Fierce Pharma

MAY 5, 2023

Protalix, Chiesi challenge Sanofi with EU approval for Fabry disease med as FDA decision looms kdunleavy Fri, 05/05/2023 - 14:13

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FDA 222

Dominic Tyer

MAY 5, 2023

Pharma has an opportunity to make more effective - and wider - use of social media, but companies are not currently meeting HCP expectations

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Media Pharma Pharmaceutical Marketing 130

Fierce Pharma

MAY 5, 2023

FibroGen's roxadustat fails in 2nd act, endangering AstraZeneca partnership aliu Fri, 05/05/2023 - 09:13

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MedCity News

MAY 5, 2023

Formus Labs, a New Zealand-based medical technology startup, has received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company hopes to start piloting the product at healthcare sites across the U.S. in the next few months.

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FDA Healthcare Healthcare Medical 108

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Fierce Pharma

MAY 5, 2023

After FDA rejection, Gilead's Hepcludex looks set for full EU nod kdunleavy Fri, 05/05/2023 - 09:45

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FDA 237

MedCity News

MAY 5, 2023

Absent the ability to bolster their ranks with more clinicians, what rural health centers need first and foremost to shift to value are technologies that amplify their clinical capacity without further burdening and burning out their core staff.

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MedCity News

MAY 5, 2023

Ask the Investor sessions at MedCity INVEST at the Ritz Carlton in Chicago May 22-24 offer opportunities for startups to talk with investors in intimate settings. Spots are limited so register today!

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Pharmaceutical Technology

MAY 5, 2023

Sanofi Canada has received approval from Health Canada for its Dupixent (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and in adolescent patients aged 12 years and above. It is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In Canada, it is commercialised by Sanofi Canada and Regeneron Canada.

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Patients Medical 98

MedCity News

MAY 5, 2023

Not everyone who visits an urgent care will seek primary care services, but the ability for clinics to provide PCP services on an as-needed basis is a massive value-add for all stakeholders – be it providers seeking to bolster their financial positions or patients who are suffering from provider shortages in primary care.

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Healthcare Healthcare Patients 98

European Pharmaceutical Review

MAY 5, 2023

Researchers have developed a physics-enhanced autocorrelation-based estimator (PEACE) machine learning algorithm that can extract the particle size distribution (PSD) of a pharmaceutical powder surface from its laser speckle. The method provides a real-time, non-invasive, far-field optical probe to monitor particle size distributions quantitatively.

Distribution 92

Distribution Pharmaceutical manufacturing Electronics Pharmaceutical 92

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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.

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MedCity News

MAY 5, 2023

Intrinsic acquires and sells brands that fill unmet women’s health needs. Its $15 million funding round brings the company’s total funding to $128 million, with investors including FCA Venture Partners, MAP Investco, Define Ventures, Link Ventures and Redesign Health.

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PharmaTimes

MAY 5, 2023

Systems will support millions of patients with chronic respiratory conditions throughout Europe

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Patients 95

MedCity News

MAY 5, 2023

Healthcare providers should deliver care to patients in all-inclusive models that focus on treatments rather than squeezing profits.

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Healthcare Provider Medical Healthcare Healthcare 79

Pharmaceutical Technology

MAY 5, 2023

TFF Pharmaceuticals and the National Institute of Environmental Health Sciences (NIEHS) have signed an agreement for the development of dry powder formulations of high molecular weight hyaluronan (HMW-HA) for respiratory diseases. Under the collaborative research and development agreement (CRADA), respirable dry powder formulations of HMW-HA will be developed for prevention and treatment.

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Engineering Government Pharmaceutical 64

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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

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Copyright Clearance Center

MAY 5, 2023

The post ChatGPT Chops Chegg Stock appeared first on Copyright Clearance Center.

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Pharmaceutical Technology

MAY 5, 2023

The European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended full marketing authorisation (MA) for Gilead Sciences ’ Hepcludex (bulevirtide) to treat chronic hepatitis delta virus (HDV) and compensated liver disease in adult patients. In July 2020, the European Commission (EC) granted conditional marketing authorisation to bulevirtide for urgent access to HDV treatment.

