Mon.Mar 04, 2024

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Covid-19 increases risk of developing autoimmune disease, but vaccination helps, large study shows

STAT

Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk. Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection.

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Did the FTC get it wrong when it blocked the Sanofi-Maze deal?

PharmaVoice

In its zeal to stamp out anticompetitive practices and lower drug prices, a consultant said the FTC might have overlooked the unique considerations in rare disease drug development.

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STAT+: White House is told the big three PBMs are ‘everything wrong with this industry’

STAT

As part of its battle to blunt the growing cost of medicines, the White House on Monday held a so-called listening session in hopes of finding ways to rein in big pharmacy benefit managers, which occupy an opaque but crucial role in pharmaceutical pricing in the U.S. The gathering resembled something of a fact-finding mission as a small group of policymakers and business people briefly shared their experiences dealing with the largest industry middlemen, who negotiate with drugmakers on behalf o

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Black Diamond looks to outwit cancer mutations

PharmaVoice

Why the company’s novel therapeutics could have a competitive edge in a crowded cancer indication.

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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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In a first, fetal cell organoids generated from amniotic fluid, new study reports

STAT

As a fetus develops, its body is bathed in amniotic fluid: a warm, salty soup of nutrients, hormones, and antibodies produced by its mother. And into that fluid, a fetus is constantly sloughing off or peeing out cells, which provide genetic material that doctors can pull out with a needle and examine for signs of disease in a process called amniocentesis.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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Leyla Hannbeck: We’ve got to work together as primary care

The Pharmacist

Following the Sigma Conference 2024, The Pharmacist sat down with Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies (AIMp) to discuss how primary care can work together. How do you think AIMp members are approaching the idea of working collaboratively, with the different professions – including GPs? We've always felt this […] The post Leyla Hannbeck: We’ve got to work together as primary care appeared first on The Pharmacist.

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STAT+: Explaining Change Healthcare and the gravity of its cyberattack

STAT

The cyberattack on Change Healthcare has fractured the country’s health care payment infrastructure. But it also exposed how complicated and vital these electronic pipes are. Using terms like “clearinghouse” and “electronic data interchange” are quick ways to lose an audience. But Ben Handel, a health economist at the University of California, Berkeley, for the past 13 years, has become intimately familiar with that language.

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Bayer pays $310M to buy into BridgeBio heart drug

BioPharma Dive

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

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STAT+: Longer treatment gave better liver outcomes for MASH patients, Akero drug study shows

STAT

Akero Therapeutics said Monday that extending treatment with its experimental drug for the liver disease known as MASH from six months to two years resulted in better outcomes for patients — most notably reductions in liver scarring at a rate three times higher than placebo without worsening other symptoms. The mid-stage study of the Akero drug called efruxifermin achieved its main goal in September 2022.

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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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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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STAT+: Medicare is a tricky market for telehealth companies. Why is Talkspace betting on it?

STAT

Over the last few years, virtual mental health company Talkspace has been on a relentless quest to conquer the insurance market. The next step in that journey, Medicare, may prove the most challenging yet. Talkspace’s pivot away from its direct-to-consumer roots has so far been a success. The company claims its 130 million people have access to its services through deals with  insurers, employers, or through other arrangements, and it is now knocking on the door of profitability 

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High ADHD comorbidity rates offer opportunity for pipeline products to capture market: GlobalData

Express Pharma

Attention-deficit/hyperactivity disorder (ADHD) is a clinically heterogenous neurodevelopmental disorder with high rates of comorbidity with other childhood-onset psychiatric disorders as well as learning disorders. As a result, pipeline products capable of targeting both ADHD and comorbid symptoms will have a competitive edge to capture a highly saturated ADHD market, says GlobalData.

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Opinion: Missing data is making it difficult for the pharmaceutical industry to help LGBTQ+ people

STAT

Lack of health data on LGBTQ+ people has real-world consequences. A participant in a 2020 report from the National LGBT Cancer Network said: “There are no guidelines for cancers that are more prevalent among Trans women. I had to fight like hell to have an anoscopy, and sure enough we found [precancerous lesions]!” That same year, the National Academies of Sciences, Engineering, and Medicine issued a hallmark report  on the health and well-being of LGBTQ+ people.

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FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment

Pharmafile

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority review. The drug has been approved in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 […] The post FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment appe

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First over-the-counter birth control pill in U.S. begins shipping to stores

STAT

WASHINGTON — The first over-the-counter birth control pill  will be available in U.S. stores later this month, allowing American women and teens to purchase contraceptive medication as easily as they buy aspirin. Manufacturer Perrigo said Monday it has begun shipping the medication, Opill , to major retailers and pharmacies. A one-month supply will cost about $20 and a three-month supply will cost around $50, according to the company’s suggested retail price.

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CVS, Walgreens to start selling abortion pill in some states

BioPharma Dive

The two pharmacy retailers will begin dispensing mifepristone in some states weeks before the start of a Supreme Court case that will decide how widely the pill can be accessed.

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STAT+: ‘It’s a nightmare’: One of the most common children’s asthma meds is no longer available, leaving families scrambling

STAT

A commonly prescribed medication for children’s asthma is disappearing from pharmacists’ shelves, forcing parents and pediatricians to scramble for alternatives just as  allergy seaso n  is about to start. In a move unusual for such a widely used drug, GlaxoSmithKline discontinued Flovent HFA, the brand name of its corticosteroid treatment fluticasone propionate, at the end of December.

