Worldwide Clinical Trials

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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Clinical Research Research Clinical Trials Clinical Trials 182

Bio Pharma Dive

OCTOBER 29, 2024

Daniel Quirk, an immunology and neuroscience executive at Bristol Myers Squibb, will be Biogen’s next chief medical officer, while Robin Kramer will replace retiring CFO Michael McDonnell.

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Pharmaceutical Technology

OCTOBER 29, 2024

The EC has approved AstraZeneca's Fasenra as an add-on therapy for adults with relapsing or refractory EGPA.

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264

Bio Pharma Dive

OCTOBER 29, 2024

The licensing deal with China’s Chimagen Biosciences is the latest example of drugmaker interest in exploring the potential of “T cell engagers” in autoimmune disease.

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Licensing Licensing Drugs 182

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

Medicine

Pharmaceutical Technology

OCTOBER 29, 2024

The registrational trial is expected to support the approval for Bavarian’s mpox/smallpox vaccine use in children 2-11 years of age.

Vaccination 147

Vaccination Vaccine Trials 147

Bio Pharma Dive

OCTOBER 29, 2024

New guidelines and the timing of COVID vaccinations impacted uptake of Abrysvo this year, according to a company executive.

Vaccination 173

Vaccination Vaccine Sales Marketing 173

Bio Pharma Dive

OCTOBER 29, 2024

Crescent Biopharma is advancing a drug its CEO claims is “purpose-built” to be a perfected version of Summit Therapeutics’ ivonescimab, which recently beat Merck’s Keytruda in a Phase 3 trial.

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Trials Drugs 173

Pharmaceutical Technology

OCTOBER 29, 2024

Organon has completed the acquisition of Dermavant Sciences, a subsidiary of Roivant, to expand its dermatology portfolio.

Dermatology 130

Dermatology 130

Bio Pharma Dive

OCTOBER 29, 2024

The company reported higher-than-expected third quarter sales and hiked its revenue forecast for the year by $1.5 billion.

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Sales 173

Pharmaceutical Technology

OCTOBER 29, 2024

At the Outsourcing in Clinical Trials Conference, US government personnel advised attendees on the transport of biologics across borders.

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Clinical Trials Clinical Trials Trials 130

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Clinical Supply

Fierce Pharma

OCTOBER 29, 2024

Incyte’s blockbuster JAK inhibitor Jakafi has been driving the company’s sales for years now, with this quarter being no different. | Meanwhile, the company also scrapped plans to expand its topical JAK Opzelura into two other skin disorders.

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Sales 121

Pharmaceutical Technology

OCTOBER 29, 2024

AbbVie has entered a definitive agreement to acquire all outstanding equity of Aliada Therapeutics in a deal valued at $1.4bn in cash.

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130

Fierce Pharma

OCTOBER 29, 2024

Amid a looming standoff with activist investor Starboard Value, Pfizer fought back against accusations of underperforming by delivering double digit revenue growth over the third quarter and notchi | The company is projecting yearly sales of $61 billion to $64 billion in a $1.5 billion boost from previous forecasts.

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Sales 119

pharmaphorum

OCTOBER 29, 2024

UK government confirms £1.8bn funding boost to NHS to cut waiting lists, including £1.

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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

Clinical Trials

Fierce Pharma

OCTOBER 29, 2024

Modified dosing regimen of Eli Lilly's Alzheimer's drug leads to significant reduction in brain swelling kdunleavy Tue, 10/29/2024 - 15:25

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Drugs 115

XTalks

OCTOBER 29, 2024

Genomic sequencing is a window into our genetic makeup. For a parent, it could prepare them or help them understand their child’s potential health needs early on. The GUARDIAN (Genomic Uniform-screening Against Rare Diseases In All Newborns) study, recently published in the Journal of the American Medical Association (JAMA) , highlights how adding genome sequencing to newborn screening could reshape early detection for rare genetic conditions.

Genomics 95

Genomics Genome Genetics Life Science 95

pharmaphorum

OCTOBER 29, 2024

An evaluation of digital health technologies for hypertension by the Peterson Health Technology Institute (PHTI) finds some provide a clinical benefit, while others are lacking.On the plus side, the health technology assessment (HTA) body has concluded that tools to help people manage their antihypertensive drug treatment can deliver benefits in reduced blood pressure.

