STAT

MAY 12, 2023

Brain cancer patients are left with few options when tumor cells spread, as most potent chemotherapies are unable to cross the blood-brain barrier. But a study published last week in the Lancet offers some hope: an ultrasound device implanted in 17 patients’ skulls successfully increased the concentration of drugs in their brains.  It’s the first, in-human trial of the novel device, which is manufactured by French device maker Carthera.

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BioPharma Dive

MAY 12, 2023

Advisers voted 8-6 in favor of an accelerated approval despite uncertainty around the treatment’s benefit. The agency is set to make a final decision by May 29.

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STAT

MAY 12, 2023

As a child, I fondly remember running through the kids’ aisle at Video World with my younger brother. We were excited to pick out VHS tapes for our family to watch over the weekend. I don’t recall whether this was every weekend or once a month, but movie nights were frequent enough that they made up for my parents’ repeated absences in those years.

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European Pharmaceutical Review

MAY 12, 2023

Swedish Orphan Biovitrum AB (Sobi ® ) has agreed to acquire CTI BioPharma for $1.7 billion, with the intention to advance an oral kinase inhibitor treatment for the rare disease myelofibrosis. Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma

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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 12, 2023

For an archived version of a live blog about Friday’s FDA advisory panel hearing, click here. A panel of independent advisers to the Food and Drug Administration narrowly voted 8-6 to recommend accelerated approval for Sarepta’s gene therapy for Duchenne muscular dystrophy , ruling that the potential benefit to patients outweighs a long list of concerns from the agency’s reviewers.

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Commonwealth Pharmacists Association

MAY 12, 2023

Celebrating our achievements at the Antibiotic Guardian Awards 2023 The sixth Antibiotic Guardian Shared Learning and Awards event took place on the 2nd of May 2023 in London [link] The Antibiotic Guardian Awards is an initiative by the UK Health Security Agency (UKHSA) to recognise individuals and organisations that have made outstanding contributions to promote the […]

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Pharmaceutical Technology

MAY 12, 2023

The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. Blood cancer patients with E coli infection are at risk of bacteria infecting the bloodstream. An E coli infection can be fatal in these cases, with a 15-20% mortality rate.

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STAT

MAY 12, 2023

The Food and Drug Administration is convening a meeting of outside experts on Friday to review clinical data on an experimental gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics. The stakes for this all-day meeting are high and deliberations could be contentious. The advisory panel meeting is one of the most pivotal moments in recent memory for Duchenne patients and their families, many of whom view Sarepta’s gene therapy as the best hope for slowing the fatal muscle-

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Pharmaceutical Technology

MAY 12, 2023

Takeda has reported a 12.8% increase in its reported revenue to $29.96bn (Y4,027bn) during the fiscal year 2022 (FY2022) compared to that reported in FY2021. At a constant exchange rate (CER), the company’s core revenue grew by 3.5% compared to the previous year. In the FY2022 ending 31 March 2023, the company also reported a 6.4% rise in its operating profit to $3.65bn (Y490.5bn) compared to 2021.

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STAT

MAY 12, 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. And here is our regular feature in which we highlight a different person each week.

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Pharmacy Management

Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. The EHA Hybrid Congress will take place on June 8-11 in Frankfurt, Germany. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.

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STAT

MAY 12, 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 will focus largely on Mrs. Pharmalot as she turns another page on the calendar and also on fostering a potential mascot — wish us luck. And of course, we hope to squeeze in another listening party.

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Packaging 171

PharmExec

MAY 12, 2023

Stefan Merlo, Vice President, Commercial Development, CSL Seqirus discusses how COVID-19 has evolved the discussion of vaccines and the long-term concerns stemming from flu vaccine fatigue.

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Vaccines 97

The Pharmacist

MAY 12, 2023

A study of almost three million women found no evidence of an increased risk of menstrual changes after Covid vaccination. Researchers suggested there was a weak association between the vaccine and menstrual disturbance or premenstrual bleeding, in a paper published in the BMJ. The authors said that the findings do not provide ‘any substantial support’ for […] The post Weak association between Covid jab and menstrual change, large study finds appeared first on The Pharmacist.

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Vaccines 84

BioPharma Dive

MAY 12, 2023

Cyclerion Therapeutics has struck an agreement to sell two of its experimental drugs, known as sGC stimulators, to a newly formed company in exchange for cash and equity.

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The Pharmacist

MAY 12, 2023

The upcoming NHS workforce plan must think about how to best use and coordinate the existing pharmacist workforce across different systems, the chief executive of the Company Chemists’ Association (CCA) has said. Speaking at the Westminster Health Forum on the future of general practice and primary care earlier today, Malcolm Harrison warned that changes in […] The post Workforce plan must coordinate pharmacists across systems, says CCA chief appeared first on The Pharmacist.

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European Pharmaceutical Review

MAY 12, 2023

A BioNTech-led Phase I trial demonstrated preliminary evidence that adjuvant autogene cevumeran, a personalised mRNA neoantigen vaccine, in combination with atezolizumab (Genentech) and mFOLFIRINOX can induce substantial T cell activity in pancreatic ductal adenocarcinoma (PDAC). In a paper published in Nature , researchers hypothesised it may correlate with delayed recurrence and elimination of micrometastases in PDAC.

