Sat.Nov 12, 2022 - Fri.Nov 18, 2022

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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

STAT

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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4 pioneering social media campaigns in pharma this year

PharmaVoice

The key to a great social media campaign is often simplicity, and these pharma companies hit the nail on the head with unique strategies that aim to educate.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

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The Bug Name Emoji Game

ID Stewardship

On this webpage you will find “The Bug Name Emoji Game” which is just like “ The Drug Name Emoji Game ” and meant to be a fun medical emoji puzzle game for people who deal with different types of microbial pathogens. Simply use the emoji symbols to decipher the corresponding organism name! These puzzles have been developed by Dr.

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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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Holmes gets more than 11 years in prison for Theranos scam

STAT

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

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Is AI just hype or a real revolution in pharma? It’s complicated

PharmaVoice

Artificial intelligence can be a useful tool and will likely augment many processes in biopharma — but it's still early days, and hype is rampant.

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More Trending

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Data privacy concerns don’t hinder digital health app usage

pharmaphorum

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

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Top U.S. addiction researcher calls for broad deregulation of methadone

STAT

BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone , a key drug used to treat opioid use disorder. American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday.

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A ‘bold vision’ to prevent diabetes

PharmaVoice

Despite hearing that there’s “no money in prevention,” the CEO of Sigrid Therapeutics is forging ahead with the company’s goal of stopping Type 2 diabetes before it starts.

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What you should know about RSV

PhRMA

You are probably reading a lot about a surge of cases of respiratory viruses like respiratory syncytial virus (RSV), influenza (the flu) and SARS-CoV-2, which causes COVID-19. The triple threat of these highly contagious respiratory viruses circulating simultaneously is causing a ripple of effects on patients, health care providers and our health care system as a whole.

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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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Novartis said to be eyeing sale of ophthalmology, respiratory units

pharmaphorum

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.

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STAT+: ‘If this works, it changes everything’: Altos Labs founders lay out plan to reverse disease

STAT

BOSTON — The executives behind Altos Labs would really, really like people to stop saying they’re trying to reverse aging. They have a couple things going against them on this count. For one, the first article about the biotech and its $3 billion stash talked about Silicon Valley billionaires “ living forever.” And then there’s their most prominent scientist’s tendency to talk openly about people living to 130.

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Why the IRA will drive up the country’s drug bill — not lower it

PharmaVoice

On the surface, the Inflation Reduction Act is designed to lower drug prices, but its impact on innovation incentives could produce a landscape of new medicines that are costlier for patients.

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New data show how insurers and middlemen shift Rx costs onto patients

PhRMA

There is only one place in the health care system where middlemen refuse to share negotiated prices with patients, and that’s at the pharmacy counter. A new report reveals how this harmful tactic leads to higher costs for patients.

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HLTH 2022 – Day 2

pharmaphorum

Early on Day 2, Matthew Holt (who we recently featured in our Health Innovators video series ) will interview Walmart EVP Dr. Cheryl Pegus & SCAN Health Plan’s Dr. Sachin Jain. Then we’ll hear from Aptar Digital Health’s Sai Shankar and Pierre Laurent in a session all about patients as partners in healthcare. The day will continue with other hot topics for pharma, including health equity, cell and gene therapy, oncology, and pharmacy model disruption.

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Pfizer CEO says Covid vaccine will remain ‘free for all Americans,’ overlooking indirect costs

STAT

BOSTON — As Pfizer prepares to hike the price of its Covid-19 vaccines, the company’s CEO, Albert Bourla, maintained at a conference this week that the jabs will continue to be “free for all Americans” because insurers are required to pay the extra cost. “Americans will see no difference,” said Bourla, speaking Wednesday at the STAT Summit.

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To explore cancer’s genetic mysteries, researchers turn to ‘MACHETE’

PharmaVoice

A new CRISPR-based tool could help scientists understand and better treat cancer by revealing the complex genetic mutations that occur.

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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

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Meeting MSL training needs in an evolving landscape

pharmaphorum

As medical treatments become more complex, the role of the Medical Science Liaison (MSL) has never been more important. Healthcare professionals trust MSLs to keep them informed and up-to-date about the latest treatments, especially in fast-moving areas like oncology. But who keeps the MSLs up-to-date, and who makes sure they have the hard and soft skills necessary to be an effective partner for healthcare professionals?

