

Genome 130
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Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

Fierce Pharma

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement t | More than 2,000 plaintiffs accused the HIV drugmaker of purposely waiting to launch safer TAF-based meds in the early 2000s in order to maximize profits from its older TDF-based products.

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Syros Pharmaceuticals gets grant for CDK7 inhibitors for treating cancer and other diseases

Pharmaceutical Technology

Discover how Syros Pharmaceuticals' patented compounds inhibit CDK7, inducing cellular apoptosis and treating diseases like cancer and ALS.

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UK pharma industry delivers election ‘wish list’

pharmaphorum

The Association of the British Pharmaceutical Industry (ABPI) is calling on political parties contesting the general election to spell out their plans to nurture and drive growth in the life sciences sector and deliver for patients.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Adcytherix launches with seed funding for ADC development

Pharmaceutical Technology

Adcytherix has announced its launch with seed funding of €30m ($32.2m) to develop antibody-drug conjugates (ADCs) for cancer treatment.

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Sage’s Dalzanemdor Shows Effect in Huntington’s Study, Analysts Say Results ‘Underwhelming’

BioSpace

While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.

Trials 99
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FDA gives accelerated approval for Ipsen’s Iqirvo for primary biliary cholangitis

Pharmaceutical Technology

Ipsen has received the US FDA accelerated approval for Iqirvo (elafibranor) 80mg tablets for primary biliary cholangitis (PBC).

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Sanders wants to subpoena Novo Nordisk exec to answer questions on Wegovy, Ozempic pricing

Fierce Pharma

Sen. Bernie Sanders, I-Vermont, is stepping up his attack on Novo Nordisk over the prices the company charges in the U.S. for its wildly popular diabetes and weight loss drugs. | Sen. Bernie Sanders is stepping up his attack on Novo Nordisk over the prices the company charges in the U.S. for its wildly popular diabetes and weight loss drugs. Sanders, the chairman of the Senate Committee on Health, Education, Labor and Pensions, is asking the committee to vote on whether it should subpoena Novo’s

Drugs 98
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.