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Vaccines Immunity Immunization Chemotherapy 92

Express Pharma

MAY 12, 2023

Scientific journal Nature said a personalised treatment based on messenger RNA by BioNTech potentially bodes well for the future of fighting an extremely aggressive form of cancer after the regimen was shown to trigger a promising immune reaction in some pancreatic cancer patients. Results of a trial in the first phase of testing on humans showed that half of the 16 trial participants, who had undergone surgery to remove their tumour, had developed T cells that can potentially recognise cancerou

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Immunity Immunization Vaccines 87

World Pharma News

MAY 12, 2023

Experts from Newcastle University found the nervous system of people with post-COVID fatigue was underactive in three key areas. Fatigue is one of the most common symptoms of long COVID. The breakthrough could lead to better treatment and tests to identify the condition and the team are already progressing the work having just started a trial.

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Pharma Times

MAY 12, 2023

Confederation responds to generally positive statistics, including cancer backlog drop

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Express Pharma

MAY 12, 2023

The US Food and Drug Administration approved Otsuka Pharmaceutical’s brexpiprazole to treat agitation in patients with Alzheimer’s, making it the first approved drug for the indication. The decision comes after an advisory panel in April voted that the company had enough data to identify the population in whom benefits from the treatment outweigh its risks.

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Pharma Times

MAY 12, 2023

The first unit of its kind in England will identify biomarkers and diagnose cancer much faster

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The agent is a human epidermal growth factor receptor 2 (HER2)-targeting ADC that utilises Eisai’s chemotherapy Halaven (eribulin) as its payload. Under the agreement, BlissBio will receive an undisclosed sum in upfront and milestone payments, and the companies will codevelop BB-1701 through an option per

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The Guardian - Pharmaceutical Industry

MAY 12, 2023

Exclusive: Haemophilia Society wrote to boss Darryn Gibson about dangers of missed deliveries and patients remain at ‘very serious’ risk The boss of a private healthcare company exposed by the Guardian for putting seriously ill children and adults at risk was warned it was failing patients three years ago. Darryn Gibson, the chief executive of Sciensus, Britain’s biggest medicines courier, was told in November 2020 that patients with bleeding disorders were being left dangerously exposed to inte

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The Honest Apothecary

MAY 12, 2023

Here is your warning. I’m sure many of you have heard about LinkedIn catfishing scams. But just in case you haven’t, catfishing, according to an article on LinkedIn, is “a deceptive activity where a person creates a fictional persona or fake identity on a digital platform, usually targeting a specific victim. A catfish scam may be used for financial gain, to compromise a victim in some way, as a way to intentionally upset a victim, or to fulfill a fantasy of taking on a differe

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Communication 59

BioPharma Dive

MAY 12, 2023

The antibody reduced RSV infections requiring hospitalization by 83% in a large study, bolstering evidence for the drug ahead of a U.S. approval decision later this year.

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Hospitals 59

pharmaphorum

MAY 12, 2023

12 shots at staying ahead of AI in the workplace Mike.

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PharmExec

MAY 12, 2023

New federal law introduces significant changes in the design of pharmacy benefit plans with aims to level the playing field between PBMs and their employee healthcare benefit plan clients.

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Pharmaceutical Commerce

MAY 12, 2023

New federal law introduces significant changes in the design of pharmacy benefit plans with aims to level the playing field between PBMs and their employee healthcare benefit plan clients.

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Drug Patent Watch

MAY 12, 2023

Annual Drug Patent Expirations for VASOSTRICT Vasostrict is a drug marketed by Par Sterile Products and is included in one NDA. It is available from six suppliers. There are fourteen… The post New patent for Par Sterile drug VASOSTRICT appeared first on DrugPatentWatch - Make Better Decisions.

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ID Stewardship

MAY 12, 2023

In this article five tips for incoming PGY2 pharmacy residents is provided. Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Pharmacy residents are headed for their second year of training and are now lined up to land at the (likely) final destination in their training journey.

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Communication Documentation Vaccines 52

Pharmaceutical Technology

MAY 12, 2023

BioNTech has ended its research collaboration with Matinas after its oral mRNA vaccine failed to demonstrate preclinical activity. Matinas announced the news in a May 10 statement. The in vivo study, conducted in mice, involved a phosphatidylserine-containing nano-formulation of mRNA supplied by BioNTech, distinct from traditional lipid nanocrystals (LNCs).

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Vaccines 52

Putting Patients First Blog

MAY 12, 2023

NHC Patient Experience Mapping Toolbox (PEMT) Session Event Time: 9:00 - 9:45 a.m. ET Event Location: Virtual Understanding the patient’s experiences living with disease is critical as it enables understanding the context, the natural history of the disease from the patient perspective, and what outcomes are important to patients. In 2022, the NHC published its Patient Experience Mapping Toolbox (PEMT) to capture these data.

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Pharmaceutical Technology

MAY 12, 2023

Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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Putting Patients First Blog

MAY 12, 2023

NHC Fair-Market Value (FMV) Calculator Session Event Time: 1:00 - 1:45 p.m. ET Event Location: Virtual The NHC wants to ensure that all stakeholders confidently enter into ongoing, compliant, and sustainable engagement efforts that effectively drive health care innovation based on patient and caregiver insights. In 2020, the NHC launched the Patient Engagement Fair-Market Value Calculator (FMV) to support sustainable agreements between stakeholders and the patient and caregiver community as pa

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