Wed.Sep 27, 2023

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STAT+: The Ozempic revolution is rooted in the work of Svetlana Mojsov, yet she’s been edged out of the story

STAT

On a mild May day in 1993, about 60 scientists and doctors gathered on a lawn in Copenhagen to commemorate the first International Symposium on GLP-1, the hormone that decades later would become the basis for highly effective diabetes and obesity drugs like Ozempic and Wegovy. The meeting was a scientific showcase of all the leading experts in the nascent field.

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Inside Bavarian Nordic’s late-stage stumbles — and its drive to become a vaccine giant

PharmaVoice

Despite recent phase 3 setbacks in RSV and COVID-19, CEO Paul Chaplin sees a promising path forward in the travel vaccine market for the Dutch biotech.

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Gene therapy death was caused by an unknown risk of the virus used, study suggests

STAT

Last October, a 27-year-old man with Duchenne muscular dystrophy died after receiving a CRISPR-based treatment custom built to treat his particular genetic mutation. Results of a detailed investigation released on Wednesday suggest that the patient, Terry Horgan, likely died of a previously undocumented adverse effect of the virus used to deliver the CRISPR machinery to his cells.

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ACMT Toxicology Visual Pearls: Mushroom Mishap

ALiEM - Pharm Pearls

What well-known adverse reaction results from ingestion of the pictured mushroom? Acute hepatitis Disulfiram-like reaction with ethanol consumption Pneumonitis from inhalation of spores Seizures from glutamate agonist activity [Image from Canstockphoto] Reveal the Answer 2. Disulfiram-like reaction with ethanol consumption Coprinus atramentarius or Ink Cap mushroom is well known to cause a disulfiram-like reaction when it is consumed prior to ethanol.

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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+: Biogen shutters digital health group, nixes Apple study, as part of cost cuts

STAT

Biogen, the iconic but embattled biotech firm, is shuttering Biogen Digital Health, its roughly 150-person group focused on using new types of data like those from mobile phones and smart watches, and ending a clinical trial being conducted with Apple early, STAT has learned. Biogen confirmed the organizational change, but said it might lean even more on digital tech startups in the future.

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ASBM Letter to Congress Defends Interchangeability Standard

Safe Biologics

In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only interchangeable biosimilars are substitutable at the pharmacy without physician involvement- referred to “automatic substitution”, due to their havi

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NHS Confederation research supports investment in NHS services

Pharma Times

Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes

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STAT+: U.S. government’s next-gen Covid effort gives small biotech up to $433 million

STAT

The U.S. government’s “Project Nextgen,” its effort to accelerate and streamline the rapid development of the next generation of Covid vaccines and treatments, said Wednesday that it would give a small biotechnology firm, Gritstone bio, up to $433 million to conduct a 10,000-volunteer clinical trial testing a new approach to creating a vaccine.

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Laura Buckley: PCN pharmacy in care homes

The Pharmacist

Primary care network (PCN) pharmacist Laura Buckley speaks to Joanna Robertson about how conducting medicines reviews in care homes helped her to connect with an often-overlooked group of patients and deprescribe an impressive number of medications. I thought reviewing care homes would be a good way to get to know my patch. I'm a primary […] The post Laura Buckley: PCN pharmacy in care homes appeared first on The Pharmacist.

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Children of color and from low-income families disproportionately harmed by toxic chemicals, study finds

STAT

Children are often exposed to harmful chemicals in air, water, soil, food, food packaging, and plastics. However, low-income children and children of color are disproportionately impacted by these exposures, according to the authors of a study that examines disparities in neurotoxic exposures and their harmful effects on children by race, ethnicity, and economic status.

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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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Portsmouth NHS Trust maternity team enhances patient experience

Pharma Times

Patient waiting times to receive an appointment have reduced from 6-8 weeks to just 24 hours - News - PharmaTimes

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Octopus tentacles inspired a new drug delivery patch that sticks to the inside of your cheek

STAT

The story of the latest development in drug administration technology — a mouth patch that can deliver peptides and proteins without injection — begins with Chinese fondue. Researcher Zhi Luo, the lead author of a new paper detailing the patch development published in Science Translational Medicine, was enjoying the spicy fondue dish when he found himself fascinated by Sichuan peppercorns.

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Former Novartis executive Tsai to lead UK heart drug startup

BioPharma Dive

John Tsai, previously Novartis’ chief medical officer, has been named CEO of Forcefield Therapeutics, an 18-month-old biotech working on a treatment for heart attacks.

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STAT+: FDA advisers vote overwhelmingly against ALS treatment from BrainStorm

STAT

A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval. After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on con

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ProQR sale of eye drugs comes undone over employment contracts

BioPharma Dive

Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.

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STAT+: Bubble bursts: 2021 health tech IPOs and SPACs lose value, burn cash

STAT

In less than two years, digital health’s high-flying class of public debuts have landed with a resounding thud. Accelerated by the pandemic’s forced adoption of telehealth and other digital health solutions, 2021 saw more than 30 health technology startups go public, raising hundreds of millions and in some cases billions of dollars. Today, three members of the class of 2021 have gone bankrupt.

