STAT

SEPTEMBER 8, 2024

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.

Immunization 145

Immunization 145

Fierce Pharma

SEPTEMBER 8, 2024

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

SEPTEMBER 8, 2024

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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Drug Topics

SEPTEMBER 8, 2024

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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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

SEPTEMBER 8, 2024

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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pharmaphorum

SEPTEMBER 8, 2024

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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pharmaphorum

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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BioPharm

SEPTEMBER 8, 2024

Weighing development costs/resources and performance benefits is essential.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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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.

FDA

Med Ed 101

SEPTEMBER 8, 2024

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmacy Management Software

Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

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

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Pharmaceutical Technology

SEPTEMBER 8, 2024

Izokibep is a fusion protein commercialized by Acelyrin, with a leading Phase III program in Psoriatic Arthritis.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

MAR-001 is under clinical development by Marea Therapeutics and currently in Phase II for Hypertriglyceridemia.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

HIL-214 is a subunit vaccine commercialized by HilleVax, with a leading Phase II program in Gastroenteritis.

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Vaccines 40