BridgeBio sends rare disease drugs to new company
Bio Pharma Dive
AUGUST 21, 2024
Backed by $300 million from investors that include Viking Global Investors and Sequoia Capital, GondolaBio will inherit several BridgeBio drug programs.
Wed.Aug 21, 2024
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Amgen’s Otezla launched for paediatric plaque psoriasis in US
Pharmaceutical Technology
AUGUST 21, 2024
Amgen has announced the availability of Otezla (apremilast) in the US for paediatric patients with moderate to severe plaque psoriasis.
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Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues
Bio Pharma Dive
AUGUST 21, 2024
Company executives had previously warned investors that a delay was likely due to issues at a facility run by third-party manufacturer.
NMPA approves AstraZeneca’s Fasenra for severe asthma
Pharmaceutical Technology
AUGUST 21, 2024
The China NMPA approved AstraZeneca's Fasenra for individuals aged 12 years and older with severe eosinophilic asthma (SEA).
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
Employers foresee higher health costs next year due to rising pharmacy spend
Bio Pharma Dive
AUGUST 21, 2024
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.
Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals
Pharmaceutical Technology
AUGUST 21, 2024
The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.
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Dr Reddy’s, Aurigene and Kainomyx to co-develop anti-malarials
Pharmaceutical Technology
AUGUST 21, 2024
Dr Reddy's Laboratories, Aurigene Pharmaceutical and Kainomyx signed an MoU to co-develop and co-commercialise an anti-malarial drug.
BioMarin taps Amgen, Roche vets in executive reshuffle
Bio Pharma Dive
AUGUST 21, 2024
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.
AMR testing technology from QuantaMatrix backed by research paper in Nature
Pharma Times
AUGUST 21, 2024
The new test takes an average of 13 hours to identify the correct treatment compared to several days with current methods
Pathalys secures $105m to advance SHPT drug through approval
Pharmaceutical Technology
AUGUST 21, 2024
The funds will support Pathalys’ lead candidate upacicalcet through two clinical trials and potentially accelerate its approval.
August 21, 2024: In This Week’s PCT Grand Rounds, Improving Quality of Life in COPD and Heart Failure
Rethinking Clinical Trials
AUGUST 21, 2024
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.
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues
Pharmaceutical Technology
AUGUST 21, 2024
The issue at a third-party manufacturer has been resolved, with an FDA re-inspection now planned.
GOSH and Oliver Patch in cancer research partnership with Innovative Trials
Pharma Times
AUGUST 21, 2024
Globally 400,000 children are impacted every year by cancers that include leukaemia and lymphoma
Enhancing mRNA drug development: how to optimise your suppliers and materials
Pharmaceutical Technology
AUGUST 21, 2024
Pharma companies seeking to commercialise in mRNA can gain a competitive edge by partnering with expert suppliers
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Ask NAVLIN: The AI chatbot innovation driving a better global customer experience
pharmaphorum
AUGUST 21, 2024
Demonstrating EVERSANA's dedication to innovation, a novel artificial intelligence technology is set to enhance the NAVLIN experience for both current and prospective customers.
How personalised medicine can revolutionise contraception
Pharmaceutical Technology
AUGUST 21, 2024
New research has recently demonstrated how contraception for women can be personalised based on genetics and individual needs.
Biogen sued for alleged PBM kickbacks scheme to boost Tecfidera in wake of generics
Fierce Pharma
AUGUST 21, 2024
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.
Licensing agreements for innovator GLP1R drugs weigh in with over $6.2bn in 2024
Pharmaceutical Technology
AUGUST 21, 2024
Innovator drugs targeting GLP1R witnessed a 595% increase in total licensing agreement deal value from 2019 to 2024 YTD.
Sustainability is increasingly important in pharma, but several hurdles are slowing the effort: survey
Fierce Pharma
AUGUST 21, 2024
A survey of 800 biopharma executives shows that sustainability is an increasingly important priority but that companies are struggling to achieve it.
Aadi axes 80% of staff after registrational Phase II trial fails
Pharmaceutical Technology
AUGUST 21, 2024
The company halted Phase II trial of its mTOR inhibitor after an independent analysis found that it would not meet the efficacy threshold.
New Brain Tumor Drug Voranigo (Vorasidenib) Targets Grade 2 IDH-Mutant Glioma
XTalks
AUGUST 21, 2024
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.
Lilly and Emgality expand migraine treatment deal to 11 new markets
Pharmaceutical Technology
AUGUST 21, 2024
Organon and Eli Lilly broadened a commercial agreement under which the former will distribute and promote Emgality in 11 new markets.
The New Age of Decentralized Clinical Trials
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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.
Study reignites debate on GLP-1 drugs and suicide risk
pharmaphorum
AUGUST 21, 2024
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
Astellas employee held in China indicted by China’s prosecutors: Reuters
Fierce Pharma
AUGUST 21, 2024
More than a year after detaining an employee of Astellas for suspected spying, Chinese authorities have indicted the Japanese expat,
Medicare plans accuse Teva of covering copays for patients
pharmaphorum
AUGUST 21, 2024
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.
Aadi lays off 80% of R&D workforce as Fyarro heads to phase 2 solid tumor fail
Fierce Pharma
AUGUST 21, 2024
Aadi Bioscience’s Fyarro is on track to fail a phase 2 solid tumor trial, leading the biotech to halt the study and lay off 80% of its R&D workforce.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
J&J's Rybrevant okay challenges Tagrisso in first-line NSCLC
pharmaphorum
AUGUST 21, 2024
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
Despite trial scare, Travere’s Filspari gains full FDA nod in kidney disease showdown with Novartis
Fierce Pharma
AUGUST 21, 2024
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.
How can digital technologies help pharma meet the changing needs of HCPs and patients?
pharmaphorum
AUGUST 21, 2024
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.
Breakthrough delivery system could revolutionize Alzheimer’s treatment
BioPharma Reporter
AUGUST 21, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
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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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