STAT

APRIL 24, 2023

A new book on the U.S. response to the Covid-19 pandemic paints a picture of a country ill-prepared to cope with a dangerous biological foe, riven by partisan politics, and led by people who saw little political gain in taking ownership of managing the crisis. It also describes a country that remains ill-equipped to battle the next pandemic or major disease threat, though it lays out changes that could strengthen the country’s position.

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PharmaVoice

APRIL 25, 2023

The longtime pharma leader is stepping down from his role as chair of Regeneron’s board in June after decades in drug development.

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Drug Development 264

BioPharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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EMCrit Project

APRIL 27, 2023

The precise utilization of ABG, VBG, and pulse oximetry remains controversial. Unfortunately, there is little high-level evidence investigating whether these interventions affect patient outcomes (for example, there is precious little evidence to support most of the target values that we're chasing after). This chapter attempts to explore the strengths, weaknesses, and indications for various techniques. […] EMCrit Project by Josh Farkas.

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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.

STAT

APRIL 25, 2023

As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders

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PharmaVoice

APRIL 24, 2023

Two decades after the Human Genome Project, scientists are on the brink of uncovering its full potential for drug development.

Drug Development 245

Drug Development 245

Pharmaceutical Technology

APRIL 26, 2023

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

Medication Delivery 115

Medication Delivery Communication Drug Development 115

STAT

APRIL 26, 2023

When Cecilia Sorensen was an emergency medicine resident practicing at Denver Health in Colorado a few years ago, summer was known as “trauma season.” Gunshot and motor vehicle accident victims, people with heart attacks and COPD would stream into the ER. Later, on a fellowship, she witnessed the health impacts of drought in Syria. The common driver, she realized, was climate change and its impact, both locally and globally.

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PharmaVoice

APRIL 24, 2023

Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

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BioPharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

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Pharmacy Management

European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

Vaccines 108

Vaccines Immunity Immunization 108

STAT

APRIL 27, 2023

In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.

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Hospitals 288

PharmaVoice

APRIL 28, 2023

An industry veteran, innovator and curator, Dr. Amir Kalali’s vision for the future is patient-focused.

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BioPharma Dive

APRIL 26, 2023

Founded by Howard Chang, John Maraganore and others, the RNA-focused startup drew investment from a large group of blue-chip venture investment firms.

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PharmaTech

APRIL 28, 2023

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

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STAT

APRIL 28, 2023

Elenoe “Crew” Smith used to faint at the sight of blood. Still, she knew from a very young age that she wanted to help people living with sickle cell disease. Now, as a research director at Vertex Pharmaceuticals, she is working on potential sickle cell medicines. Smith was in STAT’s 2017 class of Wunderkinds , an annual selection of standout researchers who are launching their careers.

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Medical Schools Hospitals 275

PharmaVoice

APRIL 26, 2023

Drug developers have tried — and failed — to create a male contraceptive for decades. Now, one group of scientists might be on the verge of success.

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Drug Development 147

BioPharma Dive

APRIL 26, 2023

The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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STAT

APRIL 28, 2023

After several quarters of promising to deliver concrete progress on key digital therapeutics projects, Swedish pharmaceutical company Orexo on Thursday reported the somber news that its efforts remained stalled. Orexo, which made almost all of its $60 million in 2022 revenues from U.S. sales of Zubsolv, a drug used to treat opioid use disorder, earned negligible income from its three software-based treatments in the first quarter of the year.

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Pharmaceutical Companies Pharmaceutical Companies 263

FDA Law Blog: Biosimilars

APRIL 25, 2023

By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.

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Documentation Labelling Communication 105

BioPharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

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Documentation 105

STAT

APRIL 27, 2023

Eleni Tsigas likens her first experience with preeclampsia to a plane crash. She was in the midst of what she thought was a healthy first pregnancy, with low risk for complications. But at 29 weeks, she was rushed to the emergency room with what she now knows are classic signs of preeclampsia: very high blood pressure, a pounding headache, nausea, blurred vision.

Hospitals 271

Hospitals 271

European Pharmaceutical Review

APRIL 27, 2023

Immunotherapy treatment blinatumomab will now become standard treatment worldwide for babies with acute lymphoblastic leukaemia (ALL). This decision is based on new results from an international trial published in the New England Journal of Medicine. Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy.

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Chemotherapy Immunity Immunization 99

BioPharma Dive

APRIL 28, 2023

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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Biosimilars 117

Pharmaceutical Technology

APRIL 24, 2023

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with cert

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Compounding Chemotherapy 105

STAT

APRIL 23, 2023

At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey’s law that allows medically assisted suicide — but she was bedbound, too sick to travel. So last Nov. 17, surrounded by three of her children, Sheridan drank a lethal dose of drugs prescribed by a doctor she had never met in person, only online.

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Pharmaceutical Business Review

APRIL 27, 2023

Opfolda will be used as an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in LOPD (acid α glucosidase [GAA] deficiency) adult patients. The European Commission (EC) is expected to take decision on miglustat’s authorisation in the third quarter of this year. Pombiliti (cipaglucosidase alfa), the biologic component of the two-component therapy, received EC approval last month.

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BioPharma Dive

APRIL 27, 2023

The cell and gene therapy developer will also cut back on manufacturing and certain research in California as it redirects resources to three priority programs.

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Board Vitals - Pharmacist

APRIL 28, 2023

The American Board of Pediatrics (ABP) General Pediatrics Certifying Exam is the final step on your journey towards becoming a pediatrician. This exam tests you on the knowledge you’ll need to practice as a general pediatrician. What do you need to know about the ABP exam, and how can you best prepare to pass? What requirements are there for certification?

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Medical Schools 98

STAT

APRIL 27, 2023

Despite decades of advancements in genomics, we still don’t know what most of our DNA does. But an ambitious international research collaboration is providing new answers about how genetics shapes human health and disease, with help from an unlikely source — a menagerie of mammals. The findings , reported in a set of 11 studies published on Thursday in the journal Science, come out of the Zoonomia Project, which compared the genomes of 240 mammalian species.

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Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).

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BioPharma Dive

APRIL 27, 2023

Partner Regeneron said the data, which showed substantial reduction of a key protein, suggests hope for the “bold dream” of silencing genes in the brain.

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European Pharmaceutical Review

APRIL 24, 2023

Included in this issue of European Pharmaceutical Review : FOREWORD New quality requirements for tobacco products David Elder, David P Elder Consultancy QA/QC MASS SPECTROMETRY The benefits of mass spectrometry for expediting biologics to patients Ian Anderson, Mostafa Zarei and Qifeng Zhang, Lonza IN-DEPTH FOCUS: Bioprocessing/Bioproduction Realising the potential of AAV gene therapies Rajiv Vaidya, Andelyn Biosciences What gene therapy manufacturers can gain from collaboration Neil Almstead,

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Drug Development 95