Fri.Jun 23, 2023

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Opinion: Peter Hotez is not alone: Online harassment of doctors is a public health issue

STAT

Father’s Day weekend was anything but calm on Twitter, which erupted as vaccine expert Peter Hotez was challenged online to a debate by podcaster and former reality TV host Joe Rogan. Rogan’s challenge began when Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and vaccine expert, tweeted his  concern about Rogan’s three-hour interview with longtime anti-vaccine activist  and presidential candidate Robert F.

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How Sanofi is taking a ‘creative’ approach to dealmaking

PharmaVoice

Dr. Monika Vnuk, SVP of global partnering and business development, is setting her sights on out-of-the-box partnerships.

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STAT+: Two type 1 diabetes patients now freed from insulin shots with cell therapy, Vertex reports

STAT

Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.  The results, presented at the American Diabetes Association conference in San Diego, bolstered experts’ hopes that the treatment could provide a functional cure for some patients.

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Top FDA official overruled review team in approval of Sarepta’s Duchenne gene therapy

BioPharma Dive

In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.

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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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How a six-in-one vaccine could soon help the world get rid of polio for good

STAT

Polio eradication is a delicate dance. And one of the biggest challenges facing the people trying to choreograph its final steps is how to phase out use of oral polio vaccines. The oral vaccines have brought the paralyzing viruses to the brink of  annihilation; so far this year there have only been six cases detected, five in Afghanistan and one in Pakistan.

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Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Pharmaceutical Technology

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

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Medicare has no surprises in planned registry for new Alzheimer’s drugs

BioPharma Dive

Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.

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STAT+: GSK settles first lawsuit set for a U.S. trial over cancer links to Zantac

STAT

GSK reached a settlement with a man who claimed its Zantac heartburn medication caused his cancer, avoiding the first such case that was about to go to trial in the U.S. In a brief statement , the company disclosed that it reached a settlement with James Goetz, who filed a lawsuit in a California state court. The deal reflected its desire “to avoid distraction related to protracted litigation in this case.

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First RNA CAR-T therapy autoimmunity trial shows potential

European Pharmaceutical Review

Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.

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Opinion: The staggering financial burden of giving birth — even with insurance

STAT

The burden of high health care costs and medical debt in the U.S. is no secret. Medical debt affects one in five adults in the U.S., with an average burden of more than $20,000 for each medical debtor. As primary care physicians, we frequently witness the effects of these financial burdens, particularly for our older or sicker patients with expensive medical conditions.

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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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Is the health secretary relying on pharmacy to fix other parts of the health service?

The Pharmacist

The Pharmacist’s news editor Megan Ford reflects on a meeting with the health secretary that took an unexpected twist, and raises questions around the government’s expectations of the sector amid increasing demands. In an interesting turn of events, I found myself writing about community pharmacy and the incoming Pharmacy First service this week after attending […] The post Is the health secretary relying on pharmacy to fix other parts of the health service?

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STAT+: Lilly’s obesity pill cuts 15% of weight at highest dose in mid-stage trial

STAT

SAN DIEGO – An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy. The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full   results,  published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the Americ

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Government announces clampdown on fraud in community pharmacy

The Pharmacist

The Government will work with pharmaceutical contractors to guard against risks of fraud relating to inappropriate claims and reimbursements and ‘contractual fraud’ to help meet a savings target of £500 million for the NHS between now and 2026. The Department of Health and Social Care (DHSC) has launched a counter fraud strategy that identifies primary […] The post Government announces clampdown on fraud in community pharmacy appeared first on The Pharmacist.

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STAT+: Using its Covid know-how, Color Health aims to make cancer screenings convenient

STAT

Color Health wants to take away any reason you might have for skipping screenings for cancer.  The Silicon Valley company, which pivoted from cancer genomics to Covid-19 testing on a large and hugely profitable scale, has a new program that incorporates both its roots in cancer testing and its logistical experience from the pandemic. Called, simply, the Cancer Prevention and Screening Program, and built in partnership with the American Cancer Society, the program aims to make it easy to get

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Blood Cancer UK extends collaboration with RareCan

Pharma Times

The organisations will focus on the delivery of clinical trials which concentrate on rare cancers - News - PharmaTimes

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In absence of Roe v. Wade, an abortion doctor dwells on all the patients she does not see

STAT

Last year, just a few months after the Supreme Court’s reversal of Roe v. Wade ended the constitutional right to abortion in the United States, Christine Henneberg published a memoir on two simultaneous life-defining experiences: carrying her first pregnancy during her first year performing abortions. This was long after another transformative journey: traveling and living in a rural Indian village at the foothills of the Himalayas when Henneberg first wanted to be a writer.

