The FDA delivered a laundry list of cited problems to a European manufacturer with production line issues that included microbiological contamination and improper cleaning procedures. The Form 483 was sent to Spanish drug materials manufacturer Bioiberica’s materials manufacturing plant in Palafolls, north of Barcelona.
In an inspection between Jan. 31 and Feb. 4 this year the FDA found that cleaning procedures for the equipment used in the drug substance manufacturing were not validated as necessary to ensure adequate cleaning and contamination prevention measure. The FDA also found microbiological contamination and a lack of established control procedures to monitor the output manufacturing processes that could potentially cause variability in the drug substance.
The plant’s quality control unit also lacked the responsibility to approve all procedures or specifications around identity, strength, quality and purity of substances and had no written testing program to assess the stability characteristics.
The FDA found that written records of investigations into previous discrepancies didn’t always include conclusions and justified follow-ups. The inspectors noted that was particularly problematic around investigations of microbiological non-conformities for an unnamed USP drug.
Bioiberica manufactures a wide range of products for animal, plant and human health. For humans, the company produces Glucosamine API, several heparin compounds and Tendaxion, among a slew of other compounds.
This marks the first time the company has received a warning from the FDA.
Merck is evaluating a potential buyout of embattled Seattle biotech Seagen, according to a report from the Wall Street Journal on Friday morning.
This is the newest development for the biotech after former CEO Clay Siegall stepped down from the company — while also forfeiting his board positions at other companies such as Umoja Biopharma — following allegations of domestic violence that surfaced last month. He was initially arrested in the early hours of April 23 after a physical altercation with his wife left her with multiple bruises, according to a police report. Siegall has denied the allegations.
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A panel of the FDA’s outside experts voted 9-3 that Acadia Pharmaceuticals’ drug doesn’t appear to be effective at treating patients with Alzheimer’s-related psychosis.
The drug, Nuplazid, is already indicated for Parkinson’s-related psychosis, but Acadia has tried — and failed last year — to get another green light in Alzheimer’s psychosis. The drug never panned out in the clinic for patients with depression or schizophrenia, causing Acadia multiple R&D headaches over the years.
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Another OK, another 2,000 potential patients.
On Thursday, Rhythm Pharmaceuticals received its second FDA green light for its obesity management drug for those with ultra-rare genetic diseases, this time for Bardet-Biedl syndrome, a disease that impacts a number of organs but with early-onset obesity as a major symptom. And the company also engineered a royalty deal netting it up to $100 million.
The FDA approved the drug, known as setmelanotide and marketed as Imcivree, for patients 6 years and up after Phase III data in 31 Bardet-Biedl patients showed it decreased BMI by around 8% compared to placebo. Rhythm chairman and CEO David Meeker noted that while BMI was not a perfect measurement, the company opted to use it over weight because its study included pediatric patients who were still growing.
More than 18 months after adults were able to start receiving Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines, kids as young as six months are on the verge of being able to get inoculated against the pandemic virus.
The FDA authorized the Pfizer-BioNTech and Moderna vaccines Friday morning under EUA after the agency’s outside advisors unanimously favored (21-0) administering the shots. Parents and caregivers just have to wait for the CDC to sign off before the youngest of America’s kids can get the vaccine.
The FDA completed less than half (48%) of its regulatory actions for pharma facilities designated as OAI or with an Official Action Indicated, within 6 months of an inspection closing, according to the latest report from the agency on the effects Covid-19 had on general oversight at manufacturing sites last year.
The agency also lost pace in issuing final facility classification letters.
In FY 2021, the report noted FDA issued 70% of final facility classification letters within 90 days of inspection closing. By comparison, in FY 2019, 87% of final facility classification letters were issued within 90 days of inspection closing, and completed 74% of regulatory actions for OAI facilities.
Amidst a hail of investments coming from South Korean conglomerates into biotech, including Lotte and Samsung, SK is looking to get in on the action.
SK Pharmteco, a CDMO and subsidiary of the second-largest conglomerate in South Korea, is investing $35 million to expand SK’s pharmaceutical manufacturing plant in the Dublin suburb of Swords, Ireland, including a new building.
According to SK, the expansion project will provide an increase in the site’s manufacturing capacity and capabilities, coming online sometime in 2024.
During Endpoints News’ time in San Diego for #BIO22, it was hard to miss all the Samsung Biologics signs plastered alongside the highway to the airport, adorning nearly every lamp post. However, advertising is not the only place where Samsung is looking to spend.
Last month, it was reported that South Korea’s Samsung Group raised spending by more than 30% to KRW 450 trillion, or around $360 billion, to invest in several lines of business including electronics and biotech, among others. Samsung Biologics CEO John Rim spoke to Endpoints at #BIO22 to discuss how this investment will affect the biotech arms of one of South Korea’s largest conglomerates.
The member countries of the World Trade Organization negotiated late into last night, finally offering up a compromised and watered-down way for some low-income countries to waive the intellectual property around certain Covid-19 vaccine ingredients and manufacturing processes, potentially paving the way for compulsory licensing for these vaccines.
While only in effect initially for five years, the waiver would hypothetically allow low-income countries to bypass certain Pfizer and Moderna patents to produce more Covid-19 vaccines.
AbbVie just scored another win in its campaign to make Skyrizi one of the top blockbusters in the portfolio while pushing the Big Pharma to the top of the industry list of money makers as their cash cow Humira faces biosimilar competition in January.
Earlier this year the FDA’s OK came through on psoriatic arthritis, following the maiden approval for psoriasis. And today we learned that the agency has stamped its approval to expand the label to include Crohn’s disease.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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