Tue.Jun 06, 2023

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Opinion: When should hospitals require masks?

STAT

Is the pandemic over ? On the one hand, Covid-19 is clearly still with us. In the U.S., over the past month there was a weekly average of 557 deaths , though the numbers are dropping sharply, from 849 four weeks ago to 208 last week. On the other, for those who are not vulnerable or immune compromised, most facets of life have returned to normal, thanks to high levels of immunity from vaccines, boosters, and past infections.

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JB Pharma: Betting big on India

Express Pharma

Pegged as one of India’s fastest growing pharma companies, JB Pharma’s recently released fourth quarter and year ended March 31, 2023 results continue to beat market growth rates. As per IQVIA MAT March 2023 data, JB Pharma continued to be the fastest growing company amongst the Top 25 in FY23, outperforming the Indian Pharma Market (IPM), growing at 22 per cent versus 8 per cent, aided by the organic business growing at 21 per cent.

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Trending Sources

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Academia’s postdoc system is teetering, imperiling efforts to diversify life sciences

STAT

For young life scientists hoping to land a prestigious faculty job in academia, postdoctoral research is practically a requirement. But it’s not a path equally open to everyone. Freshly minted life science Ph.D. graduates who have started families or have big loans, or are Black or female, say they plan to pursue postdoc positions at lower rates than their peers, according to a STAT analysis that includes previously unreported data from the National Center for Science and Engineering Stat

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Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

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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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Opinion: Four communication lessons we learned the hard way during the pandemic

STAT

Now that the Covid-19 public health emergency has ended, it’s awfully tempting to put the pandemic firmly behind us. But now is the time to look at what we have learned so that our public health communication can be more clear, consistent, and effective from now on. One thing that we haven’t talked about enough is the victories.

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How do we foster high functioning teams in the classroom?

Pulses

By: Melissa Mickley 2023 PharmD candidate If students hate it so much, why do we keep doing it? While hearing the phrase “get into your assigned groups” may cause anxiety and distress among many students, there are good reasons collaborative learning (CL) is beneficial. 1 Let’s dig into why students cringe when they hear “group work.” From an early age, schools often emphasize individual achievement and personal growth over teamwork and group achievement.

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FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

BioPharma Dive

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

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STAT+: FDA will allow troubled chemotherapy maker to resume distribution of cancer drugs in short supply

STAT

After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some   cancer medicines that are in short supply. The agency issued the import alert last week to Intas Pharmaceuticals, which is based in India, after its inspectors found a litany of quality-control problems that were detailed in a 36-page inspection report in December.

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Biocomposites embraces NanoBone technology following acquisition of Artoss GmbH

Pharma Times

The structure of NanoBone triggers bone-forming systems while also aiding rapid bone healing - News - PharmaTimes

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STAT+: Biogen board and C-suite are in step as they eye M&A opportunities, new CEO says

STAT

BOSTON — As Biogen’s new CEO Chris Viehbacher pores over Biogen’s books and scouts out M&A deals, he may have one advantage his predecessor didn’t: a good relationship with his board of directors. Investors have expressed hope over the last several years that Biogen would make more acquisition deals, but it’s been a point of contention within the company.

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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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New COVID-19 vaccine successfully tested

Pharma Times

Rocketvax and Basel University therapy uses a modified coronavirus that activates an immune response - News - PharmaTimes

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STAT+: More than 200 FDA staffers have retired in less than a year

STAT

WASHINGTON — More than 230 people have retired from the Food and Drug Administration since Oct. 1, Chief of Staff Julie Tierney said Monday. It’s part of a bigger wave of exits: In total, 634 employees have left the agency, which has a staff of about 18,000 people. There are about 2,000 vacancies at the FDA, which is a normal level at an agency that has for a long time struggled to hire and keep employees who can make bigger salaries in the private sector.

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Using twin viruses, startup AAVantgarde aims to extend gene therapy’s reach

BioPharma Dive

The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.

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STAT+: Novocure’s electric fields device prolongs survival in lung cancer, but doubts remain

STAT

CHICAGO — A medical device made by Novocure that creates electric fields in the lungs via wearable skin patches extended the survival of patients with lung cancer in a clinical trial, researchers reported Tuesday. The findings could lead to a new approval for the device, called Optune, beyond its current marketing clearance to treat a type of brain cancer.

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New AMR certification launched for antibiotic manufacturers

European Pharmaceutical Review

A new global Minimized Risk of Antimicrobial Resistance (AMR) certification has been launched to promote and demonstrate responsible antibiotic manufacturing in the global pharmaceutical supply chain. BSI, a UK standards body, developed the new certification to the Antibiotic Manufacturing Standard published in June 2022. Standard for antibiotic manufacturing to help combat AMR … Following this “ground-breaking standard” stated Courtney Soulsby, BSI Global Director for Healthcare Sustainab

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How a digital biomarker study failed, Apple’s health updates, and Carbon’s AI-driven EHR

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Closing ASCO: AstraZeneca’s ‘very special’ meeting, more CAR-T survival data and Pfizer’s PARP play

BioPharma Dive

Dramatically positive trial data for AstraZeneca’s Tagrisso capped an important conference for the British drugmaker, while Gilead built a stronger case for its cell therapy Yescarta.

