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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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).
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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.
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.
Mpox: Disease Expert Explains Why It’s Now a Global Health Emergency
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2024
The World Health Organization (WHO) has declared mpox a public health emergency of international concern, after rising cases in the Democratic Republic of the Congo and the potential for further spread.
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.
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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
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.
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.
First international conference on sickle cell disease to be held at ICMR-NIIH in Maharashtra from October 4 to 6
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2024
The first International Conference on ‘Sickle Cell Disease: Advances in the Management and Prevention’ will be held at the Indian Council of Medical Research – National Institute of Immunohaematology (ICMR-NIIH), Centre for Research Management and Control of Haemoglobinopathies (CRMCH), at Chandrapur in Maharashtra, from October 4 to 6, 2024.
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.
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
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.
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.
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.
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
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.
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
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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,
Scientists engineer brain parasite as novel drug delivery system
BioPharma Reporter
AUGUST 21, 2024
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.
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.
In launching epinephrine nasal spray, ARS Pharma has a 'blue sky opportunity,' analyst says
Fierce Pharma
AUGUST 21, 2024
Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. | Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But the San Diego drugmaker is now poised for an October launch and a “blue sky opportunity,” according to the team of analysts at Leerink Partners.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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