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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. PDA TR 22, ISO 14644, ICH Q9, Q10) adequately supported by the relevant data set.

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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

So much smaller, much leaner and definitely more startup mentality. And we’re trying to get on the line with a pharmacy and they’re working on getting a license in a certain state, so understanding pharmacy law, my MPJE definitely came in handy. So there’s still definitely a lot of PharmD in there.

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Torrent Pharmaceuticals to acquire stake in JB Pharma for $3bn

Pharmaceutical Technology

Torrent Pharmaceuticals, headquartered in Gujerat, India, has signed definitive agreements for the acquisition of a controlling stake in JB Chemicals and Pharmaceuticals (JB Pharma) from global investment firm KKR at an equity valuation of Rs256.89bn ($3bn) on a fully diluted basis. Credit: Sai Thaw Kyar/Shutterstock.

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Aytu BioPharma to commercialise Exxua for MDD in the US

Pharmaceutical Technology

Aytu is committed to royalty payments based on net sales as stipulated in their definitive agreement, including a product transfer cost. Find out more Aytu issued an initial payment to Fabre-Kramer Pharmaceuticals upon closure and will make another payment on the first anniversary of Exxua’s market release.

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Medera and Novoheart collaborate on mini-heart models for HLHS

Pharmaceutical Technology

In September 2024, Medera entered a definitive merger agreement with Keen Vision Acquisition Corporation. By generating patient-specific 3D human heart models from a simple blood draw, we aim to uncover the biological mechanisms driving disease in each child — and ultimately tailor treatments that improve their chances of survival.”

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Podcast: The importance of Social Determinants of Health (SDoH)

Pharmaceutical Technology

There are definitely policy impacts that can influence health care outcomes based on on where you live as well.” How will RFK Jr’s American dream for vaccines play out? Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Sign up for our daily news round-up!

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WHO accuses China of withholding Covid-19 genetic data

Pharmaceutical Technology

Robert Barrie June 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook While zoonotic origin is the most likely source of the virus, a report says a definitive conclusion is not possible. Credit: Dalibor Sevaljevic via Shutterstock. Give your business an edge with our leading industry insights.