Wed.Aug 21, 2024

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BridgeBio sends rare disease drugs to new company

Bio Pharma Dive

Backed by $300 million from investors that include Viking Global Investors and Sequoia Capital, GondolaBio will inherit several BridgeBio drug programs.

Drugs 278
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Amgen’s Otezla launched for paediatric plaque psoriasis in US

Pharmaceutical Technology

Amgen has announced the availability of Otezla (apremilast) in the US for paediatric patients with moderate to severe plaque psoriasis.

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Employers foresee higher health costs next year due to rising pharmacy spend

Bio Pharma Dive

Pharmaceuticals like the in-demand GLP-1 drugs for obesity are expected to drive increases in healthcare spending in 2025, per a new employer survey.

Pharmacy 277
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NMPA approves AstraZeneca’s Fasenra for severe asthma

Pharmaceutical Technology

The China NMPA approved AstraZeneca's Fasenra for individuals aged 12 years and older with severe eosinophilic asthma (SEA).

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Bio Pharma Dive

Company executives had previously warned investors that a delay was likely due to issues at a facility run by third-party manufacturer.

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Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals

Pharmaceutical Technology

The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.

Sales 245

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Dr Reddy’s, Aurigene and Kainomyx to co-develop anti-malarials

Pharmaceutical Technology

Dr Reddy's Laboratories, Aurigene Pharmaceutical and Kainomyx signed an MoU to co-develop and co-commercialise an anti-malarial drug.

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BioMarin taps Amgen, Roche vets in executive reshuffle

Bio Pharma Dive

Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.

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AMR testing technology from QuantaMatrix backed by research paper in Nature

Pharma Times

The new test takes an average of 13 hours to identify the correct treatment compared to several days with current methods

Research 150
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Pathalys secures $105m to advance SHPT drug through approval

Pharmaceutical Technology

The funds will support Pathalys’ lead candidate upacicalcet through two clinical trials and potentially accelerate its approval.

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

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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GOSH and Oliver Patch in cancer research partnership with Innovative Trials

Pharma Times

Globally 400,000 children are impacted every year by cancers that include leukaemia and lymphoma

Trials 141
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FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

Pharmaceutical Technology

The issue at a third-party manufacturer has been resolved, with an FDA re-inspection now planned.

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August 21, 2024: In This Week’s PCT Grand Rounds, Improving Quality of Life in COPD and Heart Failure

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, David Bekelman and Lyndsay DeGroot of the University of Colorado will present “Improving Quality of Life in COPD and Heart Failure: Unpacking a Successful Multicomponent Virtual Team Intervention.” The Grand Rounds session will be held on Friday, August 23, 2024, at 1:00 pm eastern. Bekelman is a professor of medicine and psychiatry at the University of Colorado School of Medicine and the Rocky Mountain Regional VAMC.

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Enhancing mRNA drug development: how to optimise your suppliers and materials

Pharmaceutical Technology

Pharma companies seeking to commercialise in mRNA can gain a competitive edge by partnering with expert suppliers

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

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Ask NAVLIN: The AI chatbot innovation driving a better global customer experience

pharmaphorum

Demonstrating EVERSANA's dedication to innovation, a novel artificial intelligence technology is set to enhance the NAVLIN experience for both current and prospective customers.

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How personalised medicine can revolutionise contraception

Pharmaceutical Technology

New research has recently demonstrated how contraception for women can be personalised based on genetics and individual needs.

Medicine 130
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J&J's Rybrevant okay challenges Tagrisso in first-line NSCLC

pharmaphorum

J&J's Rybrevant/Lazcluze combination is cleared by FDA for first-line EGFR+ NSCLC, giving AstraZeneca's top-seller Tagrisso its first direct competition

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Licensing agreements for innovator GLP1R drugs weigh in with over $6.2bn in 2024

Pharmaceutical Technology

Innovator drugs targeting GLP1R witnessed a 595% increase in total licensing agreement deal value from 2019 to 2024 YTD.

