STAT

SEPTEMBER 27, 2022

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

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PharmaVoice

SEPTEMBER 6, 2022

From standout executives to R&D pioneers — this year’s class of honorees is defining the next era of leadership.

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Pharmaceutical Technology

SEPTEMBER 13, 2022

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

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pharmaphorum

SEPTEMBER 5, 2022

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

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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.

PharmExec

SEPTEMBER 10, 2022

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

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European Pharmaceutical Review

SEPTEMBER 30, 2022

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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Hospitals 122

PharmaVoice

SEPTEMBER 16, 2022

The serial entrepreneur has relied on his gift for storytelling, creativity and a bit of “magic” as he’s launched one successful niche tech company after another.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Documentation 131

PhRMA

SEPTEMBER 20, 2022

World Trade Organization (WTO) members, including the United States, are considering waiving commitments to honor certain intellectual property (IP) rights on COVID-19 treatments, following a harmful and unnecessary decision to do the same for COVID-19 vaccines. This is referred to as the TRIPS waiver.

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Vaccines 122

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Pharmacy Management

Pharma Times

SEPTEMBER 21, 2022

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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STAT

SEPTEMBER 8, 2022

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

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PharmaVoice

SEPTEMBER 14, 2022

As the first chief medical officer of the diagnostic testing company, Dr. Katharine Knobil is focused on moving the science forward beyond precision oncology to liquid biopsy.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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pharmaphorum

SEPTEMBER 16, 2022

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

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PhRMA

SEPTEMBER 16, 2022

Guess what? The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole.

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European Pharmaceutical Review

SEPTEMBER 12, 2022

Novartis has revealed plans to invest $300 million in next-generation biotherapeutics. The multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria to create a fully integrated, “dedicated scientific environment will bolster its capacity and capabilities for early technical development of biologics”.

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STAT

SEPTEMBER 10, 2022

Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research labs for allegedly violating federal law after finding numerous instances where nearly 2,000 monkeys were shipped between facilities without required veterinary inspections. Now, the federal government appears to be acting.

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PharmaVoice

SEPTEMBER 16, 2022

The CEO of Eversana has made his mark on the life sciences by disrupting the status quo for commercialization — and he’s got more industry-shifting changes in the works.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

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Vaccines 114

pharmaphorum

SEPTEMBER 7, 2022

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

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Packaging 117

PhRMA

SEPTEMBER 23, 2022

September is National Sickle Cell Awareness Month and a time for us to underscore the biopharmaceutical industry’s ongoing commitment to improve the lives of patients, families and communities affected by sickle cell disease.

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Med Ed 101

SEPTEMBER 22, 2022

Serotonin syndrome and neuroleptic malignant syndrome (NMS) are two commonly taught drug-induced syndromes but are rarely encountered in practice. I wanted to put together some important differences between these two syndromes because many of the symptoms overlap. Some of those classic overlapping symptoms include hyperthermia, hypertension, and tachycardia.

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STAT

SEPTEMBER 12, 2022

Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.

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PharmaVoice

SEPTEMBER 16, 2022

A combination of logic and love — that’s how the CEO of Waters Corp. leads and how he inspires those around him to “solve the problems that matter.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring Covid-19 therapies, personal protective equipment, tests and vital elements to bolster health systems.

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pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

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PhRMA

SEPTEMBER 12, 2022

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

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Biosimilars 106

Med Ed 101

SEPTEMBER 11, 2022

Lowering uric acid is the key to reducing gout flares. Both allopurinol (podcast) and febuxostat are effective at performing this task. However, there are some considerations you need to be aware when deciding to utilize allopurinol versus febuxostat. I’ll break down some of those comparisons in this article. From a mechanism of action standpoint, allopurinol […].

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STAT

SEPTEMBER 29, 2022

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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Vaccines 354

PharmaVoice

SEPTEMBER 15, 2022

Sonara Health’s inexpensive, specially engineered label and web app allow for at-home, digitally supervised dosing of high-cost or high-risks drugs.

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Labelling 246

Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.

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pharmaphorum

SEPTEMBER 6, 2022

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker. The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.

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PhRMA

SEPTEMBER 12, 2022

Health care affordability is not the only hurdle facing patients, according to PhRMA’s third Patient Experience Survey (PES). The latest PES report exposes another crucial problem: the frustration and confusion people have around how to use their coverage. Administrative hurdles and other barriers imposed by health insurers and pharmacy benefit managers (PBMs), such as time-consuming paperwork or prior authorization, are a challenge for many insured Americans, including more vulnerable communiti

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European Pharmaceutical Review

SEPTEMBER 29, 2022

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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