Tue.Jul 18, 2023

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Pfizer, Flagship join forces to hunt for 10 new drugs

Bio Pharma Dive

The unusual research alliance involves the startup creator’s Pioneering Medicines initiative, which previously struck pacts with Novo Nordisk and the Cystic Fibrosis Foundation.

Medicine 246
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Scribe and Sanofi expand genetic therapy development deal

Pharmaceutical Technology

Scribe Therapeutics and Sanofi have expanded partnership to progress the development of in vivo genetic therapies to treat genomic diseases.

Genetics 246
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A cancer biotech’s collapse gives Neurogene a path to Wall Street

Bio Pharma Dive

The startup, a developer of gene therapies for brain diseases like Rett Syndrome, will bypass an IPO by merging with struggling cancer drugmaker Neoleukin.

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WHO Declares Aspartame Possibly Carcinogenic. Here’s What It Means For Your Diet Soda

AuroBlog - Aurous Healthcare Clinical Trials blog

The International Agency for Research on Cancer (IARC), which is the specialized cancer agency of the World Health Organization, has declared aspartame may be a possible carcinogenic hazard to humans.

Research 199
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EU prepares for the winter with plans to avoid an antibiotic shortage

Pharmaceutical Technology

The EC, the Heads of Medicines Agencies (HMA), and the EMA have issued recommendations to prevent shortages of antibiotics.

Medicine 244
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AI set to make tectonic shift in healthcare with accuracy in diagnostics and predictability of disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Artificial intelligence (AI) is set to make tectonic shift in healthcare with accuracy in diagnostics and predictability of disease. On the occasion of the Artificial Intelligence Appreciation Day observed annually on July 16, 2023, with the theme as ‘trust, ethics, innovation and public good’, industry experts see a paradigm shift on the healthcare landscape.

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The impact of AI and ChatGPT on health data

Pharmaceutical Technology

In the healthcare industry, AI is unlocking new possibilities and solving grand healthcare challenges by improving care outcomes, life science innovation, and patient experience in unimaginable ways.

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An Arch-backed biotech pushes its depression drug into late-stage testing

Bio Pharma Dive

Neumora Therapeutics said its oral medication, which works differently than other antidepressants, was significantly better than placebo at treating major depressive disorder in a mid-stage study.

Drugs 130
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Novartis snaps up rare disease biotech DTx Pharma in $1bn deal

Pharmaceutical Technology

The acquisition adds an siRNA delivery platform to Novartis’s armament and a potential first-in-class treatment for Charcot-Marie-Tooth Disease.

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Novartis raises drug sales forecast, plans new stock buybacks

Bio Pharma Dive

The pharma company, which will soon split off its generic drug unit, plans to repurchase up to $15 billion of its shares through the end of 2025.

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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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MHRA consults public on reclassification of codeine linctus

Pharmaceutical Technology

MHRA is consulting health professionals and the public on the potential reclassification of codeine linctus to a prescription-only medicine.

Medicine 130
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PI Focus: Building Relationships Through Clinical Trials in the United Kingdom

Velocity Clinical Research

For the team at Velocity Clinical Research in the United Kingdom, clinical trials are first and foremost about building relationships. “I’m really grateful to be involved in clinical trials, because it allows me to develop meaningful connections with people in a way that goes beyond the traditional and [usually] more formal doctor-patient relationship,” says Ahmed Elshashai, MBBCh, Medical Director, Principal Investigator (PI), and Senior Clinical Research Physician with Velocity in the UK.

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4DMT provides clinical programme updates for its wet AMD gene therapy

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT) has offered an update on the development of 4D-150 to treat wet age-related macular degeneration (wet AMD).

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Nestlé Introduces Sugar Reduction Technology for Various Products

XTalks

Nestlé’s ongoing R&D has led to a groundbreaking sugar reduction technology that not only significantly diminishes sugar content, but also brings additional benefits to a wide array of products. This latest innovation follows a similar breakthrough years ago, aimed explicitly at the candy industry. This resulted in the brief existence of the Wowsome candy line in the UK, which was first introduced in 2018 but was discontinued in 2020.

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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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Highlights from the EHA Congress 2023 meeting: allogeneic cell therapy updates

Pharmaceutical Technology

The development of allogeneic (allo) cell therapies has been a major focus of the biopharmaceutical industry for the last several years.

