Thu.Jan 11, 2024

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Newly optimistic, biotech investors weigh lessons of sector’s downturn

Bio Pharma Dive

Investors and executives interviewed by BioPharma Dive at J.P. Morgan say new companies have to be leaner, hire more conservatively and focus on their first medicines quickly.

Medicine 213
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New Class of Antibiotic Found That Kills Deadly Drug-Resistant Superbug

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs. Zosurabalpin is highly effective against the bacterium carbapenem-resistant Acinetobacter baumannii (Crab), which is classified as a “priority 1” pathogen by the World Health Organization due to its growing presence in hospitals.

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Venture funding, dealmaking slowed in biotech last year: Pitchbook

Bio Pharma Dive

Though the number of financings from private investors is down year over year, the size of those rounds has remained high, especially for drugmakers with human data in hand.

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January 11, 2024: BeatPain Utah Study Team Uses Implementation Mapping Approach to Plan Hybrid Trial

Rethinking Clinical Trials

In a new article from the NIH Pragmatic Trials Collaboratory, the BeatPain Utah study team describes the "implementation mapping" they used to plan for trial implementation. The comprehensive, systematic approach enabled the team to craft an implementation plan for a complex telehealth intervention and to identify outcomes for evaluating the success of the implementation strategies.

Trials 141
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EU regulators to consult advisers in review of Eisai Alzheimer’s drug

Bio Pharma Dive

As a result of the planned consultation, Eisai now expects an approval decision on Leqembi in Europe by the end of June, rather than March.

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How To Become a Substance Abuse Counselor

Pharma Mirror

Embarking on a career as a substance misuse counselor is both a noble and challenging path. This role demands a deep understanding of psychological principles, empathy, and the determination to support others through their recovery journey. Keep reading to discover the steps required to build a successful career in this field. Understanding the Role of a Substance Addiction Counselor Substance addiction counselors are professionals who specialize in helping people overcome addictions to drugs, a

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More Trending

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Clinical effectiveness of co-trimoxazole versus leading antibiotics proves its cost-effectiveness, efficacy & safety

AuroBlog - Aurous Healthcare Clinical Trials blog

Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

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BridgeBio gears up for FDA review of acoramidis following Phase III results

Pharmaceutical Technology

BridgeBio submitted the NDA with US FDA for the TTR stabiliser in December 2023 and plans to engage with other regulatory bodies this year.

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Generative AI and its impact on speed to market for pharmaceuticals

pharmaphorum

Generative AI is revolutionising the pharmaceutical industry, accelerating the speed to market for new drugs. Learn how regulatory processes, R&D, and clinical trials are being impacted by this innovative technology.

Marketing 113
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FDA approves import of French drug for syphilis amidst wider drug shortages

Pharmaceutical Technology

Though not approved in the US, Laboratoires Delbert’s extencilline will be the available alternative to Pfizer’s Bicillin L-A.

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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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Dermavant posts data for Vtama that bolster its case for key approval in atopic dermatitis

Fierce Pharma

Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD). | Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).

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Evotec partners with Crohn’s & Colitis Foundation for IBD therapies

Pharmaceutical Technology

Evotec has announced a collaboration with the Crohn's & Colitis Foundation to advance drug discovery and develop new therapies for IBD.

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5 changes underway for R&D IT shifting to advanced modalities and biologics

pharmaphorum

The FDA is overseeing significant changes in R&D IT as it shifts towards advanced modalities and biologics. This includes the emergence of CRISPR-Cas9 gene editing technology and its potential impact on diseases like sickle cell anaemia. Learn more about these exciting developments in this article.

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NICE expands access of Paxlovid to further 1.4 million Covid-19 patients

Pharmaceutical Technology

Expanded patient groups at risk of progression to severe Covid-19 will be eligible for Pfizer’s antiviral pill.

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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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AI-discovered ALS drug trial uses unique remote monitoring

Drug Discovery World

Verge Genomics has initiated a Phase Ib proof-of-concept study for the treatment of sporadic and familial forms of amyotrophic lateral sclerosis (ALS) with VRG50635. VRG50635 is a small molecule PIKfyve inhibitor and is reportedly one of the first drugs to enter clinical trials that was entirely discovered and developed using an AI-enabled platform.

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GSK’s Nucala for severe eosinophilic asthma gains approval in China

Pharmaceutical Technology

GSK has gained approval from the China National Medical Products Administration for Nucala (mepolizumab) for severe eosinophilic asthma.

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How DayDayCook Is Revolutionizing Asian Cuisine

XTalks

In the dynamic world of cooking, one company stands out for its dedication to bringing the richness of Asian cooking to a global audience: DayDayCook. Founded by the visionary entrepreneur Norma Chu, DayDayCook has rapidly evolved from a humble startup into a multi-brand powerhouse, reshaping the way people around the world perceive and prepare Asian cuisine.

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Q&A: Exploring the challenges behind oncology trials

Pharmaceutical Technology

Pauline Frank reflects on her talk at the 2023 CTO Europe conference and highlights some of the key issues in running oncology trials.

Trials 130
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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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Inhalable sensor to make lung cancer screening more accessible worldwide

Pharma Times

The diagnostic system can deliver particles to the lungs via aerosol or a nebuliser

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Myrobalan Therapeutics secures funding for CNS drug development

Pharmaceutical Technology

Myrobalan Therapeutics has secured $24m in a Series A funding round to develop CNS therapeutics with restorative potential.

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Biogen returns ex-U.S. rights of MS drug Fampyra to Acorda

Fierce Pharma

With sales declining for aging MS drug Fampyra, Biogen has exercised an option to return licensing rights outside of the U.S. to Acorda Therapeutics.

Licensing 101
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European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC 

Pharmaceutical Technology

Mirati filed a marketing authorisation application to the EMA for Krazati for patients within this indication in May 2022.

Marketing 130
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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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Stada, Alvotech get first EU approval for biosimilar Stelara

pharmaphorum

Stada and Alvotech get EU approval for first biosimilar of Johnson & Johnson's Stelara in psoriasis, psoriatic arthritis and Crohn's disease indications

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3M Health receives grant to develop wound treatment solutions in US

Pharmaceutical Technology

3M Health Care has received a $34.2m award to improve the treatment of traumatic wounds from point of injury to hospital.

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Promoting value-added medicines and renovating old medicines smartly

pharmaphorum

In this new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with James Burt, CEO of Pharmanovia, about the value-added medicines space.

Medicine 100
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Risk adjusted net present value: What is the current valuation of Novartis’s Opnurasib?

Pharmaceutical Technology

Opnurasib is a small molecule commercialized by Novartis, with a leading Phase III program in Non-Small Cell Lung Cancer.

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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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New data reveals out-of-hospital cardiac survival results remain low in England

Pharma Times

In 2022, around 8% of patients survived 30 days after a cardiac arrest

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Risk adjusted net present value: What is the current valuation of Taysha Gene Therapies’s TSHA-102?

Pharmaceutical Technology

TSHA-102 is a gene therapy commercialized by Taysha Gene Therapies, with a leading Phase II program in Rett Syndrome.

Gene 100
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NICE expands access to Paxlovid amid over-supply

pharmaphorum

NICE has extended the NHS availability of Pfizer’s COVID-19 drug Paxlovid as millions of doses approach their expiry date

Drugs 101
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NDA for sovleplenib in China as Hutchmed looks to bring this new treatment to ITP patients

Outsourcing Pharma

Commercial-stage biopharma company, Hutchmed, has good news for adults with primary immune thrombocytopenia (ITP).

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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.