Thu.Feb 08, 2024

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BioNTech partners with Autolus to boost cell therapy manufacturing

Bio Pharma Dive

The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.

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RegenxBio advances two candidates to make waves in the CNS space

Pharmaceutical Technology

AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards an FDA BLA.

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Antifungal Creams Could Be Triggering a Wave of Superfungal Skin Infections

AuroBlog - Aurous Healthcare Clinical Trials blog

A report by the US Centers for Disease Control and Prevention claims antifungal creams and combinations of antifungal treatments with corticosteroids are likely to be contributing to the rise and spread of severe skin, scalp, and nail fungal infections.

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Medicines access: Unlocking the immense potential in cell and gene therapy  

Pharmaceutical Technology

Despite several ground-breaking developments, pharmaceutical and biotech companies are often reluctant to invest in cell and gene therapy.

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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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Healthcare sector hails interim budget, calls for GST rationalization & increased investments

AuroBlog - Aurous Healthcare Clinical Trials blog

The healthcare industry has welcomed the interim budget presented by Union Finance Minister Nirmala Sitharaman, while adding that the government needs to prioritise spending towards healthcare sector and long standing demands like rationalisation of Goods and Services Tax (GST) and increased investments in the healthcare sector are yet to be addressed.

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Gene editing biotech Metagenomi pulls off nearly $94M IPO

Bio Pharma Dive

The company is one of three preclinical biotechs to successfully go public since last summer, but it pulled in significantly less than others who’ve debuted with more advanced medicines.

More Trending

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Neurona raises another $120 million for brain disease cell therapies

Bio Pharma Dive

The company’s haul is the latest sign brain drugs are recapturing the interest of investors after years of being passed over for other areas of research.

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Anvatabart opadotin by Ambrx Biopharma for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction.

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Pharma CEOs, pressed by Senate panel, refuse to commit to price cuts

Bio Pharma Dive

Forced into testifying by Senate HELP chair Bernie Sanders, the heads of Bristol Myers Squibb, J&J and Merck largely avoided major missteps.

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February 8, 2024: HCSRN Nears Early-Bird Registration Deadline, Announces Opening Plenary Speaker

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference , which be held from April 9 to 11 in Milwaukee, Wisconsin. This year's opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a professor of medicine, neurology, and clinical and translational science at Tufts Medical Center and Tufts University Sch

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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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Anvatabart opadotin by Ambrx Biopharma for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase I for Gastric Cancer.

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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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GEN-3014 by Genmab for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

GEN-3014 is under clinical development by Genmab and currently in Phase II for Relapsed Multiple Myeloma.

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Inside the NCVR evolution in the UK

pharmaphorum

Explore the commercial research landscape in the UK and the evolution of the National Institute for Health Research (NIHR) through an informative webinar.

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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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International Gaucher Alliance marks 30th year, unveils five-year strategic plan to 2029

Pharmaceutical Technology

In recognition of its 30th anniversary, the International Gaucher Alliance (IGA) unveiled a visionary five-year strategic plan extending to 2029.

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Gilead drops CD47 drug magrolimab for blood cancers

pharmaphorum

Gilead Sciences has said it will no longer develop its CD47-targeting antibody magrolimab in blood cancers after data suggested that patients taking the drug in clinical trials were more likely to die than those in control groups.

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Isuzinaxib by AptaBio Therapeutics for Acute Renal Failure (ARF) (Acute Kidney Injury): Likelihood of Approval

Pharmaceutical Technology

Isuzinaxib is under clinical development by AptaBio Therapeutics and currently in Phase II for Acute Renal Failure (ARF) (Acute Kidney Injury).

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AstraZeneca hit CEO Pascal Soriot's $45B revenue goal after all. But is Enhertu approaching a plateau?

Fierce Pharma

With $45.8 billion in 2023 revenues, AstraZeneca has met the $45 billion-by-2023 goal CEO Pascal Soriot established in 2014 when he was fending off a takeover bid from Pfizer. | AstraZeneca has met the $45 billion-by-2023 revenue goal that CEO Pascal Soriot established in 2014. But questions have emerged for one of the company's key growth drivers.

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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.

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FDA and EMA team up to expedite complex generic drug development

Pharmaceutical Technology

This initiative builds on the original parallel scientific advice programme launched by the FDA and EMA in 2021.

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International Day of Women and Girls in Science 2024: Elevating Innovation

XTalks

As we commemorate the International Day of Women and Girls in Science 2024, it’s a moment to reflect on and celebrate the vital contributions of women and girls in the spheres of science and technology. This day, observed globally on February 11, underscores the critical role of gender equality in science, spotlighting the achievements of women pioneers in the field while also emphasizing the need to encourage and support the next generation of female scientists.

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Otsuka’s Abilify Maintena: dual drug expiry signals sales decline

Pharmaceutical Technology

Abilify Maintena is approaching a significant market shift with the loss of market exclusivity in Europe and the US in October 2024.

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Preview of Pharma Commercials at Super Bowl 2024: From Touching Down with TUMS to Tackling Menopause

XTalks

The countdown to Super Bowl LVIII 2024 has begun and businesses across a variety of sectors, including pharma, have snapped up some of the most coveted advertising airtime of the year. Pharma commercials at Super Bowl 2024 will include ones for newly approved menopause drug Veozah and a unique partnership between antacid giant TUMS and sports betting company Draft Kings.

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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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BridgeBio and Kyowa Kirin partner for skeletal dysplasia treatment

Pharmaceutical Technology

BridgeBio Pharma has entered a partnership with Kyowa Kirin, granting the latter an exclusive licence for infigratinib in Japan.

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Movers and shakers: New appointments in pharma industry - Transgene, CN Bio and more

BioPharma Reporter

Outsourcing Pharma and BioPharma Reporter breaks down the key people on the move in the pharma industry. Enhanc3D Genomics, Cytomos and Cellular Origins are among the companies welcoming new faces to top jobs.

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FDA accepts Bristol Myers Squibb’s sBLA for NSCLC treatment regimen 

Pharmaceutical Technology

The US FDA has accepted the sBLA for Bristol Myers Squibb’s Opdivo (nivolumab) regimen for non-small cell lung cancer (NSCLC).

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Roche gets first world okay for PNH drug crovalimab

pharmaphorum

China has become the first country in the world to approve Roche’s anti-complement C5 antibody crovalimab, the only treatment for the rare disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by subcutaneous injection.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Nicox partners with Kowa to develop eye therapy in Japan

Pharmaceutical Technology

Kowa will pay €3m upfront and up to €27.5m in milestone-based payment to gain rights for Nicox’s IOP reduction drug in Japan.

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Eli Lilly agrees to provide free and lower-priced insulin in Minnesota to resolve 2018 lawsuit

Fierce Pharma

After reaching a settlement with Minnesota’s attorney general, Eli Lilly can close the book on a yearslong lawsuit in the state. | The company will provide its insulin products at $35 per month and donate free insulin at 15 clinics over the next five years. Meanwhile, Minnesota's claims against Novo Nordisk and Sanofi remain ongoing.

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Novo Nordisk to acquire CMO giant Catalent for $16.5bn

Pharmaceutical Technology

Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5bn on an enterprise value basis.

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Charac's funding from Traditum to help pharmacies digitalize in preparation for government's new edict

Outsourcing Pharma

With independent pharmacies now facing significant challenges, healthcare SaaS provider Charac was pleased to announce more investment so it can accelerate a digitization drive.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.