Malaysia approves Antengene’s XPOVIO NDA for multiple myeloma
Pharmaceutical Technology
AUGUST 6, 2024
Antengene received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO NDA for two multiple myeloma indications.
Tue.Aug 06, 2024
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Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs
Bio Pharma Dive
AUGUST 6, 2024
Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.
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GSK announces victory in Zantac cancer claim lawsuit
Pharmaceutical Technology
AUGUST 6, 2024
GSK has announced the win in the latest trial concerning allegations that its heartburn medication Zantac was linked to cancer.
Biotech Red Queen launches with $55M to build versatile antivirals
Bio Pharma Dive
AUGUST 6, 2024
The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.
Pharma casts a wide net to hook opportunities in metabolic disorders
Pharmaceutical Technology
AUGUST 6, 2024
The recent success of diabetes and weight loss medications has spurred more interest in other metabolic disorders.
Biotech entrepreneur Arie Belldegrun launches new ‘science-first’ credit firm
Bio Pharma Dive
AUGUST 6, 2024
Symbiotic Capital, which has $600 million in committed capital, aims to make credit a more accessible tool for life sciences companies.
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BioMarin pares Roctavian spending as it narrows sales focus
Bio Pharma Dive
AUGUST 6, 2024
The company plans to limit sales of the hemophilia gene therapy to the U.S., Italy and Germany, while ending most clinical development work.
Q2 2024 update: electronic medical record (emr) systems related private equity activity in the pharmaceutical industry
Pharmaceutical Technology
AUGUST 6, 2024
In the global pharmaceutical industry, there were 2 private equity deals announced in Q2 2024, worth a total value of $100m, according to GlobalData's Deals Database.
RSV vaccine makers remain optimistic about market despite CDC guidance
Bio Pharma Dive
AUGUST 6, 2024
An advisory committee’s age group recommendations could curtail wider use for now, but executives at GSK, Pfizer and Moderna still see plenty of upside.
Cranberry Juice Really Does Have Promising Benefits For UTIs
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 6, 2024
For thousands of years, Native Americans have used cranberries as a remedy for bacterial infections, like those of the bladder.
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
Chime looks to expand manufacturing capacity and establish European presence
Pharmaceutical Technology
AUGUST 6, 2024
The China-headquartered CDMO is planning to scale its manufacturing operations, expand its presence in APAC, and set up a Swiss subsidiary.
Ministry of Ayush targets infra development of 280 Ayush facilities in 2024-25
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 6, 2024
The Ministry of Ayush is targeting to upgrade or establish new infrastructure facilities of 280 Ayush facilities and supply Ayush medicines to 30,050 facilities during the current fiscal year, under the National Ayush Mission (NAM). The Union Budget 2024-25 has earmarked a financial outlay of Rs. 1,200 crore for the Central Sponsored Scheme of NAM.
Global stock market crash likely to delay biotech IPOs
Pharmaceutical Technology
AUGUST 6, 2024
Biotech IPOs were up six-fold in Q1 2024 from the previous quarter, but the current global stock market crash means a sustained rebound is in jeopardy.
Embracing innovation to drive clinical change in UK stroke care
pharmaphorum
AUGUST 6, 2024
Discover how the innovative geko device is driving clinical change in UK stroke care. Learn how this technology is revolutionising the treatment and management of stroke patients.
FDA grants RPDD to META Pharmaceuticals’ hyperoxaluria drug
Pharmaceutical Technology
AUGUST 6, 2024
The US FDA has granted rare paediatric disease designation for META Pharmaceuticals’ META-001-PH to treat primary hyperoxaluria.
Pfizer to create 500 new jobs as it upgrades Australia manufacturing plant to help fight antimicrobial resistance
Fierce Pharma
AUGUST 6, 2024
Warning of a "silent pandemic" spreading across the globe, Pfizer is taking the fight against antimicrobial resistance (AMR) Down Under. | Pfizer announced Tuesday that it has invested 150 million Australian dollars (about $98 million) to build a new manufacturing facility at its Australian site in Melbourne, where the company will help produce new antimicrobial treatments aimed at addressing the rising tide of antimicrobial resistance.
SK pharmteco and Rznomics sign MoU to develop gene therapies
Pharmaceutical Technology
AUGUST 6, 2024
SK pharmteco has entered an MoU with South Korea-based Rznomics for the development and manufacture of RNA-based gene therapies.
