Sun.Sep 08, 2024

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5 burning questions about Missouri’s mysterious H5 bird flu case

STAT

News that a person in Missouri contracted H5 bird flu despite having no known contact with infected animals or birds — in other words, no evident route of infection — raises pressing questions public health officials are surely scurrying to answer. The rationale for that urgency is this: An unexplained H5 infection raises the possibility of person-to-person spread of a flu virus that has never before circulated in humans, and to which people would not have immunity.

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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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STAT+: Detailed data show Summit therapy beat Merck blockbuster Keytruda in late-stage lung cancer trial

STAT

SAN DIEGO — For years, Merck’s drug Keytruda has dominated cancer immunotherapy, racking up dozens of approvals, extending the lives of patients, and bringing in billions of dollars to the pharma giant. But detailed data presented by Summit Therapeutics on Sunday demonstrated that the company’s experimental therapy has done what no other has done before: beat Keytruda in a head-to-head late-stage trial in lung cancer.

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Weekend ICYMI: September 2 to September 6

Drug Topics

In case you missed it, this week we had news about digital therapeutics for anxiety, "lifeguard pharmacy" services, NCPA-backed calls to action for PBM reform, and more.

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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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She was told she might have cancer: How medicine pathologizes Black patients’ normal test results

STAT

A busy medical student, Vanessa Apea wasn’t her usual energetic self. So she dragged herself to the doctor to get checked and have her blood drawn. A week later, she received a call telling her to return to the clinic; it was urgent. When she arrived, the doctor asked if she had a family history of blood or genetic disorders. Was she having shortness of breath?

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WCLC: MSD/Daiichi build case for phase 3 ADC for lung cancer

pharmaphorum

Results of Ideate-Lung01 trial at WCLC back up MSD and Daiichi Sankyo's decision to move anti-B7-H3 ADC I-Dxd into phase 3 for small cell lung cancer

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First bird flu case with no known animal contact seen in US

pharmaphorum

CDC reports the first-ever US case of an H5 strain of avian influenza without a known occupational exposure to sick or infected animals

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MNV-201 by Minovia Therapeutics for Subacute Necrotizing Encephalomyelopathy (Leigh Disease): Likelihood of Approval

Pharmaceutical Technology

MNV-201 is under clinical development by Minovia Therapeutics and currently in Phase I for Subacute Necrotizing Encephalomyelopathy (Leigh Disease).

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The Honest Apothecary – A Zero Copay Blog

The Honest Apothecary

One of the convictions I had as I began to re-imagine my blog is that it would be an entirely non-monetized form of expression. For some, blogging is actually a source of significant income, and I see nothing wrong with this. For others, writing is a way to drive potential customers to their “paid” product.

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Sonidegib phosphate by Sun Pharma Advanced Research for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

Sonidegib phosphate is under clinical development by Sun Pharma Advanced Research and currently in Phase I for Non-Small Cell Lung Cancer.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Posting Dosing – How Often?

The Honest Apothecary

Another important decision I had to make, as I began to re-imagine The Honest Apothecary blog, was about the posting cadence I intend to keep up. To put it in more pharmaceutical terms: What would the dosing frequency be? QD? QOD? PRN? Those are pharmacy shorthand for daily, every other day, or as needed.

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PEP-07 by Sentinel Oncology for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Refractory Acute Myeloid Leukemia.

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The “Great” Individual Contributor

The Honest Apothecary

“So you see Jason,” said the man we’ll call “Steve”, to me as we sipped on our coffees in the cafeteria, “Tonya is a great individual contributor. She knows her job well, better than most.

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PEP-07 by Sentinel Oncology for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Relapsed Acute Myeloid Leukemia.

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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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Biobetter Development

BioPharm

Weighing development costs/resources and performance benefits is essential.

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Safinamide mesylate by Zambon Co for Drug-Induced Dyskinesia: Likelihood of Approval

Pharmaceutical Technology

Safinamide mesylate is under clinical development by Zambon Co and currently in Phase II for Drug-Induced Dyskinesia.

