Mon.Jan 29, 2024

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Scientists document first-ever transmitted Alzheimer’s cases, tied to no-longer-used medical procedure

STAT

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease. They didn’t even have the known genetic mutations that can set people on the course for such early-onset Alzheimer’s.

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Tonix closes in on the first new fibromyalgia drug in more than a decade

PharmaVoice

In addition to the chronic disease, the non-opioid drug may have applications in other painful conditions.

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Opinion: I’m an anesthesiologist. Kenneth Smith’s execution by nitrogen gas was far from ‘textbook’

STAT

On Thursday evening, the state of Alabama executed Kenneth Eugene Smith by nitrogen gas. Now, there are dueling narratives about what happened. Alabama claims it went perfectly, proving that nitrogen is a humane, effective alternative to lethal injection (which it previously tried, unsuccessfully, to use on Smith). It says that based on this experience, other states should follow its example.

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AstraZeneca, Daiichi aim for first pan-tumor ADC approval

PharmaVoice

A “tumor agnostic” FDA approval for the companies’ Enhertu would break new ground for antibody-drug conjugates.

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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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Pricey sickle cell treatments raise daunting new challenges for Medicaid programs

STAT

Living with sickle cell disease has not been easy on Kourtney Cunningham. The genetic blood disorder typically causes her to experience three episodes of extreme pain each month and she can end up in the hospital at least twice a year due to these crises. Then there are blood transfusions every four weeks.

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Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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More Trending

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AstraZeneca, Daiichi aim for first pan-tumor ADC approval

BioPharma Dive

The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.

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Opinion: Which country has the best health care? That’s the wrong question

STAT

I’ve spent my career studying how different health care systems work. People love to ask me which country has the best care — and are often disappointed when I don’t have an easy answer for them. Every health care model involves people doing their best to balance competing priorities in the face of limited resources. In other words, every system involves tradeoffs.

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First impressions matter: Why getting your onboarding right is key for digital engagement

pharmaphorum

Creating a positive onboarding experience is crucial for engaging healthcare professionals (HCPs) in digital platforms and utilising data effectively. Discover why first impressions matter and how to get your onboarding process right for optimal digital engagement.

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Supreme Court slates abortion pill case for March

STAT

WASHINGTON — The Supreme Court will hear arguments about access to the abortion medication mifepristone on March 26. The lawsuit is the first major test of abortion limits to go before the highest court since the same panel overturned federal abortion rights in June 2022. It also could have massive ramifications for the Food and Drug Administration’s authority.

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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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CPE stresses need for Pharmacy First awareness with publicity launch

The Pharmacist

A series of resources to help pharmacists promote the incoming Pharmacy First service has been made available by Community Pharmacy England (CPE). The launch date for the new service has been confirmed as 31 January, and CPE emphasised that for its self-referral (walk-in) aspect to be a success, the general public and patients need to […] The post CPE stresses need for Pharmacy First awareness with publicity launch appeared first on The Pharmacist.

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STAT+: Cognito raises $35 million for Alzheimer’s treatment device, touts benefits compared to drugs

STAT

Just as a new wave of approved drugs for Alzheimer’s disease reaches patients, medical device company Cognito Therapeutics has raised a fresh $35 million to advance its alternative treatment for the neurodegenerative disease. With the new Series B extension funding, the Cambridge, Mass.-based company has now raised $128 million to develop its headset that uses gamma frequency light and sound stimulation to combat the cognitive decline that’s the hallmark of Alzheimer’s.

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Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

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23andMe breach targeted Chinese, Jewish populations

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. Today, we discuss how Medicaid might pay for the costly but potentially curative sickle cell gene therapies, as well as the shocking lawsuit that outlines a data breach at 23andMe that targets Chinese and Jewish customers.

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Grifols sues Gotham City over fraud allegations

pharmaphorum

Spanish drugmaker Grifols has hit back at hedge fund Gotham City Research, which claimed it had fraudulently manipulated its financial reporting, with a lawsuit filed in New York. The complaint has been brought against Gotham City and co-founders Daniel Yu and Cyrus de Weck, along with other defendants, and accuses them of being “predatory short sellers…who illicitly profit from their rigged short-and-distort schemes.

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STAT+: European regulators tout their accomplishments against pharma’s anticompetitive practices

STAT

European antitrust regulators want you to know that fighting crime in the pharmaceutical industry pays. Between 2018 and 2022, the European Commission and antitrust regulators in numerous European countries adopted 26 decisions concerning anti-competitive practices by drug companies by imposing more than $845 million in fines or accepting legally binding commitments by manufacturers to alter their corporate behaviors.

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Moderna leads the development of mRNA vaccines in infectious diseases

Pharmaceutical Technology

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

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STAT+: Pharmalittle: We’re reading about Medicaid and sickle cell, pharma CEOs, 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 returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to nudge it in a better direction with a cup or two of delicious stimulation.

