Trending Articles

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‘A target on my back’: New survey shows racism is a huge problem in nursing

STAT

A family nurse practitioner in New York City, Jose M. Maria has come to expect overt racism from patients. “I’ve been called the N-word, I’ve been called, you name it,” he said. A triple minority in nursing — Black, Latino, and male — he often gets mistaken for a janitor. More subtle racist behavior has come from supervisors and fellow nurses in past jobs, too — uncomfortable looks in the break room, extra questioning from supervisors over narcoti

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Trick of Trade: Dual Foley catheter to control massive epistaxis

ALiEM

Massive epistaxis is considered a medical emergency that requires immediate attention. Symptoms of massive epistaxis include sudden and heavy bleeding from the nose, difficulty breathing, dizziness, and a rapid heartbeat. If left untreated, it can lead to significant blood loss, shock, airway obstruction, and even death. We report a case of a 50-year-old man with end stage renal disease with massive nasal bleeding from the left nostril, shortness of breath, and confusion.

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From FTC to SCOTUS, Amgen’s woes are potential ‘game changers’ for the industry

PharmaVoice

The two institutional battles offer a glimpse into the tension between pharma innovation and regulation that could reverberate across the industry.

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J&J antibody drug combination shows promise in multiple myeloma

BioPharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

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Sentiment towards Brexit has worsened three years after UK left EU

Pharmaceutical Technology

More than half (54%) of the surveyed healthcare industry professionals indicated that their sentiment towards Brexit had become more negative. The largest proportion of them were based in the UK and the EU, with 71% and 70% recorded respectively in GlobalData’s report Thematic Intelligence: Brexit and the Healthcare Industry 2023 (Figure 1). A Brexit survey conducted previously by GlobalData in 2021 found that the majority (60%) of the respondents had a more neutral sentiment towards Brexi

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Some hoped a new oral vaccine would solve all the polio campaign’s problems. Reality is settling in

STAT

When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.

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eXmoor pharma raises $35m to boost cell and gene therapy production

Pharmaceutical Business Review

The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners , respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as a result of the financing. The investment will allow eXmoor to launch its Cell and Gene Therapy Centre, a 65,000ft 2 good manufacturing practice (GMP) facility.

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FDA pauses PepGen’s plans to test muscle disease drug

BioPharma Dive

The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.

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Insulin Injections

RX Note

Introduction In 2017, the Malaysian Diabetes Educators Society published the Forum for Injection Technique Malaysia (FIT-MY) to provide evidence-based injection technique recommendations for people with diabetes mellitus who use injectable therapy in their daily management. Proper subcutaneous administration of diabetes injectable medications requires careful consideration of factors such as The injection sites Needle length Use of a lifted skin fold Angle of injection NovoPen 3, NovoPen 4 and N

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Sen. Elizabeth Warren probes abortion access amid states’ patchwork plans

STAT

WASHINGTON — Sen. Elizabeth Warren (D-Mass.) is launching a fresh round of questioning on states’ limits to abortion rights as a battle on medication abortion hangs in the balance at a federal court. Warren and three other Democratic senators sent letters late last week to five major health care worker and pharmacy groups interrogating how last year’s U.S.

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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.

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Lawmakers look to crack down on Big Pharma tax breaks

PharmaVoice

As lawmakers shine a light on Big Pharma tax cuts, the industry’s business moves are coming under attack from multiple angles.

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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

BioPharma Dive

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

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My Takeaways From The book Fish!

The Honest Apothecary

As a pharmacist in a management and leadership role, I’m always looking for books with ideas about how to lead better. l love books about creating a better working environment, and anything that may uncover some blindspots I may have about my own organization. When I stumbled across the book Fish! in a thrift store for a mere $2.00 it caught my eye.

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STAT+: Lured by a bigger payday, a medical device maker sold fake plastic parts. Many were implanted in chronic pain patients

STAT

Stimwave’s pitch was alluring. As a startup tackling chronic pain with nerve-stimulating devices, it promised to release patients from the stranglehold of addictive painkillers. And unlike its competitors, whose devices required patients to have clunky batteries implanted in their bodies, Stimwave’s system came with a sleek, wearable battery attached to thin wires under the skin.

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Amplo Biotechnology receives NIH-NIAMS grant for gene therapy AMP-201

Pharmaceutical Technology

Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.

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CVS is exiting clinical trials. Does this spell trouble for retail-based research?

PharmaVoice

Walgreens leaders are not deterred and hope to fill the holes left behind by the pharmacy giant.

