Drug Topics

NOVEMBER 24, 2022

Take a look back at our most popular COVID-19 coverage for 2022.

201

201

STAT

NOVEMBER 24, 2022

An experimental influenza vaccine developed using messenger RNA technology appears capable of inducing what should be a protective immune response against all known subtypes of flu, at least in animals. If the work is translated into humans it could turn out to be a version of a long-sought universal vaccine. This would not be a vaccine that would block all flu infections, nor would it replace the need for an annual flu shot.

Vaccines 123

Vaccines Immunization Hospitals 123

Drug Topics

NOVEMBER 24, 2022

European research examines antibiotic exposure and its potential impact on future type 2 diabetes risk.

131

131

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

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies FDA 105

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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.

103

103

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.

Controlled Substances 145

Controlled Substances 145

Pharmacy Times

NOVEMBER 24, 2022

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

132

132

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

Chemotherapy 92

Chemotherapy Immunization 92

Pharmafile

NOVEMBER 24, 2022

Iveda, a US-based technology company, has introduced their new cloud-based artificial intelligence (AI) assistant called IvedaCare. The company says they have designed the at-home AI caregiver for ‘safety, security, and elderly care.’. read more.

72

72

Hospital Pharmacy Europe

NOVEMBER 24, 2022

A fentanyl vaccine induced significant antibody levels and reduced brain levels of the drug and could be of value in opiate use disorder. A fentanyl vaccine administered to male and female rats produced significant levels of anti-fentanyl antibodies neutralising the effects of the drug and reducing brain levels after administration and should be considered for clinical development as a treatment for opioid use disorder according to the results of a study by researchers based at the University of

Vaccines 59

Vaccines Immunization Hospitals 59

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

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.

Vaccines 59

Vaccines Packaging 59

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.

Hospitals 59

Hospitals Compounding 59

Hospital Pharmacy Europe

NOVEMBER 24, 2022

A digitised tumour-infiltrating lymphocyte scoring in non-small cell lung cancer helps to predict response to immune checkpoint inhibitor. Tumour infiltrating lymphocyte (TIL) scoring derived from a machine-learning model has superior classification accuracy for predicting an immune checkpoint inhibitor (ICI) response in patients with advanced non-small cell lung cancer (NSCLC) according to a retrospective analysis by an international research group.

Immunization 52

Immunization Hospitals 52

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.

Chemotherapy 52

Chemotherapy Immunization 52

Advertisement

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

Pharmacy Management Software

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

Compounding 52

Compounding Labelling FDA Pharmaceutical Companies 52

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

52

52

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.

52

52

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.

52

52

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.

Labelling 52

Labelling Hospitals 52

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. .

FDA 52

FDA 52

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

Documentation 52

Documentation Insurance Hospitals 52

Pharmafile

NOVEMBER 24, 2022

The University of Bristol has begun a trial to see if the rapid testing of initial symptoms could cut the number of antibiotic prescriptions given out. It is also hoped this will slow the growing problem of antibiotic immunity. It is common for doctors to prescribe antibiotics when they’re not sure of the root cause of the problem. However, antibiotics are only effective if the infection is bacterial, rather than viral. read more.

Immunization 52

Immunization 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.

Chemotherapy 52

Chemotherapy Documentation 52

Pharma Times

NOVEMBER 24, 2022

Candidate is first molecule targeting an RNA methyltransferase enzyme to enter development

48

48

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.

Packaging 95

Packaging Labelling Documentation Dosage 95

Pharma Times

NOVEMBER 24, 2022

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

47

47

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.

Packaging 94

Packaging 94

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

Chemotherapy 84

Chemotherapy Immunization Adverse Reactions Hospitals 84

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.

Labelling 52

Labelling Packaging 52

Hospital Pharmacy Europe

NOVEMBER 24, 2022

The risk of developing multiple sclerosis in those prescribed anti-diabetic medication is either higher or lower depending on their age. Patients aged 45 years and older with type 2 diabetes prescribed anti-diabetic medication, have an increased risk of developing multiple sclerosis compared to younger patients, but in the younger age group, the risk is actually significantly reduced according to the findings of a study by US researchers based at the university of Arizona.

Insurance 52

Insurance Hospitals 52