Wed.May 29, 2024

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The new menstruation: Girls are getting their periods earlier and less regularly

STAT

Menstruation is a critical indicator of health. Whether and when someone with a uterus gets their period — for the first time, and throughout their life — can reflect not only their reproductive health, but their risk of cardiovascular disease, cancer, miscarriage, and premature death. That also makes menstruation a useful measure of population health.

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Can robots break the cell therapy bottleneck?

PharmaVoice

A partnership between the cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could bring the manufacturing bottleneck under control, the CEOs said.

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Trending Sources

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New obesity drugs are seemingly everywhere. Black Americans feel left out

STAT

STAT teamed up with Word In Black, a network of 10 Black news publishers, to report over the past year on the impact of new weight loss drugs on Black America. Jonathan Gustave was diagnosed with type 2 diabetes last August after decades of struggling with his weight. To help lower his blood sugar levels, his doctor prescribed Ozempic, the diabetes drug that has become wildly popular for its weight loss effects.

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FTC request may signal trouble for Novo/Catalent deal

PharmaVoice

As Novo Nordisk aims to secure its manufacturing foothold for GLP-1s, regulators are digging for clues of anti-competitive behavior.

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From Payroll Pains to Growth Gains: Streamlining Payroll & HR for Success

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

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STAT+: Akili, maker of a video game to treat ADHD, to be acquired for $34 million

STAT

A month after announcing it was seeking strategic alternatives , Akili Interactive, maker of a video game designed to treat ADHD, said it will go private in a merger with Virtual Therapeutics. The deal is expected to net Akili’s shareholders $34 million. Akili made headlines in 2020 when it received Food and Drug Administration clearance for EndeavorRx, a video game designed to treat pediatric ADHD.

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Can robots break the cell therapy bottleneck?

BioPharma Dive

A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.

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More Trending

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Working for a mature form of genomic medicines

pharmaphorum

In a new episode of the pharmaphorum podcast, Rahul Kakkar, CEO of gene editing company Tome, speaks with web editor Nicole Raleigh about programmable genomic integration (PGI) technology.

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Wegovy linked to lower risk of alcohol use disorder in real-world study

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. I hope everyone had a restful Memorial Day weekend. I myself was engaged in what my editor calls one of the greatest joys in life — packing up all my belongings, moving two miles, and then unpacking all of my belongings.

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Allow pharmacists to amend prescriptions 'within three months', urge MPs

The Pharmacist

Legislation should be changed within the next three months to allow community pharmacists to amend prescriptions in the case of shortages, a parliamentary committee has recommended. ‘Medicine shortages cannot be ignored and left to become the norm,’ a Health and Social Care Committee (HSCC) report, published today, stated. And it warned of a ‘serious risk […] The post Allow pharmacists to amend prescriptions 'within three months', urge MPs appeared first on The Pharmacist.

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STAT+: Health insurers boast to investors about using AI, but they’d rather not talk about it

STAT

Health insurers are telling shareholders that they are ramping up the use of artificial intelligence and are hiring talent to implement the technology across their organizations. They say their artificial intelligence models can increase efficiency and “cut costs,” but they refused to discuss what models they’re using, how those models were developed, or exactly what they’re using them for.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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AstraZeneca throws its hat into the oral PCSK9 ring

pharmaphorum

AstraZeneca has reported the first clinical data with its oral PCSK9 inhibitor AZD0780, which it hopes could offer an alternative to current injectable drugs used to lower cholesterol.

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STAT+: Clinical lab trade group sues FDA over plan to regulate lab-developed tests

STAT

A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests.

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Merck KGaA announces its largest investment in Asia

Express Pharma

Merck KGaA Darmstadt Germany announced its largest investment in Asia through a ceremony of its € 300 million Bioprocessing Production Center in Daejeon, South Korea. The new facility will accelerate the biotech and pharmaceutical industry’s development by manufacturing vaccines, cell and gene therapies, and protein-based therapies. Once completed, the investment aims to create as many as 300 new jobs and continue to grow and support global demand for critical drugs and therapies.

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NIH-funded clinical trials often miss racial, gender diversity enrollment goals, report finds

STAT

WASHINGTON — Clinical trials that the National Institutes of Health funds often enroll fewer Black patients and other underrepresented racial groups than they plan to, according to a study of 30 NIH-funded trials sampled by the HHS Office of Inspector General. Policymakers want to get researchers to enroll a racially representative sample of patients in clinical trials that test whether products work and are safe.

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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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Digital therapeutics firm Akili agrees $34 million takeover

pharmaphorum

More consolidation in the digital health sector as Akili agrees a $34m takeover by Virtual Therapeutics, returning to private hands.

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STAT+: Scientists install ‘window’ in the skull to record brain activity using ultrasound

STAT

Researchers may have a new way to watch the brain pulse, thanks to an ultrasound probe and a tiny window in the skull. This acoustically transparent hole allowed a team in California to capture, using functional ultrasound imaging, an extraordinary view of human brain activity of very normal hobbies, according to a study published Wednesday in Science Translational Medicine.

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Glenmark creates mass awareness around Hypertension

Express Pharma

Glenmark Pharmaceuticals, marked the month of May as the ‘Hypertension Awareness Month’ by reportedly partnering with more than 1000 healthcare professionals (HCPs) from 250+ cities and towns across the country, and organised 400+ public awareness rallies and screening camps to create mass awareness around Hypertension (High Blood Pressure). The rallies consisted of general informative sessions led by HCPs, who provided detailed insights on the signs, symptoms, and preventive measures related to

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Opinion: Saving rural psychiatry services will require higher Medicaid payments

STAT

If there were ever to be an empty bed in the stress unit my psychiatrist dad manages, I’m certain he would admit himself. He runs the only private psychiatric practice in the rural Michigan town of Owosso and is the sole psychiatrist contracted at the local hospital. With approximately 1 in every 10 of the town’s 15,000 residents being a patient in his practice, he shoulders the responsibility for many more patients than most psychiatrists do.

