STAT

MAY 19, 2023

A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “ epigenome editing ” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwo

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ALiEM - Pharm Pearls

MAY 19, 2023

A heavy alcohol drinker, who is well known to your Emergency Department, presents with altered mental status, except that he looks different this time. He looks really bad, stating that he has been vomiting blood. He is hypotensive. He then vomits a copious amount of blood right in front of you. You intubate the patient and initiate the massive transfusion protocol, but everything you pour into him seemingly comes right back out.

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STAT

MAY 19, 2023

When cyclist Alison Tetrick joined the sport’s professional ranks, she received the perks that come with the job — new bikes and clothing included. But she could never get comfortable on the bike saddles. After several years, Tetrick suffered so much damage to her genital area that she eventually resorted to surgery to trim excess skin from her labia.

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PharmaVoice

MAY 19, 2023

Pharma leaders share what they do to keep their teams from fizzling out.

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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

MAY 19, 2023

Four different companies agreed to buy the assets of Pear Therapeutics at auction on Thursday morning after the digital health company filed for bankruptcy last month. Click Therapeutics, Welt Corp, Harvest Bio, and Nox Health Group each acquired bits of the company for $6.05 million, far short of the $32 million in debt Pear carried. A hearing to approve the sale will be held on May 22.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

Adverse Reactions 133

Adverse Reactions 133

BioPharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

Vaccines 115

Vaccines 115

STAT

MAY 19, 2023

The Food and Drug Administration on Friday approved the first treatment for a devastating condition that causes the skin to be so fragile that even a touch can cause it to splinter, bringing another gene therapy onto the market. The therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa, a genetic disease that causes painful blisters and persistent wounds.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.

Mayo Clinic 105

Mayo Clinic Dosage Biosimilars Immunity 105

STAT

MAY 19, 2023

WASHINGTON — A Food and Drug Administration official provided some insights this week into the FDA’s thinking about a groundbreaking approach to making gene therapies that could help make the products more profitable and attractive to investors. At issue is whether makers of gene therapies may one day use a common manufacturing platform.

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Pharmacy Management

European Pharmaceutical Review

MAY 19, 2023

A Phase III trial has found that the novel combination antibiotic sulbactam-durlobactam prevents at least as many fatalities of hospital-acquired pneumonia as colistin, the best currently approved treatment. This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus co

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Hospitals Medical Schools 103

STAT

MAY 19, 2023

Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug. “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy.

Diabetes 233

Diabetes 233

European Pharmaceutical Review

MAY 19, 2023

Final draft guidance has been published for the first National Institute for Health and Care Excellence (NICE)-recommended treatment for symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. The regulatory body’s decision means up to 150,000 patients would be eligible for AstraZeneca-made dapagliflozin (Forxiga).

Hospitals 101

Hospitals 101

STAT

MAY 19, 2023

Viral hepatitis affects almost 400 million people and kills more than 1 million each year. Yet it was left off the agenda of the Millennium Development Goals. Now, 20 years later, we have a cure for hepatitis C and a highly effective vaccine and treatment for hepatitis B — but annual deaths from the two are projected to outnumber deaths from HIV, tuberculosis, and malaria combined by 2040.

Vaccines 230

Vaccines 230

Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.

Labelling 98

Labelling 98

STAT

MAY 19, 2023

A panel of expert advisers to the Food and Drug Administration voted Friday against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines. The group voted 12-2, with two abstentions, that the benefits of Intercept’s medicine did not outweigh its risks, citing serious concerns about fatal drug-related liver damage and uncertainty over whether the drug’s modest effects will ultimately improve the lives of

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Pharmaceutical Technology

MAY 19, 2023

Multiple sclerosis (MS) is a primary autoimmune disease in which inflammation is a core contributor to the degeneration of the central nervous system (CNS), leading to neurological disability and affecting sensory, visual, motor, and autonomic systems. While MS is not a terminal diagnosis, the effect of the disease on the CNS can significantly impact patients’ independence and disturb their daily lives.

Biosimilars 98

Biosimilars 98

STAT

MAY 19, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going.

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The Pharmacist

MAY 19, 2023

The chief executive of the Company Chemists’ Association, Malcolm Harrison, has called for an immediate stop to the recruitment of pharmacists into general practice. This follows the government’s announcement yesterday that it had surpassed its target to recruit 26,000 more staff into primary care nearly one year ahead of schedule. Leaders across the pharmacy sector […] The post Stop ARRS recruitment immediately, says CCA appeared first on The Pharmacist.

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STAT

MAY 19, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to manicure the Pharmalot grounds, catch up on our reading, promenade with the official mascot and his stay-over playmate, and of course, hold a listening party with Mrs.

