The People's Pharmacy
MAY 8, 2023
Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.
Pharmaceutical Technology
OCTOBER 5, 2022
Bringing an end to a 13-year deliberation on a whistleblower lawsuit, Biogen recently agreed to pay a $900 million settlement , amidst increased government alertness on pharmaceutical fraud. In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings.
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Impact Pharmaceutical Services
AUGUST 9, 2022
IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity.
PharmaShots
MARCH 29, 2023
Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. The exact mechanism of action is uncertain.
pharmaphorum
DECEMBER 28, 2022
In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness?
PharmaShots
FEBRUARY 21, 2023
The company's main radiopharma asset includes CycloSam (Samarium-153 DOTMP), a bone-targeting radiopharmaceutical developed by IsoTherapeutics. In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. The company expects to commence P-I clinical trials on metastatic and pediatric primary bone cancer patients.
pharmaphorum
SEPTEMBER 18, 2020
But although it was dubbed a “dangerous game”, some companies came out on top… On 6th April 1999, two companies with similar science-based cultures and a shared vision of the pharmaceutical industry came together to form what’s now considered as one of the top ten pharma companies in the world: AstraZeneca.
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