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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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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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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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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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STAT+: Muscular dystrophy patient who was first in line for a custom CRISPR therapy dies

STAT

Richard Horgan founded the nonprofit in 2017 when he was a student at Harvard Business School. Like many gene therapy companies, Cure Rare Disease packaged the therapy in adeno-associated viruses. High doses of gene therapies based on these viruses have been linked to deaths in other experimental gene therapies.

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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

The FDA Law Blog

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A.

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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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