Thu.Jun 30, 2022

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Biotech spotlight: Twist Bioscience aims to remove limits on drug discovery with DNA synthesis platform

PharmaVoice

As ‘the Amazon of DNA,’ Twist CSO, Aaron Sato, discusses the company’s breakthrough approach to DNA production and its expansion into drug development.

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Takeda’s Peter Schnack on digital’s role in driving innovation and improving patient outcomes

Dominic Tyer

Why digital and data should be available to everybody in a pharma commercial organisation

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FDA rejection of Spero’s tebipenem ‘raises resistance threat’

pharmaphorum

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.

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Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign

MedCity News

New Covid-19 vaccine booster shots are coming and they’ll include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.

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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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Merck launches accelerator programme for AI startups

pharmaphorum

Merck & Co is looking for startup companies applying artificial intelligence , machine-learning and other digital approaches to drug discovery and development for a new accelerator programme. The big pharma – known as MSD outside North America – is initially offering support to 12 companies though the newly-formed Merck Digital Sciences Studio (MDSS) and is now taking applications from would-be participants.

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Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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LGBTQ patients’ preventive health knowledge lags behind the general population, report says

MedCity News

LGBTQ Americans have a lack of understanding of the preventive health services they need, compared to the general population, a new report found. In order to create targeted messaging campaigns to increase preventive health knowledge among the LGBTQ community, the healthcare industry needs to include more LGBTQ patients in medical research to better understand the population’s health.

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Analytics Starts with a Question: How to Better Understand Your Data

Copyright Clearance Center

The post Analytics Starts with a Question: How to Better Understand Your Data appeared first on Copyright Clearance Center.

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Trinity Health Of New England partners with telehealth startup to help more mothers breastfeed

MedCity News

Mothers don’t have enough resources for breastfeeding support. However, many feel like they have to breastfeed due to the nationwide formula shortage. To address these problems, Trinity Health Of New England teamed up with Nest Collaborative, a startup providing breastfeeding telehealth appointments, to offer its services to patients free of charge.

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Neglected tropical diseases: non-profits lead the way as private sectors lags

Pharmaceutical Technology

Stagnating interest from private players and added pressure due to the Covid-19 pandemic has put the onus on academia and non-profits to drive new therapies for neglected tropical diseases (NTDs). New therapies and repurposed assets, could bring conditions like African trypanosomiasis closer to near extinction. Nonprofits like the Drugs for Neglected Diseases initiative (DNDi) and independent researchers are studying diseases such as river blindness, which are missing more targeted and effective

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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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Improving health equity through decentralized clinical trials [Sponsored]

MedCity News

A recent webinar by Medable discussed steps it’s taking to improve clinical trial design through decentralized clinical trials.

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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

Pharmaceutical Technology

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. As against other existing messenger ribonucleic acid (mRNA) vaccines that need ultra-cold storage, the Gemcovac vaccine is stable at refrigerator temperatures.

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From trial design for patients to trial design with patients: a key topic at DIA ’22

pharmaphorum

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. As an industry, we recognise patients as partners in the development process, but if we aim to enhance the patient experience in clinical trials and ultimately, improve patients’ lives, we need to continue to c

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Atos opens Life Science Centre of Excellence

PharmaTimes

Centre will accelerate drug development and enable precision health solutions

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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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Eczac?ba?? to acquire Turkish pharma company Gensenta for $135m

Pharmaceutical Technology

The Eczac?ba?? Group has entered an agreement for the acquisition of a 99.96% stake in Turkish pharmaceutical company Gensenta from Amgen, in a deal worth $135m. Eczac?ba?? is the founder of the first modern pharmaceutical facility in Turkey. With the takeover of Gensenta, Eczac?ba?? will move a step closer to becoming a key healthcare player in Turkey and global markets.

