Wed.Jun 05, 2024

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Bio-Sourcing and Afrigen Biologics partner on biomanufacturing platform

Pharmaceutical Technology

Belgian biotech, Bio-Sourcing, and Cape Town based company, Afrigen Biologics, have signed a partnership for a technology transfer pilot programme in South Africa of a biotherapeutic platform named BioMilk.

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[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Bio Pharma Dive

How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

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Be Bio’s haemophilia B treatment gains FDA orphan drug status

Pharmaceutical Technology

The US FDA has granted orphan drug designation to Be Biopharma’s (Be Bio) BE-101 for the treatment of haemophilia B.

Drugs 246
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DCGI emphasises need for sample test for standards for medical devices and IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

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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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Scientists push for ‘greener’ drugs in published study

Pharmaceutical Technology

5 June marks World Environment Day, an annual celebration that encourages global awareness and action to protect the environment.

Scientist 182
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Surprise Discovery Reveals Ozempic Lowers Risk of Diabetic Kidney Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists are learning about the pros and cons of Ozempic in real-time, as prescriptions of the appetite-suppressing drug explode into the millions worldwide.

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More Trending

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June 5, 2024: This Week’s PCT Grand Rounds to Feature PCORnet-Based COVID-19 and Diabetes Assessment (CODA) Study

Rethinking Clinical Trials

Dr. Russell Rothman and Dr. Jason Block In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern.

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Lilly CFO leaves to join Alphabet

Bio Pharma Dive

Anat Ashkenazi is switching industries after a 23-year career at the Indianapolis drugmaker.

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How to streamline your pharma mass production by leveraging the Körber Ecosystem

Pharmaceutical Technology

Having a competent and efficient partner by your side can elevate your mass production to new levels of efficiency and sustainable success.

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Bristol Myers puts more than 860 jobs on chopping block in NJ as $1.5B savings campaign rolls ahead

Fierce Pharma

The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.

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

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Bluejay touts positive data for chronic hepatitis D treatment

Pharmaceutical Technology

The biopharma shared preliminary Phase II data at EASL for its IgG1 monoclonal antibody, BJT-778

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Resolution unveils data for liver disease treatment at EASL 2024

Pharma Times

Extended phase 2 study highlights macrophage cell therapy’s efficacy

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AbbVie’s RINVOQ now indicated for paediatric arthritis in US

Pharmaceutical Technology

AbbVie's RINVOQ is now indicated for polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) in paediatric patients.

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From one juggernaut to another: Lilly CFO Anat Ashkenazi takes same role at tech giant Alphabet

Fierce Pharma

After 23 years at Eli Lilly, including the last three as its CFO, Anat Ashkenazi is leaving to take the same role at Google's parent company Alphabet.

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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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MDMA therapy wait goes on as FDA panel rejects Lykos’ PTSD treatment

Pharmaceutical Technology

An FDA advisory committee, whilst noting improvement in patient symptoms, was not convinced by Lykos’ trial design.

Trials 130
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Sanofi’s Sarclisa shows significant promise in treating myeloma

Pharma Times

Phase 3 research suggests a significant leap forward in myeloma management

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AstraZeneca completes Fusion Pharmaceuticals acquisition

Pharmaceutical Technology

AstraZeneca has announced the conclusion of its acquisition of clinical-stage biopharmaceutical company Fusion Pharmaceuticals.

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First rare disease therapies chosen for FDA START programme

pharmaphorum

An initiative set up by the FDA to accelerate the development of therapies for rare disease in the same way that Operation Warp Speed delivered COVID-19 vaccine has chosen its first pilot programme candidates.

Vaccine 116
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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J&J seeks expanded approvals for paediatric HIV-1 therapy

Pharmaceutical Technology

Johnson & Johnson has sought approval from the US FDA for the use of its HIV-1 therapy, PREZCOBIX, in children aged six years and above.

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ASCO: KRAS upstarts set their sights on NSCLC market

pharmaphorum

KRAS inhibitors from Eli Lilly, Genfleet, and InxMed make their case for use in NSCLC at ASCO, as they case down Amgen and Bristol-Myers Squibb's market drugs

Marketing 116
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Lilly touts fibrosis win as it pads case for tirzepatide in MASH

Fierce Pharma

Back in February, Eli Lilly teased “clinically meaningful” results around the ability of its dual GLP-1/GIP med tirzepatide to curb fibrosis in patients with fatty liver disease. | Back in February, Eli Lilly teased “clinically meaningful” results around the ability of its dual GLP-1/GIP med tirzepatide to curb fibrosis in patients with fatty liver disease.

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PHTI backs virtual therapies for musculoskeletal disorders

pharmaphorum

PHTI's latest report finds that digital therapies for musculoskeletal conditions like low back pain can deliver clinically meaningful benefits

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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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Pharma Pulse 6/5/24: Polypharmacy and the Pivotal Role of the Payer, Patients and Data Disrupt the Industry & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Gilead, Ipsen build the case for their PBC drugs at EASL

pharmaphorum

Gilead Sciences is just a few weeks away from an FDA decision on seladelpar for rare liver disease primary biliary cholangitis (PBC) and will be buoyed by new data pointing to its long-term efficacy and safety.

Drugs 111
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New pDNA Facility in the Works for Bionova Scientific

Pharmaceutical Commerce

The development and manufacturing plant will be constructed in Texas, and is expected to become operational by Q1 2025.

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Cyberattack disrupts patient care at London hospitals

pharmaphorum

NHS hospitals in London have declared a critical incident caused by a ransomware attack on a pathology services provider, leading to cancelled procedures and patients having to be transferred to different care providers. The attack on Synnovis has had an impact on patient care at Guy’s and St Thomas’ and King’s College Hospital NHS Foundation Trusts, as well as GP services in southeast London, according to an NHS England statement.

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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

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FDA hearing set to discuss advisory committee members’ conflicts and more

Pharmaceutical Technology

FDA officials outline what to expect at the upcoming hearing on AdComs, and elaborated how the right data can drive accelerated approvals.

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Embracing Inclusivity: How Biopharmas Connect With LGBTQ+ Employees

BioSpace

There are multiple ways biopharmas create inclusive workplaces for LGBTQ+ employees, and they go beyond employee resource groups and benefits.

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AI at DIA 2024: GiftHealth unveils game-changing patient support innovations

BioPharma Reporter

Get ready for a big reveal at the DIA conference in San Diego as GiftHealth introduces its latest AI-enabled features designed to revolutionize patient care.

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Amgen Phase III Win Positions Uplizna for Label Expansion in Rare Autoimmune Disease

BioSpace

Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.

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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.