Wed.May 17, 2023

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STAT+: Biotech and pharma execs wrestle with the ‘nightmare’ of developing digital biomarkers

STAT

TARRYTOWN, N.Y. — As post-lunch drowsiness settled on an auditorium full of leaders from the drug development industry, Peter Fernandes, CEO of Bellerophon Therapeutics, seized the presentation clicker and jolted them awake. “I don’t believe in dreams, I believe in nightmares,” he told the audience, drawing a laugh.  “And I love nightmares.

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FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

LifeProNow

May 12, 2023: “The U.S. FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.

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Opinion: Starting breast cancer screening at 40 saved my life

STAT

In 2015, the year I turned 40, the American Cancer Society updated its guidelines for breast cancer screenings. Instead of urging women to get mammograms beginning at 40, it would now recommend yearly mammograms beginning at age 45, and then every two years from age 55 on. I was greatly relieved by this news. I was a little more than a year into a wildly busy job at a news media startup.

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FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

LifeProNow

May 11, 2023: “The U.S. FDA is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. “Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease.

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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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Opinion: Do chatbots have more time to be empathetic than physicians?

STAT

As an oncologist, Jennifer Lycette gets to know her patients particularly well. She’s doubtful that artificial intelligence could replace that personal connection, but new research based on, of all things, Reddit Q&As, says otherwise. The study, which Lycette wrote about in her essay, “ Why a chatbot might seem more empathetic than a human physician, ” found that chatbot-generated notes were, in some ways, better than notes from actual humans.

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EM Match Advice 40: Program Directors Reflect on the 2023 Match

ALiEM - Pharm Pearls

The 2023 Emergency Medicine Match was an unprecedented year that took many of us in the education community by surprise. There were 132 (46%) EM residency programs with at least one unfilled PGY-1 position, and there were 554 (18.4%) overall unfilled EM positions. Dr. Sara Krzyzaniak (EM program director at Stanford) hosts this important episode with Dr.

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A day in the life of a pharma exec: Lyndra’s Patricia Hurter

PharmaVoice

How the CEO starts each day with a ride on one of her horses, reduces daily meetings and uses her network to get through crises like the SVB Bank collapse.

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STAT+: Could an upcoming Supreme Court case make the FDA slower?

STAT

WASHINGTON — The Food and Drug Administration could take longer to write regulations and make decisions if the U.S. Supreme Court rules against a long-standing legal doctrine giving agencies extra discretion, food and drug lawyers said Wednesday. The decades-old so-called Chevron doctrine directs judges to defer to reasonable federal agency interpretations of ambiguous or technically challenging aspects of the law.

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Woman of the Week: Genentech’s Veronica Sandoval

PharmaVoice

How the Genentech diversity exec is using a ‘3 Ms’ approach to reduce health disparities and improve access for under-supported communities.

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STAT+: FTC widens probe into pharmacy benefit managers to include group purchasing organizations

STAT

The Federal Trade Commission is widening its probe into pharmacy benefit managers and their impact on drug pricing by looking into a pair of group purchasing organizations that are owned by these industry middlemen, but are not well understood outside the industry. By seeking documents from Zinc Health Services and Ascent Health Services, the agency is attempting to unravel what critics complain is an opaque set of business practices and relationships.

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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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Siren emerges from stealth with plans to marry gene therapy to cancer immunotherapy

BioPharma Dive

Spun out of the lab of former UCSF researcher Nicole Paulk, the biotech is targeting brain and eye tumors with a new kind of treatment it has dubbed “immuno-gene therapy.

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STAT+: A new startup looks to turn the workhorse of gene therapy against cancer

STAT

In 1980, Life and Time magazines introduced America to a new cancer wonder drug: interferon, a protein ripped from the body’s own immune system that showed exciting early results, before ultimately proving both too impotent and too toxic to be useful beyond a couple of malignancies.  Researchers have spent the decades since searching for ways to bottle and repeat the early success seen in those first studies for interferon and another immune-signaling molecule called interleukin-2, w

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Roche pushes forward with MS drug amid rivals’ setbacks

BioPharma Dive

The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.

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Opinion: How ‘Lessons From the Covid War’ falls short

STAT

The stream of books about the government response to the pandemic that began with Michael Lewis’ “The Premonition” has just yielded its most important product to date. “ Lessons From the Covid War ” is public policy analysis at its near-best: lucid, sober, probing, at once analytical and engaging. But the book ultimately comes up a bit short, in ways that interestingly mirror the national response it chronicles and critiques.

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Consultation launched on major diseases strategy

The Pharmacist

Patients and professionals have been asked to share their thoughts on how to prevent, diagnose and manage six conditions that account for 60% of ill health and early deaths in England. The online survey for individuals and organisations asks questions on what the priorities should be for cardiovascular disease – including stroke and diabetes – […] The post Consultation launched on major diseases strategy appeared first on The Pharmacist.

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Opinion: New draft recommendations for mammograms take a one-size-fits-all approach

STAT

On May 9, the United States Preventive Services Task Force (USPSTF) released updated draft recommendations for breast cancer screening. In contrast to their prior recommendations that most women start screening at 50, the USPSTF — a major national body making preventive care recommendations — now recommends screening mammography every two years for all women ages 40 to 74 years.

