Sat.Jun 24, 2023 - Fri.Jun 30, 2023

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STAT+: Grail faces uphill battle to get Medicare to cover its cancer screening test

STAT

WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.

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Pursuing a Career in Pharmacy: Empowering LGBTQIA+ Students through Advocacy and Diversity

Pharmacy Is Right For Me

Join us as we explore the inspiring journey of Cayden Miller, a passionate pharmacy graduate from Southern Illinois University at Edwardsville School of Pharmacy. Cayden’s experience as a member of the LGBTQIA+ community has shaped his path in pharmacy, driving him to become an advocate for diversity, equity, and inclusion (DEI) within the profession.

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Transgender patients are rarely included in clinical trials. Can pharma fix it?

PharmaVoice

Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.

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BioMarin finally secures FDA approval of hemophilia gene therapy

BioPharma Dive

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

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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+: Illumina to lay off 10% of research and development team in bid to cut costs by $100 million

STAT

SAN DIEGO — Months after announcing plans to cut costs by $100 million, DNA sequencing giant Illumina has begun to lay off 10% of its research and development team, according to internal emails obtained and reviewed by STAT. The layoffs, which began last Wednesday, impact research teams across the company’s California sites in San Diego and Foster City, as well as locations in Madison, Wisconsin; Singapore; and the United Kingdom.

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Your favourite nutraceuticals can be toxic: Discovered by Nutrify Genie

Express Pharma

Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. However, it is crucial to consider potential concentrations of unwanted substances like pesticides and contaminants, including mycotoxins, during the extraction process The integration of plant-based nutraceuticals into a diverse diet has gained global attention due to their ability to promote health.

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5 FDA decisions to watch in the third quarter

BioPharma Dive

By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.

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How abortion access changed in the first year after Roe v. Wade, in 8 charts

STAT

One year ago, the Supreme Court struck down Roe v. Wade in a landmark decision that would fundamentally change abortion access in America. Perhaps one of the most dramatic signs of that shift is in the patchwork legal landscape that has emerged as states have enacted laws banning or restricting abortions.

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In Depth Focus QA/QC Microbiology/RMM 2023

European Pharmaceutical Review

A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.

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A pharma summer — how leaders unwind and recharge their teams in the warmer months

PharmaVoice

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.

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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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With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy

BioPharma Dive

The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

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Malaria cases in Florida and Texas: Here’s what you need to know

STAT

The five cases of malaria diagnosed in Florida and Texas in recent weeks — the first cases of local transmission in the United States in 20 years — have worried some residents and led state and federal officials to issue public alerts about the cluster of infections. But scientists and public health officials, while advising people in the affected areas to take precautions, say there is little cause for alarm, for several reasons: The number of cases is very low; there are easy, lo

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Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

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A unique study on COVID shows how machine learning can help personalize medicine

PharmaVoice

Based on real-world data from patients in China, researchers were able to pinpoint factors that led to recurring infections — and which drug combos helped.

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Positive results for Astellas’ Fezolinetant

Pharma Times

Trial involved over 450 women across Europe, Turkey and Canada who were unsuitable for hormone therapy - News - PharmaTimes

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Medical leaders decry Supreme Court decision on affirmative action

STAT

Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.

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NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

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F-Prime’s Ketan Patel on ‘reverse ageism’ in biotech and investing in a downturn

BioPharma Dive

The life sciences investor spoke with BioPharma Dive about emerging life sciences markets around the globe and why the firm invests in first-time biotech founders.

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Genfit and Ipsen announce elafibranor results

Pharma Times

ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes

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Gates Foundation to fund trial of long-awaited new tuberculosis vaccine candidate

STAT

The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. The 26,000-person, Phase 3 study, set to begin next year, will test a vaccine known as M72/AS01 that showed promising results from a smaller trial in 2019. The findings stoked excitement at the time.

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More than 60 researchers ask Congress to support innovation

PhRMA

Earlier this month, 62 researchers from our member companies came to Washington, DC to meet with congressional offices during our annual fly-in event. This year included a record-breaking number of meetings — 145 over the course of the day.