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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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UK-based company selling breakthrough cannabis-based medicines now supplying the US

Outsourcing Pharma

UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.

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Opinion: The uphill battle to provide noninvasive treatment for fibroids

STAT

If an effective treatment is available for one common disease in men, and that same treatment is available for a different common disease in women, a logical expectation would be that the treatments are equally accessible to men and women. That is not the current reality. The treatment I am talking about is focused ultrasound. It has been approved by the Food and Drug Administration for a range of conditions, including prostate cancer, fibroids, liver tumors, essential tremor and Parkinsonȁ

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Two novel biosimilars approved in EU and US

European Pharmaceutical Review

The European Commission (EC) has granted the first approval for an omalizumab biosimilar in Europe. Omlyclo ® (CT-P39) is authorised as a biosimilar referencing Xolair ®. CT-P39 is indicated for allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). The authorisation is based on clinical data, including findings from a Phase III clinical trial comparing Omlyclo ® to the reference product in patients with chronic spontaneous urticaria up to

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STAT+: Biohaven protein-degrader drug falls short of investor expectations in early-study test

STAT

Biohaven Pharmaceuticals said Wednesday that a new type of experimental medicine reduced levels of a disease-causing immune molecule by up to 37% in an early-stage study of human volunteers — a result that the company called “positive” as a proof of concept but that also fell short of investor expectations. The drug, called BHV-1300, belongs to a new class of antibody medicines that shuttle harmful proteins to the liver so they can be removed from the body.

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LBP-immunotherapy could benefit oncology patients

European Pharmaceutical Review

The safety and tolerability of rationally-designed live bacterial product (LBP) BMC128 combined with nivolumab has shown initial positive trends in non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC), new data from an ongoing Phase I clinical trial suggests. Biomica’s microbiome -based immuno-oncology candidate and the anti-PD1 immune checkpoint inhibitor is being evaluated in eleven participants.

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STAT+: Reports: Looking to expand its pipeline, Merck to buy eye-disease startup EyeBio

STAT

LONDON — Merck is buying ophthalmology-focused startup EyeBio in a deal worth up to $3 billion, according to media reports, as the pharma company looks to diversify its pipeline.   Under the deal, Merck will pay $1.3 billion upfront, with another $1.7 billion if certain milestones are met. The Wall Street Journal first reported the news Tuesday night, and EyeBio’s CEO and board chair outlined in the deal in an interview with the Financial Times published Wednesday.

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Update: MSD confirms $3bn takeover of EyeBio

pharmaphorum

MSD has confirmed a $3 billion takeover deal for ophthalmology biotech EyeBio and its drug candidate for diabetic macular oedema (DME) and neovascular age-related macular degeneration (AMD).

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Opinion: Listen: What happens when kids become caregivers?

STAT

When it comes to childhood and young adulthood, most people in the U.S. think of carefree times of life with few major responsibilities. But for a small subset of young people, these years also mean caring for loved ones. Harvard medical students Kimia Heydari and Romila Santra both have firsthand experience being young caregivers, and they wrote about this often overlooked group in their First Opinion essay “ Caring for young caregivers, a hidden population.

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Celebrities join campaigners in call for cheaper version of ‘gamechanger’ HIV drug for poorer countries

The Guardian - Pharmaceutical Industry

Letter urges US company Gilead Sciences to ‘shape history’ by providing fair access Former world leaders, celebrities and a Nobel prize-winning scientist who helped discover HIV have written to a leading pharmaceutical company to urge it to make a “gamechanger” HIV medicine available to people living outside wealthy countries. The US company Gilead Sciences has been urged to “shape history” by avoiding a repeat of the “horror and shame” of the early years of the Aids pandemic, when 12 million li

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STAT+: Pharmalittle: We’re reading about a Merck deal, weight loss drugs, and lots more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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Tris Pharma receives USFDA approval for ONYDA XR, a liquid non-stimulant ADHD medication

Express Pharma

Tris Pharma, a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the USFDA has approved ONYDA XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in paediatric patients six years and older.

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CPCF should be ‘completely overhauled’, recommends parliamentary committee

The Pharmacist

The Community Pharmacy Contractual Framework (CPCF) in England is ‘not fit for purpose’ and has contributed to the financial pressures that pharmacies are facing, a parliamentary committee has found. Following an inquiry into the sector, the Health and Social Care Committee (HSCC) published a report today which recommended that the CPCF be ‘completely overhauled’, with […] The post CPCF should be ‘completely overhauled’, recommends parliamentary committee appeared first on The Pharmacist.

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FDA grants priority review to Genentech’s Inavolisib

Express Pharma

Genentech, a member of the Roche Group, announced that the USFDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within

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FDA clears Amgen’s Bkemv as first biosimilar of Soliris

pharmaphorum

Amgen’s Bkemv is first FDA-approved biosimilar to AstraZeneca’s Soliris in the US, getting interchangeable status for rare diseases PNH and aHUS

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BHF awards £35m funding to nine UK universities for cardiovascular disease

Pharma Times

Affecting more than 7 million people in the UK, cardiovascular diseases are conditions that affect the heart or circulation

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