Tue.Dec 19, 2023

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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 

Pharmaceutical Technology

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

Drugs 263
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Investors still aren’t sold on UniQure’s gene therapy for Huntington’s

Bio Pharma Dive

The biotechnology company’s share price fell more than 10% Tuesday after the disclosure of more data from a small study.

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Sanofi licenses fourth NK cell engager from Innate Pharma

Pharmaceutical Technology

Sanofi and Innate’s cancer collaboration agreement stretches back to 2016, with two of Sanofi’s NK cell engagers in clinical studies.

Licensing 245
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Merck gets FDA decision date for new pneumococcal vaccine

Bio Pharma Dive

The company’s shot targets 21 strains of pneumococcal bacteria and, if approved, would compete with Pfizer’s Prevnar 20.

Bacteria 268
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Kronos Bio swivels focus towards multiple myeloma after AML failure

Pharmaceutical Technology

Kronos Bio is prioritising its multiple myeloma therapy after reviewing negative Phase Ib AML data for lanraplenib.

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A Neuroscientist Explains How to Survive The Stress of The Holidays

AuroBlog - Aurous Healthcare Clinical Trials blog

Just as the shift to shorter days and colder weather can bring with it mood swings and other emotional challenges, the holiday season can also bring about somewhat predictable changes in mood and behavior. Around this time of year, many of us experience more stress, anxiety and frustration than usual.

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PCI to integrate Aadhaar authentication to DIGI-PHARMed portal

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has requested all pharmacy institutions to fill the correct data as per Aadhaar card details in the Standard Inspection Format (SIF) and PCI portal as part of its process of integrating Aadhaar authentication for the faculties, pharmacists, students and pharmacy institutions in the portal as per the recent notification […]

Pharmacy 158
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FTC, DOJ finalize merger guidelines that could impede healthcare deals

Bio Pharma Dive

The new guidelines may give regulators more ammunition to go after vertical and cross-market M&A that has historically been more difficult to challenge.

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Magazine: What’s in a name

Pharmaceutical Technology

In this issue: Fixing drug nomenclature to avoid confusing names, gene therapies for sickle cell disease, childproof packaging for drugs, and UK pharma manufacturing gears up for a shake up in 2024

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Roche, Novartis move Xolair closer to FDA finish line for food allergies

Fierce Pharma

On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. | On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. The agency granted a priority review to Roche's filing and plans to make a decision during the first quarter of next year.

Allergies 117
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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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It’s a CRISPR-mas miracle: CRISPR approval marks early present for Vertex

Pharmaceutical Technology

Last month, Vertex Pharmaceuticals and CRISPR Therapeutics made history, by gaining approval for the first clustered regularly interspaced short palindromic repeats (CRISPR)-based drug, exagamglogene autotemcel (Casgevy).

Drugs 130
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Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

Fierce Pharma

A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. | A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech.

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How COP28 raised the profile of ‘super pollutants’ like black carbon

Pharmaceutical Technology

Super pollutants like black carbon found their way onto the agenda of COP28, which hosted the annual conference's first 'Health Day'

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World’s first engineered B cell therapy enters human trials

Drug Discovery World

The first patient has been dosed with an engineered B cell investigational therapy in a Phase I trial in Mucopolysaccharidosis type I (MPS I). Developer Immusoft has received FDA Orphan Drug Designation and Rare Pediatric Disease Designation for the therapy, designated ISP-001, in this indication. MPS I is a rare, genetic disease that affects the body’s ability to produce the enzyme alpha-L-iduronidase (IDUA).

Engineer 113
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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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INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data

Pharmaceutical Technology

The FDA has requested information on long-term potency after the Phase II trial was put on clinical hold due to manufacturing issues in 2022.

