Market Place
Biohaven’s new drug fails to get FDA nod due to Apotex’s manufacturing problems
Last week, Biohaven Pharmaceutical Holding Company Limited said the US Food and Drug Administration (FDA) failed to approve its treatment for amyotrophic lateral sclerosis, or Lou Gehrig’s disease.
The company said FDA issued a complete response letter (CRL), raising concerns related to an active pharmaceutical ingredient (API) used in a 2017 study that was made by Apotex Pharmachem India Private Limited between 2014 and 2016.
Biohaven said the API is now being sourced from another supplier, with which no chemistry, manufacturing, and control issues have been identified.
Amyotrophic lateral sclerosis is a rare neurologic disease, which mainly affects the nerve cells responsible for controlling voluntary muscle movement such as walking or talking.
FDA posts Indoco’s warning letter: Last week, Indoco Remedies had shared that it has received a warning letter for its tablet manufacturing operations. The FDA recently posted the letter on its site. As PharmaCompass had previously reviewed the Form 483 issued after inspection, the warning letter does not contain any surprises.
The FDA has raised concerns over Indoco’s process control values, which were inadequately reported in the batch production records. In multiple batch records, handwritten values were routinely within process parameters, while the values recorded by the programmable logic controller (PLC) were frequently outside Indoco’s established process parameters.
The concerns highlighted in the January 2019 inspection were a repeat observation from a previous inspection in March 2018 where similar discrepancies were found between the values in batch records and the PLC data. The warning letter states “the integrity of all data” within Indoco’s manufacturing records “is called into question” by the actions of its staff. The letter also questions Indoco’s practice of investigating deviations.
Dinesh Thakur on Indian drug industry: In an opinion piece published in Stat News this week, the Ranbaxy whistleblower Dinesh Thakur has said that the Indian pharmaceutical industry has lashed back at Katherine Eban’s book ‘Bottle of Lies’.
“This industry, which has rarely been subjected to such rigorous journalistic scrutiny, has lashed back at Eban, attacking her integrity and her work,” Thakur wrote in the article.
The latest salvo comes from Kiran Mazumdar Shaw, who calls Eban’s exposé anecdotal, biased, unfair, and unbalanced, and accuses the author of playing up to the poor perceptions of the Indian pharmaceutical industry and the country. “Shaw did this in a softball interview she gave to an Indian publication in which she is an investor,” Thakur said.
“Her characterization of the problem is unfortunate because it represents a stubborn denial of reality. There are reams upon reams of official documentation showing that the fraud at Ranbaxy was not a one-off event,” Thakur added.
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