Beraprost

Name: Beraprost (2-Hydroxy-1-(3-hydroxy-4-methyl-1-octen-6-ynyl)-2,3,3A,8B-tetrahydro-1H-cyclopenta(B)benzofuran-5-butanoic acid)

CAS#  88430-50-6

Structure:

Beraprost
Beraprost

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AbbVie invests in switchable CAR-T therapies for cancer

AbbVie is partnering with Calibr to develop universal CAR T cells directed to different tumors via antibody switches. he partnership shows AbbVie’s excitement about new, controllable versions of cell therapy that are just now beginning to move into clinical studies.

In the partnership with AbbVie, Calibr will receive an up-front payment and will grant AbbVie exclusive access to its switchable CAR-T system for up to four years. AbbVie may acquire an exclusive license for the system during that time. Calibr will also develop multiple switchable CAR-Ts directed at several solid-tumor antigens picked by AbbVie. The duo isn’t disclosing financial details about the partnership, but Calibr Chief Operating Officer Matt Tremblay says, “This is the biggest deal that we’ve done by far.”

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5-Bromo-2-iodopyrimidine

NAME: 5-Bromo-2-iodopyrimidine ( 2-iodine-5-bromopyrimidine )

CAS# 183438-24-6

STRUCTURE:

5-Bromo-2-iodopyrimidine
5-Bromo-2-iodopyrimidine

PLEASE NOTE:

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Shire wins FDA approval to make Gammagard Liquid at new U.S. plant, ramps up hiring

It took longer than expected, but the FDA has approved the first product to be manufactured at Shire’s new $1.2 billion plasma plant in the U.S.

The Dublin, Ireland-based drugmaker said Thursday that the FDA has approved its Gammagard Liquid, a replacement therapy for primary humoral immunodeficiency (PI), to be manufactured at the plant in Covington, Georgia.

Commercial production began in January, and Shire expects to be distributing the injected therapy soon now that it has won approval for the facility. It also is ramping up hiring for the facility where 900 employees already work. Shire says the new facility will add 30% capacity to Shire’s internal plasma manufacturing network once it is fully operational.

“The increased manufacturing capacity from the site will support Shire’s growing Immunology franchise and further strengthens our ability to deliver complex therapies for patients around the world living with a range of rare and immune-mediated conditions,” Matt Walker, head of technical operations for Shire.

French regulators cite contamination, other issues at factory of Indian API maker Dhanuka Labs

The French National Agency for Medicines and Health Products Safety issued a warning letter to Indian API maker Dhanuka Labs after inspectors found a risk for product contamination and other issues at its Gurgaon, Haryana, plant.

In its letter posted on the EudraGMPD website, the French regulatory agency said an inspection conducted in late March found a total of 24 deficiencies at the factory that produces APIs for antibiotics, including cephalosporin.

Of the issues, one was critical in that inspectors found multiple risks of contamination. Other problems listed as major included water-quality control, insufficient maintenance of the plant, material storage issues and validation problems.

In its letter, the agency recommended a recall be issued of batches already released. Additionally, it called for the plant to be prohibited from supplying APIs until the issues at the facility are resolved.

2-chloro-3-nitropyrazine

3-Chloro-2-nitropyrazine is a building block to prepare substituted benzodiazepine calcitonin gene-related peptide (CGRP) receptor antagonists. It is also used to prepare hypoxic cell radiosensitizers.

CAS# 87885-43-6

2-chloro-3-nitropyrazine
2-chloro-3-nitropyrazine

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Drug shortages again on the rise after 5 years of improvements, FDA says

After 5 years of declines in the number of new drug shortages in the U.S., they jumped to 39 last year from 26 in the two preceding years. And while that is a far cry from the peak of more than 250 registered in 2011, the FDA acknowledges that many of the current shortages have been for critical drug products and “are having a tangible impact on patients.”

Those critical shortages spanned the spectrum from Mylan’s EpiPen, to injectable painkillers used in hospitals, to mundane but essential IV fluids.

“These shortages greatly impact patient treatment options and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies,” the FDA said in a statement this week.

Manufacturing problems at one of the largest U.S. drugmakers, Pfizer, are at the heart of some of the most troubling shortages for the the FDA and the healthcare system.