Sat.Nov 26, 2022 - Fri.Dec 02, 2022

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After three years in prison, ‘CRISPR babies’ scientist is attempting a comeback

STAT

He Jiankui, the Chinese biophysicist who created the first gene-edited children , had been quiet since completing a three-year prison sentence in April, leaving many to wonder whether he had plans to return to scientific research. Earlier this month, we got his answer. On Nov. 9, He posted photos to Twitter of himself sitting at a computer in a white office.

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5 enduring mysteries of the Barry and Honey Sherman murders

PharmaVoice

After nearly five years, the homicide case involving pharma billionaires continues to perplex investigators.

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GaBI Publishes Report on ASBM Webinar on Biosimilar Success Factors

Safe Biologics

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The report summarizes the presentations from the June 29th webinar which examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US” View the webinar below: The report also addresses audience questions that were unable to be answered during the programs due to time constraints.

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Five Things Pharmacists Should Know About Ventilator Associated Pneumonia (VAP)

ID Stewardship

In this article a pharmacist with advanced training and experience in infectious diseases discusses five things pharmacists should know about ventilator associated pneumonia (VAP). Authored By: Lucia Rose, PharmD, BCIDP. Article Posted 1 December 2022. It was the fall of 2009; I was a proud PGY-1 resident at UMass Medical Center rounding with a large team in the ICU.

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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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STAT+: Alzheimer’s researchers try out an unfamiliar sensation: optimism

STAT

SAN FRANCISCO — Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success. This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-lo

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Non-toxic and addiction free: The promise of a new pain med

PharmaVoice

Why South Rampart Pharma’s novel new molecule could be a key to solving the global pain epidemic.

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More Trending

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Steps to building a more patient-centric industry

pharmaphorum

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. In 2021, a CISCRIP Perceptions and Insights Study reported more disruption to daily routines compared to previous years, citing length of visits, travel, and diagnostic tests as top burdens

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Opinion: Congress: Close the gap between funding for nutrition research and the toll diet-related disease takes on Americans

STAT

You are what you eat. Every year, new scientific discoveries make clear that food is critical to health. In recent years, nutrition research trials have shown that a Mediterranean diet reduces cardiovascular disease; ultra-processed foods increase weight gain; omega-3 fatty acids improve IQ in preterm babies; cocoa prevents heart attacks; and vitamin D supplements do — well, almost nothing.

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Evommune’s unique method of drug discovery is more than skin deep

PharmaVoice

The biotech is using human skin squares from plastic surgery to find the best immunological molecules for solving conditions like dermatitis.

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AstraZeneca enters $320m deal to acquire Neogene

Pharmaceutical Technology

AstraZeneca has signed an agreement for the acquisition of all outstanding equity of clinical-stage biotechnology firm Neogene Therapeutics in a deal totalling up to $320m. Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies.

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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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Stories from the lab: Researchers discuss innovative treatments for cancers of the blood

PhRMA

The biopharmaceutical industry is one of the most research-intensive of all sectors in the U.S. economy and supports a broad range of STEM jobs through R&D and manufacturing. At the backbone of the biopharmaceutical ecosystem are its researchers. Each day, in labs across the country, these individuals work tirelessly on the front lines of research and development to help bring novel medicines to patients.

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STAT+: Detailed data on Alzheimer’s therapy from Eisai, Biogen hold up to scientific scrutiny

STAT

SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy. The drug, lecanemab, slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo in a roughly 2,000-volunteer clinical trial.

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5 final FDA action dates to watch this year

PharmaVoice

A potential flurry of regulatory activity could be on the horizon yet this year — and several key drug approvals are at stake.

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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

For several decades, researchers have been investigating the role of ketamine in treating depression. Now, efforts are underway to study ketamine’s effects in Parkinson’s disease, fibromyalgia, and Rett syndrome. On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease.

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Touchlight receives funding to develeop DNA vaccine platform

Pharma Times

Bill & Melinda Gates Foundation grant will boost potential of nanoparticle-formulated doggybone DNA

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Opinion: Breakthrough Therapies Act: Good idea, wrong solution

STAT

The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.) as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The act would automatically reclassify to Schedule II any experimental medicine designated by the Drug Enforcement Agency as a Schedule I controlled substance — defined as a

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10 of our most popular articles in 2022

PharmaVoice

Methadone, rock ‘n’ roll, clinical trial overhauls — here’s a look at our most-read stories of the year.

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C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

Pharmaceutical Technology

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD).

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How automation can help to address supply chain challenges in pharma

pharmaphorum

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Incidents such as the hormone replacement therapy drug shortage in early 2022 have shown the damaging impact supply chain issues can have on people who depend on these drugs.

