Sat.Aug 20, 2022 - Fri.Aug 26, 2022

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Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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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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With market success at stake, can tech help solve the diversity problem in clinical trials?

PharmaVoice

Diversity in clinical trials isn’t only important for the health of the overall patient population — it can save millions in lost profits.

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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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First 90 Days: Agios Pharmaceuticals’ Brian Goff

PharmaVoice

The rare disease veteran and first-time CEO is bringing his expertise to the company as it launches the first FDA-approved treatment for pyruvate kinase (PK) deficiency.

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Bayer unit BrainVectis cleared to start Huntington gene therapy trial

pharmaphorum

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of

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MIT’s AI model can detect Parkinson’s by tracking breathing patterns

Pharma Times

The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing

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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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Oncolytic viruses: past and present

European Pharmaceutical Review

IN 2022, treating glioblastoma (GBM) remains an uphill battle. Current therapeutic options show limited success and neuro-oncology teams often struggle to balance their benefits with a patient’s quality of life. Cutting-edge strategies, however, are now revisiting the use of oncolytic viruses – viruses that selectively infect and kill cancer cells – which may broaden and advance the therapeutic landscape.

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The story behind the PharmaVoice 100

PharmaVoice

Taren Grom, our editor-in-chief emeritus, explains how the coveted PharmaVoice 100 awards got its start and what makes it stand out in the industry.

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Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft

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Pfizer’s RSV vaccine candidate shows promise in older adults study

Pharma Times

It is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year in the US alone

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7 Things You Need to Know Before Taking the Child Neurology Certification Exam 

Board Vitals - Pharmacist

The American Board of Psychiatry and Neurology (ABPN) Certification Exam in Child Neurology is a board examination that tests a candidate’s knowledge of the fundamentals of child neurology. The exam is held once a year, and is required to become board certified in Child Neurology. We’ve compiled some of the most frequently asked questions about the test.

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Patents, pandemics and pricing: a peek at the top drug from every big pharma

PharmaVoice

A look at how the biggest pharma companies in the world and their top-selling drugs fared in the first half of the year.

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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is banking on a collaborative approach to scientific innovation to address the growing problem of drug resistance in tuberculosis (TB). Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023.

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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Pharma Times

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

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Outsourcing strategists thinking farther ahead than ever: CPHI

Outsourcing Pharma

The groupâs latest report glimpses inside the minds of pharma leaders, who are looking at a productâs full life-cycle development at the preclinical stage.

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Flipping the script to disrupt, redefine and accelerate the patient care journey

PharmaVoice

A new, digitally innovative care model empowers patients and expedites their access to treatment.

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New patent for Alkermes Inc drug ARISTADA

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are sixteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

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Fatty liver disease: With little early detection, more challenging drug development

pharmaphorum

For most of my adult life, I had been the typical American fat guy, gaining a pound or two a year and thinking little of it. That was until my doctors stunned me with the news that I had cirrhosis caused by non-alcoholic steatohepatitis, or NASH, a severe form of fatty liver disease that often has few or no symptoms until very late stages. I had never heard of NASH, and I was even more shocked when I started searching online and discovered the prevalence of the disease and the tragic reality tha

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My adult ADHD drugs felt like a lifeline. Then came the scary side-effects …

The Guardian - Pharmaceutical Industry

After a year on prescription stimulants, I started to unravel. Would a desperate experiment with street narcotics make me see things differently? At first being diagnosed with ADHD came as a relief. I cried in the psychiatrist’s office: maybe I wasn’t lazy after all. He gave me pills that, within days, offered me a glimpse of what I thought a neurotypical person’s brain might feel like: focused and smooth, like a game of leisurely tennis rather than a ball machine going berserk.

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Woman of the Week: Glympse Bio’s Dr. Tram Tran

PharmaVoice

How the chief medical officer of the emerging diagnostic company is using the patient perspective as a guiding light.

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EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

EMCrit Project

It is unacceptable to have the rates of Awareness during Paralysis seen in a recent ED sedation study--We are better than this. EMCrit Project by Scott Weingart, MD FCCM.

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Management is Messy

The Honest Apothecary

I am convinced that one of the reasons why so many healthcare professionals struggle when transitioning to management roles is the sheer messiness of it all. Medical folks are trained to insist upon good order, and rightly so. Chaos is the enemy of workplace safety and patient care. Doctors, nurses, and pharmacists generally prefer consistent and well-defined workflows and have a low tolerance for ambiguity.

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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

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Moderna, Eli Lilly and Schrödinger seek to boost financial and people strategies with key new hires

PharmaVoice

How the latest personnel shifts are impacting each company and the industry at large.

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Environmental Monitoring In-Depth Focus 2022

European Pharmaceutical Review

A strategic approach to optimisations of testing bacterial endotoxins. Given industry’s recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise.

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Janssen’s teclistamab gets CMA from European Commission

Pharma Times

Teclistamab is the first bispecific antibody worldwide to be approved for patients with relapsed and refractory multiple myeloma

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Amazon healthcare push shifts with closure of telehealth service

pharmaphorum

Amazon’s ambitious plan to disrupt the healthcare category seems to have had a course correction after the online retail giant announced it plans to shut down its telehealth service Amazon Care. It’s a dramatic change in direction, coming just a few months after Amazon was trumpeting its intention to make the three-year-old telehealth service available to employers nationwide in the US.

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Innovation Leads to Transformation | Avant Pharmacy and Wellness Center

PioneerRx

In the world of independent pharmacy, Amina Abubakar is something like a celebrity. For over a decade, Amina has promoted the profession and practiced at the top.

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018. 2.

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Alpha Cognition announces bioequivalence study results for Alzheimer’s

Pharma Times

In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over

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Axsome bounces back as FDA clears depression drug

pharmaphorum

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The FDA has cleared Auvelity (dextromethorphan/bupropion) for the treatment of major depressive disorder (MDD) in adults, setting up a launch in the fourth quarter of this year. It is the first and only oral NMDA receptor antagonist to be approved for this use, and the first oral therapy with a new mechanism of action in around