Tue.Aug 06, 2024

article thumbnail

Malaysia approves Antengene’s XPOVIO NDA for multiple myeloma

Pharmaceutical Technology

Antengene received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO NDA for two multiple myeloma indications.

243
243
article thumbnail

Biotech Red Queen launches with $55M to build versatile antivirals

Bio Pharma Dive

The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.

Drugs 334
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharma casts a wide net to hook opportunities in metabolic disorders

Pharmaceutical Technology

The recent success of diabetes and weight loss medications has spurred more interest in other metabolic disorders.

246
246
article thumbnail

Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Bio Pharma Dive

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.

Licensing 334
article thumbnail

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

article thumbnail

GSK announces victory in Zantac cancer claim lawsuit

Pharmaceutical Technology

GSK has announced the win in the latest trial concerning allegations that its heartburn medication Zantac was linked to cancer.

Trials 246
article thumbnail

Biotech entrepreneur Arie Belldegrun launches new ‘science-first’ credit firm

Bio Pharma Dive

Symbiotic Capital, which has $600 million in committed capital, aims to make credit a more accessible tool for life sciences companies.

More Trending

article thumbnail

BioMarin pares Roctavian spending as it narrows sales focus

Bio Pharma Dive

The company plans to limit sales of the hemophilia gene therapy to the U.S., Italy and Germany, while ending most clinical development work.

Sales 182
article thumbnail

Ministry of Ayush targets infra development of 280 Ayush facilities in 2024-25

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

RSV vaccine makers remain optimistic about market despite CDC guidance

Bio Pharma Dive

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.

Marketing 162
article thumbnail

Q2 2024 update: electronic medical record (emr) systems related private equity activity in the pharmaceutical industry

Pharmaceutical Technology

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.

147
147
article thumbnail

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

article thumbnail

August 6, 2024: Workshop Materials Now Available From NIH-Hosted Workshop, ‘Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues’

Rethinking Clinical Trials

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by NIH Director Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.

Research 147
article thumbnail

Chime looks to expand manufacturing capacity and establish European presence

Pharmaceutical Technology

The China-headquartered CDMO is planning to scale its manufacturing operations, expand its presence in APAC, and set up a Swiss subsidiary.

article thumbnail

Pfizer to create 500 new jobs as it upgrades Australia manufacturing plant to help fight antimicrobial resistance

Fierce Pharma

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.

article thumbnail

Embracing innovation to drive clinical change in UK stroke care

pharmaphorum

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.

131
131
article thumbnail

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

article thumbnail

Concentric Analgesics highlights data on vocacapsaicin for pain relief

Pharmaceutical Technology

Vocacapsaicin has demonstrated significant pain relief and early opioid cessation post-surgery in Phase II clinical trials.

article thumbnail

Servier snags FDA approval for Voranigo, the 1st targeted therapy for a common type of brain tumor

Fierce Pharma

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.

article thumbnail

Global stock market crash likely to delay biotech IPOs

Pharmaceutical Technology

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.

Marketing 130
article thumbnail

Bayer's transformation gathers steam as its job cut total reaches 3,200 this year

Fierce Pharma

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.

121
121
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Developing high-potent APIs: The necessary steps to follow

Pharmaceutical Technology

The toxicity of HPAPIs requires careful management and expert CDMOs to assist across development and production stages.

article thumbnail

Harnessing genetics to propel cancer research and clinical success

pharmaphorum

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.

Genetics 119
article thumbnail

FDA grants RPDD to META Pharmaceuticals’ hyperoxaluria drug

Pharmaceutical Technology

The US FDA has granted rare paediatric disease designation for META Pharmaceuticals’ META-001-PH to treat primary hyperoxaluria.

Drugs 130
article thumbnail

Penn accuses BioNTech of skimping out on Comirnaty-related royalties in lawsuit

Fierce Pharma

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.

Sales 119
article thumbnail

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.

article thumbnail

SK pharmteco and Rznomics sign MoU to develop gene therapies

Pharmaceutical Technology

SK pharmteco has entered an MoU with South Korea-based Rznomics for the development and manufacture of RNA-based gene therapies.

article thumbnail

Researchers reveal brain parasites could be used to treat cognitive disorders

Pharma Times

Neurological conditions, including Alzheimer’s disease, are the leading cause of ill health globally

Research 117
article thumbnail

How SaaS platforms are breaking the mold for clinical trials

Pharmaceutical Technology

Clinical trials are increasingly relying on software-as-a-service (SaaS) providers to optimize efficiencies.

article thumbnail

Biopharma, finance vets launch $600m life science loan firm

pharmaphorum

There's a new source of funding for life science companies, Symbiotic Capital, which is providing credit as an alternative to other financing routes

article thumbnail

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

article thumbnail

Bayer looks ahead to Nubeqa, Kerendia expansions amid Xarelto's downward sales spiral

Fierce Pharma

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.

Sales 111
article thumbnail

BMS ducks out of $1.56bn TIGIT alliance with Agenus

pharmaphorum

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.

Licensing 111
article thumbnail

BHF’s HIF funds five heart research projects over £800,000

Pharma Times

Cardiovascular diseases currently affect around seven million people in the UK, including coronary heart disease

Research 106
article thumbnail

Changing Faces May-June 2024: Government, non-profit, and professional organisation

pharmaphorum

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.

110
110
article thumbnail

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.