European Pharmaceutical Review

NOVEMBER 24, 2022

Patients with refractory systemic lupus erythematosus (SLE) were able to go into remission within three months of one small dose of a personalised anti-CD19 CAR T-cell immunotherapy in a clinical study. The German study showed all five young adult patients with systemic lupus erythematosus went into remission, enabling them to stop taking their lupus medications within three months of just one small dose of the CAR T therapy , as it essentially removed their existing B cells.

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Side effects Medicine Doctors Patients 106

pharmaphorum

NOVEMBER 24, 2022

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). A Bloomberg report published ahead of the Thanksgiving holiday in the US suggested that potential buyers are waiting for the results from a phase 2 trial of the drug in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in patients with previously-untreated KRASG1

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Tribeca Knowledge

NOVEMBER 24, 2022

W ith only weeks left to run in 2022, new drug approvals across the two most important markets for the pharmaceutical industry were in only middling shape. The European Medicines Agency, at least, looked as though it might get close to its approval tally for 2021. In the US, however, 2022 new drug approvals seemed to be heading for a distinct slump.

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PharmExec

NOVEMBER 24, 2022

In episode 122, Marcella Milliet Sciorra, Chief Marketing Officer at DeepIntent, discusses Connected TV, or CTV, how it differs from over the top, and how CTV fits into the future of pharmaceutical marketing.

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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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European Pharmaceutical Review

NOVEMBER 24, 2022

Nivolumab (Opdivo), together with chemotherapy has been recommended in the National Institute for Health and Care Excellence NICE final draft guidance for untreated HER2-negative, advanced or metastatic gastric, gastroesophageal junction (GEJ) or oesophageal adenocarcinoma where tumours express programmed death-1 receptor (PD-L1). Clinical data showed nivolumab plus chemotherapy increases life expectancy and delays the cancer becoming worse, offering patients eight percent long-term remission co

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Medgadget

NOVEMBER 24, 2022

Researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have developed a DNA toolbox that allows researchers to explore binding interactions between ligands and their respective receptors based on receptor density and arrangement. The basis for many pharmacological interactions between drugs and cells, and indeed many physiological or pathological interactions involving biological signaling molecules, involves a molecule, termed a ligand, binding to a receptor that is typic

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Pharmaceutical Technology

NOVEMBER 24, 2022

South African bio-pharmaceutical firm Biovac and the International Vaccine Institute (IVI) in South Korea have signed a licencing and technology transfer agreement for developing and manufacturing an oral cholera vaccine (OCV). The deal will aid Biovac in establishing drug substance manufacturing expertise for producing the antigen/raw material required to make the vaccines.

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PharmaTimes

NOVEMBER 24, 2022

Patients on the trial will have one of the particular genetic mutations among rare cancers

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pharmaphorum

NOVEMBER 24, 2022

Following the launch of LifeArc’s £100 million programme, Chronic Respiratory Infection Translational Challenge (CRI TC) – for the acceleration of the development of new clinical solutions to tackle chronic lung conditions – the medical research charity has now announced that it is committing £10 million to fund up to five collaborative projects to repurpose existing therapies as new treatments for bronchiectasis and cystic fibrosis.

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Pharmaceutical Technology

NOVEMBER 24, 2022

The National Institute for Health and Care Excellence (NICE) in the UK has recommended Bristol Myers Squibb ’s (BMS) nivolumab (Opdivo) plus chemotherapy as an option for patients with advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma. As per the final draft guidance issued by the health institute, the treatment is intended for usage in such untreated HER2-negative cancers and if the tumour expresses PD-L1.

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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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Impetus Digital

NOVEMBER 24, 2022

Roland Mattern , Director of Product Marketing at eSight Eyewear , sat down with me in this episode of Healthcare Goes Digital. Among many other things, he shared how eSight’s technologies are being used to bring sight back to people living with central vision loss, key learnings from his 30-year career in the pharma and medical device sectors, and his predictions and hopes for the future of ‘smart eyewear.’.