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Nanopharmaceutics and PrecisionLife in research collaboration

Pharma Times

Companies’ precision medicine approach has potential to increase clinical trial success rates - News - PharmaTimes

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Biden directs HHS to boost contraception access, a year after Dobbs decision

STAT

WASHINGTON – President Biden on Friday told federal health officials to boost contraception access, the administration’s latest attempt to shore up reproductive rights as abortion limits snowball across the country. The president’s executive order, released this morning, instructs the Health and Human Services Department to ensure people on commercial insurance are getting contraception at no cost — a requirement under the Affordable Care Act — and consider mov

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Learning from Leaders: Competitive Intelligence in Health & Life Sciences

Fuld & Company Blog

Join our webinar on June 27th at 10-11am ET In response to the economic downturn, supply chain disruption, and geopolitical tensions, companies are increasingly relying on competitive intelligence and research. Join our webinar to gain critical insights and maximize your competitive advantage in the rapidly changing landscape of the Health & Life Sciences sector.

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STAT+: At a defunct power station, the U.K. and Moderna celebrate a partnership meant to be an engine for science

STAT

LONDON — Back in the 1950s, Battersea Power Station, a towering brick structure on the south bank of the Thames, supplied a fifth of London’s electricity, an economic engine that even powered Buckingham Palace. The coal-fired plant was decommissioned decades ago. But on Thursday evening, in an art deco, gold-and-glass control room in the recently retrofitted power station — now a multi-use development complete with apartments and a cinema — the U.K. government and the

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The State of Employers’ Pharmacy Benefits: A Review of 2022 and the 2023 Outlook for Copay Programs (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding. Click here to see the original post from January 2023. Now that 2023 is underway, let’s review employer-sponsored coverage for prescription drugs and speculate on what’s ahead.

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STAT+: EU poised to reject Amylyx’s ALS drug, as the company vows an appeal

STAT

LONDON — European regulators are on the verge of rejecting an ALS drug from Amylyx Pharmaceuticals, all but dooming the medicine’s chances of entering the E.U. market for now. The negative recommendation issued Friday by a European Medicines Agency committee is not a surprise. Last month, Amylyx said that the agency was headed toward a negative review.

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Reducing bioburden testing and sterility testing volumes for gene therapies

European Pharmaceutical Review

A report published by BioPhorum titled ‘ Minimizing the impact of bioburden and sterility testing on gene therapy batch yield ’ offers recommendations for reducing the volumes required for testing. This approach conserves product for patients, maintains compliance and delivering assay and process information on the microbiological status of gene therapy products.

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STAT+: Pharmalittle: FDA approves first gene therapy for Duchenne muscular dystrophy; states join FTC to stop Amgen deal

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 exceedingly modest. Rain or shine, we plan to promenade with the official mascots, catch up on our reading and make time for a listening party — the rotation will likely include this , this , this and this.

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Magdeburg researchers discover a new mechanism of cancer immune defense

World Pharma News

Modern immunotherapies boost the body's own defenses against cancer. They activate killer T cells of the immune system that can specifically recognize and destroy cancer cells. In many patients, however, cancer cells adapt and become invisible to killer T cells so that the treatment is no longer effective. An interdisciplinary team of researchers from Magdeburg has now discovered a new mechanism that enables the immune system to also eliminate such invisible cancer cells.

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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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Gaps in breast cancer care in Europe and the importance of genomic testing

pharmaphorum

Gaps in breast cancer care in Europe and the importance of genomic testing Mike.

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Amylyx’s ALS drug gets pushback from European regulators

BioPharma Dive

An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.

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Generative Health: A new standard of care

pharmaphorum

Generative Health: A new standard of care Mike.

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Intercept to abandon NASH research, lay off staff after FDA drug rejection

BioPharma Dive

The FDA for the second time turned back Intercept’s application for approval of its drug obeticholic acid in the liver disease, spurring the restructuring.

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Intercept changes course as OCA is rejected for NASH again

pharmaphorum

Intercept changes course as OCA is rejected for NASH again Phil.

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Best Important Benefits of Fish Oil

Welltopia Pharmacy

Fish oil supplement have become increasingly popular in recent years, with people taking them for variety of health benefits. Fish oil supplements are derived from the tissues of oily fish, such as salmon, mackerel, and sardines. These supplements contain high levels of omega-3 fatty acids, which are essential nutrients that our bodies need but cannot produce on their own.

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Viseven at Dublin Tech Summit 2023: Driving IT in Tense Environment

Viseven

Summer is here. Viseven embraced its beginning by attending Dublin Tech Summit in Ireland—one of Europe’s hottest B2B events for IT companies—on May 31-June 2, 2023. Dublin Tech Summit 2023 is a massive technology hub that hosted over 200 international speakers, over 150 startups, 80 corporate partners, and more than 200 media from 60 countries worldwide.

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FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act

PharmaTech

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

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New patent for Bausch drug JUBLIA

Drug Patent Watch

Annual Drug Patent Expirations for JUBLIA Jublia is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are sixteen patents protecting… The post New patent for Bausch drug JUBLIA appeared first on DrugPatentWatch - Make Better Decisions.

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