Sat.Oct 14, 2023 - Fri.Oct 20, 2023

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The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

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Researchers try to tease out possible ties between long Covid and menopause

STAT

When she stopped getting her period in March 2022, Daryn Schwartz wasn’t especially concerned. At 42, she had recently come off birth control, and figured her cycles were still adjusting. When it hadn’t come back by the summer, she sought gynecological care, but was told to wait it out. So she did, with no changes. She was having other symptoms, too — fatigue, chronic pain, and difficulty focusing.

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MHRA finds fake Ozempic pens in UK supply chain

The Pharmacist

Pre-filled pens falsely labelled as Ozempic have been identified in the UK supply chain, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed. The pens were identified before reaching UK patients, and all affected pens have now been recalled and accounted for, the MHRA said. The products were imported from legitimate suppliers in Austria […] The post MHRA finds fake Ozempic pens in UK supply chain appeared first on The Pharmacist.

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UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

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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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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

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Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’

STAT

If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. Theories about why symptoms persist long after the acute infection has cleared often point to two suspects: viral reservoirs where SARS-CoV-2 lingers and inflammation sparked by the infection that doesn’t subside.

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More Trending

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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Has the science of anti-aging caught up with the dream of a longer life?

PharmaVoice

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

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Is there a nursing shortage in the United States? Depends on who you ask

STAT

Hospitals are frustrated with a nationwide nursing shortage that’s only gotten worse since the pandemic. In 2022, the American Hospital Association quoted an estimate that half a million nurses would leave the field by the end of that year, bringing the total shortage to 1.1 million. At the same time, National Nurses United insists there isn’t a nurse shortage at all.

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FIP urges governments to address medicine misinformation

The Pharmacist

Regulating against medicine misinformation is one of several recommendations to governments made by the International Pharmaceutical Federation (FIP) in a newly published statement of policy. The new policy statement, replacing one published in 2017, also takes into account the increasing use of digital information sources, including artificial intelligence, and puts a stronger emphasis on the […] The post FIP urges governments to address medicine misinformation appeared first on The Pharm

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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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Parkinson’s UK grants £400,000 to research projects in Scotland

Pharma Times

The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes

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The PharmaVoice 100: Rare disease warriors

PharmaVoice

Biopharma leaders pounding away at rare diseases so patients with few other options can have healthier lives.

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Zuckerberg and Chan announce a New York biohub to build disease-fighting cellular machines

STAT

Meta founder Mark Zuckerberg and his wife, pediatrician and philanthropist Priscilla Chan, announced on Wednesday plans to invest $250 million over 10 years to establish a new “biohub” in New York City focused on building a new class of cellular machines that can surveil the body and snuff out disease. The new initiative, publicly revealed at the 2023 STAT Summit and previewed exclusively to STAT, is the latest program from the Chan Zuckerberg Initiative, or CZI, a company the coup

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DHSC rejects claim it failed on promise to review community pharmacy funding

The Pharmacist

The Department of Health and Social Care has refuted a claim that it has failed to meet a commitment to review the funding model for community pharmacy. The DHSC has today published its response to a report by the Health and Social Care Committee (HSCC) that found the government’s progress on its commitments to support […] The post DHSC rejects claim it failed on promise to review community pharmacy funding appeared first on The Pharmacist.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Focussing on finding value in health sciences marketing

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with life sciences advisor Randall Hein, CEO of Heinsight LLC, and health sciences marketing expert Krystle Buntemeyer, CEO of SCORR Marketing, about the trends and changes for health sciences marketing over the past few years.

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Measuring the long-term cost of restricting abortion access

STAT

When Diana Greene Foster and her team at the University of California, San Francisco, started their study on the lives of women who were denied abortions in 2008, they sought to investigate a rather commonly held view: That having an abortion hurt women’s mental and physical health, including by leading to PTSD and drug and alcohol use disorder.

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Inclusion of pharmacy technicians in New Medicine Service considered

The Pharmacist

Discussions have taken place over the inclusion of pharmacy technicians in the delivery of the NHS New Medicine Service, according to Hammaad Patel, national pharmacy integration lead at NHS England. Speaking at the Pharmacy Show at NEC Birmingham today, Mr Patel expressed the view that pharmacy technicians were ‘well placed’ in community pharmacies to provide […] The post Inclusion of pharmacy technicians in New Medicine Service considered appeared first on The Pharmacist.

