Wed.Dec 06, 2023

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AbbVie to buy Cerevel in $8.7B bet on brain drugs

Bio Pharma Dive

The deal hands AbbVie a portfolio of psychiatric medicines that originated within Pfizer, among them a closely watched schizophrenia treatment that’s in late-stage testing.

Medicine 305
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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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Novartis gets FDA approval of closely watched rare disease drug

Bio Pharma Dive

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

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IGM jettisons workforce and blood cancer programme to refocus pipeline

Pharmaceutical Technology

IGM will lay off 22% of its staff and suspend four clinical activities to advance autoimmune diseases and colorectal cancer programmes.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Biotech venture firms continue ‘recalibration’ in third quarter, Pitchbook report finds

Bio Pharma Dive

Data collected by the research firm suggests venture funding totals are still sliding amid a "strategic shift" by investors towards fewer, but more substantial deals.

Research 183
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December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness." The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.

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The link between oral health and overall body health

Pharma Mirror

Oral health is a critical component of overall well-being, and growing research suggests that the health of your mouth is closely connected to your body’s overall health. The mouth serves as a gateway to the body, and any issues or infections that begin in the oral cavity can impact other systems and organs. We will explore the intricate relationship between oral health and overall body health, shedding light on how taking care of your teeth and gums can benefit your well-being.

Research 130
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German Merck’s MS drug falls short in pair of Phase 3 tests

Bio Pharma Dive

The results dim the outlook of so-called BTK inhibitors as potential autoimmune disease treatments and could have ramifications for Roche, Sanofi and Novartis.

Drugs 156
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Odyssey Therapeutics secures $101m in Series C funding round

Pharmaceutical Technology

Odyssey Therapeutics, a biotechnology company developing immunomodulators and oncology therapy, has secured $101m in a Series C funding round.

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Pharvaris shares spike as drug appears to prevent symptoms of rare disorder

Bio Pharma Dive

The company moved quickly to capitalize on the stock surge, announcing plans to raise $300 million through a secondary stock offering.

Drugs 164
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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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Health Canada authorises Novavax’s updated Covid-19 vaccine 

Pharmaceutical Technology

Health Canada has granted expanded authorisation for Novavax’s updated Covid-19 vaccine, Nuvaxovid XBB.1.5.

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Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)

Rethinking Clinical Trials

        Speaker James P. Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. Each of the clusters receive the control and treatment, and each cluster is sequenced to the intervention at different times.

Trials 152
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AbbVie partners with BigHat to develop antibody therapies

Pharmaceutical Technology

AbbVie will pay $30m upfront and up to approximately $325m in milestone-based payments for treatments in neuroscience and oncology.

Antibody 130
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Merck’s Keytruda, Anti-TIGIT Combo Fails Phase II NSCLC Trial

BioSpace

A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.

Antibody 126
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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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Merck partners with HiberCell for Phase Ib renal carcinoma trial

Pharmaceutical Technology

The Phase Ib trial will evaluate the combination therapy of Welireg and HC-7366 in patients with clear cell renal cell carcinoma.

Trials 130
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FDA endorses Novartis' 'pipeline in a pill,' granting first nod for potential blockbuster Fabhalta

Fierce Pharma

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

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Tislelizumab by BeiGene for Gastroesophageal (GE) Junction Carcinomas: Likelihood of Approval

Pharmaceutical Technology

Tislelizumab is under clinical development by BeiGene and currently in Phase III for Gastroesophageal (GE) Junction Carcinomas.

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Study reveals motor neuron region is affected in ALS

Pharma Times

The neurological condition currently affects one in 300 people in the UK - News - PharmaTimes

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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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FDA accepts Bristol Myers Squibb’s sBLA for urothelial carcinoma therapy

Pharmaceutical Technology

The US FDA has accepted Bristol Myers Squibb’s sBLA for Opdivo plus cisplatin-based chemotherapy as a first-line treatment

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Study shows osteoarthritis could be reversible

Drug Discovery World

Osteoarthritis may be treatable and reversible, according to a new University of Adelaide study. The researchers have discovered a novel population of stem cells – marked by the Gremlin 1 gene – responsible for the progression of osteoarthritis. Treatment with fibroblast growth factor 18 (FGF18) stimulated the proliferation of Gremlin 1 cells in joint cartilage in mice, leading to significant recovery of cartilage thickness and reduced osteoarthritis.

Trials 105
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CG Oncology’s bladder cancer drug gets fast track to approval

Pharmaceutical Technology

CG Oncology has received fast track designation and breakthrough designation needed to accelerate US FDA submission.

Drugs 130
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AbbVie Continues Buying Spree with $8.7B Cerevel Acquisition to Bolster Neuro

BioSpace

The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases.

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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.

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The state of the clinical trial supply chain: what you need to know

Pharmaceutical Technology

The clinical trial market is in a state of flux; to navigate it, supply chain optimisation will be essential.

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Secretary of state sets out priorities for UK health and social care systems

Pharma Times

The commitments will make health systems faster, simpler and fairer for patients - News - PharmaTimes

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XmAb-662 by Xencor for Small-Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

XmAb-662 is under clinical development by Xencor and currently in Phase I for Small-Cell Lung Cancer.

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Recruiters Turn to Scientific Publications to Find Skilled Professionals

BioSpace

Although looking for candidates on platforms like LinkedIn continues to be the norm, some headhunters are also combing Google Scholar and PubMed for authors with relevant skills.

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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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DB-1310 by Duality Biologics (Shanghai) for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer): Likelihood of Approval

Pharmaceutical Technology

DB-1310 is under clinical development by Duality Biologics (Shanghai) and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).

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Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case

Fierce Pharma

After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. | In 2017, Daiichi's former subsidiary Plexxikon alleged that Novartis stepped on its Zelboraf patents with its GSK-acquired medicine Tafinlar. Many years later, Novartis is settling the case.

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XmAb-662 by Xencor for Cervical Cancer: Likelihood of Approval

Pharmaceutical Technology

XmAb-662 is under clinical development by Xencor and currently in Phase I for Cervical Cancer.

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Sanofi expands genAI drug discovery pact with Aqemia

pharmaphorum

Sanofi has deepened an existing collaboration with artificial intelligence specialist Aqemia in the latest among a flurry of collaborations between pharma companies and generative AI (genAI) companies. The French pharma group has signed a multi-year agreement with Paris-based Aqemia, focused on the discovery of small-molecule drug candidates across multiple therapeutic categories, through the application of genAI and deep physics algorithms that can model molecular interactions.

Drugs 91
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.