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I Prefer Contacts to Comments

The Honest Apothecary

A post on my preference for connections rather than simple comments

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BR-6002 by Boryung Pharmaceutical for Cardiovascular Disease: Likelihood of Approval

Pharmaceutical Technology

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Cardiovascular Disease.

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PEP-07 by Sentinel Oncology for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Mantle Cell Lymphoma.

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MNV-201 by Minovia Therapeutics for Pearson Syndrome: Likelihood of Approval

Pharmaceutical Technology

MNV-201 is under clinical development by Minovia Therapeutics and currently in Phase I for Pearson Syndrome.

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BR-6002 by Boryung Pharmaceutical for Gastric Ulcers: Likelihood of Approval

Pharmaceutical Technology

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Gastric Ulcers.

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BR-6002 by Boryung Pharmaceutical for Duodenal Ulcer: Likelihood of Approval

Pharmaceutical Technology

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Duodenal Ulcer.

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Risk adjusted net present value: What is the current valuation of SpringWorks Therapeutics’s Mirdametinib?

Pharmaceutical Technology

Mirdametinib is a small molecule commercialized by SpringWorks Therapeutics, with a leading Pre-Registration program in Neurofibromatoses Type I (Von Recklinghausen's Disease).

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Risk adjusted net present value: What is the current valuation of Celcuity’s Gedatolisib?

Pharmaceutical Technology

Gedatolisib is a small molecule commercialized by Celcuity, with a leading Phase II program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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Interferon alfa-2b by Center for Genetic Engineering and Biotechnology for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

Interferon alfa-2b is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase II for Genital Warts (Condylomata Acuminata).

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Risk adjusted net present value: What is the current valuation of AbbVie’s Navitoclax dihydrochloride?

Pharmaceutical Technology

Navitoclax dihydrochloride is a small molecule commercialized by AbbVie, with a leading Phase III program in Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).

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Risk adjusted net present value: What is the current valuation of Soleno Therapeutics’s Diazoxide choline CR?

Pharmaceutical Technology

Diazoxide choline CR is a small molecule commercialized by Soleno Therapeutics, with a leading Pre-Registration program in Prader-Willi Syndrome (PWS).

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Risk adjusted net present value: What is the current valuation of Aslan Pharmaceuticals’s Eblasakimab?

Pharmaceutical Technology

Eblasakimab is a monoclonal antibody commercialized by Aslan Pharmaceuticals, with a leading Phase II program in Atopic Dermatitis (Atopic Eczema).

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Risk adjusted net present value: What is the current valuation of Fusion Pharmaceuticals’s FPI-1434?

Pharmaceutical Technology

FPI-1434 is a monoclonal antibody conjugated commercialized by Fusion Pharmaceuticals, with a leading Phase II program in Cervical Cancer.

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Chenodiol by Mirum Pharmaceuticals for Cerebrotendinous Xanthomatosis: Likelihood of Approval

Pharmaceutical Technology

Chenodiol is under clinical development by Mirum Pharmaceuticals and currently in Pre-Registration for Cerebrotendinous Xanthomatosis.

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Risk adjusted net present value: What is the current valuation of Revolution Medicines’s RMC-6236?

Pharmaceutical Technology

RMC-6236 is a small molecule commercialized by Revolution Medicines, with a leading Phase II program in Metastatic Colorectal Cancer.

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Omalizumab biosimilar by Kashiv BioSciences for Chronic Urticaria Or Hives: Likelihood of Approval

Pharmaceutical Technology

Omalizumab biosimilar is under clinical development by Kashiv BioSciences and currently in Phase III for Chronic Urticaria Or Hives.

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Risk adjusted net present value: What is the current valuation of Tenaya Therapeutics’s TN-201?

Pharmaceutical Technology

TN-201 is a gene therapy commercialized by Tenaya Therapeutics, with a leading Phase I program in Hypertrophic Cardiomyopathy.

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RD-129 by Nanjing IASO Biotherapeutics for Autoimmune Disorders: Likelihood of Approval

Pharmaceutical Technology

RD-129 is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase I for Autoimmune Disorders.

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