Servier snags FDA approval for Voranigo, the 1st targeted therapy for a common type of brain tumor
Fierce Pharma
AUGUST 6, 2024
Servier has expanded its IDH drug armamentarium with the FDA approval for an IDH1/2 dual inhibitor. | Servier's Voranigo, or vorasidenib, is now the first systemic therapy for low-grade IDH-mutant brain cancer.
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.
Concentric Analgesics highlights data on vocacapsaicin for pain relief
Pharmaceutical Technology
AUGUST 6, 2024
Vocacapsaicin has demonstrated significant pain relief and early opioid cessation post-surgery in Phase II clinical trials.
Bayer's transformation gathers steam as its job cut total reaches 3,200 this year
Fierce Pharma
AUGUST 6, 2024
Bayer’s transformation under CEO Bill Anderson has picked up momentum. In reporting second-quarter earnings on Tuesday, the company revealed it has cut 3,200 jobs since the start of this year. | Bayer’s transformation under CEO Bill Anderson has picked up momentum. In reporting second-quarter earnings on Tuesday, the company revealed it has cut 3,200 jobs since the start of this year.
Developing high-potent APIs: The necessary steps to follow
Pharmaceutical Technology
AUGUST 6, 2024
The toxicity of HPAPIs requires careful management and expert CDMOs to assist across development and production stages.
Harnessing genetics to propel cancer research and clinical success
pharmaphorum
AUGUST 6, 2024
Discover how Step Pharma is harnessing genetics and developing therapeutics targeting CTPS1 to advance cancer research and enhance clinical success. Learn more about their innovative approach.
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
How SaaS platforms are breaking the mold for clinical trials
Pharmaceutical Technology
AUGUST 6, 2024
Clinical trials are increasingly relying on software-as-a-service (SaaS) providers to optimize efficiencies.
Penn accuses BioNTech of skimping out on Comirnaty-related royalties in lawsuit
Fierce Pharma
AUGUST 6, 2024
As sales from COVID-19 vaccines continue to flounder, lawsuits associated with the products keep on piling up. | The university accused Pfizer's Comirnaty partner of failing to pay the full total of royalties owed on worldwide product sales through a sublicense agreement to Penn's mRNA patents.
Terran Biosciences - the difficulties of getting new schizophrenia treatments to market
BioPharma Reporter
AUGUST 6, 2024
Experience with severe mental health disorders in close friends and family gave Sam Clark the drive to found Terran Biosciences to explore new approaches to therapeutics in neuropsychiatry.
Bayer looks ahead to Nubeqa, Kerendia expansions amid Xarelto's downward sales spiral
Fierce Pharma
AUGUST 6, 2024
Amid Bayer's massive reorganization, the company's pharma group is moving | The company plans to keep building out blockbuster hopeful Nubeqa, popular eye drug Eylea and newer Kerendia as its top-selling Xarelto succumbs to generic competition.
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.
BMS ducks out of $1.56bn TIGIT alliance with Agenus
pharmaphorum
AUGUST 6, 2024
Bristol-Myers Squibb has handed back rights to a TIGIT drug partnered with Agenus, ending an alliance that could have been worth up to $1.56 billion to the biotech.Agenus revealed BMS' decision in a Securities & Exchange Commission (SEC) filing (PDF), saying it was a result of a "broader strategic realignment of their development pipeline which involves other licensed products.
BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets
Fierce Pharma
AUGUST 6, 2024
After previously floating the possibility of div | After previously floating the possibility of divesting Roctavian, BioMarin has decided to keep the hemophilia A gene therapy—but with a narrowed focus. The reorg comes with cost cuts across the medicine's R&D, manufacturing and commercialization support functions.
Changing Faces May-June 2024: Government, non-profit, and professional organisation
pharmaphorum
AUGUST 6, 2024
Explore the latest updates and collaborations between the Gates Foundation, UCL, DSRU and more in the May-June 2024 issue of Changing Faces. Learn about their impactful work in government, non-profit, and professional organisation sectors.
GSK knocks out another Illinois lawsuit claiming once-popular heartburn med Zantac causes cancer
Fierce Pharma
AUGUST 6, 2024
Following a string of legal wins this year—plus one major setback in May—GSK has washed its hands of yet another lawsuit alleging the once-popular heartburn med Zantac can cause cancer. | GSK revealed in a statement Monday that it’s emerged victorious in Illinois state court after a jury determined that the company was not liable for a plaintiff’s colorectal cancer.
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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