Fri.Jun 07, 2024

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Smoke exposure from California’s wildfires linked to 52,000 early deaths, study says

STAT

When large swaths of the East Coast were shrouded in wildfire smoke last summer, scientists in California grimly joked that maybe, finally, power brokers in New York and Washington, D.C. would be spurred to act on the burning issue that has long plagued the West Coast. Despite wildfire seasons that regularly burn hundreds of thousands of acres in California alone each year, researchers know relatively little about the long-term effects of chronic wildfire smoke on the body , and funding to reduc

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

BioPharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults

STAT

The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50. Arexvy, which was the first RSV vaccine approved , now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.

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Why commercialisation is the next frontier for digital innovation in pharma

pharmaphorum

Explore how commercialisation is the new frontier for digital innovation in the pharmaceutical industry, with a focus on GLP-1 drugs, digital strategies, and reducing patient acquisition costs.

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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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NIH will bring clinical research into primary care offices with $30 million pilot

STAT

For many Americans, health care means going to a local primary care office. But the vast majority of clinical research is conducted inside the walls of large, specialized academic health centers. Millions of patients are left out of those studies, which often fail to capture the population in all its diversity. Now, for the first time, the National Institutes of Health is investing in the creation of a national primary care research network to try to address this issue.

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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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Geron announces FDA approval of RYTELO (imetelstat)

Express Pharma

The telomerase inhibitor, will be used for the treatment in Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia Geron Corporation biopharma company, announced the U.S. Food and Drug Administration (FDA) approval for RYTELO (imetelstat). The drug is for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have

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STAT+: Pharmalittle: We’re reading about Lilly’s Alzheimer’s drug, the GSK-Elsie deal, and more

STAT

Good morning, Jason Mast here filling in for Ed. Today, we’re sipping a hot cup of caffeinated black, while mulling the rise and fall and, apparently (!), rise again of Luckin Coffee, a chain whose cashless kiosks and discount lattes were once seen as China’s answer to Starbucks, before allegations emerged of widespread accounting fraud.

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Pharma’s R&D gamble: picking pipeline winners in a risky field

PharmaVoice

How leaders from biotech, Big Pharma and the investment world know when they've found the right candidate or company to back.

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Vanda Pharmaceuticals has another suitor

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Anyone else as zonked as I am? Today, we discuss the impact that the BIOSECURE Act is already having on the industry, preview what FDA reviewers want to know about donanemab, and more.

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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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Cycle Pharma makes $466m takeover bid for Vanda

pharmaphorum

UK group Cycle Pharma has made an unsolicited takeover bid to buy Vanda Pharma, which is already fending off an overture from Future Pak.

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Opinion: Obesity drugs pose a big challenge for health care equity

STAT

Weight loss treatments have the potential to revolutionize health care in rich countries. They are driving a race among drugmakers for a slice of a market that could exceed $100 billion by 2030. But little thought has apparently been given to helping people in low- and middle-income countries, where obesity rates are soaring despite poor nutrition. Without decisive action to develop fair access plans to these drugs for people living in poorer countries, there is a real danger that a significant

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Nestle bids to take control of Seres’ C diff drug Vowst

pharmaphorum

Nestle Health Science bids to take control of Seres Therapeutics’ oral microbiome product Vowst for preventing C. diff infections.

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Opinion: When medical debt relief is not enough: A study showing what doesn’t work may help point to better solutions

STAT

Philanthropists and foundations like the one I work for take a lot of calculated risks. We invest in research, advocacy, strategic communications, technical assistance, and many other activities, hoping they will help us advance our strategic priorities. We evaluate our efforts whenever we can, but many defy measurement — assessing the impact of our work is a persistent challenge.

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PharmaCord to boost pharma services with Permira’s investment

Pharmaceutical Business Review

The investment is managed by the funds of Permira and is expected to close by the fourth quarter of 2024, subject to necessary approvals and conditions. The companies did not disclose the financial terms of the deal. PharmaCord, known for its role as a commercialisation partner for life sciences organisations, focuses on enhancing the patient experience with specialty medications.

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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.

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NICE recommends tirzepatide for NHS primary care

The Pharmacist

The National Institute for Health and Care Excellence (NICE) has recommended that tirzepatide be prescribed by NHS primary care services, in draft guidance currently out for consultation. The weekly injection has been recommended alongside diet and exercise advice for people with a BMI of at least 35kg/m2 and one weight-related comorbidty with lower thresholds for […] The post NICE recommends tirzepatide for NHS primary care appeared first on The Pharmacist.

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Borosil Scientific announces listing on exchange upon strategic demerger from Borosil

Express Pharma

The listing follows the strategic demerger of the scientific business from Borosil, completed in December’ 2023 Borosil Scientific, announced its successful listing on both Stock Exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). The milestone was marked with the ringing of the opening bell at BSE in the presence of Pradeep Kheruka, Promotor of Borosil Group, Vinayak Patankar, Whole-time Director and Chief Executive Officer and Kewal Handa, Chairman and Independent

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Building resilience in cancer trials

pharmaphorum

Learn how building resilience can positively impact cancer trials in the field of oncology. Learn more about CancerEngage.