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Pharmaceutical Technology

NOVEMBER 24, 2022

The metaverse will make digital media experiences more immersive, inclusive, and accessible than today. However, it will raise social concerns ranging from data privacy to other forms of online harm. Listed below are the key regulatory trends impacting the metaverse theme , as identified by GlobalData. Net neutrality. Net neutrality refers to the concept that a telecom network should be a neutral gateway to the Internet rather than a gatekeeper with the power to decide what content is available

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Media Digital Media Networking Government 52

pharmaphorum

NOVEMBER 24, 2022

Novartis and the non-profit Medicines for Malaria Venture (MMV) have advanced a novel drug combination for malaria into a phase 3 programme, raising hopes of a regimen that could be used to treat resistant infections. The pairing of novel drug ganaplacide with a new formulation of established therapy lumefantrine that can be delivered less frequently provides a novel non-artemisinin regimen to treat uncomplicated Plasmodium falciparum infection – in other words, patients who are infected, but ha

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Pharmaceutical Technology

NOVEMBER 24, 2022

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. This shift will be driven by the future of work and digital transformation initiatives ongoing across sectors ranging from retail to healthcare and financial services. Big Tech is championing the metaverse, with Microsoft and Meta promoting it as the ideal environment to support hybrid working.

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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

pharmaphorum

NOVEMBER 24, 2022

pharmaphorum Editor-in-Chief Jonah Comstock travelled to Las Vegas last week with thousands of other healthcare stakeholders for the HLTH 2022 conference. In three days of sessions, attendees heard from some of the biggest voices in the healthcare industry, big tech, and U.S. government. In this post-show edition of the pharmaphorum podcast, Jonah welcomes Matthew Holt, editor of The Healthcare Blog and former digital health event organiser, to discuss the show itself and content therein.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Xeris Biopharma and Horizon Therapeutics have sig n ed a research partnership and option agreement for developing a ready-to-use, highly-concentrated, subcutaneous injection of teprotumumab. Under the deal, Xeris will leverage XeriJect, its technology platform to develop the formulation of teprotumumab. Horizon will also hold an option to licence this technology of Xeris. .

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pharmaphorum

NOVEMBER 24, 2022

Johnson & Johnson’s Spravato therapy for treatment-resistant depression (TRD) hasn’t made the impact the company hoped for in the market, and it is looking to new clinical results to accelerate its take-up. Yesterday, the drugmaker added to the evidence behind Spravato – an intranasal formulation of esketamine – with the release of top-line data from a head-to-head study with a long-acting formulation of the antipsychotic quetiapine, which is also used to treat TRD.

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Sales Patients Competition Marketing 52

Pharmacy Times

NOVEMBER 24, 2022

Although the anticonvulsant is not considered a controlled substance, some state legislation focuses on monitoring the use of or reclassifying it.

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Safety

pharmaphorum

NOVEMBER 24, 2022

Two years ago, the EMA proposed a set of recommendations to unlock the potential of big data for public health, headlined by the creation of a platform to access and analyse healthcare data from across the bloc. The Data Analysis and Real World Interrogation Network (DARWIN) EU platform aims to create a network of databases of verified, quality, and secure content that can be used to support “scientific evaluations and regulatory decision making” with reliable evidence from healthcar

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Networking Medicine Healthcare Healthcare 52

Pharmacy Times

NOVEMBER 24, 2022

Legislation expands protection of original 1965 act to individuals younger than 60 years.

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Patients 52

pharmaphorum

NOVEMBER 24, 2022

Bristol-Myers Squibb’s Opdivo has been recommended as a treatment for around 3,000 people with rare forms of gastro-oesophageal cancer via the NHS in England and Wales. In final guidance, NICE has backed Opdivo (nivolumab) as a first-line treatment with chemotherapy for previously untreated HER2-negative advanced gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma tumours that express PD-L1 with a combined positive score (CPS) of 5 or more.

Patients 52

Patients Medicine Marketing 52

European Pharmaceutical Review

NOVEMBER 24, 2022

The European Union Intellectual Property Office/ Europol joint report confirms that counterfeit pharmaceuticals continue to be a big problem across the European Union zone and a substantial threat for most, if not all, member states. Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million.

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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

pharmaphorum

NOVEMBER 24, 2022

The ‘as a service’ (AAS) model transformed the IT industry – making innovative technologies accessible to businesses without the high price point that would previously have been a barrier. Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis.

Pharma 89

Pharma Pharmaceutical manufacturing Manufacturing Marketing 89

European Pharmaceutical Review

NOVEMBER 24, 2022

The European Commission (EC) has approved Regeneron Pharmaceuticals, Inc.’s Libtayo ® (cemiplimab) for adults with recurrent or metastatic cervical cancer and disease progression while on or after platinum-based chemotherapy. The approval is based on Phase III trial results showing 12 months overall median survival (OS) for the overall patient population. “Libtayo ® was the first programmed cell death protein (PD)-1 inhibitor to demonstrate significant improvements in survival compared to

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Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. Well-planned ADME investigations are conducted in the early stages of clinical research to generate this important data, which is needed for regulatory submissions. ADME studies require the use of a radiolabeled version of the investigational drug.

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