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Pharmacist in practice: Sharing your struggles opens up a conversation

The Pharmacist

The Pharmacist caught up with Melissa Dadgar, the Primary Care Network (PCN) clinical pharmacist behind the @MelsMedicines social media channels. @MelsMedicines has over 15k followers on Instagram and 3000+ on Twitter. What was your vision for those social media channels? I actually started it off as a kind of public awareness of what pharmacists do, […] The post Pharmacist in practice: Sharing your struggles opens up a conversation appeared first on The Pharmacist.

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STAT+: PTC Therapeutics’s PKU drug succeeds in trial, but bigger hurdles for company are ahead

STAT

Biotech firm PTC Therapeutics said Wednesday that its drug for phenylketonuria, or PKU, met its key goal in a Phase 3 study. In PKU, patients’ bodies are unable to break down the amino acid phenylalanine, resulting in intellectual disability, memory problems, and other neurological issues. In the 156-volunteer trial, the drug, sepiapterin, reduced levels of phenylalanine by 63% compared to a placebo, PTC said in a press release.

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Chinook and Ionis partner to develop ASO therapy for kidney disease

Pharmaceutical Technology

Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.

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STAT+: CVS Health to close clinical trial unit two years after launch

STAT

WOONSOCKET, R.I. — Two years after its launch, CVS Health is planning to close down its clinical trials unit by the end of 2024, to refocus on core operations. Since the pandemic began, the drug store chain  has doubled down on its efforts to build a health care business  that would move it further into the home health and primary care spaces.

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FDA grants priority review to Takeda’s BLA for cTTP therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP). By replacing the missing or deficient ADAMTS13 enzyme, TAK-755 offers targeted therapy for addressing an unmet medical need for thrombotic thrombocytopenic purpura patients.

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STAT+: Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? Consider the alternatives, after all. And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started.

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PTC’s drug for PKU succeeds in late-stage clinical trial

BioPharma Dive

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

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Intratumoural viral delivery improves glioblastoma survival

European Pharmaceutical Review

An engineered oncolytic virus (DNX-2401) targeting glioblastoma (GBM) cells combined with subsequent immunotherapy using intratumoural delivery , gave a 52.7 percent 12-month overall survival (OS) rate for patients with recurrent GBM. According to the Phase I/II trial results published in Nature Medicine , this is higher than the prespecified efficacy threshold of 20 percent.

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Immuno-oncology agents continue to transform cancer treatment landscape:  GlobalData

Express Pharma

Immuno-oncology (IO) agents have transformed the oncology landscape in the last decade, particularly immune checkpoint inhibitors (ICIs) in solid tumor settings and chimeric antigen receptor (CAR) T-cells in hematological malignancies, with patients who previously had very limited therapeutic options achieving long term remissions and even cure. Continued investment into IO R&D in both academia and industry will further improve the clinical outlook of oncology patients, says GlobalData.

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Digitalisation to boost quality management systems market

European Pharmaceutical Review

A market report has shown that to improve efficiency, quality and to reduce costs in drug manufacturing , Pharma has been adopting automated quality management systems, digitalisation of processes and integration of data analytics. The data observed the global pharmaceutical quality management systems (QMS) market is expected to reach a value of $4.44 billion by 2031.

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Pharmanovia and Closed Loop Medicine in precision medicine partnership

Pharma Times

Dosing optimisation technology will be incorporated alongside anti-hypertensive drugs

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Researchers identify 10 pesticides toxic to neurons involved in Parkinson's

World Pharma News

Researchers at UCLA Health and Harvard have identified 10 pesticides that significantly damaged neurons implicated in the development of Parkinson’s disease, providing new clues about environmental toxins' role in the disease. While environmental factors such as pesticide exposure have long been linked to Parkinson's, it has been harder to pinpoint which pesticides may raise risk for the neurodegenerative disorder.

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FIND and VIA Global Health expand access to diagnostics

Pharma Times

Partnership will provide a healthcare boost across in low and middle-income countries

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Pharmacy Salaries: How to Find Out How Much I Should Be Paid

The Script

The post Pharmacy Salaries: How to Find Out How Much I Should Be Paid appeared first on Rx relief.

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FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

BioPharma Dive

Staff scientists are concerned Intercept Pharmaceuticals’ drug — which could be the first for non-alcoholic steatohepatitis — may cause liver damage and other health problems, documents show.

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AstraZeneca, LaNova Medicines Reach License Agreement on Antibody Drug Conjugate

PharmExec

Biotech company to receive $55 million upfront, per terms of the deal.

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Billy Dunn, former FDA neuroscience head, joins Prothena board

BioPharma Dive

Dunn is joining the neurological drug developer less than three months after stepping down from his role leading an agency office responsible for several controversial regulatory reviews.

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Episode 818: What Is Better to Add to Norepinephrine – Hydrocortisone or Vasopressin?

Pharmacy Joe

In this episode, I’ll discuss vasopressin vs hydrocortisone as an adjunct to norepinephrine in sepsis. Episode 818: What Is Better to Add to Norepinephrine – Hydrocortisone or Vasopressin? Subscribe on iTunes , Android , or Stitcher When patients with septic shock require increasing doses of norepinephrine to maintain adequate perfusion, both hydrocortisone and vasopressin are potential second agents to add.

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When to Utilize Commercial Outsourcing

PharmExec

When deciding on the right commercialization model, organizations must consider multiple factors, including the asset or platform they possess, the launch timing, the funding required, and staffing expertise.

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