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Bristol Myers data make case for earlier use of bone marrow disease drug

BioPharma Dive

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

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Priority review granted by FDA for 'landscape changing' colorectal cancer drug

Outsourcing Pharma

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

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Opinion: In defense of being ‘Cali sober’

STAT

The phenomenon of being “Cali sober” is taking the recovery world by storm. It is defined as dedicating oneself to a life free of drugs and alcohol — except for cannabis and other psychedelics. (Though many consumers don’t think of cannabis as a psychedelic, policy experts often consider it one because of its effects.) Hardcore proponents of abstinence-based recovery, such as Alcoholics Anonymous, dismiss the Cali sober approach as dangerous and “not really rec

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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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Eisai to grant 625 mn yen to GHIT Fund for developing medicines for neglected tropical diseases, malaria

Express Pharma

Eisai Co has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (GHIT Fund) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by Japanese pharma companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to c

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Biohaven sends latest drug to FDA, despite past trial setback

BioPharma Dive

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

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CHMP meeting highlights – May 2023

European Pharmaceutical Review

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.

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Opinion: Newly diagnosed cancer patients need help navigating the system

STAT

“Hey, I’m sorry to bother you, but I could really use your advice on something.” As fellows in oncology training programs, we’re both accustomed to fielding texts, emails, and calls that start out like the above from family, friends, and acquaintances seeking guidance for themselves or their loved ones after a cancer diagnosis.

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Immuno-oncology market set to grow in billions, but access concerns remain

Pharmaceutical Technology

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.

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Indegene, ConTIPI Medical partner to launch ProVate, a device to treat pelvic organ prolapse in women

Express Pharma

Indegene announced that it will be expanding its partnership with ConTIPI Medical, a provider of non-surgical and disposable solutions for women with various pelvic floor dysfunctions, to bring a new device to the market. ConTIPI’s ProVate is a ready-to-use device that is inserted vaginally by the user thanks to an easy-to-use applicator, very similar to a menstrual tampon.

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Amylyx’s ALS drug could face rejection in Europe

BioPharma Dive

The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.

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PulmCrit: “ARDS” is not a real thing

EMCrit Project

My dear pulmonologists, I have some bad news. Santa Claus isn't real. Neither is “ARDS.” “ARDS” has traditionally been conflated with a specific histopathological form of lung injury: diffuse alveolar damage (DAD). Lectures, chapters, and articles typically juxtapose these two entities, promoting the concept that they're one and the same.

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Opinion: Adopting the term ‘preaddiction’ would be a serious mistake

STAT

The National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism recently proposed a new addition to the addiction vernacular: “ preaddiction.” The idea is that the word will help identify and intervene on harmful substance use earlier and more effectively. While it’s an admirable goal, the term fails to align with the evidence.

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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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Glenmark Pharma becomes part of SBTi, sets GHG emission targets for FY2035

Express Pharma

Glenmark Pharmaceuticals has joined the Science Based Targets initiative (SBTi) business ambition for well below 2°C. A company statement informed, “The SBTi’s has approved Glenmark’s commitment to reduce its absolute scope 1 and 2 GHG emissions by 35 per cent (from an FY2021 base year) by FY2035. The target boundary includes biogenic land‐related emissions and removals from bioenergy feedstock.

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Serial biotech founder Tim Springer on investing in startups and democratizing antibody research

BioPharma Dive

Springer, who became a billionaire after an early investment in Moderna, spoke with BioPharma Dive after gifting $210 million to his nonprofit institute in Boston.

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Michael J Fox Foundation chooses platform to help with Parkinson's research

Outsourcing Pharma

H1, a US data healthcare data technology company has been selected by non-profit funder of Parkinsonâs Disease (PD) research, The Michael J Fox Foundation (MJFF), for its Trial Landscape solution.

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Sacklers win appeal that shields them from opioid lawsuits, clearing way for bankruptcy settlement

STAT

A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. The Sackler family members insisted a bankruptcy deal would not be possible unless they were released from all future liability related to the harm caused by Purdue’s OxyContin painkiller.

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Janssen submits NDA to FDA for PAH combination therapy

Pharmaceutical Technology

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH). The company is seeking approval for the combination therapy for the long-term treatment of PAH in adult patients with World Health Organisation functional class II-III.

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Parkinson’s unmet needs present significant opportunity for new entrants: GlobalData

Express Pharma

Parkinson’s Disease (PD) is a complex, multi-system neurodegenerative disorder that affects movement control. Current treatments focus on the management of dopamine levels in the brain, with levodopa-based therapies remaining the standard of care in the PD market for the past half-century. However, the effectiveness of levodopa declines with time, and both motor and non-motor complications arise.