Trials 130
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FDA approves Arcutis’ skin foam for seborrheic dermatitis

Outsourcing Pharma

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

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EC approves Merck’s Keytruda combo for gastrointestinal cancers

Pharmaceutical Technology

The EC has granted approval for Merck’s (MSD) anti-PD-1 therapy, Keytruda, plus chemotherapy for two indications in gastrointestinal cancers.

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Compass Pathways’ Psilocybin Treatment ‘Well-Tolerated’ in Phase II PTSD Trial

BioSpace

The biotech’s investigational COMP360 psilocybin treatment showed positive safety and tolerability with no serious adverse events in a mid-stage study of people with post-traumatic stress disorder.

Trials 111
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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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Ionis and Otsuka sign agreement for hereditary angioedema therapy

Pharmaceutical Technology

Ionis has signed a licence agreement under which Otsuka will gain sole rights to market donidalorsen for hereditary angioedema in Europe.

Marketing 130
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Why digital therapeutics (DTx) are effective and safe, but not being prescribed

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Joel Morse, CEO and co-founder of Curavit Clinical Research, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), for a discussion on why it is that digital therapeutics (DTx) are effective and safe, but not being prescribed.

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Gaucher disease market expected to reach $1.3bn across 7MM by 2032

Pharmaceutical Technology

The Gaucher disease market is expected to grow at a CAGR of 0.79%, reaching $1.3bn across 7MM by the end of this forecast period (2032).

Marketing 130
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GSK Inks Potential $1.7B ADC Deal with China’s Hansoh Pharma

BioSpace

With an upfront payment of $185 million, GSK on Wednesday added another exclusive antibody-drug conjugate license agreement with China-based Hansoh Pharma.

Licensing 117
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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 risk of market contraction facing the IBD space

Pharmaceutical Technology

For the IBD market to grow, it is critical for biologics to continue to show efficacy over current biological/small-molecule therapies.

Marketing 130
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BioMed X and Ono Pharmaceutical enter joint cancer research project

Pharma Times

The BioMed X Institute and Ono Pharmaceutical have announced a new joint research collaboration for cancer research. The project, ‘New Strategies to Engage Neutrophils in Solid Tumors’, will help to design next-generation immunotherapies by advancing the antitumour effects of neutrophils. Neutrophils are a type of white blood cell that helps the immune system fight infections and heal injuries.

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Organon and Lilly sign deal to supply two migraine drugs in Europe 

Pharmaceutical Technology

Organon has signed a commercialisation agreement with Eli Lilly and Company for two migraine medicines, Emgality and RAYVOW, in Europe.

Medicine 130
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Top Food News of 2023 on Xtalks.com

XTalks

This year has been a pivotal year for the food industry, marked by intriguing developments, surprising trends and groundbreaking innovations. As we reflect on this dynamic year, it’s exciting to revisit the food news of 2023 that captivated our readers’ imaginations and sparked the most discussions. From the mystery of missing ingredients to the introduction of unconventional products, these top ten food news stories on Xtalks.com showcase the food industry’s resilience, innov

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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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BioNTech inaugurates mRNA vaccine manufacturing facility in Rwanda

Pharmaceutical Technology

BioNTech has inaugurated a new messenger RNA (mRNA) vaccine manufacturing facility in Kigali, Rwanda, which will have BioNTainers.

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Agno Pharma snaps up Particle Sciences to beef up drug product formulation

Outsourcing Pharma

The US contract development and manufacturing organization (CDMO) Agno Pharma has taken over compatriot firm Lubrizol Particle Sciences to increase its drug product formulation offerings.

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POINT’s prostate cancer trial meets primary endpoint as Lilly’s offer looms 

Pharmaceutical Technology

The topline data announcement comes on the same day as Lilly further extends its tender offer for the acquisition of POINT.

Trials 130
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Anagenex and Nimbus join forces to develop small molecule treatments using AI

Outsourcing Pharma

The drug discovery specialist Anagenex has sealed a collaboration pact with Nimbus Therapeutics to co-develop small molecule drugs with the help of artificial intelligence (AI).

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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.