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STAT+: Pharmalittle: Italy probes Pfizer over profit transfers; FDA postpones meeting for OTC birth control pill

STAT

This calls for celebration with a cup of stimulation, and we are opening a new package of Pumpkin Spice for the occasion. The investigation began in February and covers 2017, 2018, and 2019. Autumn, after all, is in full swing. Meanwhile, our ever-growing to-do list requires attention. Sound familiar?

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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

The FDA Law Blog

Drug manufacturers have had electronic systems in place since 2017. FDA will exercise enforcement discretion concerning the implementation of the electronic interoperable exchange of information between trading partners to the package level. Guidance at 4. So what is FDA going to do?

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Frontiers Health Digital Innovators: Aptar’s Sai Shankar

pharmaphorum

He joined Aptar in April 2017, having spent 15 years in big pharma – Allergan (CMC team leader, Head of R&D Packaging development, Product Development) and Sanofi (Packaging Engineering, Industrial Affairs). Sai has 20 years of product development and business strategy experience in the pharmaceutical industry.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Hikma had to start a whole new trial to answer the FDA’s questions following a rejection in 2017 and then had to put its launch on hold this year while the regulator reviewed a packaging update. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Economic unrest results in an average pharmaceutical price trend of 1,123% in Lebanon

Pharmaceutical Technology

An average 236% price increase occurred in Lebanon between 2017-21 Signs of sharp price increases at the manufacturer level started back in 2021 due to the removal of state subsidies on many products. This is a price jump of an additional 887% compared to between 2017–21.

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Fixed-Dose 4-Factor Prothrombin Complex Concentrate for Emergent Vitamin K Antagonist Reversal

Pharmacy Friday Pearls

The package insert for Kcentra® indicates dosing is to be based on both INR and weight, resulting in possible confusion and delayed time to administration of Kcentra®. Dosing According to Package Insert. 2017 Retrospective review, (n=37) Fixed dose 4F-PCC 1500 units vsvariable-based dosing INR ?1.5 2017): 64-69.

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RedX Pharma CEO focuses on pipeline that found Lilly’s rising star

pharmaphorum

Back in 2017, the UK biotech RedX Pharma had to sell its prized asset after administrators stepped in to stave off a debt crisis, with Loxo Oncology snapping up the BTK inhibitor for $40 million.

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