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BMS subcutaneous Opdivo clears first phase 3 trial

pharmaphorum

Bristol-Myers Squibb is getting closer to offering a subcutaneous version of its cancer immunotherapy Opdivo to patients after it matched the current intravenous formulation in a head-to-head trial in kidney cancer.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. 1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way t

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Moderna leads development of mRNA vaccines in infectious diseases: GlobalData

Express Pharma

The global messenger ribonucleic acid (mRNA) vaccines market currently consists entirely of vaccines for COVID-19. The rapid sequencing of the SARS-CoV-2 viral genome and the subsequent development of mRNA vaccines in response to the pandemic led to the authorisation of the first of these vaccines in December 2020. However, several pharma companies have mRNA vaccines in late-stage development for other infectious diseases, with Moderna dominating in terms of research and development (R&D) in

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GSK’s Omjjara EU-cleared for splenomegaly in myelofibrosis

pharmaphorum

GSK has claimed EU approval of Omjjara for the treatment of splenomegaly or symptoms in adult myelofibrosis patients with moderate-to-severe anaemia

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Expert Speak | Saif Mehkri, Founder & Director, Bio-gen Extracts Pvt. Ltd.

Express Pharma

Express Pharma – Nutrify Today Boardroom series offers a platform for meaningful dialogues on the vast ocean of opportunities in nutraceuticals, provided the right course is set for long and sustainable growth. In this video, Saif Mehkri, one of the three co-founders of Bio-gen, speaks about starting from a 1000 square feet facility, with one angel investor to becoming one of India’s largest nutrition ingredients companies in 23 years.

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Keytruda improves survival in early-stage kidney cancer

pharmaphorum

MSD’s Keytruda is the first cancer immunotherapy to improve survival when used as adjuvant therapy in renal cell carcinoma (RCC).

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Ascidian launches first-ever clinical study of RNA exon editor for vision loss

Pharmaceutical Technology

An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.

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Key achievement for Repare Therapeutics after receipt of $40 million Roche payment

Outsourcing Pharma

Clinical-stage precision oncology company, Repare Therapeutics Inc., has received a $40 million milestone payment from Roche after dosing the first patient in a clinical trial.

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Expanding Pharmacy First to cover earwax removal 'could solve postcode lottery’

The Pharmacist

The chief executive of the Company Chemists’ Association (CCA) has suggested Pharmacy First could be expanded to help fill gaps in NHS earwax removal provision in England. Recent research by the Royal National Institute for Deaf People (RNID) found that fewer than half of integrated care boards (ICBs) provide full earwax removal services in line […] The post Expanding Pharmacy First to cover earwax removal 'could solve postcode lottery’ appeared first on The Pharmacist.

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NHS delivers a further 5,000 permanent hospital beds

Pharma Times

A total of 103,277 general and acute beds are now available to NHS patients

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Nick Kaye: LPCs have a responsibility to ‘demystify’ Pharmacy First

The Pharmacist

Local Pharmaceutical Committees (LPCs) have a responsibility to help other healthcare providers and commissioners understand what Pharmacy First is, and what it is not, National Pharmacy Association (NPA) chair Nick Kaye has told our sister title, Healthcare Leader. Speaking to the publication, Mr Kaye said that directors of primary care ask him to ‘tell us […] The post Nick Kaye: LPCs have a responsibility to ‘demystify’ Pharmacy First appeared first on The Pharmacist.

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Revised ISO guideline highlights toxicological evaluation of extractables and leachables

European Pharmaceutical Review

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Also covered in the guideline are “the methods and criteria used to assess whether exposure to a constituent is without appreciable harm”. As highlighted by the International Organization for Standardization (ISO), the process described in the standard is relevant to chemical characterisation, such as extractable data or leachable data ( E&L ), information obta

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Cell and gene therapies – top pharmaceutical industry trend to watch for 2024

Pharmaceutical Technology

The full potential of cell and gene therapies (CGTs) has not yet been discovered as these therapies promise life-changing treatments.

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The Link Between Calcium Intake and Strong Bones

Welltopia Pharmacy

Boost Calcium Intake and Strong Bones with Welltopia's Calcium Reserve, the key to enhanced bone health and osteoporosis prevention.

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FDA starts swift review of tumour-agnostic use of Enhertu

pharmaphorum

AstraZeneca and Daiichi Sankyo’s Enhertu could become the first therapy approved by the FDA for use in any HER2-positive cancer, regardless of its location in the body. The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.

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Bristol Myers Squibb’s Abecma recommended for EU approval

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Bristol Myers Squibb’s Abecma for multiple myeloma.

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IQVIA: Healthcare data regional compliance complexity requires AI, ML and NLP automation

Outsourcing Pharma

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear.

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