Mon.Feb 26, 2024

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STAT+: Liver disease MASH is next target for obesity drugs in development

STAT

As drugmakers race to join the obesity drug market ignited by the approval of Wegovy and Zepbound , they’re not just competing on their drugs’ weight loss effects. They’re also competing on their products’ ability to treat a severe form of liver disease. A new update of the STAT Obesity Drug Tracker shows that at least 23 — about one-fifth — of the 105 obesity treatments in development or on the market are also being investigated for metabolic dysfunctio

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SAEM Clinical Images Series: Neonatal Rash

ALiEM - Pharm Pearls

An 18-day-old male presented for a rash on his face for two days. The patient was born via spontaneous vaginal delivery full term without complications to a mom who has a history of genital HSV but without active lesions at delivery and on acyclovir. The patient presented with a vesicular rash on his face including around his eyes. He had conjunctival discharge noted by mom.

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STAT+: MD Anderson tried — and failed — to resolve research credit dispute between two scientists, new documents show

STAT

Early last year, MD Anderson Cancer Center leadership had a problem on their hands: a contentious dispute between one of its most powerful researchers and a junior scientist over authorship, credit, and charges of verbal abuse. High-ranking officials at the cancer center tried — and failed — to resolve the feud, and documents obtained by STAT shed new light on the deep divisions at the heart of this case.

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Ozempic for liver disease? Weight loss drugs could have even more to offer

PharmaVoice

GLP-1 drugs indications could expand as research shows potential benefits in treating MASH, where pharma has previously failed in the past.

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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: A new Louisiana capital-punishment bill would fundamentally alter physician licensing

STAT

After the recent nitrogen gas execution in Alabama of Kenneth Smith, state Attorney General Steve Marshall said that nitrogen gas “was intended to be — and has now proved to be — an effective and humane method of execution.” It is hard to imagine a statement so obviously disconnected from facts. Eyewitness accounts described Smith’s death as a harrowing experience of dry heaving, thrashing, straining against leather straps, seizures, and terror.

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Nearly 400,000 vape kits to be sent to smokers

The Pharmacist

Nearly 400,000 vape kits are set to be sent to smokers in England under the government’s swap-to-stop scheme, our sister title Healthcare Leader has exclusively revealed. At least four integrated care boards (ICBs) and more than 80 localities have expressed interest in the scheme with 379,562 ‘vape starter kits’ requested as of February 2024, data […] The post Nearly 400,000 vape kits to be sent to smokers appeared first on The Pharmacist.

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How a 15-year-old Genzyme drug shortage became a smorgasbord of pharma’s thorniest issues

PharmaVoice

Rare disease treatments, drug shortages, a market monopoly and march-in rights all play a role in the story of newly revived litigation against Sanofi’s Genzyme.

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STAT+: The quest for psychedelics in the Amazon would push a Harvard botanist to his limits

STAT

The Aztecs called it teonanácatl, or “flesh of the Gods.” Some who ate the intoxicating mushroom “saw themselves dying in a vision and wept,” according to an account by a 16th-century Franciscan friar. “Others saw themselves being eaten by a wild beast; others imagined that they were capturing prisoners in battle, that they were rich.

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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.

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STAT+: Pharmalittle: We’re reading about state moves on drug pricing, an asthma med for kids and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you know what we are going to say — that oh-so familiar routine of online meetings, endless calls and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So let us be optimistic and convince ourselves we can nudge it in a better direction with a cup of stimulation.

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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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Shell refines its focus on the hydrogen market

Fuld & Company Blog

Last week, Shell made a move that looked very much like a major nail in the coffin of the hydrogen passenger car market. In October 2023, Shell quietly shut down its three UK hydrogen filling stations for passenger cars. Following this, last week, it did the same in California. Originally planning to establish 48 stations across the state, Shell scrapped these plans last year and announced the closure of all five passenger car stations, while maintaining its three heavy-duty hydrogen stations

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STAT+: Private equity firm offers $5.8 billion buyout of hospital billing company R1 RCM

STAT

R1 RCM, a large publicly traded technology company that helps hospitals and physicians collect money from insurers and patients, may be going private. Private equity firm New Mountain Capital has offered to purchase R1 for $13.75 per share, or roughly $5.8 billion in cash, according to new financial disclosures filed Monday. New Mountain Capital is R1’s second-largest investor, owning nearly one-third of the company’s shares.

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Obesity drug from Boehringer, Zealand succeeds in MASH trial

BioPharma Dive

Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.

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The FDA isn’t afraid to yank a disappointing drug

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, everyone. Damian here with a look at some renewed interest in a yesteryear biotech craze, news of an FDA flex, and a dive into the science of vaccinology.

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Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma

Drug Patent Watch

Switching pharmaceutical excipients, the inactive components used in drug formulations, can have significant implications for both production costs and market appeal. These components, while not contributing directly to the therapeutic… The post Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma appeared first on DrugPatentWatch - Make Better Decisions.

