Wed.May 03, 2023

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For Eli Lilly’s head scientist, Alzheimer’s results cap a 25-year scientific quest

STAT

If you flip to the 1,031st page of the May 1998 edition of the Journal of Cell Biology, you’ll find the first scientific byline for Daniel Skovronsky, then a young trainee at the University of Pennsylvania, on an article describing how beta-amyloid, a vexing molecule thought to play a role in Alzheimer’s disease, was more complicated than the field understood.

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Attracting up-and-coming talent in biotech

PharmaVoice

The CEO of a Bay-area startup shares his strategies for growing a team from the ground up.

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RJ Reynolds is threatening to sue vape shops for selling flavored vapes

STAT

WASHINGTON – The tobacco giant RJ Reynolds is threatening to sue small vape shops if they do not stop selling flavored vapes, according to two letters obtained by STAT. The letters, both of which were sent in March, give the vape shops just a few days to confirm they will no longer sell flavored tobacco products. Failure to comply could result in “legal action, and the costs, attorneys’ fees, and adverse publicity to which a lawsuit would subject [the vape shop],” the

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FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

BioPharma Dive

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

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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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DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs

STAT

The Drug Enforcement Administration is holding off on making sweeping changes to the way certain drugs can be prescribed via telemedicine — for now. The DEA announced Wednesday that it was temporarily extending its Covid-era emergency telehealth policies, allowing doctors continued leniency in how they prescribe some controlled substances. The affected medications include buprenorphine, the most common medication used to treat opioid addiction, and stimulants like Adderall used to treat A

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Lilly drug slows Alzheimer’s decline in large study

BioPharma Dive

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

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More Trending

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Woman of the Week: Jazz Pharmaceuticals’ Neena Patil

PharmaVoice

Patil’s dual interests in healthcare and law are at the intersection of her C-suite role.

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FDA approves first RSV vaccine, a long-sought scientific achievement

STAT

The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus, or RSV , completing an elusive quest that has been decades in the making. The product, GSK’s Arexvy, was approved for adults ages 60 and older. GSK beat a crowded field of competitors to cross the finish line first. A vaccine that was developed by Pfizer and aimed at the same demographic is expected to be approved by the end of the month.

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Pharma á la carte – 05/04/2023

The Honest Apothecary

Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. I might throw in a something off-topic from time to time which I found while wandering throughout the endless hallways and corridors of the internet. All article shared will be free to read and not locked behind an annoying paywall.

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Now 18, the first child to ever receive CAR-T cancer therapy is ready for a new identity

STAT

The Food and Drug Administration approves dozens of cancer drugs every year, but the vast majority of them offer gradual improvements. A treatment might shrink tumors in a third of patients, or extend survival by a couple months, and a company can still haul in billions. The results were much more revolutionary when, at six years old, Emily Whitehead became the first child to receive CAR-T cell therapy, in which researchers arm a patient’s own immune cells against their cancer.

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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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Magenta agrees to reverse merger with Dianthus after setbacks

BioPharma Dive

The deal comes months after Magenta reported a clinical trial setback, began a strategy review of its business and laid off most of its workforce.

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Opinion: The Global North can’t solve its health care worker shortage by stealing from the Global South

STAT

The U.S. is facing unprecedented  health care labor shortages  and related cost pressures. In the U.K., the National Health Service has witnessed its  largest nursing strike in history  alongside  junior doctor strikes , which have been prompted by staffing shortfalls and inadequate pay.  Europe is endangered  by an aging workforce, growing absenteeism, and health care workers simply quitting the field.

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Digital transformation to drive biomanufacturing market

European Pharmaceutical Review

A market report has shown that the digital biomanufacturing market is anticipated to grow at a compound annual growth rate (CAGR) of 11 percent between 2023-2035, driven largely by digital transformation. Influencing factors identified in the report include higher competition, competitive pricing and inflation rate, technological advancements and evolving regulatory guidelines.

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STAT+: Immunogen ovarian cancer drug shown to extend patients’ lives

STAT

A drug approved in November as the first new treatment for advanced ovarian cancer in over seven years has now been shown to extend patients’ lives, its developer, Immunogen, said Wednesday. Immunogen released data from a trial comparing the new drug, Elahere, to traditional chemotherapy in 453 ovarian cancer patients who had already progressed on at least one other therapy and had a particular protein marker on their tumor.

