Wed.Sep 18, 2024

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Cutting Costs with a CDMO: Strategies for Success in Biopharmaceutical Manufacturing

Drug Patent Watch

The biopharmaceutical industry is constantly evolving, with the demand for complex biologics on the rise. To stay competitive, companies must navigate the complexities of biopharmaceutical development while managing costs effectively. One key strategy for achieving this balance is partnering with Contract Development and Manufacturing Organizations (CDMOs).

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FDA expands Novartis’ Kisqali label to include early breast cancer patients

Pharmaceutical Technology

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

Sales 246
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The Dangers of Sleep Deprivation Are Very Real, Expert Warns

AuroBlog - Aurous Healthcare Clinical Trials blog

(Niklas Hamann/Unsplash) Most of us will be all too familiar with that dopey, groggy feeling of being tired after a restless night. Some social media users have taken tiredness to the extreme, however, by taking part in what they call a “no-sleep challenge.

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MHLW accepts GSK’s multiple myeloma treatment NDA for review

Pharmaceutical Technology

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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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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Pharmexcil schedules EGM for September 25, 2024 to adopt new Articles of Association

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced an Extra Ordinary General Meeting (EGM) scheduled for 25th September, 2024 at 3:00 pm (IST). The meeting will take place in a hybrid format, allowing both physical attendance at the Pharmexcil head office in Hyderabad and virtual participation.

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“Leave politics out of healthcare” – controversy swirls around BIOSECURE Act

Pharmaceutical Technology

At the Clinical Trial Supply West Coast 2024 conference, serial biotech entrepreneur Umar Hayat said science should be allowed to advance without political interference.

More Trending

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September 18, 2024: Comparing Pragmatic Trials and Effectiveness-Implementation Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. John Fortney In this Friday’s PCT Grand Rounds, John Fortney of the University of Washington will present “Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.” The Grand Rounds session will be held on Friday, September 20, 2024, at 1:00 pm eastern. Fortney is a professor of psychiatry and behavioral sciences in the University of Washington School of Medicine and a senior research career scientist in the HSR Center of Innovat

Trials 147
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Roivant dermatology subsidiary to be acquired by Organon

Bio Pharma Dive

The deal hands Organon a psoriasis and eczema cream called Vtama, while Roivant will get more cash to fund its R&D plans.

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NHS Trust to evaluate AI software for prostate cancer diagnosis

Pharma Times

It is hoped that the tool will improve the diagnostic pathway and free up radiologists’ time

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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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

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Ossium treats first leukaemia patient in cryopreserved bone marrow trial

Pharmaceutical Technology

Ossium Health’s PRESERVE I trial is evaluating the safety and effectiveness of its deep-frozen bone marrow from deceased organ donors.

Trials 130
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GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales

Fierce Pharma

This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

Sales 126
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Nura Bio secures funding to advance neuroprotective therapies

Pharmaceutical Technology

Nura Bio has secured additional $68m in a Series A financing round to advance the development of its neuroprotective therapies.

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AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease

Fierce Pharma

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.

Marketing 126
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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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BeiGene’s TEVIMBRA gains approval for OSCC in Israel

Pharmaceutical Technology

The Israeli Ministry of Health granted approval for BeiGene’s TEVIMBRA for unresectable or metastatic oesophageal squamous cell carcinoma.

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PBM strikes back at FTC over drug pricing report

pharmaphorum

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

Drugs 124
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Orbis and Vivtex partner to develop oral macrocycle drugs

Pharmaceutical Technology

Orbis Medicines and Vivtex have partnered to support the development of next-generation orally dosable macrocycle drugs.

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Theratechnologies warns of Egrifta supply disruption after third-party plant shutdown

Fierce Pharma

Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could | Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Solution Spotlight: Aktiia Blood Pressure Technology

pharmaphorum

In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.

Engineer 112
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FlyPharma Europe, Vienna – October 2024 conference

Pharma Times

The conference will return to Vienna AirportCity on 23 to 24 October 2024

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Organon makes dermatology play with $1.2bn Dermavant buyout

pharmaphorum

Organon has agreed a $1.

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World Alzheimer’s Day 2024: Innovative Therapies and More

XTalks

World Alzheimer’s Day, observed annually on September 21, unites the global community to raise awareness and challenge the stigma surrounding Alzheimer’s disease. The theme of World Alzheimer’s Day 2024 is “Time to Act on Dementia, Time to Act on Alzheimer’s.” This theme will reflect ongoing efforts to ensure that individuals living with dementia, their caregivers and their families are supported.

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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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Lilly on alert as new Kisqali approval threatens Verzenio

pharmaphorum

Novartis' Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over rival Verzenio from Eli Lilly

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Women in science - Alison O'Neill at YPrime on thinking out loud and collaborating

BioPharma Reporter

Alison has more than 35 years of broad experience delivering clinical trials to sponsors with a patient centric mindset.

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The high cost of inequality: High US healthcare spend falls short

pharmaphorum

Explore the high cost of inequality in the US healthcare system and why despite the significant spending, it falls short in delivering adequate services and outcomes. Gain insights into the challenges and potential solutions.

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The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause

FDA Law Blog

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provides that a dietary supplement does not include: (i) an article that is approved as a new drug under section 355 of [the FDC Act], certified as an antibiotic under section 357 of [the FD

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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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Aurora Biosynthetics launches to boost RNA therapeutics manufacturing in Asia-Pacific

BioPharma Reporter

The new company focuses on producing components needed to manufacture RNA-based therapies for which there is increasing demand.

RNA 59
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Noom offers cut-price compounded GLP-1 drug for obesity

pharmaphorum

Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.

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Cellevate bags €3.2 million to smash viral vector manufacturing bottleneck

BioPharma Reporter

The Swedish biotech company Cellevate has raised â3.2 million in a seed round to fuel the commercialization of its nanofiber-based viral vector manufacturing technology in November.

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Optimizing Patient Support Through Effective Information Governance: Balancing Risks and Rewards

Fierce Pharma

Authors: | Unlock the potential of patient support data with effective information governance. Manage risks, ensure compliance, and drive innovation for better patient outcomes.

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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.