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BrainStorm’s ALS therapy not effective, FDA panel finds

BioPharma Dive

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Opinion: Paxlovid is not fully accessible to those who need it most: the immunocompromised

STAT

The pandemic is over for most of the world. But for the 2.7% of adults in the United States who are immunocompromised , it isn’t. I’m one of them. As we are all increasingly expected to return to pre-pandemic routines, including traveling abroad, those of us with a weakened immune system are attempting to be proactive — to plan ahead for possible illness.

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Government urged to close funding gap for pharmacy students

The Pharmacist

The Royal Pharmaceutical Society (RPS) and the British Pharmaceutical Students’ Association (BPSA) have issued a joint call to the government to allow pharmacy students to access the Learning Support Fund available to other health professionals. Under the scheme, eligible students on nursing, midwifery, medical, dental and allied health profession courses will be able to claim […] The post Government urged to close funding gap for pharmacy students appeared first on The Pharmacist.

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Women in Science: ScaleReady’s Jenny Stjernberg and her fervent passion for cell and gene therapies

Outsourcing Pharma

At Advanced Therapies Europe 2023, BioPharma Reporter caught up with ScaleReady's Jenny Stjernberg to discuss her work at the biotech company, her journey from academia to commercial and female representation in the cell and gene therapies industry.

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Roche bets on Ionis RNA medicines with neuroscience deal

BioPharma Dive

The Swiss drugmaker is restocking its pipeline by buying into preclinical Ionis medicines for Alzheimer’s and Huntington’s diseases.

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Answering Your Patients’ Most Frequently Asked Medicare Part D Questions (Free Download)

Digital Pharmacist

Navigating Medicare Part D can be complex for both patients and pharmacies. Medicare Part D is crucial for providing prescription drug coverage to beneficiaries, and understanding its nuances, enrollment periods, and coverage options is key to ensuring patients get the medications they need while managing costs. This blog is your resource for answering patients’ inquiries about eligibility, plan selection, costs, and Medicare Open Enrollment Information.

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BrainStorm’s ALS therapy not effective, FDA panel finds

BioPharma Dive

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Sun Pharma Canada launches WINLEVI for acne

Express Pharma

Sun Pharma Canada has launched WINLEVI (clascoterone cream 1% w/w) in Canada. WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older. WINLEVI is thought to reduce the effects of acne hormones on skin by disrupting the androgen cascade. While the exact way that WINLEVI works is unknown, it aims to inhibit the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in

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Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

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Cosmo, Glenmark signs distribution and license pacts for Winlevi in Europe, South Africa

Express Pharma

Cosmo Pharmaceuticals and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals announced the signing of distribution and license agreements for Winlevi (clascoterone cream 1%) in Europe and South Africa. Under the terms of the agreements, Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries (Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Roman

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Interactive videos to showcase pharmacy careers to young people

The Pharmacist

A new series of virtual reality videos will give 14 to 18-year-olds an insight into pharmacy roles within community, general practice and hospital settings. The interactive and immersive videos have been developed by the NHS England Technology Enhanced Learning (NHSE TEL) team to showcase the day-to-day working life of pharmacy teams. Using an internet browser, […] The post Interactive videos to showcase pharmacy careers to young people appeared first on The Pharmacist.

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Glenmark to market Winlevi in Europe and South Africa after Cosmo deal

Pharmaceutical Technology

The popular acne treatment will soon be available in 15 EU countries in addition to UK and South Africa.

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Five strategies for delivering digital that makes a difference

pharmaphorum

Five strategies for delivering digital that makes a difference Mike.

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New patent for Pfizer drug NURTEC ODT

Drug Patent Watch

Annual Drug Patent Expirations for NURTEC+ODT Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Pfizer drug NURTEC ODT appeared first on DrugPatentWatch - Make Better Decisions.

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NICE turns down Enhertu in “devastating” move, says charity

pharmaphorum

NICE turns down Enhertu in “devastating” move, says charity Phil.

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Drug Patent Expirations for the Week of September 24, 2023

Drug Patent Watch

NUZYRA (omadacycline tosylate) Paratek pharms inc Patent: 7,326,696 Expiration: Sep 24, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of September 24, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Protecting Public Health through Accreditations and Inspections 

National Association of Boards of Pharmacy

NABP is proud to offer accreditation and inspection programs for pharmacies, drug distributors, and medical device distributors. In the role of Compliance Senior Manager, Accreditation and Inspection Programs, Betty Jones tackles complex compliance issues to keep patients safe around the nation. In this blog, she shares stories from her career and how the NABP accreditation and inspection team works to protect public health.

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Academia Tutorial Series – Master Your Analytical Skills With These Essential Tips & Tricks

Express Pharma

Tutorials Designed to Maximize Potential We know that not everyone can attend our live events or workshops to get product and workflow updates and guidance. However we still like to offer access to the educational material that is relevant to your everyday work. With this in mind, we have prepared a series of tips & tricks targeted at your main analytical instruments: Dissolution , LC , GC , and Spectroscopy systems.

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Alfasigma to acquire Intercept Pharmaceuticals for $19 per share

Pharmafile

Alfasigma and Intercept Pharmaceuticals have announced that they have entered into a definitive merger agreement, meaning Alfasigma will acquire Intercept for $19 per share. This is intended to expand Alfasigma’s gastrointestinal and hepatology portfolio and its presence within the US market. Ocaliva (obeticholic acid) is Intercept’s lead medicine and is approved in the US and […] The post Alfasigma to acquire Intercept Pharmaceuticals for $19 per share appeared first on Pharmafile.

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