Fri.Apr 19, 2024

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STAT+: New antibiotics were underprescribed for hard-to-treat infections, study finds

STAT

Although U.S. regulators approved several new antibiotics for combating hard-to-treat bacteria during a recent five-year period, hospital doctors instead gave older, generic remedies to more than 40% of patients battling those stubborn pathogens, according to a new analysis. Moreover, 80% of the time these older antibiotics were already known to be highly toxic or ineffective, according to the analysis.

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Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug

PharmaVoice

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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Opinion: Moving the conversation about obesity beyond the scale

STAT

Every so often, the conversations that people in health care have become so pervasive that they dominate the zeitgeist, intersecting with mainstream media and popular culture. Oprah Winfrey’s recent ABC special “Shame, Blame, and the Weight Loss Revolution” is a good example of this. Now streaming on Hulu, the broadcast garnered widespread attention, including coverage from People Magazine and The New York Times.

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Reuters Pharma USA 2024 – Serena Goodwin

pharmaphorum

Stay updated on the latest STEM Healthcare news from Reuters Pharma USA 2024, featuring insights from global account lead at STEM, Serena Goodwin on the impact of AI in healthcare.

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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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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Roche wins FDA OK for targeted drug in early lung cancer

BioPharma Dive

The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

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LogiPharma Europe 2024: Niklas Adamsson Discusses Ways to Improve Visibility and Risk Management for Cold Chain Shipping

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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STAT+: Pharmalittle: We’re reading about plans for generic Wegovy, cough syrup warnings, and more

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape. However, we do foresee several naps in our future, if only to recover from promenading with the official mascots. We also hope to catch up on our reading and hold another listening party with Mrs.

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Vox Pop Pharma - companies keen to find alternatives to animal testing - read their views

Outsourcing Pharma

Earlier this week, Charles River Laboratories International, Inc. revealed its Alternative Methods Advancement Project (AMAP), which it said is a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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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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A Look at the Impact of Industry Trends on Sensor Technologies (INTERPHEX 2024)

PharmaTech

Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.

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Cerevel Parkinson’s data adds lustre to AbbVie acquisition

pharmaphorum

Cerevel's first phase 3 trial of Parkinson's drug tavapadon is positive - good news for AbbVie which is trying to buy the biotech for $8.

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Catching up with LGM Pharma ahead of CPhI North America to find out about its pipeline

Outsourcing Pharma

LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.

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FDA clears Roche’s Alecensa for adjuvant use in NSCLC

pharmaphorum

Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC

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Microbial burden assessment of solid pharmaceutical products

European Pharmaceutical Review

The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden , stated Prada-Ramírez et al.

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Hyundai Bio plans trials of antiviral for dengue fever

pharmaphorum

Hyundai Bioscience is preparing to start clinical trials of what it hopes could become the first antiviral treatment for dengue fever

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Q&A: Cell and gene therapy value assessments need a rework to allow access

Pharmaceutical Technology

Paolo Morgese, vice president of European public affairs at the Alliance for Regenerative Medicine, discusses the barriers affecting access to gene therapies.

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Regulator meets with DHSC to discuss prescription amendments

The Pharmacist

The chief executive of the pharmacy regulator has met with the Department of Health and Social Care (DHSC) to discuss whether pharmacists could be allowed to make substitutions or minor amendments to prescriptions in the case of medicines shortages. Speaking at a council meeting this week, Duncan Rudkin said that medicines shortages ‘often feature’ in […] The post Regulator meets with DHSC to discuss prescription amendments appeared first on The Pharmacist.

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Experimental AI predicts whether cancer drugs will work

pharmaphorum

Researchers in the US have developed an artificial intelligence tool that can predict how a patient will respond to cancer treatment

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CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Pharma Times

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications

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GPhC working through implications of Cass Review for pharmacists

The Pharmacist

The General Pharmaceutical Council (GPhC) has reached out to the Department of Health and Social Care (DHSC) to begin work on the recommendations of a major review into gender identity services for children and young people. Speaking in a council meeting on Thursday, GPhC chief executive Duncan Rudkin, said the regulator recognised ‘a degree of […] The post GPhC working through implications of Cass Review for pharmacists appeared first on The Pharmacist.

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Giving the gift of health by finding solutions to the cost and complexity of prescription drugs

Outsourcing Pharma

Gifthealth began operations just under four years ago to provide a scalable solution for the cost and complexity of prescription drugs.

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New clinical trial aims to investigate skin patches to spot lung transplant rejection

Pharma Times

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%

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Health professionals should not be ‘coerced’ into working beyond competence

The Pharmacist

The Scottish Trade Unions Congress (STUC) has carried a motion which aims to protect the public from ‘the consequences of role substitution in healthcare’. It was proposed by the Pharmacists’ Defence Association (PDA) at the Congress this week and calls for ‘clear role definition’ of health professionals that it says would benefit both patients and […] The post Health professionals should not be ‘coerced’ into working beyond competence appeared first on The Pharmacist.

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Alvotech deal could heighten biosimilar pressure on Humira

BioPharma Dive

The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.

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How New Regulations Are Impacting Pharmaceutical Manufacturing Facility Design

PharmaTech

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

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SK pharmteco signs agreement to manufacture Ferring’s ADSTILADRIN

Pharmaceutical Business Review

This partnership follows the US Food and Drug Administration’s approval of ADSTILADRIN in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. After technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be responsible for manufacturing, testing, and release of the drug substance, subject to US FDA regul

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Roche’s Alecensa approved by FDA as lung cancer treatment

Pharmafile

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The post Roche’s Alecensa approved by FDA as lung cancer treatment appeared first on Pharmafile.

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Fresenius Kabi Announces Launch of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

Big Molecule Watch

On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported , Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations.

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Researchers develop a new way to safely boost immune cells to fight cancer

World Pharma News

Cancer is the monster of our society. Last year alone, more than 600,000 people in the United States died from cancer, according to the American Cancer Society. The relentless pursuit of understanding this complex disease has shaped medical progress on developing treatment procedures that are less invasive while still highly effective. Immunotherapy is on the rise as a possible solution.

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Ardena announces €20m expansion following first GMP approval

Pharmafile

Ardena has announced that it has received Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority for its new analytical laboratories in its expanded facility. The post Ardena announces €20m expansion following first GMP approval appeared first on Pharmafile.

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FDA approves Takeda’s ENTYVIO SC for Crohn’s disease

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

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Pharma Pulse 4/19/24: The Real Cost of State Drug Importation Programs, Millions in Africa Will Miss HPV Shots After Merck Production Problem & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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NIH team develops AI tool to predict cancer drug response

Pharmaceutical Technology

Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed an AI tool that can predict drug responses in cancer treatment.

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New patent expiration for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier.

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