News

The CRO’s FortreaRx doubles in size, including a boost in cold chain storage, while also continuing to improve its patient access services.

Trial data show Dupixent is the first and only novel biologic drug to significantly improve lung function and reduce severe acute exacerbations in adults with uncontrolled chronic obstructive pulmonary disease.

The latest news for pharma industry insiders.

The annual report published by IQVIA examines movement surrounding drug launches and new clinical trials, during the post-pandemic era.

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

Ocifisertib (CFI-400945) is a first-in-class, novel PLK4 inhibitor that has been found to regulate centriole duplication in patients with acute myeloid leukemia.

OneScan 7.1 is expected to boost compliance, while also improving pharma supply chain efficiencies.

A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets.

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

Arshad M. Khanani, MD, MA, FASRS, will help lead development efforts for sozinibercept, a potential wet AMD treatment.

As part of the agreement, Novo will be paid both development and commercial milestone payments for NN-8828, is currently in Phase II of non-dermatological indications.

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

The lack of transparency in the pharmaceutical industry further exacerbates the challenges faced by consumers.

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.

The new seals include sustainable film material containing recyclate content of up to 90%.

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

Strategic and proactive thinking are vital in providing supply chain leaders with an opportunity to shift their focus to a more holistic, value-centered approach.

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

Personalized medicine approaches, informed by predictive modeling, could optimize treatment outcomes and reduce patient burden and costs.

The financial commitment features construction of new warehouses in Pennsylvania and North Carolina.

The Masimo product is expected to address a significant gap in the market for dependable home-use medical devices.