Mon.Jan 29, 2024

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Moderna leads the development of mRNA vaccines in infectious diseases

Pharmaceutical Technology

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

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AstraZeneca, Daiichi aim for first pan-tumor ADC approval

Bio Pharma Dive

The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.

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Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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Bristol Myers gets positive data in subcutaneous Opdivo trial

Bio Pharma Dive

An under-the-skin Opdivo shot produced similar results to an intravenous formulation in kidney cancer, giving Bristol Myers a chance at sustaining sales past a key patent expiration in 2028.

Sales 189
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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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Ascidian launches first-ever clinical study of RNA exon editor for vision loss

Pharmaceutical Technology

An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.

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Sarepta data show new Duchenne drug’s potency, but highlight side effects

Bio Pharma Dive

A successor medicine to Sarepta's Exondys 51 appeared better at boosting dystrophin protein production, but was associated with electrolyte imbalances.

Protein 162

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January 29, 2024: IMPACT Collaboratory Announces Health Equity Certificate Program for Pragmatic Trials Researchers

Rethinking Clinical Trials

The NIA IMPACT Collaboratory announced a new online certificate program designed to empower researchers at all levels in integrating health equity considerations into embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners. Program Overview This comprehensive training program, aligned with the IMPACT Collaboratory’s “Best Practices for Integrating Health Equity into ePCTs for Dementia Care” document, equips researchers with the knowled

Trials 162
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Cell and gene therapies – top pharmaceutical industry trend to watch for 2024

Pharmaceutical Technology

The full potential of cell and gene therapies (CGTs) has not yet been discovered as these therapies promise life-changing treatments.

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Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Fierce Pharma

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

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FDA grants priority review for Daiichi Sankyo-AstraZeneca’s Enhertu

Pharmaceutical Technology

The US FDA has granted priority review to the sBLA for ENHERTU, a treatment developed by Daiichi Sankyo and AstraZeneca for solid tumours.

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

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WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threats

Fierce Pharma

New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. | New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. WuXi Bio, for its part, says it's not affiliated with the military in China.

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Celltrion USA seeks FDA approval for CT-P47 biosimilar

Pharmaceutical Technology

Celltrion USA has filed a biologics licence application (BLA) with the US FDA for its biosimilar candidate CT-P47.

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NHS delivers a further 5,000 permanent hospital beds

Pharma Times

A total of 103,277 general and acute beds are now available to NHS patients

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Navigating clinical trial operations in the era of collaboration

Pharmaceutical Technology

The upcoming OCT West Coast 2024 conference will feature experts talking about emerging techologies, clinical trial operations for pharma and medical devices, and patient participation in studies.

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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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Patient Perspective: Jamie Troil Goldfarb shares her clinical trial experience [video]

Antidote

For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Not only will patients be able to gain access to potential new treatments, but they will also be directly contributing to research that can save lives — something that Jamie Troil Goldfarb has experienced firsthand. Jamie received a diagnosis of stage IV melanoma in 2011, only 11 weeks after giving birth to her child.

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King Charles’ diagnosis raises awareness on prostate condition 

Pharmaceutical Technology

UK monarch King Charles was discharged from hospital today following treatment for an enlarged prostate or benign prostatic hyperplasia.

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First impressions matter: Why getting your onboarding right is key for digital engagement

pharmaphorum

Creating a positive onboarding experience is crucial for engaging healthcare professionals (HCPs) in digital platforms and utilising data effectively. Discover why first impressions matter and how to get your onboarding process right for optimal digital engagement.

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Pfizer and Astellas seek updated EMA approval for Padcev with Keytruda

Pharmaceutical Technology

Results from a Phase III trial indicated that adding MSD’s blockbuster drug boosted survival rates in advanced bladder cancer patients.

Trials 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Grifols files lawsuit against hedge fund for making 'false and misleading statements'

Fierce Pharma

Grifols has filed a lawsuit against Gotham City that accuses the hedge fund of manipulating "the value of Grifols’ stock for their own monetary gain.

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Cristália signs licensing deal for Formosa’s APP13007

Pharmaceutical Technology

Cristália has signed an agreement to license exclusive rights to market Formosa Pharmaceuticals’ APP13007 in Brazil.

Licensing 130
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Orion licenses digital pain therapeutic from Newel Health

pharmaphorum

Orion licenses digital pain therapeutic from Newel Health Phil.

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Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

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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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Keytruda improves survival in early-stage kidney cancer

pharmaphorum

MSD’s Keytruda is the first cancer immunotherapy to improve survival when used as adjuvant therapy in renal cell carcinoma (RCC).

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Study suggests heart stress test could transform patient diagnosis

Pharma Times

The EST identified 30% of patients with a blood supply/demand mismatch

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Grifols sues Gotham City over fraud allegations

pharmaphorum

Spanish drugmaker Grifols has hit back at hedge fund Gotham City Research, which claimed it had fraudulently manipulated its financial reporting, with a lawsuit filed in New York. The complaint has been brought against Gotham City and co-founders Daniel Yu and Cyrus de Weck, along with other defendants, and accuses them of being “predatory short sellers…who illicitly profit from their rigged short-and-distort schemes.

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Healthcare Consulting Jobs: How to Succeed in This Competitive Field

XTalks

Healthcare consulting is an increasingly dynamic and evolving field, offering extensive opportunities for those eager to significantly impact the healthcare industry. Read on to learn more about healthcare consulting jobs, covering the role specifics, necessary education, experience requirements and the career’s potential rewards. Healthcare consultants are pivotal in shaping healthcare delivery and policies.

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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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GSK’s Omjjara EU-cleared for splenomegaly in myelofibrosis

pharmaphorum

GSK has claimed EU approval of Omjjara for the treatment of splenomegaly or symptoms in adult myelofibrosis patients with moderate-to-severe anaemia

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Not-for-profit alliance advocates for greater collaboration in life sciences

Outsourcing Pharma

The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.

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BMS subcutaneous Opdivo clears first phase 3 trial

pharmaphorum

Bristol-Myers Squibb is getting closer to offering a subcutaneous version of its cancer immunotherapy Opdivo to patients after it matched the current intravenous formulation in a head-to-head trial in kidney cancer.

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Key achievement for Repare Therapeutics after receipt of $40 million Roche payment

Outsourcing Pharma

Clinical-stage precision oncology company, Repare Therapeutics Inc., has received a $40 million milestone payment from Roche after dosing the first patient in a clinical trial.

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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.