Licensing 130
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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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New Brain Tumor Drug Voranigo (Vorasidenib) Targets Grade 2 IDH-Mutant Glioma

XTalks

The US Food and Drug Administration (FDA) has approved Voranigo (vorasidenib) for Grade 2 IDH-mutant glioma, a challenging brain tumor that has seen limited effective treatments for nearly 25 years. Developed by Servier Pharmaceuticals, Voranigo offers the first targeted therapy for patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma that harbor isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation.

Drugs 111
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Aadi axes 80% of staff after registrational Phase II trial fails

Pharmaceutical Technology

The company halted Phase II trial of its mTOR inhibitor after an independent analysis found that it would not meet the efficacy threshold.

Trials 130
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Study reignites debate on GLP-1 drugs and suicide risk

pharmaphorum

Debate over the safety of GLP-1 drugs resurfaces after study finds 'disproportional' risk of suicidal thinking adverse event reports with Novo Nordisk's semaglutide

Drugs 111
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Lilly and Emgality expand migraine treatment deal to 11 new markets

Pharmaceutical Technology

Organon and Eli Lilly broadened a commercial agreement under which the former will distribute and promote Emgality in 11 new markets.

Marketing 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Medicare plans accuse Teva of covering copays for patients

pharmaphorum

A class action suit has been filed in the US against Teva, claiming that the company illegally subsidised the copays for patients prescribed its multiple sclerosis therapy Copaxone to boost its sales.The suit filed on behalf of Medicare Advantage coverage providers accuses the company of "funnelling hundreds of millions of dollars" to Copaxone (glatiramer acetate) patients through third-party foundations and companies.

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Biogen sued for alleged PBM kickbacks scheme to boost Tecfidera in wake of generics

Fierce Pharma

As Biogen’s relentless patent defense for blockbuster multiple sclerosis med Tecfidera came up short in the U.S., the company separately worked to fend off competition through an anticompetitive ki | A multi-employer health benefit plan in Illinois accused the drugmaker of scheming with pharmacy benefit managers to keep its Tecfidera in a more favorable spot on their formularies.

Pharmacy 100
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How can digital technologies help pharma meet the changing needs of HCPs and patients?

pharmaphorum

Digital technologies play a crucial role in helping the pharmaceutical industry meet the changing needs of healthcare providers (HCPs) and patients. Learn how digital innovations are transforming healthcare delivery and improving patient outcomes in this comprehensive guide.

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Sustainability is increasingly important in pharma, but several hurdles are slowing the effort: survey

Fierce Pharma

A survey of 800 biopharma executives shows that sustainability is an increasingly important priority but that companies are struggling to achieve it.

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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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Breakthrough delivery system could revolutionize Alzheimer’s treatment

BioPharma Reporter

In a groundbreaking development, a team of biochemical engineers from South Korea has unveiled a new exosome-based delivery system, termed MAPLEX, that holds the potential to transform treatments for various diseases, including Alzheimerâs.

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Despite trial scare, Travere’s Filspari gains full FDA nod in kidney disease showdown with Novartis

Fierce Pharma

A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. | A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgAN into a full approval but left a liver toxicity monitoring requirement in place.

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Scientists engineer brain parasite as novel drug delivery system

BioPharma Reporter

A team of scientists from the universities of Glasgow and Tel Aviv has developed a groundbreaking method to transform the brain parasite Toxoplasma gondii into a potential vehicle for delivering therapeutic treatments directly to brain cells.

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Tony Blair: digital health records 'will prepare NHS for AI'

pharmaphorum

The Tony Blair Institute (TBI) has called for a digital health record (DHR) for everyone in the UK within five years to "ensure that the NHS is ready for the artificial intelligence era."The DHR would serve as a "single source of truth" for health and care data that is currently fragmented across multiple NHS sources and phones, and serve as a "building block" for the way health will be delivered in future, according to the think tank.

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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