Tue.Oct 29, 2024

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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Worldwide Clinical Trials

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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Biogen refreshes its C-suite; Novartis writes down MorphoSys assets

Bio Pharma Dive

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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EC approves AstraZeneca’s Fasenra for EGPA treatment

Pharmaceutical Technology

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

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GSK to pay $300M to license drug it sees as potential lupus treatment

Bio Pharma Dive

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.

Licensing 182
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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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Bavarian eyes Mpox vaccine label expansion to include toddlers, kickstarts Phase II trial

Pharmaceutical Technology

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

Vaccine 147
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Pfizer sales of RSV vaccine ebb, but company gains market share

Bio Pharma Dive

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

Vaccine 173

More Trending

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Paragon spinout joins hunt for new type of cancer immunotherapy

Bio Pharma Dive

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.

Trials 173
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Dermavant acquisition expands Organon’s dermatology portfolio

Pharmaceutical Technology

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

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Pfizer answers Starboard challenge with beat-and-raise quarter

Bio Pharma Dive

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

Sales 173
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US Border Protection warns pharma of risks with incorrect biologic importation

Pharmaceutical Technology

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

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

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With Jakafi's patent cliff looming, Incyte looks to 2025 launches to bulk up revenue by decade's end

Fierce Pharma

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.

Sales 121
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AbbVie signs agreement to acquire Aliada for $1.4bn

Pharmaceutical Technology

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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Pfizer bumps up revenue outlook by $1.5B in Paxlovid rebound amid criticism from activist investor Starboard

Fierce Pharma

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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NHS funding boost confirmed ahead of tomorrow's Budget

pharmaphorum

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

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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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Modified dosing regimen of Eli Lilly's Alzheimer's drug leads to significant reduction in brain swelling

Fierce Pharma

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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GUARDIAN Study Reveals How Genomic Sequencing Could Bridge Gaps in Newborn Screening

XTalks

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.

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PHTI review of digital hypertension tools gives mixed results

pharmaphorum

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.

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COPD Awareness Month 2024: Get Active and Lace-Up for Lungs

XTalks

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.

Vaccine 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer rebuffs Starboard criticism as it raises forecasts

pharmaphorum

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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Orlynvah Approved for Uncomplicated UTIs After Initial FDA Rejection and Amid Concerns of Antimicrobial Resistance

XTalks

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.

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AbbVie gets bigger in Alzheimer's R&D with Aliada takeover

pharmaphorum

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

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Protega scores FDA nod for new dosage of abuse-deterrent opioid Roxybond

Fierce Pharma

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
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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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Joy as NICE lifts restrictions on myeloma drug Elrexfio

pharmaphorum

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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Bristol Myers partner Zai Lab plots KarXT filing in China after trial win

Fierce Pharma

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.

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Orlynvah Approved for Uncomplicated UTIs After Initial FDA Rejection and Amid Concerns of Antimicrobial Resistance

XTalks

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.

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Drug pricing and the 2024 presidential election

Fierce Pharma

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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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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Aldevron’s Anu Codaty on passion, leadership, and innovation

BioPharma Reporter

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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GSK beefs up US manufacturing site with $800 million investment

Outsourcing Pharma

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

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CRO NovAliX teams with Bruker to advance drug development

BioPharma Reporter

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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How Stevanato’s digital twins cut pharma manufacturing costs

Outsourcing Pharma

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.

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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.