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STAT+: Biotech’s trade secrets face growing threat from foreign influences, science leaders warn

STAT

BOSTON — While most panel discussions at the Biotechnology Innovation Organization’s international convention tend to be heavy on jargon and light on urgency, a conversation on Tuesday about the growing threat foreign influences pose to the industry’s trade secrets could not have been more direct. “It’s really easy to wake up one morning and realize that you might actually be an industrial spy for a foreign government,” said Allen Phelps, CEO of IPTalons

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Small molecule treatment reduces risk of death by half in NSCLC

European Pharmaceutical Review

Eighty-eight percent of lung cancer patients were alive after five years after being treated with AstraZeneca’s small molecule treatment TAGRISSO ® (osimertinib) in a Phase III trial. This was compared to 78 percent of patients on placebo in the overall trial population. The adjuvant treatment was given to early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer ( NSCLC ) patients following a complete tumour resection with curative intent.

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STAT+: Pharmalittle: Merck sues U.S. to halt Medicare drug-price negotiation; FDA oncology head wants advisory panels to keep voting on new drugs

STAT

Rise and shine, everyone, another busy day is on the way. We can tell by the steady stream of vehicles passing under our window and the outsized number of emails arriving in our inbox. But busy is generally a good thing, yes? So to help things move along as smoothly as possible, we are firing up the trusty coffee kettle and brewing another cup of stimulation.

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Oragenics secures CQDM funding for Covid-19 vaccine antigen development

Pharmaceutical Technology

Oragenics has secured funding from the Canadian bioresearch consortium CQDM to develop a variant-agnostic protein antigen for use in its Covid-19 intranasal vaccine. SynergiQC, the Quebec-based funding programme created by CQDM, has awarded the funding. The project is a partnership with Inspirevax and the National Research Council of Canada (NRC). In March 2023, Oragenics and Inspirevax entered an exclusive global licence deal to develop the former’s lead intranasal Covid-19 vaccine candidate, N

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STAT+: The woman behind AstraZeneca’s cancer winning streak

STAT

CHICAGO — It was the kind of moment scientists who develop new medicines wait their entire careers to experience. On Sunday, thousands of oncologists applauded after researchers presented data on AstraZeneca’s Tagrisso. When given after surgery to the right lung cancer patients, selected using genetic tests, it cut the death rate in half.

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The Cross-Roads Of Artificial Intelligence & Infectious Diseases Education: Witty Insights From ChatGPT

ID Stewardship

In this article, ChatGPT provides witty insights into the cross-roads of artificial intelligence and infectious diseases. Interview with: ChatGPT by OpenAI Interview by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 7 June 2023 With the exception of the questions in bold, this entire text was written by ChatGPT. The only thing removed from the questions is the instruction “in a witty way” and a character limit was used in each of the questions.

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New England Journal of Medicine publishes results from Phase 3 induction and maintenance programs evaluating upadacitinib (RINVOQ®) in Crohn's disease

World Pharma News

AbbVie (NYSE: ABBV) announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase 3 clinical trials - U-EXCEL, U-EXCEED and U-ENDURE - evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent.

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Patient recruitment - what the problems are and how Greenphire is tackling them

Outsourcing Pharma

Jim Murphy is Greenphire's CEO and leads the company's strategy and he says he is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Under his leadership, the company has expanded exponentially - in product depth, client adoption and geographic coverage.

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FDA announces additional steps to modernize clinical trials

World Pharma News

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products.

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Amgen’s Lumakras data and research shows positive results across CodeBreaK clinical trial program

Outsourcing Pharma

Research has reinforced the efficacy of Lumakras (sotorasib), a small molecule inhibitor in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).

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Venus Remedies gets Ukrainian GMP approval for carbapenem, oncology parenteral facilities

Express Pharma

Venus Remedies has received Good Manufacturing Practices (GMP) certification from Ukraine for Meropenem 500 mg, Meropenein 1000 mg, Meropenem 2000 mg, Oxaliplatin 5mg/ml, Paclitaxil 6 mg/ml, Cisplatin l mg/ml, Imipenem/Cilastatin 500 mg/500 mg of its carbapenem and oncology production facilities at its unit in Baddi, Himachal Pradesh. Granted by the State Service of Ukraine on Medicine and Dug Control (SMDC), this certification is expected to pave the way for GMP certifications for Venus Remedie

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Evotec receives grant from Open Philanthropy for discovery of RNA-targeting Henipavirus therapeutics

Outsourcing Pharma

The development of small molecule antivirals that target viral RNA in Henipaviruses will benefit from a $1.7million grant from Open Philanthropy, a philanthropic funder prioritizing global health and wellbeing.

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FDA staff appear supportive of RSV drug from AstraZeneca, Sanofi

BioPharma Dive

Agency scientists raised no major red flags in their review of the antibody medicine in documents posted ahead of a Thursday meeting of FDA advisers.

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UK plans $40m pilot of obesity drug Wegovy in primary care

pharmaphorum

UK plans $40m pilot of obesity drug Wegovy in primary care Phil.

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Merck sues to block Medicare negotiation of drug prices

BioPharma Dive

The drugmaker’s lawsuit claims the new pricing powers granted by the Inflation Reduction Act are unconstitutional and “tantamount to extortion.

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Eisai is latest pharma to suffer ransomware attack

pharmaphorum

Eisai is latest pharma to suffer ransomware attack Phil.

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'Exciting results' for Grail and UK's Oxford University study with multi-cancer detection test

Outsourcing Pharma

A healthcare company on a mission to produce a multi-cancer early detection (MCED) test so patients have more chance of being cured, has produced 'exciting results' from a study.

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Say goodbye to sagging skin with our ultimate guide to the best collagen supplements.

Welltopia Pharmacy

Say goodbye to sagging skin with our ultimate guide to the best collagen supplements. Discover the top picks for bovine, marine, and plant-based collagen supplements, as well as those with skin-boosting ingredients like vitamin C and hyaluronic acid. Learn about natural collagen-boosting foods, herbs, and vitamins. Find the best collagen supplements for anti-aging and skin health.

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