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Novo Nordisk stops trial of Ozempic in kidneys as interim analysis shows success

Pharmaceutical Technology

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

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Pharmacists’ Role in Treating Substance Use in Adolescents 

National Association of Boards of Pharmacy

Young People and Substance Use Disorder October is Youth Substance Use Prevention Month , highlighting prevention and treatment efforts to keep adolescents drug free. Although drug use has always been a concern for teens, there are specific challenges that today’s youth face. Thankfully, since the coronavirus disease 2019 (COVID-19), a National Institutes of Health survey has shown that illicit use of drugs in teens has decreased, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 1

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STAT+: Zuckerberg and Chan on track to put $50 billion toward science: ‘That’s the trajectory we’re on’

STAT

Mark Zuckerberg and Priscilla Chan sit atop a fortune that is currently valued at $113 billion, and they’ve promised to give almost all of it away. Their philanthropic funding group, the Chan Zuckerberg Initiative, is committed to investing in an array of fields, including science, education, housing insecurity, and expanding access to startup capital to entrepreneurs of color.

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More than 31,000 ARRS staff recruited since 2019

The Pharmacist

More than 31,000 staff – including pharmacists, mental health practitioners and social prescribers – have been recruited to work in general practice under the Additional Roles Reimbursement Scheme (ARRS) since 2019. The total was announced today by NHS England (NHSE), alongside a video to raise awareness of the roles available to patients, after a new […] The post More than 31,000 ARRS staff recruited since 2019 appeared first on The Pharmacist.

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Influencers of Generic Drug Utilization

Drug Patent Watch

In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.

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First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

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Michael J. Fox on how far Parkinson’s research has come: ‘We don’t want to be celebrated. We want to get things done.’

STAT

When Michael J. Fox was diagnosed with Parkinson’s disease at age 29, his clearest symptom was a small one — his pinky finger was twitching. But even by that stage, 70% to 80% of a patient’s dopamine-producing cells are already gone, Fox said. “What happens in that time, that shadowy place?” Fox said, referring to the period before his pinky finger first started twitching.

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Exclusive: Lack of pharmacy representation on ICBs, warns health committee chair

The Pharmacist

Integrated care boards (ICBs) do not have ‘enough’ pharmacy representation, the Health and Social Care Committee chair Steve Brine has told The Pharmacist. The former pharmacy minister and Conservative MP for Winchester also said he felt primary care networks (PCNs) were ‘way too GP dominated’. Mr Brine was speaking to The Pharmacist following an address […] The post Exclusive: Lack of pharmacy representation on ICBs, warns health committee chair appeared first on The Pharmacist.

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Deep brain stimulation could improve memory loss in Alzheimer’s disease

Pharma Times

The new technology was safely trialled on 20 healthy volunteers for the first time ever - News - PharmaTimes

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Beam to lay off 100 employees, seek partners in research restructuring

BioPharma Dive

The base editing specialist will prioritize medicines for sickle cell and alpha-1 antitrypsin deficiency, while trimming its plans for other programs in cancer and hepatitis B.

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STAT+: How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse

STAT

Lotte Bjerre Knudsen was still getting used to all the empty benches in her lab when she ran into a tall man with black wide-framed glasses in the hallway: Mads Krogsgaard Thomsen, the new head of research at the Danish drugmaker Novo Nordisk, and her new boss. He was just one of many changes she had found upon returning from maternity leave earlier that week — along with the departures of nearly every colleague with whom she had spent the last three years struggling to create a potential

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Sanofi treatment could slow type 1 diabetes progression

European Pharmaceutical Review

TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes. Data from the Phase III PROTECT clinical trial , presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. As the primary endpoint, 94.9 percent of participants in the TZIELD group maintained peak C-peptide levels ≥0.2 pmol/mL.

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UKRI awards £10m in funding to tackle antimicrobial resistance

Pharma Times

UK researchers can apply to receive a share of £3m to set up transdisciplinary networks - News - PharmaTimes

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BrainStorm, after setbacks, withdraws approval application for ALS drug

BioPharma Dive

A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.

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STAT+: In an unusual arrangement, UnitedHealth’s board chair also owns a personal investment firm

STAT

Stephen Hemsley, the former CEO of UnitedHealth Group and its current board chair, also owns an investment firm that manages his own portfolio of UnitedHealth stock and oversees other wealthy individuals’ accounts that have held shares of companies that have direct business with or indirect ties to United. It’s an unusual arrangement for someone in such a prominent role at one of the largest health care corporations in the world, according to several experts in securities and corpo

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Starvation stress key in Micrococcus luteus cleanroom survival

European Pharmaceutical Review

A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.

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New £30m initiative launched to support innovation against antimicrobial resistance

Pharma Times

Global innovators can apply to PACE to receive up to £1m per project - News - PharmaTimes

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