pharmaphorum

JULY 2, 2021

AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients. . Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel damage due to inflammation and scar tissues formation (fibrosis) in models of cardiovascular disease, by 69% after 30 days in the phase 2a SATELLITE stu

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Labelling FDA 98

Outsourcing Pharma

JUNE 29, 2021

The trial solutions firm is working with Childrenâs Oncology Group to expand in-home research and care options for investigational immune-oncology therapy.

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Immunization 97

Dr. Jamie Hardy: The Lifestyle Pharmacist

JUNE 27, 2021

Heat stroke and heat exhaustion are serious, life-threatening conditions. More than 600 people in the United States are killed by the extreme heat every year, according to the Centers for Disease Control and Prevention. How to protect yourself from heat exhaustion and heat stroke. Protecting yourself from the dangers of heat exhaustion and heat stroke is a must.

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Hospitals 52

Med Ed 101

JUNE 30, 2021

An 89-year-old female has a history of frequent UTIs. She has been taking ciprofloxacin for UTI prophylaxis at 250 mg once daily for about 1 year. She has not had a UTI since starting on the ciprofloxacin. She takes it in the morning with her breakfast. She has a history of diabetes, CKD, osteoarthritis, neuropathy, […]. The post Ciprofloxacin for UTI Prophylaxis – Case Study appeared first on Med Ed 101.

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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.

pharmaphorum

JUNE 30, 2021

bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.

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FDA 98

Outsourcing Pharma

JUNE 28, 2021

The companyâs Ryze technology combines a clinical MDR and study automation platform, designed to accelerate and optimize design and execution of trials.

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Med Ed 101

JUNE 27, 2021

In this article, we take a look at the Alpha-2 Adrenergic Agonists. In comparing Alpha-2 Adrenergic Agonists, we will primarily look at dosing, adverse effects, and notable indications. Clonidine is FDA-approved for attention deficit hyperactivity disorder (ADHD), cancer pain, and hypertension. It is also used off-label for a variety of reasons, such as hot sweats, […].

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Labelling FDA 40

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . It’s a big disappointment for Altimmune, which said back in February that it was hoping to find a more convenient alternative to injected COVID-19 vaccines – and one which would be stable at room temperature, making distribution and delivery easier.

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Vaccines Immunization FDA 98

Outsourcing Pharma

JULY 1, 2021

On July 7, a group of seasoned industry leaders will offer insights at Rare/orphan diseases, special patient population, a focused, free online event.

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Pharma Times

JULY 1, 2021

Checkpoint inhibitor approved in combination with chemotherapy in the first-line setting for these patients

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Chemotherapy 49

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

pharmaphorum

JUNE 30, 2021

Pharma has both an opportunity and a responsibility to do its part in tackling climate change – and the time to act is now, according to speakers at a recent event. Amanda Barrell reports. The pharma industry has clearly stated its commitment to a net zero future, but where are we on that journey, what else can be done, and could organisations achieve more if they worked together?

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Hospitals 98

pharmaphorum

JULY 2, 2021

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans. . Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could stand in the way of its rollout, including a need for three doses, whereas all India’s current vaccines only need two.

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Vaccines 93

pharmaphorum

JULY 1, 2021

Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices. The German drugmaker will work with startup neuroloop on bioelectronics , put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis and inflammatory bowel disease. neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device

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Labelling 94

pharmaphorum

JUNE 28, 2021

Exelixis has suffered a blow to its efforts to expand the use of Cabometyx into additional indications after reporting mixed results in a phase 3 trial in liver cancer. The COSMIC-312 study is comparing Cabometyx (cabozantinib) given alongside Roche’s cancer immunotherapy Tecentriq (atezolizumab) to Bayer’s Nexavar (sorafenib) as a first-line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer.

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FDA 88

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Pharmacy Management Software

pharmaphorum

JULY 1, 2021

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, infectious diseases, and rare, undertreated indications.

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Pharmaceutical Companies Pharmaceutical Companies Patient Care Vaccines 78

pharmaphorum

JUNE 29, 2021

Patient recruitment has begun in a National Institutes of Health (NIH) trial of two digital therapeutics (DTx) for people with opioid use disorder (OUD), developed by Pear Therapeutics and Chess Health. . The CTN-0100 study is test strategies to help keep people with OUD on drug treatment, improve the chances that those stabilised with drug treatments for OUD can come off medication without relapsing, as well as to find ways to predict the risk of relapse based on patient characteristics.

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FDA 84

pharmaphorum

JUNE 30, 2021

The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies. . Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a role in prevention and early detection of disease and helping more patients to receive treatment outside the hospita

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Hospitals FDA 80

pharmaphorum

JULY 1, 2021

Introduction. The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to receive, process, review and archive submissions efficiently.

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pharmaphorum

JULY 2, 2021

Swiss food giant Nestle has firmed up its five-year-old alliance with US microbiome specialist Seres, paying $175 million upfront for North American co-marketing rights to its lead drug for Clostridium difficile infections. Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDA approves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets.

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pharmaphorum

JUNE 29, 2021

Artificial intelligence (AI) has the potential to improve the delivery of healthcare, but only if ethics and human rights are put at its heart of its design and use, according to the World Health Organisation (WHO). Digital technologies and AI are already being deployed to improve the speed and accuracy of diagnosis and screening for diseases, assist with clinical care, support R&D, and guide public health policy, according to a just-published WHO document called Ethics and governance of art

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Documentation 64

pharmaphorum

JULY 1, 2021

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range for Aduhelm (aducanumab) upwards, but only by a small amount.