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In Philadelphia, ‘tranq’ is leaving drug users with horrific wounds. Other communities are bracing for the same

STAT

PHILADELPHIA — The volunteers were handing out the staples of harm reduction: safe injection and smoking kits, condoms, and Narcan, the opioid overdose reversal medication. Down the line, they were distributing hats, socks, coats, and blankets to the people who use drugs who came to this outreach event on a recent Saturday, a bright, cold morning a few days before Thanksgiving.

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Avoiding a ‘bad trip’ in psychedelic clinical trials

PharmaVoice

Psychedelic drug trials pose a number of challenges, but researchers can take these steps to boost patient safety.

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Eisai and Biogen present promising lecanemab study results

Pharma Times

Phase 3 research shows that Alzheimer’s disease treatment meets primary and secondary endpoints

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Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

PharmaTech

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment. The sources said its members were frustrated that it was late to engage when Congress was debating the Inflation Reduction Act, which gives Medicare the power to negotiate drug prices.

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Healthcare tech’s biggest busts

PharmaVoice

The metaverse, blockchain, DCTs and more — here are some of the most recent fails in healthcare tech.

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Current pipeline developments could bring new hope for patients with PPMS

Pharmaceutical Technology

Multiple sclerosis (MS) is an autoimmune disease causing chronic inflammation and demyelination of the nerves, affecting around 2.5 million people worldwide. While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options.

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Increasing sustainability in pharma requires an industry-wide effort

pharmaphorum

With COP27 concluding in November, Ben Hargreaves takes a look at what efforts pharma companies are making to limit their environmental impact. The past eight years are set to be the eight warmest on record. The rate of sea level rise has doubled since 1993; the past two and half years alone represent 10% of the overall rise in sea level since records began 30 years ago.

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Stanford is investigating its president over allegations of research misconduct

STAT

Stanford University has opened an investigation into its president, Marc Tessier-Lavigne, a renowned neuroscientist and former biotech executive, for research misconduct after experts alleged papers on which he was an author included altered images, the university confirmed. The university’s board will oversee the investigation.

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How Do You Become an Anesthesiologist?  

Board Vitals - Pharmacist

Anesthesiologists are medical doctors who specialize in the administration of anesthesia. These specialists work together with surgeons, surgical technologists, and other medical professionals to ensure patients are comfortable and healthy before, during, and after surgical procedures. Like with most specialties, the road to becoming an anesthesiologist is long and challenging to ensure practitioners are prepared to deliver the utmost quality in patient care.

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First adaptive clinical trial for flu

European Pharmaceutical Review

A £2.9 million, UK-wide adaptive platform trial (APT) has been launched to find effective treatments for people hospitalised with severe flu for the first time, testing multiple options simultaneously in thousands of people then modifying treatments quickly. The research aims to find treatments that reduce deaths from flu and prevent patients needing intensive care.

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. The challenge the industry faces, however, is that operational certainty is exacerbated by the impact of global disruptions, such as the effect of COVID-19, natural disasters, and regional conflicts.

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Image manipulation in science is suddenly in the news. But these cases are hardly rare

STAT

In 2004, Mike Rossner and Kenneth Yamada, two top editors at the Journal of Cell Biology, wrote an editorial alerting readers to what they saw as an emerging problem in science: Thanks to Photoshop, researchers could prettify the images in their manuscripts in ways that might cross the line into deception in an effort to clear the bar of peer review.

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Respiratory vaccination candidate tested in German hospitals

Pharma Times

Novel tuberculosis vaccine tested in a large phase 3 trial against severe respiratory infection disease

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Vaccines Europe launches first pipeline review

European Pharmaceutical Review

Vaccines Europe has unveiled its first pipeline review of its 15 members companies, with 100 vaccine candidates as of July 2022. . The review revealed a pipeline aimed at tackling current and future challenges, such as antimicrobial resistance (AMR) and respiratory tract infections, through leveraging a wide range of new technology platforms. The data indicated 46 percent of the vaccine candidates target infections that do not have an available vaccine.

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Supporting the era of green pharmaceuticals in the UK

pharmaphorum

According to a report by the Office of Health Economics (OHE), commissioned by the Association of the British Pharmaceutical Industry (ABPI), immediate action must be taken by governments, health systems, and companies to secure the era of green pharmaceuticals. ‘Supporting the era of green pharmaceuticals in the UK’ highlights that, while Britain can play a leading role in the sustainability agenda for pharmaceuticals, action must also be taken on a global scale to ensure impact.