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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.

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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

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Cipla receives USFDA approval for plazomicin injection in India

Express Pharma

Plazomicin is a new Intravenous (IV) aminoglycoside indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis Cipla receives approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic plazomicin in India. Plazomicin is a new Intravenous (IV) aminoglycoside indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis.

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Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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Bristol Myers Squibb opens new site in Hyderabad

Express Pharma

The site will expand the company’s global drug development and IT & digital capabilities Bristol Myers Squibb has announced the official opening of a new facility in Hyderabad. The site will expand the company’s global drug development and IT & digital capabilities and is expected to be home to over 1,500 employees. The company has invested over $100 million in the creation of this cutting-edge facility.

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Boehringer reveals major data from liver disease trial

European Pharmaceutical Review

[The Phase II trial showed that] up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH)” Up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2 percent) in a Phase II trial.

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BioAsia 2024: Delegates witnessed Telangana’s progress in life-sciences

Express Pharma

The 21 st edition of BioAsia which has been much talked about summit in the beginning of the year has been attracting both domestic and international stakeholders in life-sciences and healthcare industry Around 200 delegates comprising both international delegates and Indian companies were taken in for a guided tour of the Genome Valley in Hyderabad in two groups on the inaugural day of BioAsia 2024.

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CHMP backs AZ’s danicopan for anaemia in patients with PNH

pharmaphorum

AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).

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Takeda partner with Biological E. to accelerate access to dengue vaccine

Express Pharma

The partnership will build upon existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany and Takeda’s long-term partnership with IDT Biologika GmbH Takeda and Biological E. Limited (BE) has announced a strategic partnership to accelerate access to QDENGA▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs).

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CHMP meeting highlights: February 2024

European Pharmaceutical Review

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of influenza A virus: Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunisation during outbre

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PhaSER Biomedical receives $2.3m drug discovery grant from the Gates Foundation

Pharma Times

Every year, tuberculosis, malaria and HIV cause over five million deaths worldwide

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Shionogi takes Akili’s ADHD digital therapy to Japan

pharmaphorum

Digital health company Akili expands beyond the US as partner Shionogi files for approval for its ADHD digital therapeutic (DTx) in Japan

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Researchers develop terahertz biosensor to detect skin cancer for early diagnosis

Pharma Times

Results from the study could also be used for other forms of cancer and diseases

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FOPE request govt for funding to MSME to upgrade manufacturing facilities for revised Schedule M

Express Pharma

The letter states that the said scheme may be similar to that which is for upgrading for WHO GMP The Federation of Pharma Entrepreneurs (FOPE) has written a letter to the Department of Pharmaceuticals requesting a new scheme for funding to MSME to upgrade the manufacturing facilities to meet the requirement of revised Schedule M The letter states that the said scheme may be similar to that which is for upgrading for WHO GMP.

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SK bioscience’s typhoid vaccine receives WHO prequalification

Pharmaceutical Technology

SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.

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Boehringer’s survodutide shows monster MASH potential

pharmaphorum

Boehringer Ingelheim and Zealand Pharma report stellar top-line results for GLP-1/glucagon agonist survodutide in liver disease MASH.

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Don’t expect ‘revolutionary’ contract, says CPE as negotiations begin

The Pharmacist

Negotiations on the next Community Pharmacy Contractual Framework have begun, but Community Pharmacy England (CPE) has warned the sector to avoid having too high expectations of its outcome. Speaking to delegates at the 2024 Sigma Conference by live video link, Janet Morrison, CPE chief executive, confirmed the negotiator had recently met with the government for […] The post Don’t expect ‘revolutionary’ contract, says CPE as negotiations begin appeared first on The Pharmacist.

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Innovative chemotherapy approach shows promise against lung cancer

World Pharma News

Lung cancer is not the most common form of cancer, but it is by far the deadliest. Despite treatments such as surgery, radiation therapy and chemotherapy, only about a quarter of all people with the disease will live more than five years after diagnosis, and lung cancer kills more than 1.8 million people worldwide each year, according to the World Health Organization.

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Pharmacy First minimum consultation numbers a ‘major concern’ for CPE

The Pharmacist

Community Pharmacy England (CPE) chief executive Janet Morrison has expressed concerns regarding the minimum number of consultations pharmacies will be required to deliver for the Pharmacy First service from October this year. In order to receive a fixed payment of £1,000 per month, Pharmacy First providers in England need to deliver a minimum number of […] The post Pharmacy First minimum consultation numbers a ‘major concern’ for CPE appeared first on The Pharmacist.

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EMCrit 369 – Iodinated Contrast Issues: Part 1 – Is Contrast-Induced Nephropathy (CIN) a Thing in Patients with Tenuous Renal Function

EMCrit Project

Do you still need to worry about contrast in patients with tenuous renal function? EMCrit Project by Scott Weingart, MD FCCM.

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