Sat.Apr 01, 2023 - Fri.Apr 07, 2023

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Hospitals pledge to protect patient privacy. Almost all their websites leak visitor data like a sieve

STAT

Every hospital in America promises to protect the privacy of its patients and the details of their medical care. And almost every one of them uses sophisticated data tools to track and share the personal information of visitors as soon as they start clicking on their websites. A new study found that 99% of U.S. hospitals employed online data trackers in 2021 that transmitted visitors’ information to a broad network of outside parties, including major technology companies, data brokers, an

Hospitals 360
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A drug just launched for a disease discovered only 10 years ago

PharmaVoice

Pharming just landed an FDA approval for a treatment targeting an ultra-rare immunodeficiency disorder discovered only a decade ago — and it’s already in the hands of patients.

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FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

LifeProNow

April 03, 2023: “The U.S. FDA announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. “Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of their unused opioid medications is part of the agency’s comprehensive a

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5 FDA decisions to watch in the second quarter

BioPharma Dive

By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.

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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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Federal judge suspends FDA approval of abortion pill

STAT

In a case that could reshape pregnancy in America, a federal judge on Friday sided with anti-abortion groups seeking a nationwide ban on abortion pills, ruling that the Food and Drug Administration acted improperly in approving mifepristone in 2000. The ruling will go into effect in seven days if a stay is not granted by an appeals court or by the Supreme Court.

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The silver linings in biotech’s wobbly market

PharmaVoice

A report from accounting firm BDO compares biotech’s tough times with the booming last few years — and points to some silver linings.

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More Trending

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Gene therapy startup Vedere to close two years after launch

BioPharma Dive

The startup, a successor to an eye gene therapy biotech that Novartis bought in 2020, will wind down after preclinical experiments didn’t meet the bar set by its leaders.

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STAT+: ‘True disruption’: Mark Cuban’s company will sell brand-name diabetes medicines from J&J

STAT

For the first time, Mark Cuban’s Cost Plus Drug Company is selling medicines made by a large drug manufacturer directly to consumers at a greatly reduced price, the latest sign that the billionaire is trying to make good on his vow to disrupt the opaque pharmaceutical supply chain. Until now, the company has focused on selling generic versions of brand-name medicines.

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Staff shortages cause slowdowns in booming cell and gene therapy market

PharmaVoice

New reports highlight the need for more targeted biotech education curriculums to shore up a sustainable workforce.

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Job interview questions for Health Economics and Outcomes Research(HEOR)

LifeProNow

1. What is HEOR, and why is it important in the healthcare industry? HEOR stands for Health Economics and Outcomes Research. It is important in the healthcare industry because it provides insights into the value of healthcare interventions and helps to inform decision-making regarding resource allocation. 2. What are the different types of economic evaluations used in HEOR, and how are they conducted?

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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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Clinical in pharmacy: In airport pharmacy the day can start early at 4am!

The Pharmacist

Hala Jawad is a community pharmacist based at Boots, London Gatwick Airport. She talks about the opportunities and challenges in helping the patients visiting an airport pharmacy. How long have you been working in community pharmacy? What attracted you to working in community? I have worked in community pharmacy for around nine years, and I […] The post Clinical in pharmacy: In airport pharmacy the day can start early at 4am!

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Opinion: I declined to share my medical data with advertisers at my doctor’s office. One company claimed otherwise

STAT

I care deeply about privacy, and as a professional researcher, I take meticulous notes. During my recent maternity leave, I spent most of my hands-free time trying to figure out why my doctors were trying to give my medical data away to advertisers — even after I opted out.

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5 minutes with — Parexel’s Peyton Howell

PharmaVoice

The company’s chief operating and growth officer on her personal quirks and why every pharma leader should read "Getting Naked.

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Seagen, Astellas win expanded FDA approval for bladder cancer drug

BioPharma Dive

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

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Biocon Academy conducts graduation ceremony for 185 students across four programs

Express Pharma

Biocon Academy, a Centre of Excellence for Advanced Learning in Applied Biosciences and a CSR initiative of Biocon held its seventh Graduation Day at its Bengaluru Campus, with 185 students graduating this year. Eight batches across four programs of Biocon Academy namely Biocon KGI Certificate Program in Biosciences, Biocon JSS AHER Certificate Program in Global Regulatory Affairs, Biocon Ramaiah Certificate Program in Quality Control Analytical, and BITS Biocon Certificate Program in Applied In

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1 in 6 people experience infertility worldwide, according to WHO report

STAT

One in six people across the globe face infertility at some point in their lifetime, according to the first new estimates from the World Health Organization in a decade. The prevalence is “staggering,” Pascale Allotey, director of sexual and reproductive health and research at WHO, said at a press conference Monday. The report estimates that 17.8% of adults in high-income countries and 16.5% in low- and middle-income countries experience infertility.

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All eyes turn to Karuna as it aims for an approval of a would-be blockbuster

PharmaVoice

In the red-hot race for new schizophrenia treatments, Karuna Therapeutics is close to an FDA submission.

