Fri.Oct 13, 2023

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Opinion: Yes, everyone should get an updated Covid-19 vaccine

STAT

Last month, the Centers for Disease Control and Prevention recommended that everyone in the U.S. 6 months and older receive an updated Covid vaccine targeting the XBB.1.5 variant. Since then, some notable voices, including Paul Offit , have publicly questioned whether the updated vaccine is needed for those who are not in a high-risk group. He recently wrote, “At this point in the pandemic, it is hard to make a case for vaccinating everyone.

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Branded: The trademarks pharma leaders look up to

PharmaVoice

What do brands like Patagonia, Nike and Lego have to do with pharma? Here are some of the brands industry leaders relate to most — and how they inspire work in the life sciences.

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STAT+: Like a vampire, some cancer cells can suck the energy source from immune cells

STAT

As elite hunters of the immune system, T cells are constantly prowling our bodies for diseased cells to attack. But when they encounter a tumor, something unexpected can happen. New research shows that some cancer cells can fire a long nanotube projection into the T cell that, like a vampire’s fang, sucks energy-creating mitochondria from the immune cell, turning the predator into prey.

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Pfizer to cut costs, lay off staff on waning demand for COVID products

BioPharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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Position Your Pharmacy for Expansion

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.

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He was named a MacArthur ‘genius’ fellow for research on gene regulation, but still has imposter syndrome

STAT

The youngest of this year’s class of MacArthur “genius grant” fellows, 35-year-old Jason Buenrostro was just a graduate student when he pioneered a technique that’s become a mainstay for studying how cells regulate gene expression. While doing his doctoral work at Stanford University, with geneticists William Greenleaf and Howard Chang, he developed the assay for transposase-accessible chromatin, or ATAC-seq, a highly sensitive and accurate method for identifying regi

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The PharmaVoice 100: Patient heroes

PharmaVoice

Leaders innovating new ways to incorporate patient voices in drug development and decrease barriers to access.

More Trending

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An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

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STAT+: European regulators once again recommend Amylyx’s ALS drug be rejected

STAT

LONDON — European regulators on Friday reiterated their view that an ALS treatment from Amylyx Pharmaceuticals should not be approved, likely dooming the drug’s chances for now.   A European Medicines Agency committee had initially recommended against approving the drug , known as Albrioza, in June. Friday’s confirmation of that position came after the company appealed the decision.

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UCL researchers recommend AI language models for schizophrenia diagnosis

Pharma Times

Automated analysis of language could help diagnose and assess psychiatric conditions - News - PharmaTimes

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Kaiser Permanente reaches tentative agreement with workers

STAT

After a historic strike, healthcare giant Kaiser Permanente and the Coalition of Kaiser Permanente Unions announced early Friday that they have reached a tentative union contract agreement. More details will be disclosed soon, they said. The agreement was reached with the help of acting U.S. Labor Secretary Julie Su, who was also on hand for the failed last-minute set of negotiation talks before the unions went on strike last week.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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UKRI awards three projects £25m for vaccine development

Pharma Times

The projects will support the development of new and longer-lasting vaccines - News - PharmaTimes

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STAT+: Medicare to cover more brain scans related to Alzheimer’s drugs

STAT

Medicare has officially expanded its coverage policy for brain scans that detect a brain plaque associated with Alzheimer’s disease, the agency announced on Friday. Amyloid PET scans are important tools to help determine whether patients with mild cognitive impairment are good candidates for new Alzheimer’s drugs, including Eisai and Biogen’s drug Leqembi , which means there will likely be an increase in demand for the scans as uptake increases.

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PulmCrit Blogitorial – Why the new brain death guidelines are unacceptable

EMCrit Project

Hello fellow nerds, let's take a look at the new American Association of Neurology (AAN) brain death guidelines. Instead of a tweetorial, I'll jot my thoughts here, so they're accessible to everyone. Disclaimer: the following discussion applies only to adult medicine. Most of these guidelines are consistent with the 2020 World Brain Death Project, so […] EMCrit Project by Josh Farkas.

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STAT+: Eye docs urge Medicare to lower insurance hurdles amid shortage of repackaged Avastin

STAT

Due to a shortage of a widely used compounded medicine for serious eye diseases, two leading ophthalmologic groups want Medicare contractors to halt practices that limit coverage of other — albeit costlier — treatments over concerns about patient access. At issue is Avastin, an older cancer medicine that is often used by physicians to treat age-related macular degeneration and macular edema, among other ailments.

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Biopharma Stock Check: Market Review and Outlook

PharmExec

Exploring the pharma and biotech financing, M&A, and stock market pictures through the first half of 2023—and implications for the future, as market challenges continue to weigh heavily in senior management decision-making.

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Vampiric cancer cells, a brain atlas, & alleged misconduct at Cassava

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Today, we learn about energy-sucking cancer cells, explore a map of the human brain, and update you on the downfall of Cassava Sciences. Have a good weekend.

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‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

BioPharma Dive

The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.