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Dr Mansukh Mandaviya inaugurates 27 greenfield bulk drug park projects and 13 medical devices plants under the PLI Scheme

Express Pharma

Dr Mansukh Mandaviya, Union Minister for Chemicals & Fertilizers and Health & Family Welfare virtually inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for medical devices recently. Addressing the gathering, Dr Mandaviya said, “Medicines are an essential requirement for any society. During the COVID-19 pandemic, the dangers of supply chain getting affected, the risks of being highly dependent on imports of critical resources like bulk drugs and med

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STAT+: He’s 19 months old and has one of the world’s rarest diseases. His parents are determined to find a cure.

STAT

SOMERVILLE — At 19 months old, Lucas Guo has never crawled, walked, or stood by himself. He babbles but can’t say words. He struggles to chew and swallow. He gets most of his nutrition through a feeding tube attached to his belly. Lucas has one of the world’s rarest diseases, ZTTK syndrome, a complex neurological disorder caused by a genetic mutation.

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Dark factories for a bright future

pharmaphorum

Explore the future of drug manufacturing with dark factories, robotic and automated facilities that promise efficiency and innovation. Learn how these advancements are shaping a bright future for the pharmaceutical industry.

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Serum Institute of India wants government HPV contract

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! A thought: I moved to San Diego last year and am always on the lookout for interesting news. If you’re here, reach out! In today’s newsletter, we discuss embryonic stem cell ethics, learn of parents searching for a treatment for their son’s ultra-rare neurological disease, and more.

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Smokers’ views on harms of vaping worsened in recent years

The Pharmacist

Perceptions of the safety of vaping have worsened considerably over the past decade amongst people who smoke, a UK study has found. The Cancer Research UK funded analysis has tracked survey responses since 2014 among more than 28,000 smokers in England. They found there had been an overall increase in the perceived harm of e-cigarettes […] The post Smokers’ views on harms of vaping worsened in recent years appeared first on The Pharmacist.

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STAT+: Massachusetts lawmakers consider $1 billion proposal to bolster region’s life science leadership

STAT

Next stop: Beacon Hill. Governor Maura Healey’s long-awaited plan to double down on state funding for the biotech and medical technology sector came into focus Thursday with the announcement she’ll seek $1 billion over the next decade to reauthorize the state’s 16-year-old life sciences initiative. But lawmakers so far are noncommittal on funding the plan.

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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

pharmaphorum

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer. The EMA has validated the two parallel applications for the drug, also known as Dato-DXd, in adults with previously treated non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer.

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STAT+: Pharmalittle: We’re reading about a nixed Medicare negotiation lawsuit, an Obamacare challenge, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup of stimulation.

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EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Pharmaceutical Technology

The EMA has validated the jointly developed TROP2-directed therapy for patients with breast or lung cancer following positive Phase III data.

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Delivery systems for biologics

European Pharmaceutical Review

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. These biopharmaceuticals encompass a range of products including vaccines, recombinant therapeutic proteins, tissues, cells and gene therapies – all sourced from living organisms. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs.

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Poor spatial navigation could predict Alzheimer’s before symptom onset

Pharma Times

Around 900,000 people in the UK are affected by the progressive neurodegenerative disease

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Vriddhi 2024, IDMA’s Annual Conference held in FLAME University

Express Pharma

FLAME University hosted the annual conference of the Indian Drugs Manufacturers’ Association (IDMA) – vriddhi 2024, in association with Bain & Company on February 23-24. Held on its campus in Pune, the two-day conference welcomed over 40 business leaders, 50 organisations, investors, and policymakers, convening for a national summit. The agenda of this event was to examine and assess the opportunities, challenges, and strategic directions of the Indian pharma industry.

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Researchers reveal two different subtypes of prostate cancer using AI

Pharma Times

In the UK alone, the aggressive form of cancer affects around 52,000 men every year

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New data revealed for Novartis SMA gene therapy

European Pharmaceutical Review

According to new data in older and heavier children treated with Novartis’ spinal muscular atrophy (SMA) gene therapy, nearly all participants in the Phase IIIb trial maintained or improved motor milestones after 52 weeks. Final data from the Phase IIIb SMART study of Zolgensma ® (onasemnogene abeparvovec) highlighted its safety and efficacy in children weighing ≥ 8.5kg to ≤ 21kg, with a mean age of 4.69 years.

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Novartis presents new data on safety and efficacy of Zolgensma

World Pharma News

Novartis today presented new data that continue to support the clinical benefits of Zolgensma® (onasemnogene abeparvovec), the only one-time gene therapy for the treatment of spinal muscular atrophy (SMA). Final data from the SMART study highlight the safety and efficacy profile of Zolgensma in children with SMA weighing ≥ 8.5 kg to ≤ 21 kg, with a mean age of 4.69 years, most of whom (21/24, 87.5%) had discontinued use of another disease modifying therapy at the time of treatment.

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Bayer pays $310m for Euro rights to ATTR therapy acoramidis

pharmaphorum

Bayer licenses European rights to BridgeBio's acoramidis, putting some big pharma muscle behind the ATTR cardiomyopathy treatment

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NHSE: Pharmacists are ‘managing antimicrobials appropriately’

The Pharmacist

Antimicrobials are being managed ‘appropriately’ under Pharmacy First, NHS England (NHSE)’s Head of Delivery for Community Pharmacy Clinical Strategy has told general practitioners. Pallavi Dawda also revealed that, as of mid-last month, community pharmacies in England had delivered 32,000 Pharmacy First consultations. And she told GPs concerned about patients being ‘bounced back’ to general practice […] The post NHSE: Pharmacists are ‘managing antimicrobials appropriately’ appeared first