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Labelling FDA 59

pharmaphorum

JUNE 30, 2021

Shares in Pfizer spinout Cerevel Therapeutics have more than doubled after it reported positive early-stage results with CVL-231, a drug for schizophrenia that it thinks could have a clear side-effect profile than current therapies. The drug – a selective muscarinic M4 receptor positive allosteric modulator (PAM) – is designed to have limited effect on dopamine neurotransmission, a mechanism thought to contribute to tolerability issues with the current generation of antipsychotic drugs.

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pharmaphorum

JUNE 28, 2021

AstraZeneca’s fast-growing SGLT2 inhibitor Forxiga could soon get a further boost from approval in the EU as a treatment for chronic kidney disease (CKD) in adults with and without type-2 diabetes. Forxiga (dapagliflozin) has been recommended for approval to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure in adults with CKD who are at risk of progression by the EMA’s Committee for Medicinal Products for Human Use

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Labelling FDA 53

pharmaphorum

JULY 2, 2021

The Association of the British Pharmaceutical Industry (ABPI) has launched its 2021 Code of Practice to help companies operate to high ethical standards. . The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public. It is independently administered by the Prescription Medicines Code of Practice Authority (PMCPA).

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Patient Care 52

pharmaphorum

JULY 2, 2021

GlaxoSmithKline’s board had responded to the broadside attack delivered by activist investor Elliott Management yesterday, saying it stands firmly behind the leadership of chief executive Emma Walmsley. The drugmaker rejected calls by Elliott to change its board and accelerate the complete divestment of its consumer health unit which is due to be split from the ‘new GSK’ pharma business next year, and said it had “widespread and strong support” among shareholders fo

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Communication 52

pharmaphorum

JULY 2, 2021

Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this setting were a bust. . The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment option for patients with PD-L1-expressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received two or more earlier lin

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FDA Chemotherapy Immunization 52

pharmaphorum

JULY 2, 2021

In this episode of Health Innovators , pharmaphorum founder Paul Tunnah interviews Eliot Forster, CEO of F-Star – a clinical-stage, NASDAQ-listed biopharmaceutical company focused on transforming the lives of patients with cancer. About the author. Dr Paul Tunnah is chief content officer and UK managing director for Healthware Group , a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a uni

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Communication 52

pharmaphorum

JULY 1, 2021

Global health innovation company Real Chemistry has announced the appointment of Mary Stutts to lead its diversity, equity and inclusion strategy. . Stutts joins Real Chemistry having led corporate relations and communications at Genentech, Bristol Myers Squibb, Bayer, UnitedHealth Group, Kaiser Permanente, Stanford Health Care and Comcast NBCUniversal.

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Communication 52

pharmaphorum

JULY 1, 2021

The two firms are collaborating to create a unique, end-to-end labeling solution tailored for medical device organizations. Wokingham, United Kingdom — 22 nd June 2021 — Labeling software specialist PRISYM ID has joined the Siemens Digital Industries Software Solution Partner Program. Together with Siemens, they are working on a new hybrid solution designed to digitally integrate all labeling processes with an organization’s product lifecycle management (PLM) and manufacturing operations manage

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Labelling 52

pharmaphorum

JULY 1, 2021

GlaxoSmithKline chief executive Emma Walmsley was no doubt hoping that an upbeat assessment of the firm’s prospects at an investor meeting last week would deflect criticism of her leadership from activist investor Elliott Management – but finds herself in the firing line once again today. The US hedge fund, run by billionaire Paul Singer, has bought a sizeable stake in GSK thanks to in part to its slumping share price in recent months, and has been grumbling about the direction that GSK ha

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pharmaphorum

JUNE 30, 2021

This has probably been the toughest year for oncology researchers in memory. As this issue’s contributors discuss, funding gaps, paused trials and patients’ health anxiety will have reverberations impacting outcomes for years to come. But it’s perhaps a testament to the sector’s strength that even among these challenges, all of our speakers see the huge potential for cancer research going forward.

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pharmaphorum

JUNE 30, 2021

Merck & Co’s Keytruda has become the first cancer immunotherapy to be approved as a first-line oesophageal cancer therapy in the EU, ahead of Bristol-Myers Squibb’s rival Opdivo, but BMS’ drug could end up winning the category. . The European Commission cleared Keytruda (pembrolizumab) alongside chemotherapy for previously-untreated patients with oesophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma with PD-L1 combined positive score of 10 or mo

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pharmaphorum

JUNE 30, 2021

In the latest episode of the pharmaphorum podcast, pharmaphorum’s web editor Catherine Longworth speaks to Gerald Finken, the founder and CEO of RxE2. The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinical research. As a licensed pharmacist with experience in biotech and pharma, Gerald sees pharmacies as an untapped resource for clinical research and believes they can be leveraged to improve recruitment and clinical trial outcomes.

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pharmaphorum

JUNE 30, 2021

In 2020, healthcare technology investment went into overdrive. We speak to Sunny Kumar, Partner at GSR Ventures, to find out how COVID?19 has transformed the industry and whether healthcare technology can bring us one step closer to a value-based model of care. The COVID-19 pandemic has brought about the most unexpected and unprecedented challenges, stretching our finite healthcare resources to an extent where they have reached a breaking point.

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