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Webinar Recap: John Muir Health Talks Data-Driven Strategies for Growth

Clarify Health

Now more than ever before, health systems are focused on driving sustainable growth. New volume growth, patient retention, and service line expansion are key levers of focus. Growing volume and expanding service lines don’t guarantee success, though. Many healthcare providers lack the trusted insights they need to make fast, strategic decisions that will future-proof their system against increasing competition and changing consumer demands.

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The Benefits of Creating a Developmental Team to Minimize Risk

Rep-Lite

Building and managing companies and businesses always involve risks. That is why risk management is an essential factor in maintaining companies. The detection, analysis, and reaction to risk elements that are inherent in a business's operations are all included in risk management. Effective risk management is acting proactively rather than reactively to influence future events as much as feasible.

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Territory Sales Managers: What They Do & Steps For Success

Spotio

A territory sales manager is an individual contributor that executes the sales process for an organization in a defined geographic area (or territory). They’re required to develop effective sales strategies, meet territory sales quotas, and maintain excellent customer relationships. Typically, territory sales managers hold a bachelor’s degree along with some management experience.

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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.

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From operator to API: how the future of micronisation means no more compromise

Pharmaceutical Technology

Despite industry investment in large molecule drugs, demand for small molecule active pharmaceutical ingredients (API) manufacturing remains high. Driven by the rise of oncology pipeline drugs coupled with small or virtual pharma companies being unable to acquire or access containment capabilities in-house, the increase in high potency small molecule APIs means that the demand for these innovative, specialised capabilities is likely to continue.

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Webinar Recap: John Muir Health Talks Data-Driven Strategies for Growth

Clarify Health

Now more than ever before, health systems are focused on driving sustainable growth. New volume growth, patient retention, and service line expansion are key levers of focus. Growing volume and expanding service lines don’t guarantee success, though. Many healthcare providers lack the trusted insights they need to make fast, strategic decisions that will future-proof their system against increasing competition and changing consumer demands.

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Introducing Inizio: Ashfield and Huntsworth Unite Expertise to Form Strategic Partner

PharmExec

Inizio will act as a strategic partner to health and life science companies throughout the life cycle of their drug products.

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Sirana enters into collaborative research agreement with Pfizer

PharmaTimes

Companies will combine to investigate a novel treatment for a rare bone disease

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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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Why Oncology Pharmacists Should Be at the Helm of Precision Medicine in Oncology

Pharmacy Times

Andre Harvin, PharmD, MS, executive director of Pharmacy, Oncology Services at Cone Health, discusses the importance of putting precision medicine programs into oncology practices with pharmacists leading the way.

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ParcelShield Announces Agreement with Walmart Specialty Pharmacy to Expand Services

Pharmaceutical Commerce

ParcelShield Intelligent Tracking and Planning Solution is designed to prevent parcel delays before shipping.

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Novel C. Difficile Treatment Reduces Recurrence in Key Subgroups

Pharmacy Times

Paul Feuerstadt, MD, FACG, AGAF, discussed research into the novel C. difficile treatment RBX2660 and what investigators have found about its efficacy in key subgroup analyses.

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FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

PharmaTech

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Addressing the Mystery of Long Hauler COVID: The Time is Now

Pharmacy Times

As we learn more about inflammatory syndromes, we may get better at using laboratory tests to identify and isolate the actual cellular and chemical processes that drive them.

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Ipsen Expands Oncology Portfolio with $247 Million Epizyme Acquisition

PharmaTech

Ipsen will acquire Epizyme, who recently had their lead medicine Tazverik (tazemetostat) approved by FDA for treatment of relapsed or refractory follicular lymphoma.

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How Layered Learning in Oncology Pharmacy Residency Programs Can Impact, Support Professional Growth in the Field

Pharmacy Times

Andrea Iannucci, PharmD, BCOP, member of the Board of Directors of the Hematology/Oncology Pharmacy Association (HOPA), discusses some common challenges hematology oncology pharmacists face in the field during their pursuit of professional growth and development.

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Getinge Launches New DPTE-EXO with Sleeveless DPTE-BetaBag for Aseptic Transfer

PharmaTech

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.