Fri.Sep 27, 2024

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Bavarian Nordic nets large mpox vaccine supply pact, boosts revenue outlook after string of deals

Fierce Pharma

In the latest of several recent mpox vaccine supply deals, Bavarian Nordic plans to provide 1 million doses of its shot, Jynneos, to affected African countries through an agreement with UNICEF. | The agreement is the latest in a string of mpox vaccine supply deals that have come in response to the ongoing outbreak in Africa.

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AI Holds Promise, But Concerns Around Costs and Data Remain

MedCity News

The new generation of healthcare AI innovation is promising, but there are some problems that remain when it comes to AI, such as data generalization and the high cost of adopting new tools, pointed out Dr. Arash Harzand. The post AI Holds Promise, But Concerns Around Costs and Data Remain appeared first on MedCity News.

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Travere pumps brakes on late-stage enzyme replacement therapy study, citing production scale-up problems

Fierce Pharma

Shortly after winning full FDA approval for its rare kidney disease drug Filspari, San Diego’s Travere Therapeutics has run into trouble with its enzyme replacement candidate pegtibatinase. | Travere is pausing enrollment in its Harmony study evaluating pegtibatinase in classic homocystinuria to make improvements on manufacturing scale-up for commercial production and to fully enroll the phase 3 trial.

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Why Accessible, Worldwide Biomanufacturing Solutions are Paramount

MedCity News

Precision medicine relies on understanding how differences affect drug response. Researchers can develop more precise treatments that are effective for more patients when prioritizing diversity. The post Why Accessible, Worldwide Biomanufacturing Solutions are Paramount appeared first on MedCity News.

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

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Fierce Pharma Asia—Daiichi, AZ's ADC setback; Fosun, Kite JV's separation; Yuhan's busy week

Fierce Pharma

AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead Sciences' Kite will bow out of its China joint venture with Fosun Pharma. | AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead's Kite will bow out of its China joint venture with Fosun Pharma.

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BMS ends decades-long drought in novel schizophrenia drugs

pharmaphorum

BMS' acquisition of Karuna looks set to pay off after it gets FDA approval for the schizophrenia drug at the heart of the $14bn takeover

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How AI Can Help Hospitals Overcome Patient Flow Barriers

MedCity News

Artificial intelligence (AI) holds potential to forecast and predict where hospital leaders should direct limited resources such as clinicians, staff, and beds to improve operational efficiency and drive better patient outcomes. The post How AI Can Help Hospitals Overcome Patient Flow Barriers appeared first on MedCity News.

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UNICEF secures one million mpox vaccines for Africa

Pharmaceutical Technology

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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Pomelo Care Acquires The Doula Network to Link Patients with Community-Based Doulas

MedCity News

Pomelo Care recently acquired The Doula Network. Through the acquisition, Pomelo’s patients can now be matched with a community-based doula. The post Pomelo Care Acquires The Doula Network to Link Patients with Community-Based Doulas appeared first on MedCity News.

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Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market following FDA approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

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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.

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World leaders seek 10% cut in antibiotic resistance deaths

pharmaphorum

World leaders seek 10% cut in antibiotic resistance deaths Phil.

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FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

MedCity News

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics. The post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News.

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Roche's PNH drug PiaSky backed for NHS use by NICE

pharmaphorum

NICE backs Roche's PiaSky for NHS treatment of paroxysmal nocturnal haemoglobinuria, the first drug that can be self-administered by patients.

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Data-Driven Programmatic Advertising in Pharma Marketing

Pharma Marketing Network

In recent years, the pharmaceutical industry has increasingly embraced digital transformation, and one of the most impactful areas of this change is in marketing. Programmatic advertising, which involves the automated buying and selling of online ads, has become a cornerstone of modern marketing strategies. By leveraging vast amounts of data, programmatic advertising allows for more precise targeting and personalized messaging than traditional methods.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Sanofi's Dupixent scores double COPD win in US, China

pharmaphorum

Sanofi's Dupixent scores double COPD win in US, China Jonah.

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FDA Approves Dupixent as First-Ever Biologic Treatment for Chronic Obstructive Pulmonary Disease

PharmExec

Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.

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Decoding the Complexities of Breast Cancer Treatment: The Role of Lab Data & HCP Engagement

Prognos Health

Breast cancer treatment is an intricate field, with ongoing research and development leading to new and innovative therapies. Ensuring that these therapies reach the right patients at the right time requires a deep understanding of the patient journey and the healthcare professionals (HCPs) involved in their care. Lab data, coupled with strategic HCP engagement, plays a crucial role in helping pharmaceutical manufacturers navigate this complex landscape.

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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults. “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” shared Dr Chris Boerner , PhD, Board Chair and Chief Executive Officer at Bristo

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Managing Shipment Variety

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Gautam Prem Join, GoComet’s Co-founder and CEO, discusses obstacles encountered by shippers in the pharmaceutical sector.

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Disposing of Non-Core Assets with Minimal Disruption

PharmExec

In this part of his Pharmaceutical Executive video interview, Jonathan Scheinberg, of the Northeast Science and Technology Center, discusses strategies companies employ to effectively identify and dispose of non-core assets while minimizing disruption to their operations.

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Direct-to-patient communication: Bridging the gap in medication adherence

Pharmaceutical Technology

Direct-to-patient communication is emerging as a powerful solution to the challenges of non-adherence to medication. By leveraging innovative technology, patients can receive personalised reminders, educational content, and support.

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Honoring Dad: How My Father Turned My Diagnosis Into Opportunity

Scott Burrows

My father shaped the person I am today. He showed me what it means to be a loving husband and father, while always pushing me to go beyond my own limits. His guidance and encouragement set me on the path to success. I will never forget my accident or the challenges that followed. Life seemed to stop the moment I was told I’d never be able to use my arms or legs again.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Biocon and Tabuk partner to launch GLP-1 products in Middle East

Pharmaceutical Technology

Biocon has entered a partnership with Tabuk for the commercialisation of glucagon-like peptide-1 (GLP-1) products in the Middle East.

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EMA Suspends Sickle Cell Disease Medicine

PharmaTech

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

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Physicians highlight need for improved non-opioid treatments for opioid use disorder

Pharmaceutical Technology

Opioid use disorder (OUD) is a chronic neurological disorder characterised by the compulsive, repeated use of opioids, leading to prolonged self-administration.

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Results from CPHI Milan Survey Find No Favor Among Industry for BIOSECURE Act While Predicting Faster Growth for CDMOs in 2025

PharmaTech

According to the survey results, 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

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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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AI and the Human Factor: Overcoming Challenges in Adoption

ALULA

Organizations integrating AI for hybrid or flexible work should focus on behavioral change so that workforce employees succeed with new ways of working.

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FDA Approves Bristol Myers Squibb’s Cobenfy for Schizophrenia

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Phare Bio receives ARPA-H funds for AI drug discovery platform

Pharmaceutical Technology

Phare Bio has received up to $27m from the Advanced Research Projects Agency for Health (ARPA-H) to advance its drug discovery platform

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RxPreferred Launches AI-Powered Savings Program for Members

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.