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European Commission approves CAR T therapy for lymphoma

European Pharmaceutical Review

The European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The CAR T-cell therapy has a 4-1BB costimulatory domain which enhances the expansion and persistence of the CAR T cells. The treatment is indicated for adults with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who re

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STAT+: In early glimpse at data, Akili’s video game shows positive results with adults with ADHD

STAT

Akili Interactive on Wednesday revealed earlier-than-expected top-line clinical trial results suggesting its video game treatment for attention deficit hyperactivity disorder is effective for adults. That’s very good news for a company that’s racing to reach more patients in hopes of building a sustainable business.

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Talking therapies may cut cardiovascular disease risk in patients with depression

The Pharmacist

Using ‘talking therapies’ to treat patients with depression could reduce the risk of developing cardiovascular disease, researchers have said. A large analysis of 636,955 people over the age of 45 who accessed therapy through the national Improving Access to Psychological Therapies (IAPT) service found an impact on future cardiovascular disease and death from all causes. […] The post Talking therapies may cut cardiovascular disease risk in patients with depression appeared first on The Pha

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STAT+: Vinod Khosla predicts AI doctors could be here sooner than you think

STAT

Sun Microsystems co-founder Vinod Khosla is famous for predictions that have helped usher in the high tech world we live in today — and made him very wealthy in the process. On Wednesday, he made another bold forecast: A fully computerized doctor could be seeing patients before the decade is out. “Within 5 to 6 years, the FDA will approve a primary care app qualified to practice medicine like your primary care physician,” he said onstage at the STAT Breakthrough Summit

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Considering alcohol as a drug changes patient perceptions, study finds

The Pharmacist

Treating alcohol as a drug that interacts with medicines and conditions, rather than a lifestyle question on structured medicine reviews (SMRs) gives patients a new perception of their alcohol use, a small-scale study has found. As part of wider research on whether alcohol should be included on medication reviews as a legitimate subject for discussion […] The post Considering alcohol as a drug changes patient perceptions, study finds appeared first on The Pharmacist.

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STAT+: Eli Lilly’s Alzheimer’s therapy slowed patients’ rate of cognitive decline, data show

STAT

A new treatment for Alzheimer’s disease developed by Eli Lilly slowed patients’ rate of cognitive and functional decline by 35% compared to placebo, the company said Wednesday, paving the way for a submission to the Food and Drug Administration and boosting hopes for a new class of Alzheimer’s drugs. But the positive outcome of the study involving the drug, called donanemab, could be tempered by the deaths of two patients, and possibly a third, from a type of brain swelling

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Antares Vision Group acquires software company, Smart Point Technologies

Express Pharma

Antares Vision Group has acquired, through its subsidiary rfxcel, 100 per cent of Smart Point Technologies, an Indian software product development company. The total cash-out for Smart Point has been agreed to as €7.8 million, of which €5.4 million was paid at closing and the remaining portion will be paid within 18 months. A company statement informed, “Smart Point has built expertise mainly in the pharma Track and Trace and it works directly with top pharma companies in the world, which are en

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STAT+: The CEO of 23andMe says people are willing to share health data — if ‘treated like adults’

STAT

When it comes to personal health information, many people are actually willing to share their data, according to Anne Wojcicki, co-founder and CEO of genetic testing company 23andMe. But the health care system has to start treating people less like test subjects, and more like people who want to contribute to medical research. “There needs to be more of that mindset: give people choice, give people transparency.

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London PCN eradicates blood pressure inequality

The Pharmacist

A team at a South London primary care network has eradicated a large gap in blood pressure control between white patients and those from a Black or minority ethnic background, after a year-long project. AT Medics Streatham PCN in Lambeth found that among their patients under 80 diagnosed with hypertension, there was a 12% inequality […] The post London PCN eradicates blood pressure inequality appeared first on The Pharmacist.

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After early-stage breast cancer, interrupting endocrine therapy to become pregnant didn’t raise risk of recurrence

STAT

Women who’ve been treated for hormone-sensitive breast cancer often face five to 10 years of endocrine therapy to lower the chances of their tumors coming back. Because that drug regimen is toxic during pregnancy, women who haven’t begun their families yet may lose that chance before they even try. New research published Wednesday in the New England Journal of Medicine suggests there might be another option.