Drugs 107

Drugs 107

XTalks

OCTOBER 29, 2024

Chronic obstructive pulmonary disease (COPD) is a serious, progressive lung disease affecting millions globally. COPD Awareness Month 2024 this November shines a light on the condition, aiming to educate, support and empower people impacted by COPD. From sharing preventive strategies to advocating for advancements in treatment, the month is an essential time for spreading awareness and understanding.

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Vaccination Vaccine Development Production 105

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Clinical Supply

pharmaphorum

OCTOBER 29, 2024

Pfizer CEO Albert Bourla hit back at activist investor Starboard Value, saying measures to reset the pharma group are already well in hand

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XTalks

OCTOBER 29, 2024

Iterum Therapeutics has won approval from the US Food and Drug Administration (FDA) for Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli , Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options. The FDA nod marks the first approved product for Iterum and the first approved indication for Orlynvah.

FDA Approval 105

FDA Approval Bacteria Clinical Trials Clinical Trials 105

pharmaphorum

OCTOBER 29, 2024

AbbVie agrees a $1.4bn cash deal to acquire Aliada Therapeutics, adding another anti-amyloid antibody to its Alzheimer's pipeline.

Antibody 105

Antibody 105

Fierce Pharma

OCTOBER 29, 2024

The FDA has approved the first abuse-deterrent, immediate-release, 10 mg opioid tablet for pain management. The drug, Roxybond, has been approved in other dosages.

Drugs 104

Drugs 104

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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.

Clinical Trials

pharmaphorum

OCTOBER 29, 2024

Patients in England and Wales with multiple myeloma are celebrating a decision by NICE to relax strict restrictions on eligibility to receive Pfizer's Elrexfio.In June, the cost-effectiveness agency cleared the use of the BCMAxCD3 bispecific antibody with 'optimised guidance' that allowed it to be used for a narrower range of patients than was covered by the approved label for the drug.

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Drugs Antibody 105

Fierce Pharma

OCTOBER 29, 2024

After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of th | In a phase 3 bridging study run by Zai Lab in China, Bristol Myers Squibb's KarXT helped schizophrenia patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale versus placebo at week 5, teeing up a forthcoming regulatory filing.

FDA Approval 110

FDA Approval Trials Drugs 110

XTalks

OCTOBER 29, 2024

Iterum Therapeutics has won approval from the US Food and Drug Administration (FDA) for Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli , Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options. The FDA nod marks the first approved product for Iterum and the first approved indication for Orlynvah.

FDA Approval 98

FDA Approval Bacteria Clinical Trials Clinical Trials 98

Fierce Pharma

OCTOBER 29, 2024

As the 2024 U.S. | This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy.

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Drugs 98

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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

Clinical Research

BioPharma Reporter

OCTOBER 29, 2024

Anu Codaty, VP of global marketing and strategy at Aldevron, is blazing trails in biotech, inspired by a family legacy in medicine and driven to create life-changing therapies.

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Medicine Marketing Clinical Development Development 93

Outsourcing Pharma

OCTOBER 29, 2024

The big pharma company GlaxoSmithKline will inject up to $800 million into its manufacturing site in Marietta, Pennsylvania, to double its size and capacity.

Manufacturing 85

Manufacturing Pharma Companies Contract Manufacturing 85

BioPharma Reporter

OCTOBER 29, 2024

In a move set to transform drug discovery, CRO NovAliX has partnered with Bruker, a leader in scientific instruments, through a strategic investment aimed at enhancing drug development success rates.

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Development Drugs Contract Manufacturing Manufacturing 83

Outsourcing Pharma

OCTOBER 29, 2024

Riccardo Butta, a leader at Stevanato Group, delves into how cutting-edge digital twin technology, advanced data management, and AI-driven systems are transforming manufacturing efficiency and quality in the pharmaceutical sector.

Manufacturing 77

Manufacturing 77

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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.

Clinical Trials