STAT

APRIL 19, 2024

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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Hospitals 326

PharmaVoice

APRIL 19, 2024

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

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STAT

APRIL 19, 2024

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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pharmaphorum

APRIL 19, 2024

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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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.

STAT

APRIL 19, 2024

WASHINGTON — A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, a Centers for Medicare and Medicaid Services official said on Thursday. The agency has faced intense pressure from device makers frustrated with the slow pace of Medicare reimbursement decisions. Medical technology lobby AdvaMed sent CMS a strongly-worded letter  in March asking why it has taken so long to get the breakthrough device program moving.

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BioPharma Dive

APRIL 19, 2024

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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Labelling 112

The Pharmacist

APRIL 19, 2024

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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STAT

APRIL 19, 2024

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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Pharmaceutical Commerce

APRIL 19, 2024

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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The Pharmacist

APRIL 19, 2024

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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Pharmaceutical Technology

APRIL 19, 2024

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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The Pharmacist

APRIL 19, 2024

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.

Pharmacy Technician 101

Pharmacy Technician 101

pharmaphorum

APRIL 19, 2024

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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PharmaTech

APRIL 19, 2024

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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pharmaphorum

APRIL 19, 2024

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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Outsourcing Pharma

APRIL 19, 2024

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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pharmaphorum

APRIL 19, 2024

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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European Pharmaceutical Review

APRIL 19, 2024

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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Pharma Times

APRIL 19, 2024

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

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Vaccines 113

pharmaphorum

APRIL 19, 2024

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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Pharmaceutical Technology

APRIL 19, 2024

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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Outsourcing Pharma

APRIL 19, 2024

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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Compounding Pharmacies Compounding 80

Pharma Times

APRIL 19, 2024

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

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BioPharma Dive

APRIL 19, 2024

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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Biosimilars 73

Outsourcing Pharma

APRIL 19, 2024

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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PharmaTech

APRIL 19, 2024

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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Pharmaceutical Manufacturing 73

Pharmaceutical Business Review

APRIL 19, 2024

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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Pharmafile

APRIL 19, 2024

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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Big Molecule Watch

APRIL 19, 2024

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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Biosimilars 62

Pharmafile

APRIL 19, 2024

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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Pharmaceutical Technology

APRIL 19, 2024

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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Pharmaceutical Commerce

APRIL 19, 2024

The latest news for pharma industry insiders.

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Pharmaceutical Technology

APRIL 19, 2024

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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World Pharma News

APRIL 19, 2024

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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Immunity Immunization 60

Pharmaceutical Technology

APRIL 19, 2024

Following the success of the COVID-19 vaccines, there has been an increasing focus on mRNA’s potential to address a wide range of diseases, including cancer.

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Vaccines 59