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Regulation and legislation in the era of automation and digitalisation

European Pharmaceutical Review

Friend or foe? Pharmaceutical companies ask themselves this question before embracing the latest technologies because every innovation comes with both opportunities and risks. Today, technological advancements in artificial intelligence (AI), machine learning (ML), digitalisation, and robotic manufacturing automation solutions stand to revolutionise R&D, clinical trials, and manufacturing in the pharmaceutical industry.

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ASCO 2024 - Suzanne Trudel

pharmaphorum

Join us for an exclusive interview with Dr Suzanne Trudel at ASCO 2024, where she will share insights on the latest advancements in cancer research and treatment. Stay tuned for this exciting conversation!

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First-in-class telomerase inhibitor approved for blood cancer

European Pharmaceutical Review

The first telomerase inhibitor has been approved by the US Food and Drug Administration (FDA). RYTELO ( imetelstat ) is authorised for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia. The first-in-class oligonucleotide telomerase inhibitor is indicated for these patients who need four or more red blood cell units over eight weeks, who are unresponsive to or ineligible for erythropoiesis-stimulating agents (ESA).

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Geron finally brings a drug to market as FDA clears Rytelo

pharmaphorum

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo. The US regulator has cleared Rytelo (imetelstat) for adults with lower-risk MDS who have transfusion-dependent anaemia and have stopped responding to or cannot be treated with erythropoiesis-stimulating agents (ESAs) like erythropoietin (EPO).

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Boehringer Ingelheim’s survodutide shows promise in liver fibrosis treatment

Pharma Times

Phase 2 trial reveals significant improvement in MASH patients

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Beyond one-size-fits-all: How compounding pharmacies address allergies with precision

pharmaphorum

Discover how compounding pharmacies use genetic information to create precision medications tailored to individual allergies. Learn how personalised treatments can benefit you.

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Serac’s imaging agent marks a breakthrough in endometriosis detection

Pharma Times

Early-stage endometriosis now visible through non-invasive imaging

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Climate change to drive growth in multiple sclerosis market: GlobalData

Express Pharma

Climate change-related exacerbations of MS will necessitate the development of more effective DMTs as disease flare ups become more frequent with fluctuating temperatures A June 2024 literature review, published in the Lancet Neurology, by Sisodya and colleagues revealed that climate change has the potential to intensify multiple sclerosis (MS) symptoms.

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Geron wins long-sought drug approval; Califf talks China, GLP-1s at BIO

BioPharma Dive

After 34 years, Geron finally has an approved medicine in Rytelo. Elsewhere, Shionogi disclosed disappointing obesity drug data and AbbVie got some good trial news.

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Nuclera gains £1.14m funding from Innovate UK

Pharmafile

Nuclera has announced that it has been awarded two grants from Innovate UK, totalling £1.14m. The post Nuclera gains £1.14m funding from Innovate UK appeared first on Pharmafile.

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Combining RWE and AI to Bend the Adherence Curve

Pharmaceutical Commerce

By marrying real-world evidence and AI, pharma stakeholders can identify new opportunities to tailor interventions in a way that is most impactful to patients—helping them overcome roadblocks in initiating and maintaining therapy.

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FDA approves Geron’s Rytelo for treatment of MDS with transfusion-dependent anaemia

Pharmafile

Geron Corporation has announced that the US Food and Drug Administration (FDA) has approved Rytelo (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia who require at least four red blood cell units over eight weeks and who have not responded, or lost response to, or are ineligible for erythtopoiesus-stimulating agents (ESA).

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UBC-developed oral insulin drops offer relief for diabetes patients

World Pharma News

Diabetes rates continue to rise, with 11.7 million Canadians living with diabetes or pre-diabetes. At UBC, scientists have created a pain-free drug delivery method to help people with diabetes manage the disease and maintain their health more easily. Researchers at the Li Lab have developed oral insulin drops that when placed under the tongue are quickly and efficiently absorbed by the body, potentially replacing the need for insulin injections.

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FDA admonishes Jiangsu Hengrui’s manufacturing site following inspection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

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Pharma industry focuses on strategic investments amid reduced deal activity by 26.1 % compared to May 2023: GlobalData

Express Pharma

Merck, Biogen, and Novartis lead major transactions In May 2024, the pharmaceutical industry strategically pursued key acquisitions and significant venture capital investments amidst a reduction in overall deal activity, while the healthcare sector witnessed a decline in transactions. Despite this drop, three major transactions accounted for 51 per cent of the total deal value in May.

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Tips for Improving Your Mental Health

Compounding Pharmacy of America

Discover effective tips for enhancing your mental well-being during Mental Health Awareness Month and explore vitamins and supplements to support your journey. The post Tips for Improving Your Mental Health appeared first on The Compounding Pharmacy of America.