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STAT+: UnitedHealth’s profit jumps as medical costs come in lower than expected

STAT

UnitedHealth Group has made it clear that more people, especially older adults, are seeing their doctors and getting more medical care this year. But that is certainly not dragging down the company’s profits. In the third quarter of this year, UnitedHealth’s net profit increased by more than 11%, to more than $5.8 billion, the company reported Friday.

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GLP-1 drug demand leaves employers in a bind over coverage

BioPharma Dive

Employers face a difficult decision over whether to cover the popular weight loss therapies, which cost between $900 and $1,400 for a typical month’s supply at list price.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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SGD Pharma expands Sterinity range of RTU Type I molded glass vials

Express Pharma

SGD Pharma announced the latest expansion of its Sterinity range of ready-to-use (RTU) Type I molded glass vials. A company statement informed, “SGD Pharma’s range of RTU Sterinity vials offer customers an efficient solution to the lengthy stages of vial-sterilisation and provides the flexibility they require to prioritise patient safety and distribute medicines significantly faster.

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Follicular lymphoma BTK inhibitor recommended by CHMP

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BRUKINSA ® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab. BeiGene’s anti-cancer treatment is indicated for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.

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FDA lifts clinical hold on PepGen’s myotonic dystrophy type 1 candidate

Pharmaceutical Technology

The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.

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A Blueprint for Balance

PharmExec

Stephen Rivera, vice president, global technical accounting advisory services and policy, Johnson & Johnson, capitalizes on his lively personality—and a courageous career journey—to bring people together to shape the future of biopharma.

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Study reports rapid method for microbial contaminant detection

European Pharmaceutical Review

A paper published in Pharmaceuticals has reported the first demonstration of the possibility of using fluorescent optical respirometry (FOR) to detect aerobic bacteria in selected sterile pharmaceutical products. Rapid , real-time measurement of living aerobic microorganism cells was achieved using the fluorescent sensor tris-[(4,7-diphenyl-1,10 phenanthroline)ruthenium(II)] dichloride (Ru(DPP) 3 Cl 2 ).

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Supervision: ‘We need pharmacists in the pharmacy doing things differently’

The Pharmacist

Having a responsible pharmacist in every pharmacy is not something that is likely to change, nor does it need to, the chief executive of the Company Chemists’ Association (CCA) has told The Pharmacist in an exclusive interview reflecting on recent supervision discussions. Instead, he said that the pharmacist would be present in the pharmacy but […] The post Supervision: ‘We need pharmacists in the pharmacy doing things differently’ appeared first on The Pharmacist.

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CPHI Annual Survey: global pharma resilient with India the chief beneficiary of macro changes

World Pharma News

Ahead of this month's CPHI Barcelona - the world's largest pharma event, held at Fira Barcelona (October 24-26th, 2023) - and CPHI & PMEC India to be held at India Expo Centre, Greater Noida, Delhi NCR (November 28-30) key highlights from the CPHI pharma survey are announced. The full findings will be published at CPHI Barcelona as part of the CPHI Annual Report.

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Lupin gets tentative nod from US FDA for apalutamide tablets

Express Pharma

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech. This product will be manufactured at Lupin’s Pithampur facility in India. Apalutamide Tablets, 60 mg, (RLD Erleada) had estimated annual sales of $1,185.5 million in the US (IQVIA MAT July 2023).

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Pfizer wins FDA approval for its $7B colitis drug

BioPharma Dive

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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FDA fast tracks MimiVax’s glioblastoma vaccine SurVaxM

Pharmaceutical Technology

The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.

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Common ailments schemes have ‘significant’ clinical and economic benefits, finds FIP

The Pharmacist

Pharmacy-led common ailments schemes generate ‘significant national savings’, reduce GP workload and improve patients’ quality of life and symptom relief, a global survey carried out by the International Pharmaceutical Federation (FIP) has found. Despite concerns of competition, FIP reported that common ailments schemes strengthened collaborations between GPs and pharmacists, while in Scotland, the Pharmacy First […] The post Common ailments schemes have ‘significant’ clinical and economic

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Amneal partners with mAbxience for denosumab biosimilars

Pharmaceutical Technology

Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.

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PDA ‘cannot support’ PGDs for pharmacy technicians proposal

The Pharmacist

The Pharmacists Defence Association (PDA) has said that it ‘cannot support’ the government’s proposal to allow pharmacy technicians to supply medication under a patient group direction (PGD). It has raised concerns that the move could pose an issue to patient safety, and queried whether the current pharmacy technician workforce would be ready to safely supply […] The post PDA ‘cannot support’ PGDs for pharmacy technicians proposal appeared first on The Pharmacist.

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AGC Biologics Unveils Completed pDNA and mRNA Expansion Project

Pharmaceutical Commerce

CDMO’s Heidelberg facility will house the newly-completed manufacturing line.

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Update on Ophthalmic Anti-VEGF Therapeutics

Big Molecule Watch

Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA ® HD (Aflibercept, 8 mg) Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea ® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA ® (aflibercept, 2 mg) in patients with wet AMD.