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.

Drugs 245
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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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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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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 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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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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.

Research 130
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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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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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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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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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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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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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JCVI announces advice for 2024 spring COVID-19 vaccine programme

Pharma Times

The committee has advised that the vaccine should be given to those at the highest risk

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

Drugs 119
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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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Researchers discover new type of memory B cell that remembers allergies

Pharma Times

The cell could be a target for new immunotherapies for the chronic disease

Allergies 118
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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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Telix to acquire QSAM Biosciences for $123.1m

Pharmaceutical Technology

Telix Pharmaceuticals has agreed to acquire US-based QSAM Biosciences for a total purchase price of $123.1m.

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Could the next Alzheimer’s drug discovery be… Viagra?

pharmaphorum

Epidemiological studies can often throw out intriguing and sometimes erroneous correlations between a variable and a disease, but UK scientists say a finding that Alzheimer’s disease seems to be less common in Viagra users warrants further investigation.

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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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This week in clinical trials: 22nd to 26th January 2024

pharmaphorum

Stay up to date with the latest updates in the world of clinical trials. This week's highlights include Bayer's new study on aflibercept, BioNTech's groundbreaking research, and the exciting developments from Duality Bio. Get all the important information here.

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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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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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Amid tough generics market, Sandoz to lay off 213 and shutter Eon Labs plant in NC

Fierce Pharma

Roughly an eon ago in the pharma industry (read: 20 years), Sandoz carved out a sizable generics foothold through dual mergers with Germany’s Hexal and U.S.-based Eon Labs. | Nearly 20 years after Sandoz carved out a sizable generics foothold via dual mergers with Germany’s Hexal and U.S.-based Eon Labs, the Swiss manufacturing giant is mothballing one of the latter company’s main manufacturing sites.

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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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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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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.