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Microbiome therapies: a maturing movement

European Pharmaceutical Review

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Have you heard of low dose naltrexone, or LDN? Since the beginning of my Hashimoto’s journey, this medication has been on my radar – and in recent years, I have learned so much more about it. In 2015, I conducted a survey of over 2000 readers with Hashimoto’s , asking for the most helpful interventions in their health journeys. One reader wrote: “Low Dose Naltrexone changed my life for the better.

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Supreme Court strikes down use of affirmative action, a blow to efforts to diversify medical schools

STAT

Overturning decades of precedent, the U.S. Supreme Court on Thursday struck down the use of affirmative action, ruling that it is unconstitutional for colleges, universities — and professional schools for law, medicine, and nursing — to consider race as one factor in deciding who they will admit. The decision comes as a blow to many in the field of medicine, which has been unable to appreciably increase the numbers of Black, Hispanic, and Indigenous doctors in recent decades.

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Lilly takes over partner working on cell therapies for diabetes

BioPharma Dive

Sigilon Therapeutics, a biotech that’s been collaborating with Lilly since 2018, has agreed to be bought for up to $310 million in the pharma’s second announced buyout this month.

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Wine drinking linked to lower risk of cardiovascular disease

The Pharmacist

Wine drinking is linked to a lower risk of death from cardiovascular disease (CVD) but also reduces the risk of developing both CVD and coronary heart disease (CHD), according to the findings of a recent meta-analysis. Previous studies have hinted that the polyphenolic content of wine confers a cardio-protective effect whereas consumption of spirits, increases the risk of […] The post Wine drinking linked to lower risk of cardiovascular disease appeared first on The Pharmacist.

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five patents… The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: STAT-Harris Poll: Nearly half of U.S. adults would spend $100 a month for Ozempic, other weight-loss drugs

STAT

Almost half of Americans would be willing to spend up to $100 a month for new weight-loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll. Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month.

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10 clinical trials to watch in the second half of 2023

BioPharma Dive

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

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Ambulatory BP monitoring: 'We're hoping to get a second monitor'

The Pharmacist

Lisa Olins, pharmacist manager at Crown Pharmacy in Shenley, Hertfordshire, talks to Saša Janković about a tie-up between ambulatory blood pressure monitoring (ABPM) and NMS services Service type: Ambulatory blood pressure monitoring and New Medicine Service Name and location of pharmacy: Crown Pharmacy, Shenley Name of pharmacist: Lisa Olins Why did you start offering this service?

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Orsini Selected by Sarepta Therapeutics to Dispense ELEVIDYS (delandistrogene moxeparvovec-rokl), the First Gene Therapy to Treat Duchenne Muscular Dystrophy

Orsini Pharmacy

Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, has been selected by Sarepta Therapeutics, Inc. as one of its limited distribution providers of ELEVIDYS (delandistrogene moxeparvovec-rokl). ELEVIDYS is the first gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene and is contraindicated in patients with any deletion in

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Opinion: OB-GYNs could have solidified abortion as health care after Roe. They missed their chance

STAT

Reflecting on this first anniversary of the Supreme Court’s decision in Dobbs to overturn Roe v. Wade, I think first about the unconscionable health risks faced by pregnant people in states where abortions are now banned, when their pregnancies turn dangerous. But the decision has also been a nightmare for physicians (mainly OB-GYNs) in those states.

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Positive results for Evgen’s rhabdomyosarcoma therapy

Pharma Times

Update on radiosensitising impact of SFX-01 when treating common soft tissue sarcoma condition - News - PharmaTimes

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Pharmacists defend anti-abuse signage at Tesco branch

The Pharmacist

Signs displayed in a supermarket pharmacy outlining a zero-tolerance policy to violence against staff and urging patients to ‘think’ before they speak, reflects a ‘decimation of morale’ among the pharmacy workforce, those in the sector have said. The signs, put up at a Tesco pharmacy in Oxfordshire, have been at the centre of an online […] The post Pharmacists defend anti-abuse signage at Tesco branch appeared first on The Pharmacist.

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Novartis, continuing revamp, sells eye drugs to Bausch + Lomb for up to $2.5B

BioPharma Dive

An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.

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