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FDA slaps import alert on India's Shilpa after sterile injectables issues multiply

Feb 19, 2021 9:41am
The FDA hit India s Shilpa with an import alert on all but three of its drugs after the company failed to address problems cited in an October warning letter. (Pixabay/qimono)
Just a few months after India-based drugmaker Shilpa Medicare found itself in the FDA s crosshairs, the company now faces a ban on the vast majority of its products in the U.S.
The FDA slapped an import alert on Shilpa Medicare s formulation plant in Telangana, India, according to a notice posted Thursday. The product ban comes on the heels of an FDA warning letter that cited the Indian drugmaker for multiple manufacturing violations. ....

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Pfizer to open 'global capability hub' in Tampa, joining Amgen, BMS and J&J in the city

Pfizer's already gracing headlines worldwide with its COVID-19 vaccine rollout. Now, it's making a big splash in Tampa Bay. The drug giant is opening a “global capability hub” in the city, bringing multiple services including finance, human resources, digital, and sourcing to one office. ....

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Fierce Pharma Asia—Takeda's CMV drug win; Merck and Eisai's kidney cancer showing; Botox rival Jeuveau's settlement

Merck and Eisai showed their Keytruda-Lenvima combo could cut the risk of death by 34% over Pfizer’s old standard treatment Sutent in newly diagnosed kidney cancer. While the overall survival showing was very similar to the numbers for three other immuno-oncology cocktails based on Keytruda or Bristol Myers Squibb’s Opdivo, SVB Leerink analyst Daina Graybosch pointed to other efficacy data in crowning the Keytruda-Lenvima pairing as the “clear choice.” But the win is not a done deal at this point, she noted.
AbbVie’s Allergan and its South Korean partner MedyTox have decided to settle the legal battle they waged against Evolus and its own Korean partner Daewoong Pharmaceutical over their wrinkle-lifting drugs. The news came on the heels of a U.S. appeals court s decision to temporarily allow the Evolus pair’s Botox rival, Jeuveau, to stay on the U.S. market as it reviewed an import ban installed by the U.S. International Trade Commission. AbbVie and Medytox aba ....

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Charles River jumps into cell and gene therapy manufacturing with $875M Cognate buy

Feb 18, 2021 8:36am
Cognate s buyout-to-be comes shortly after the company plotted cell and gene therapy manufacturing expansions in Europe and the U.S. (Cognate BioServices)
Just a few weeks after Cognate BioServices moved to beef up its cell and gene therapy manufacturing, the company has attracted a buyer eager to tap that expertise.
Charles River Laboratories agreed to throw down $875 million cash for Cognate in a deal designed to create a one-stop-shop in cell and gene therapies. Cognate s production muscle will complement Charles River s own work in the field to bring development, testing and manufacturing under one umbrella, the companies said Wednesday. ....

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Bring on the boosters: Studies show Pfizer, Moderna COVID vaccines are less protective against aggressive variant

In letters published in The New England Journal of Medicine, Pfizer and Moderna acknowledged that laboratory experiments showed their mRNA vaccines aren't as potent against the aggressive new COVID-19 variant identified in South Africa. Wall Street analysts are worried. ....

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