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New Approaches to Cell and Gene Therapy Manufacturing Needed to Meet Demand

BioSpace

Next-gen biomanufacturers are particularly susceptible to the challenges inherent in manufacturing cell and gene therapies, risking getting derailed by unexpected costs for already-tight budgets.

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FDA approves AstraZeneca’s RSV monoclonal antibody treatment for infants

Pharmaceutical Technology

AstraZeneca’s Beyfortus becomes the first preventative option specifically designed for infants in their first RSV season.

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Unleashing the Potential of Brand Journalism in the Healthcare Industry

XTalks

Brand journalism is a strategic approach that combines the art of storytelling with journalistic principles to create compelling and authentic content that engages and informs the target audience. It involves crafting narratives and delivering news-like stories that are relevant, educational and entertaining, while also aligning with the brand’s values and objectives.

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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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Neoleukin to merge with Neurogene for $200m in cash reserves

Pharmaceutical Technology

Neurogene and Neoleukin Therapeutics have entered a definitive agreement to merge as part of an all-stock transaction.

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Novartis unveils another $15B share buyback plan despite Entresto legal setback

Fierce Pharma

On the heels of wrapping up a $15 billion share buyback program, Novartis has unveiled another stock repurchase plan of the same size. | On the heels of wrapping up a $15 billion share buyback, Novartis has unveiled another stock repurchase plan of the same size. This comes even as the company's top-selling drug, Entresto, faces patent challenges.

Drugs 96
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Sangamo Therapeutics signs agreement with Prevail to study AAV capsids

Pharmaceutical Technology

Sangamo has signed an evaluation and option agreement with Eli Lilly and Company’s subsidiary Prevail Therapeutics.

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Phase III Data Show Keytruda’s Promise in Earlier-Stage Cervical Cancer

BioSpace

Late-stage study suggests Merck’s Keytruda is a promising treatment candidate in newly diagnosed patients with locally advanced cervical cancer, inducing better progression-free survival.

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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 next generation of pharmaceutical supply chain innovation has arrived – are you prepared?

Pharmaceutical Technology

Business decision makers can get ahead of future pharmaceutical disruption by thinking innovatively today

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GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears

Fierce Pharma

In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. When those standards start to slip, recalls are sure to follow. | In tandem with Taiwan’s Food and Drug Administration, GSK this week initiated a recall of two batches of its severe asthma injection Nucala after glass fragments were found in a vial of the drug.

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How Turquoise Health is Making Healthcare Pricing Data Meaningful

XTalks

Turquoise Health was recently featured in an article on the leading companies in healthcare price transparency. To learn more about the Centers for Medicare and Medicaid Services (CMS) Hospital Price Transparency Rule and the Turquoise approach to making publicly available pricing data meaningful to providers, payers and patients, Xtalks spoke with Carol Skenes, Payer/Provider Strategist at Turquoise Health.

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Johnson & Johnson becomes 4th drugmaker to file suit against IRA's drug price negotiations

Fierce Pharma

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA). | Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth Big Pharma company to sue the U.S. government over drug price negotiations in the Inflation Reduction Act.

Drugs 94
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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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House Judiciary Committee Probes Big Pharma’s Potential Role in COVID-19 Censorship

BioSpace

J&J, Merck and Pfizer are the subjects of a House Judiciary Committee investigation for their alleged participation in a government-sanctioned censorship campaign during the COVID-19 pandemic.

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Roche licenses drug to target cancer DNA damage response

Outsourcing Pharma

Roche has entered a licensing and collaboration deal with the U.S. company KSQ Therapeutics to co-develop KSQâs lead cancer drug, which is designed to sabotage the DNA repair mechanisms of cancer cells.

DNA 98
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CDC vaccine committee sets August date to weigh use of Sanofi, AZ's RSV antibody Beyfortus

Fierce Pharma

After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee's calendar to determine its place in U.S. | After the FDA approved Sanofi and AstraZeneca's RSV antibody for infants, the next step in the launch is a discussion and potential recommendation from the CDC's vaccine advisory committee.

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Convatec to manufacture new infusion set for with Tandem Diabetes Care

Outsourcing Pharma

Convatec Group, a medical products and technologies company focused on chronic conditions, has partnered with Tandem Diabetes Care on a new five-inch infusion set for Tandem Mobi, the worldâs smallest durable automated insulin delivery system.

Insulin 97
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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.