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Eli Lilly Invests Heavily in Debut Mounjaro TV Ad Campaign for Diabetes

PharmExec

Eli Lilly debuts its first Mounjaro TV commercial amid high demand for the diabetes injection, which also shows promise in weight loss applications and outperformed rivals Ozempic and Wegovy in clinical trials.

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AbbVie removes two approvals for blood cancer drug Imbruvica

BioPharma Dive

In paring back use of Imbruvica, the drugmaker has become the latest developer to voluntarily withdraw indications for a cancer medicine following a setback in confirmatory testing.

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STAT+: The biotech scorecard for the second quarter: 24 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the second quarter: When is “mid-year”? This is not an existential question. Practically speaking, when a drugmaker, let’s say Bridge Bio , tells investors that an important readout of all-cause mortality data from a clinical trial of its heart drug acoramidis is coming “mid-2023,” does that mean the end of June or the beginning of July?

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PulmCrit Blogitorial – Why we will never know how to manage stress hyperglycemia

EMCrit Project

(Blogitorials are short, informal blogs that are written in the spirit of a tweetorial). Stress hyperglycemia is an everyday occurence in the ICU, but we hardly know how to treat it. I've been waiting years for this topic to be clarified… but I've realized that such clarity will probably never be reached. Why? The traditional […] EMCrit Project by Josh Farkas.

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Latest WHO Covid-19 vaccine guidance may decrease future demand

Pharmaceutical Technology

The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The latest guidance applies to the current phase of the pandemic and reflects the impact of the Omicron variant, which has led to high levels of immunity in all age groups through both vaccination efforts and infections across the globe.

Vaccines 111
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Freeline cuts more jobs and halts Fabry gene therapy work

BioPharma Dive

The U.K. biotech will lay off 30% of its workforce and focus on an experimental Gaucher disease treatment, five months after an initial restructuring that cut a hemophilia gene therapy.

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Opinion: In a world of synthetic biology, publishing virus DNA sequences may mean perishing

STAT

The wholly synthetic mRNA vaccines for Covid-19 saved nearly 20 million lives in just their first year of use, according to data published in 2022 by The Lancet. That success stands as the most prominent example of the power of synthetic biology, a field whose possibilities have excited me since I first heard the term more than 15 years ago. As scientists gain increasing dexterity in manipulating the basic elements of life, they are designing not only other synthetic vaccines, but also therapies

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Positive results from hVIVO study of Cidara flu candidate

Pharma Times

Study demonstrated a reduction in viral replication in the upper respiratory tract as well as influenza infection

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Enanta secures FDA fast track designation for EDP-323 to treat RSV

Pharmaceutical Technology

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

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In NEJM, full Pfizer data show RSV vaccine’s protection

BioPharma Dive

Results from two large clinical trials, published in the high-profile medical journal Wednesday, detail the shot’s safety and efficacy against the common respiratory infection.

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STAT+: Liver disease researchers are hoping AI can improve their trial design

STAT

Liver disease researchers, stumped by a complex disease, are looking for new investigative tools. Artificial intelligence might be one of them.  At a small conference of the American Association for the Study of Liver Diseases in Los Angeles last month, experts gathered to compare notes on nonalcoholic steatohepatitis, a form of nonalcoholic fatty liver disease commonly known as NASH.

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Recruitment of pharmacists in PCNs ‘exacerbating’ workforce shortages

The Pharmacist

The recruitment of pharmacists in primary care networks (PCNs) has ‘exacerbated’ workforce shortages across the profession, an independent review of integrated care systems (ICSs) has claimed. In addition, it also recognised the new opportunities for integration born out of a recent move of pharmacy commissioning responsibilities to integrated care boards (ICBs).

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MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease

Pharmaceutical Technology

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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Vertex, CRISPR finish US filing for gene editing drug approval

BioPharma Dive

The approval application is the first in the U.S. for a CRISPR-based medicine and puts the partners ahead of a rival therapy from Bluebird bio.

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Often overlooked, a common infection during pregnancy kickstarts a conversation about newborn screening

STAT

On a spring day in the late 1980s, pediatrician Mark Schleiss was confronted with a difficult case: a months-old infant who had developed pneumonia. While many infants with pneumonia recover, this particular baby had grown so sick he was admitted to the ICU, where he died. The autopsy showed he had disseminated cytomegalovirus, which had caused his pneumonia and then his death.

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Cancer and heart disease vaccines ‘ready by end of the decade’

The Guardian - Pharmaceutical Industry

Exclusive: Pharmaceutical firm says groundbreaking jabs could save millions of lives ‘A silver lining’: how Covid ushered in a vaccines golden era Millions of lives could be saved by a groundbreaking set of new vaccines for a range of conditions including cancer, experts have said. A leading pharmaceutical firm said it is confident that jabs for cancer, cardiovascular and autoimmune diseases, and other conditions will be ready by 2030.

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EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa.

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Biogen taps a deals expert in latest C-suite appointment

BioPharma Dive

Hiring Adam Keeney, a Sanofi veteran, to lead corporate development could be seen as timely, given that dealmaking has come into focus at Biogen since the recent appointment of Chris Viehbacher as CEO.

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