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WHO, Uganda plan to test three candidate Ebola vaccines in outbreak

STAT

The World Health Organization and the government of Uganda plan to test three candidate Ebola vaccines in a clinical trial during the ongoing outbreak in the East African nation, Director-General Tedros Adhanom Ghebreyesus announced Wednesday, acting on the advice of experts convened by the global health agency. The first doses of vaccine should arrive in Uganda next week, Tedros said, though the WHO has not yet indicated a start date for the trial.

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#HLTH: ‘Unicorns are real’ — and here’s how they can navigate a challenging biotech market

PharmaVoice

Venture capitalists tackle ways companies can stay afloat while the market’s turbulent waters rise.

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NICE to update endometriosis guidelines to improve diagnosis and surgical management

Pharmaceutical Technology

The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update. This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike.

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GSK, J&J, and AZ head this year’s access to medicines ranking

pharmaphorum

The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. GSK scored highly as its R&D programmes encompass a sizeable chunk of the 83 high burden priority diseases covered in the assessment, an integrated access to medicine strategy in its governance, and robu

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Opinion: We know what it’s like to live in fear of polio. We also know how to stop it

STAT

Polio, a dangerous and even deadly infectious disease, is a distant memory for many global citizens. We have never known life without it. Despite growing up in two countries — Pakistan (Z.B.) and Cameroon (R.L.) — separated by 7,000 kilometers, we both know what it is like to live and work in communities plagued by polio. As a physician, one of us (Z.B.) has sat beside countless parents as they come to terms with the life-long disability, and sometimes even death, of their child.

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4 ways to bring COVID’s ‘warp speed’ to the next era of drug development

PharmaVoice

An IQVIA Institute for Human Data Science report outlines how companies can improve communication, recruitment, data and investing strategies to accelerate clinical trial timelines.

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Kidney Cancer UK receives commission from NICE

Pharma Times

The charity commissioned a two-year service quality audit of over 18,000 kidney cancer patients

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Roche deepens ties with Jnana with a second licensing deal

pharmaphorum

Swiss pharma group Roche has doubled down on a partnership with Jnana Therapeutics, paying $50 million upfront to tap into the Boston-based biotech drug discovery platform for a wide-ranging push across cancer, immune-mediated, and neurological diseases. The new agreement – announced on the same day that Jnana finalised a $107 million series C financing – has a potential deal value of around $2 billion and comes two years after Roche paid $40 million upfront with $1 billion at the back-end for a

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Opinion: Unseen mental health experts: people with mental illness

STAT

When I was seven years old, I watched as police carted my father out of the house and took him away. He had severe bipolar disorder and was experiencing what I know now to be an “episode”  of this mental illness. What I learned over the 40 years that my dad was alive is that he could foster a loving relationship despite not ever mastering his recurrent episodes.

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Hybrid work is here to stay — here’s how leaders should adjust

PharmaVoice

Executives across the life sciences share their tips for navigating the new norm of remote work.

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ElevateBio and Affini-T collaborate to develop T cell therapies

Pharmaceutical Technology

ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic.

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Dupixent nears EU approval for rare skin disease prurigo nodularis

pharmaphorum

Sanofi and Regeneron’s Dupixent is on track to become the first targeted drug in the EU to be approved for prurigo nodularis (PN), a rare and highly debilitating skin disease. The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

Immunity 101
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In armadillos, leprosy expands healthy liver tissue. Could that tell us something about regenerating our own?

STAT

The mystery started with some skin samples. Anura Rambukkana was a Ph.D. student in Amsterdam, analyzing biopsies from migrants with Hansen’s disease, or leprosy. The illness could be painful and disfiguring, but in the lab, the infected cells didn’t look sickly. To Rambukkana’s eye, they seemed to be doing great. He noticed the same thing with nerve cells from mice.

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How to Become a Cardiovascular Surgical Intensive Care Unit Nurse Practitioner

Board Vitals - Pharmacist

I have been a nurse practitioner (NP) in the adult cardiovascular surgical intensive care unit (CVICU) for over four years, and I often get asked how I was able to begin working there as a new NP. There are multiple paths to becoming an NP in the CVICU, but there are a few key components to achieving this final goal that can never be skipped no matter the path one should choose.

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FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly.

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Hope in sight with Apellis’ pegcetacoplan OAKS/DERBY results for GA

pharmaphorum

Last month, pharmaphorum spoke with Dr Charles C. Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the r

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