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Food and Drug Administration Marketing Medicine Food 59

PharmaTimes

MAY 5, 2023

The vital recommendation ensures marketing authorisation for treating the hepatitis delta virus

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Marketing 77

Scott’s Directories

MAY 5, 2023

MD Select is a Canadian database of medical professionals that is designed to help businesses access the best healthcare providers. This tool offers a wide range of information about doctors across the country, including their specialties, locations, and contact information. If you’re looking to make B2B sales in the healthcare industry, MD Select is an invaluable resource for building a list of targeted contacts.

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B2B Sales Sales pitches Sales Doctors 52

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Safety

Pharmaceutical Technology

MAY 5, 2023

Regeneron Pharmaceuticals has reported a 7% rise in total revenue to $3.16bn in the first quarter (Q1) of 2023 compared to $2.96bn in Q1 2022. During the first quarter, the generally accepted accounting principles (GAAP) diluted earnings per share (EPS) and non-GAAP diluted EPS stood at $7.17 and $10.09 respectively, representing declines of 17% and 12% respectively compared to Q1 2022.

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Food and Drug Administration Sales Food Pharmaceutical 52

Pharmacy Times

MAY 5, 2023

There are still significant unresolved issues in artificial intelligence and machine learning, which must be addressed before they can be safely and effectively used more broadly in medicine.

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Patients Medicine 55

Pharmaceutical Technology

MAY 5, 2023

Spanish biopharmaceutical company Palobiofarma has collaborated with the Foundation for Prader Willi Research (FPWR) to develop its PBF-999 to treat Prader Willi syndrome (PWS). The company has received a new venture philanthropy award as a convertible loan from FPWR. It intends to utilise the funding from FPWR to partially fund its ongoing Phase II clinical trial of PBF-999, a dual adenosine A2a receptor antagonist/phosphodiesterase 10 (PDE-10) inhibitor.

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Safety Recruitment Patients 52

PharmaVoice

MAY 5, 2023

The biotech CEO is bullish on the company’s pioneering T cell receptor platform and innovating new immunology-based treatments.

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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.

Specialization

Pharmaceutical Technology

MAY 5, 2023

The World Health Organization (WHO) announced the end of the public health emergency for Covid-19, marking the end of a declaration that had been in effect for more than three years. During a meeting on Friday, WHO officials pointed toward decreasing trends in infections, hospitalisations, and deaths stemming from Covid-19 in the international community.

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Pharma 52

Pharmaceutical Commerce

MAY 5, 2023

New capability will support manufacturing of commercial-stage therapies to help combat cancers and genetic diseases.

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Manufacturing 52

Pharmaceutical Technology

MAY 5, 2023

Switzerland-based Siegfried has purchased a 95% stake in DiNAMIQS, a biotechnology firm that focuses on the development and production of viral vectors for cell and gene therapies. Siegfried will leverage DiNAMIQS’ capabilities to commercial scale by constructing a facility that complies with good manufacturing practice standards. The facility will be situated with DiNAMIQS’ existing operations at Bio-Technopark in Zurich-Schlieren, Switzerland, and is anticipated to become operational in 2025.

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Leads Manufacturing Management Pharmaceutical 52

Pharmaceutical Commerce

MAY 5, 2023

March stats show a 7.7% decline in demand compared to March 2022, but an improvement over the previous month.

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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

Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The drug-device combination product Xhance nasal spray combines a nasal anti-inflammatory drug with an exhalation delivery system (EDS). The EDS has been designed to deliver a topical anti-inflammatory high and deep into the sinuses and sino-nasal drainage tracts that are difficult to access.

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Food and Drug Administration FDA Physicians Prescription 52

Pharmacy Times

MAY 5, 2023

Illegal online sellers threaten the health, privacy, and security of patients by failing to comply with the laws of the jurisdiction in which they are located, or the jurisdiction in which they are selling their medicines.

Medicine 49

Medicine Patients 49

Pharmaceutical Technology

MAY 5, 2023

Hasten Biopharmaceutic has purchased the commercial rights for Rocephin in mainland China from Swiss healthcare firm Roche. There will now be a transition period between the two firms, following the completion of the deal earlier in 2023. Hasten also purchased Rocephin’s marketing authorisation and intellectual property including trademarks. Rocephin is a long-acting, broad spectrum cephalosporin antibiotic for parenteral use.

Biopharma 52

Biopharma Healthcare Healthcare Leads 52

Pharmacy Times

MAY 5, 2023

Mental health interventions are a critical part of the global response to HIV, with multiple potential roles for psychiatrists and other mental health professionals.

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Training 48

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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