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Indoco receives EIR for its manufacturing facility in Goa (Plant I)

Express Pharma

Indoco Remedies announced the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for their facility for solid dosages (Plant I) located in Verna, Goa. The recent inspection held from January 16, 2023, to January 20, 2023, was a surveillance inspection. The receipt of the EIR with VAI status also signifies the imminent closeout of the Warning Letter issued by the USFDA in July 2019 for the manufacturin

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Opinion: Listen: Two medical residents debate their hospital’s unionization drive

STAT

In training to become a physician, medical residency can be a grueling period. Residents and other trainees work long hours for little pay and don’t have much power within each hospital or institution. As with many other parts of life, the pandemic exacerbated and highlighted these problems. Now, medical residents across the country have begun fighting to unionize their ranks.

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Lilly’s new Alzheimer’s data may both help and hinder rival Biogen

BioPharma Dive

The success of Lilly’s donanemab in slowing Alzheimer’s progression should reinforce the potential of Leqembi — a similar, recently approved medicine from Eisai and Biogen — but may also make for stiff competition.

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An MRI helmet out of ‘Back to the Future’ wins STAT Summit research pick

STAT

The pitches are as ambitious as they are exciting: a gel to rub onto your teeth to fight gum disease, sparing patients trips to the dentist for painful cleanings. A way to trick immunotherapy-resistant solid tumors into being less resistant to the treatment. Or a simple, fashionable way to get faster, clearer MRI images.  Those futuristic ideas were front and center at the STAT Breakthrough Summit in San Francisco on Wednesday, where entrants in the annual STAT Madness competition —

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New Alzheimer’s drug slows cognitive decline by 35%, trial results show

The Guardian - Pharmaceutical Industry

Donanemab is second drug in a year to succeed in trials in what could be ‘beginning of the end’ of disease A new Alzheimer’s drug slowed cognitive decline by 35%, according to late-stage trial results, raising the prospect of a second effective treatment for the disease. Donanemab met all goals of the trial and slowed progression of the condition by 35% to 36% compared with a placebo in 1,182 people with early-stage Alzheimer’s, the drugmaker Lilly said.

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Oft-prescribed beta blockers may not be wise for many heart patients

STAT

Beta blockers have long been widely prescribed for patients with heart issues, but two new studies this week question the benefit of the therapies in certain patients with strong heart function. One study , published Tuesday in Heart, looked at people who experienced a heart attack but didn’t develop heart failure or dysfunction in their heart’s pumping.

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Otsuka’s Lupkynis receives NICE green light

Pharma Times

Recommendation applies across England and Wales and the treatment is available now

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STAT+: What the Covid-19 pandemic can teach us about drug patents

STAT

Inventing treatments and vaccines is only part of the battle in an epidemic and pandemic, according to Priti Krishtel, the co-founder of the Initiative for Medicines, Access, and Knowledge (I-MAK). Once invented, we must find a way to get those products to everyone. “Thirty years after the HIV epidemic, why is there still a time lag of years to get medical products to different regions in the world?

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'Black sheep' of helper T cells may hold key to precision allergy treatment

World Pharma News

A new Nature Immunology study led by University of Pittsburgh and National Institutes of Health researchers sheds light on how a rare type of helper T cell, called Th9, can drive allergic disease, suggesting new precision medicine approaches to treating allergies in patients with high levels of Th9.

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STAT+: CAR-T research is flourishing but is hampered by outdated precautions, experts say

STAT

Twenty years ago, CAR-T cell therapy was not quite “believed in,” said Michel Sadelain, director of the Center for Cellular Engineering at Memorial Sloan Kettering Cancer Center. It was hard to find patients to put in a trial, he said, because physicians were skeptical of the new technology. Then, when the first patients were successfully treated, there was “suddenly this turnabout, a tsunami as some would say, of young scientists and not-so-young scientists embracing this.

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Vicore begins vital endothelial dysfunction study

Pharma Times

The wide-ranging research aims to unlock the potential of angiotensin II type 2 receptor agonists

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