Fierce Pharma

AUGUST 16, 2023

With plasma collection as its stock-in-trade, the struggles of | With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a surge in post-pandemic collections—and an $11.7B acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech. With plasma collections up 31% and to a record level for the company, CSL reported revenue of $13.3 billion for fiscal year 2023.

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PharmaTech

AUGUST 16, 2023

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

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Fierce Pharma

AUGUST 16, 2023

Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines. | Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found. Two pollsters presented results from their recent survey on Tuesday.

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Prescription 211

MedCity News

AUGUST 16, 2023

Epic announced that it will integrate Abridge’s clinical documentation tool into its EHR workflow. The startup’s generative AI tool listens to visits and creates a near-instant summary that adheres to physicians’ prototypical note structure.

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Fierce Pharma

AUGUST 16, 2023

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. | Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option.

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Clarivate

AUGUST 16, 2023

Derwent World Patents Index (DWPI ) turns 60 this year. In this blog, Ed White, Senior Director and Principal Analyst, celebrates how DWPI evolved from a newsletter of patent abstracts into an integral part of the global patent system. With 22 years of experience in the intellectual property industry, Ed White is devoted to helping people capture the right insights from the world’s patent data.

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MedCity News

AUGUST 16, 2023

A recent survey on nurses’ mental health offers some reasons for cautious optimism. The survey showed that nurses’ mental health has continued to improve since its bleakest days during the peak of the pandemic. However, most nurses said they remain unhappy with their employer’s efforts to prioritize their mental wellbeing.

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Fierce Pharma

AUGUST 16, 2023

The tale of Biogen’s Reata courtship is being laid bare. | Earlier this week, a securities filing showed Biogen beat out another Big Pharma rival in its quest to obtain Texas-based rare disease outfit Reata. That company’s identity has been revealed as Sanofi, Bloomberg reports, citing people close to the matter.

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Pharma 135

MedCity News

AUGUST 16, 2023

Amazon Pharmacy announced Tuesday that it is launching automatic coupons for more than 15 insulin and diabetes care brands. The move, while incremental, solves a major pain point for consumers with diabetes, as many struggle to afford insulin products.

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Prescription 95

European Pharmaceutical Review

AUGUST 16, 2023

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar a

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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.

Safety

MedCity News

AUGUST 16, 2023

New York City-based Hey Jane, a virtual abortion provider, announced last week that it is now offering vaginal infections treatment. This includes treatment for urinary tract infections, bacterial vaginosis and herpes. It is also offering birth control and emergency contraception.

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European Pharmaceutical Review

AUGUST 16, 2023

Amicus Therapeutics has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for Pombiliti ® (cipaglucosidase alfa) + Opfolda ® (miglustat) for adults living with late-onset Pompe disease. Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat (an enzyme stabiiser) for adults with the rare disease.

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MedCity News

AUGUST 16, 2023

Imugene gains global rights to Precision BioSciences’ most advanced program, an allogeneic cell therapy for advanced cases of blood cancer. Precision will now focus on in vivo gene editing therapies, some of which is partnered with Novartis and Eli Lilly.

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Pharmaceutical Technology

AUGUST 16, 2023

The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.

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Healthcare Healthcare 98

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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

Distribution

PharmaTimes

AUGUST 16, 2023

The collaboration will focus on multiple enzyme cargoes modified using Aliada's modular delivery platform - News - PharmaTimes

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Pharmaceutical Technology

AUGUST 16, 2023

Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.

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FDA 98

PharmaTimes

AUGUST 16, 2023

The new vaccine is an alternative to injected versions and no medical training is needed to deliver it - News - PharmaTimes

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Training Medical 67

Pharmaceutical Technology

AUGUST 16, 2023

Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.

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Manufacturing 98

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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.

Safety

PharmaTech

AUGUST 16, 2023

Gilead and Tentarix established three multi-year collaborations to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.

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PharmExec

AUGUST 16, 2023

Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses workforce trends in pharma and fostering an environment for psychological safety in this Pharmaceutical Executive Podcast video.

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PharmaTech

AUGUST 16, 2023

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

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Manufacturing 52

PharmExec

AUGUST 16, 2023

In its second warning letter issued in 2023, the FDA has sternly cautioned AstraZeneca for misleading claims in the promotional materials of its Breztri Aerosphere inhalation aerosol; this marks the first warning letter AstraZeneca has received this year.

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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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Legacy MEDSearch

AUGUST 16, 2023

Ceribell, Inc. ® announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S.

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Pharmaceutical Commerce

AUGUST 16, 2023

Illinois Governor JB Pritzker signed into a law a bill prohibiting PBM retaliation against pharmacists who disclose information during government proceedings.

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Government 52

PharmaTech

AUGUST 16, 2023

The collaboration between Parexel and Partex is designed to leverage artificial intelligence-powered solutions to accelerate drug discovery and development.

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Pharmaceutical Technology

AUGUST 16, 2023

The US FDA has approved Artiva's IND application for the combination of AlloNK (AB-101) and rituximab to treat systemic lupus erythematosus

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FDA 52

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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

Leads

PharmaTech

AUGUST 16, 2023

HitGen has entered into a research service agreement with Nested Therapeutics for use of HitGen’s DNA-encoded library for drug discovery.

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Pharmaceutical Technology

AUGUST 16, 2023

Precision BioSciences and Imugene have concluded a strategic transaction for worldwide rights to the former’s allogeneic CAR T candidate

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PharmaTech

AUGUST 16, 2023

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks on integrating data processes into pharma operations.

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Pharma 52

Pharmaceutical Technology

AUGUST 16, 2023

Gilead Sciences has entered into partnerships with Tentarix for the development of new therapies for oncology and inflammatory diseases.

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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.

Management