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Vaccines Immunity Immunization Hospitals 188

Pharma Times

MAY 19, 2023

Screening patients to assess their clopidogrel resistance status will allow for alternative treatments

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BioPharma Dive

MAY 19, 2023

The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.

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Vaccines Immunity Immunization 98

The Pharmacist

MAY 19, 2023

The Department of Health and Social Care (DHSC) has issued a serious shortage protocol (SSP) for Utrogestan 100mg capsules, restricting the amount that a pharmacist can dispense to just two months’ supply with immediate effect. DHSC said that Utrogestan, a progesterone hormone replacement therapy (HRT) drug, was expected to be in intermittent supply until late […] The post Utrogestan restricted to two months’ supply appeared first on The Pharmacist.

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Express Pharma

MAY 19, 2023

To combat AMR, the report recommends modifying procurement practices, adding essential antimicrobials in state drug procurement lists A new report released by the Indian School of Business’ Max Institute of Healthcare Management and the Center for Global Development calls on key stakeholders across national and regional governments to improve antimicrobial innovation, accessibility, and stewardship practices to combat Antimicrobial Resistance (AMR) in India.

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Hospitals Compounding 90

The Pharmacist

MAY 19, 2023

More transparency is needed about where General Pharmaceutical Council (GPhC) fees are spent if pharmacists are to be asked to pay more, pharmacy representatives have said. Earlier this week, the GPhC proposed raising its fees by 7.5% - meaning that from April 2024, the pharmacist registration renewal fee would increase by £19, from £257 to […] The post GPhC must justify fee increase, say trade bodies appeared first on The Pharmacist.

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Pharma Times

MAY 19, 2023

Treatment concerns up to 150,000 patients in England with chronic heart failure

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World Pharma News

MAY 19, 2023

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316.

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Vaccines Immunity Immunization 85

The Pharmacist

MAY 19, 2023

New approaches to ease pain and suffering in end-of-life community care are needed, according to a paper published this week in the BMJ. Researchers, led by Dr Ben Bowers at Cambridge University Primary Care Unit, highlighted four new additional options to ensure fast access to medications for patients in their last few days and hours of […] The post Rapid and tailored access to end-of-life drugs requires reforms, say researchers appeared first on The Pharmacist.

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Express Pharma

MAY 19, 2023

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has proposed testing cough syrups in government laboratories before they are exported India is considering a change to its pharmaceutical industry policy after cough syrups made in the country were linked to the deaths of children overseas, according to a document from Prime Minister Narendra Modi’s office, which noted that “important things” about the industry had been “overlooked̶

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Documentation Generic Medicine 76

Big Molecule Watch

MAY 19, 2023

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis. Per the announcement, “the primary outcome measure [of the study] will be to demonstrate comparative efficacy of AVT05 with Simponi at week 16 based on the change from baseline on a s

Biosimilars 70

Biosimilars Diabetes 70

Express Pharma

MAY 19, 2023

This alliance aims to equip students with professional knowledge to inculcate industry readiness ICRI, institute in India offering new-age programs, announced its new alliance with SAS to provide joint training certification for Clinical Research and Healthcare professionals. It is a joint program provided by ICRI and SAS, which allows clinical research professionals to increase their employability.

Hospitals 74

Hospitals 74

The Guardian - Pharmaceutical Industry

MAY 19, 2023

Experts predict US-approved fezolinetant can be a ‘blockbuster’ for thousands of women in the UK Menopause treatments will be revolutionised by a drug that acts directly on the brain to prevent hot flushes, leading doctors have predicted. Speaking after the US approved the first non-hormonal menopause drug , made by Astellas Pharma, experts said the treatment could be transformative for the hundreds of thousands of women in the UK for whom hormone replacement drugs (HRT) are not suitable.

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Pharmaceutical Commerce

MAY 19, 2023

Document reveals that 20 of 28 of participating Big Pharma manufacturers saw their DIO increase by an average of 5%, suggesting that large amounts of inventory do not necessarily offer protection from running low on medication.

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Documentation 59

The Guardian - Pharmaceutical Industry

MAY 19, 2023

University is latest body to distance itself from sponsorship by owners of Purdue Pharma, makers of OxyContin King’s College London has become one of the latest UK institutions to sever all ties with the Sackler family following outrage over its role in the deadly opioids epidemic in the US. Several other UK organisations that have recently been funded by Sackler cash, including the Royal Opera House, continue to take active steps to distance themselves from the family and expunge all records of

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The new investigational therapeutic product candidate STS101 is a nasal powder formulation of dihydroergotamine mesylate (DHE), an anti-migraine drug, which is given through the company’s nasal delivery device.

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Labelling 59