Tue.Aug 29, 2023

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Opinion: How the twin crises of climate change and poor public housing are harming people’s health

STAT

Climate change is an existential problem for human health. As climate change intensifies, the frequency and severity of extreme weather events such as heatwaves, cold fronts, and floods will increase. Undoubtedly, this will result in devastating effects for human health and wellbeing, contributing to increased susceptibility to infectious diseases, an already growing mental health crisis, and, most directly, heat-related mortality.

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‘We need to do better:’ A biotech CEO on standing apart from the crowd

PharmaVoice

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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Opinion: Every senator should fill out a legislative advance directive

STAT

Advance directives were born in the Senate. Now they can help preserve the dignity of its aging members. In Cruzan v. Director, Missouri Department of Health , the parents of Nancy Cruzan, a young woman who had been left in a permanent vegetative state after a car accident, wanted the right to remove her life support. In 1990, the Supreme Court ruled in favor of her parents, affirming the constitutional right to refuse life-sustaining treatment.

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5 of the best places to work in pharma, according to employees

PharmaVoice

Work-life balance is one major common denominator among the top-ranked pharma employers on Glassdoor.

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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+: As competition looms, Insulet sues a rival for allegedly stealing trade secrets on diabetes tech

STAT

Insulet filed a lawsuit this month against its rival EOFlow, accusing it of stealing trade secrets in a case that could shake up the diabetes technology market and throw a wrench in Medtronic’s planned $738 million acquisition of EOFlow. Insulet alleges that the South Korea-based EOFlow copied the design for its only product, a patch pump, called the Omnipod that delivers insulin to people with diabetes.

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Bristol Myers gets key FDA approval for bone marrow disease drug

BioPharma Dive

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

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Medicare names first 10 drugs for price negotiations

BioPharma Dive

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

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FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML

Pharma Times

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme - News - PharmaTimes

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Biggest ever analytica Anacon India, India Lab Expo, Pharma Pro&Pack Expo in Hyderabad”

Express Pharma

analytica Anacon India, India Lab Expo and Pharma Pro&Pack Expo will be held from 14-16 September 2023 at HITEX Exhibition Center, Hyderabad After the successful conclusion in Mumbai, analytica Anacon India and India Lab Expo 2023 is all set to take place along with Pharma Pro&Pack Expo in the pharma hub of India, Hyderabad. This is the largest-ever edition of the event in Hyderabad and with this year’s theme, ‘Epicentre of Progress’, the event showcases solutions for the entire value ch

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How to Better Invest in Your Pharmacy’s Future

PioneerRx

Pharmacy work is an ongoing journey. Whether we’re talking about your fill queue, vaccine quotas, or your patient’s health journey, the work of an independent.

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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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Strides gets USFDA approval for Mycophenolate Mofetil for Oral Suspension

Express Pharma

Strides Pharma Science announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), CellCept for Oral Suspension, 200 mg/mL of Roche Palo Alto.

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Community pharmacy blood pressure checks more than double in a year

The Pharmacist

Community pharmacies in England delivered a total of 149,865 blood pressure checks to over 40s in May 2023 – over double the 58,345 delivered in the same month last year. This comes as the NHS announces a major drive to tackle cardiovascular health, with local projects offering blood pressure checks in non-healthcare settings such as […] The post Community pharmacy blood pressure checks more than double in a year appeared first on The Pharmacist.

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European regulatory perspective on nitrosamine mitigation strategies

European Pharmaceutical Review

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated.

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Hypertension service must use approved IT system from this week

The Pharmacist

From 1 September community pharmacies will be required to use an approved clinical IT system to record clinical details and payment claims for the NHS hypertension service. And all claims for August must be submitted manually through MYS by Tuesday 5 September. The NHS Blood Pressure Check Service began in October 2021, with pharmacy technicians […] The post Hypertension service must use approved IT system from this week appeared first on The Pharmacist.

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Mankind Pharma launches 120 DMF quality drugs for Indian patients

Express Pharma

The Drug Master File (DMF) has all the information on an API (Active Pharmaceutical Ingredient/Raw material for medicine) Mankind Pharma has introduced 120 DMF (Drug Master File) Quality Medicines in the Indian market. This initiative aims to ensure universal access to medicines of international calibre. India stands as a global leader in offering generic medicines that adhere to the stringent DMF quality standards set for Active Pharmaceutical Ingredients (APIs).

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Roche subcutaneous cancer immunotherapy granted MHRA approval

European Pharmaceutical Review

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration.

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Transcell partner with Quantiphi to develop DART

Express Pharma

One standout aspect of DART is its seamless integration into existing workflows, enhancing end-user engagement The FDA Modernisation Act 2.0 marks a pivotal moment in reshaping the global pharma and biopharmaceutical industry. Additionally, the Indian DCGI has granted authorization for the use of alternative methods to animal testing, such as cell-based assays and computer models.

