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.
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 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.
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.
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.
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.
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.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
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.
STAT
SEPTEMBER 16, 2022
Intellia Therapeutics said Friday the first six patients to receive its CRISPR-based treatment for a genetic swelling disorder have safely had small, corrective changes made to dysfunctional DNA inside their liver cells. Preliminary results from the study — just the second to show that CRISPR-based gene editing can be delivered systemically and performed in vivo, or inside the body — found that the treatment, NTLA-2002, reduced levels of the disease-causing protein, kallikrein, by
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.
Pharmaceutical Technology
SEPTEMBER 16, 2022
Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients. The guideline update comes after the treatment received recommendation from the health agency for treating non-severe Covid-19 in patients at increased risk of hospitalisation.
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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”.
STAT
SEPTEMBER 12, 2022
President Joe Biden plans to appoint longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health. Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized.
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.
Pharmaceutical Technology
SEPTEMBER 15, 2022
Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.
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.
STAT
SEPTEMBER 16, 2022
Rheumatology — the study of immune-system-driven diseases of the bones, joints, muscles, and in-betweens — has inherited plenty of hand-me-downs from cancer research. For example, there are ways of squelching an immune system in order to shrink certain kinds of cancerous tumors. And scientists have found that, when retrofitted, those strategies can also alleviate some symptoms of autoimmune conditions.
PharmaVoice
SEPTEMBER 13, 2022
COVID-19 has inspired renewed urgency in the need for weapons to combat antimicrobial resistant infections and new hope of government funding to meet the challenge.
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 […].
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
STAT
SEPTEMBER 13, 2022
Akero Therapeutics said Tuesday that an experimental medicine improved liver scarring at twice the rate of a placebo without worsening other symptoms — achieving the main goal of a mid-stage clinical trial involving patients with the fatty liver disease known as NASH. If the encouraging study results are confirmed in later Phase 3 clinical trials, the Akero drug, called efruxifermin, could become an effective treatment for a chronic disease that has grown into one of the leading causes of
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.
pharmaphorum
SEPTEMBER 14, 2022
A $14 million research project is getting underway in the US to see whether cancer and other diseases can be diagnosed by picking up subtle changes in a person’s voice patterns. The National Institutes of Health (NIH)-funded project is being run by researchers at the University of South Florida in collaboration with Weill Cornell Medicine in New York City, 10 other institutions in the US and Canada, and with the help of French/US artificial intelligence specialist Owkin.
Digital Pharmacist
SEPTEMBER 12, 2022
When you go to the website for Amazon Pharmacy it states they are “The pharmacy that really delivers. Upfront pricing. Easy refills. No more waiting in pharmacy lines.” But what does this all mean? Let’s dive deeper into the business side of Amazon Pharmacy. . 💰 Cost of Medications. Amazon is encouraging patients to check their medication prices.
STAT
SEPTEMBER 16, 2022
NEW YORK — The scene: a fashion show on Fifth Avenue. The catwalk was not elevated, as it usually would be. People were packed tightly on benches alongside it in the dark. The first person to walk it was a singer/songwriter, James Ian, dressed in a flashy suit with a howling wolf embroidered in beadwork on the back. Ian walked with a slight limp.
PharmaVoice
SEPTEMBER 12, 2022
Improved patient affordability is an important lever that can increase adherence, which in turn can improve health outcomes.
pharmaphorum
SEPTEMBER 15, 2022
The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.
PharmaTech
SEPTEMBER 15, 2022
You have your drug substance and need a parenteral formulation to administer it. This podcast will focus on the key factors to consider when choosing the ideal parenteral manufacturing CDMO partner.
STAT
SEPTEMBER 10, 2022
Alphabet’s life sciences offshoot Verily said Friday that it has raised $1 billion to fuel its next stage of development — one that will be steered by a new corporate leader as CEO Andy Conrad plans to shift to an advisory role. The eye-popping funding round was led by Alphabet, reinforcing Verily’s ties to its corporate parent even as it seeks to assert its independence and build a profitable business after years of sometimes scattershot projects and investments.
PharmaVoice
SEPTEMBER 16, 2022
Our annual PharmaVoice 100 “hall of fame” winners raise the bar on transformative leadership in life sciences.
pharmaphorum
SEPTEMBER 11, 2022
A personalised cell therapy based on tumour-infiltrating lymphocyte (TIL) cells has been shown to be more effective at improving progression-free survival than Bristol-Myers Squibb’s immunotherapy Yervoy in patients with advanced melanoma. It is the first time that a cell therapy for solid tumours has been tested in a phase 3 trial, and the first time that the approach has been directly compared with standard second-line immunotherapy in melanoma.
Pharmaceutical Technology
SEPTEMBER 14, 2022
Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years. As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Before TIL infusion, the patient undergoes lymphodepletion, which reduces the proportion of myeloid immune suppressive cells and creates space for the incoming lymphocytes.
STAT
SEPTEMBER 15, 2022
Artificial intelligence is a transformative tool in the workplace — except when it isn’t. For top managers, state-of-the art AI tools are a no-brainer: in theory, they increase revenues, decrease costs, and improve the quality of products and services. But in the wild, it’s often just the opposite for frontline employees who actually need to integrate these tools into their daily work.
PharmaVoice
SEPTEMBER 12, 2022
The highs of the sector in early 2021 gave way to a bear market that persisted into the second half of this year — but there's hope the bubble hasn't popped for good.
pharmaphorum
SEPTEMBER 12, 2022
BioNTech has been thrust into the limelight with its mRNA-based vaccines and therapeutics – most notably its Pfizer-partnered COVID-19 shot – but the other side of its business is CAR-T therapies for cancer, and it is making progress in this area as well. At the ESMO congress the German biotech reported updated results from a phase 1/2 trial of its lead candidate BNT-211 for solid tumours, which consists of a CAR-T directed at the antigen Claudin-6 on cancer cells, coupled with an mRNA vaccine (
Pharmaceutical Technology
SEPTEMBER 12, 2022
The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy. It should not be used along with other immunosuppressants.
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