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Three-Way Collaboration Between Rentschler Biopharma, CGT Catapult, and Refeyn Aims to Improve PAT for Gene Therapy Manufacturing

PharmaTech

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

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Takeda and ImmunoGen partner to develop and commercialise Elahere in Japan

Pharma Times

ImmunoGen is expected to receive an upfront payment from Takeda plus additional payment - News - PharmaTimes

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Letby case: ‘Lessons need to be learned’ in community pharmacy

The Pharmacist

The Pharmacists’ Defence Association (PDA) ‘routinely’ receives reports about managers overruling the clinical judgement of registered pharmacists, potentially impacting patient safety, it has said. And it raised ‘significant concerns’ about the power of non-clinical managers in community pharmacies, especially those operated by large private companies.

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Why Medication Therapy Management Is More Important Than Ever?

cureatr

The Centers for Medicare & Medicaid Services (CMS) released its 2024 Medicare Advantage and Part D Final Rule in April. Notably absent from all 724 pages of the final rule? Proposed changes to eligibility requirements for the Part D Medication Therapy Management (MTM) Program.

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EMCrit 356 – More on Accidental Hypothermia with Ken Zafren

EMCrit Project

A deeper dive on accidental hypothermia in anticipation of my much awaited winter EMCrit Project by Scott Weingart, MD FCCM.

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Biden names 10 drugs for first negotiations to cut Medicare prices

The Guardian - Pharmaceutical Industry

Government claims prices could fall for 9m seniors but pharma companies claim cost-reduction program is unconstitutional The Biden administration has selected 10 drugs for the first round of price negotiations between Medicare and pharmaceutical companies in an effort to lower costs for seniors, it announced on Tuesday. The list of prescription drugs includes blood thinners and treatments for diabetes, as well as drugs used to treat kidney disease, heart failure and arthritis.

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BlueRock clears key hurdle in Parkinson's stem cell trial

pharmaphorum

BlueRock clears key hurdle in Parkinson's stem cell trial Phil.

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Drug Channels News Roundup, August 2023: Maximizer Problems, Hospital vs. MD Reimbursement, Bureaucracy vs. Costs, And My Favorite Chart Updated

Drug Channels

We’re wrapping up one of newsiest summers in recent memory. Time to pack away your bathing suit, send the kids back to school, and cherish these curated curiosities that I combed from the Jersey Shore: Fresh evidence of patients’ copay maximizer pain How payers pay more to hospitals than to physician offices Surprise? Rationing care via bureaucracy saves money Plus, the June 2023 update to my all-time favorite chart.

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FTC hold raises hope of Amgen/Horizon deal progress

pharmaphorum

FTC hold raises hope of Amgen/Horizon deal progress Phil.

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Drug that targets scar-like tissue in tumours shows promise for aggressive pancreatic cancer

World Pharma News

Findings from the Garvan Institute of Medical Research reveal a new Australian drug that targets scar-like 'fibrotic' tissue within tumours shows promise for treating pancreatic ductal adenocarcinoma, one of the most aggressive forms of pancreatic cancer with a five-year survival rate of less than 10%. The research in mouse models showed that when given in combination with chemotherapy, the drug PXS-5505 increased survival time by more than 35%, compared to chemotherapy treatment alone.

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BMS grabs key approval for Reblozyl in MDS

pharmaphorum

BMS grabs key approval for Reblozyl in MDS Phil.

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Janssen submits sNDA to FDA for full approval of Balversa

Pharmafile

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for full approval of Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). The drug received Breakthrough Therapy Designation from the […] The post Janssen submits sNDA to FDA for full approval of Balversa appeared first on Pharmafile.

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An overview of AI in pharma – Part 2

pharmaphorum

An overview of AI in pharma – Part 2 Mike.

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Takeda and ImmunoGen collaborate for development and commercialisation of Elahere in Japan

Pharmafile

ImmunoGen has announced that it has entered into an exclusive collaboration with Takeda Pharmaceutical Company for the development and commercialisation of Elahere (mirvetuximab soravtansine-gynx) in Japan. Under the terms of the agreement, ImmunoGen is expected to receive a one-time, upfront payment as well as an additional payment upon conversion of the US Food and Drug […] The post Takeda and ImmunoGen collaborate for development and commercialisation of Elahere in Japan appeared first

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First 10 drugs subject to Medicare negotiations named

pharmaphorum

First 10 drugs subject to Medicare negotiations named Phil.

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FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab

Pharmafile

Faron Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukemia (AML). The ODD will offer clinical development and commercialisation benefits that will ultimately strengthen the drug programme. The drug is currently in a phase 1 study where it is being […] The post FDA gives Orphan Drug Designation to Faron Pharmaceuticals’ Bexmarilimab appeared first on Pharmafile.

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GB first to approve Roche's subcutaneous Tecentriq

pharmaphorum

GB first to approve Roche's subcutaneous Tecentriq Phil.

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Introducing Our New Line of STAAR LABS Supplements

Compounding Pharmacy of America

Our new line of STAAR LABS supplements converge at the crossroads of modern science and traditional well-being practices. The post Introducing Our New Line of STAAR LABS Supplements appeared first on The Compounding Pharmacy of America.