CDMO hit with FDA warning shutters plants, files for bankruptcy

Ei, a North Carolina CDMO that was hit with a warning letter from the FDA earlier this year for manufacturing pharmaceuticals in the same building with the same equipment used to produce pesticides, has shut its doors as its parent company declared bankruptcy.

Product Quest Manufacturing, which operates the Ei facility located Kannapolis, North Carolina, filed for Chapter 11 protection last week. Operations at the facility ceased abruptly, leaving 296 employees without jobs. Although a letter to the state about the layoffs said they would not occur until November, WSOC-TV reported that a note left on a door of the facility informed employees that plant closed effective last Thursday.

Operations at the Florida plant ended July 30, the company said. Product Quest said in its filing that “extensive product quality issues” that lead to the recall of products produced at the Kannapolis and its Daytona Beach, Florida, plants were among the reasons for declaring bankruptcy. The company said in the filing that it would cost $3 million to $4 million to address the issues related to cross-contamination. (cr:FiercePharma)

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Takeda to move U.S. headquarters to Boston, affecting 1,000 employees

As Takeda works to close its massive Shire buy, the company has unveiled a plan to close its Chicago-area U.S. headquarters and center its U.S. operations in the Boston area where Shire has operations. The move will affect 1,000 employees.

Following a “successful closing” of the Shire buyout, Takeda will “progressively consolidate from Deerfield into the greater Boston area,” spokeswoman Julia Ellwanger said. The deal is subject to shareholder and regulatory approvals, she noted.

 

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“This move, while difficult, will allow closer collaboration across Takeda to best position our future pipeline for success,” Ellwanger added. “It will also simplify our existing Takeda U.S. operations.”

 

China’s drug regulator clears 45 vaccine makers in sweeping, scandal-triggered inspections

When Changchun Changsheng Life Sciences’ manufacturing malpractice sparked a nationwide outcry over vaccine safety in July, the Chinese drug authority dispatched teams to inspect all other vaccine companies. Now, the results are in.

China’s recently rebranded National Medical Products Administration (NMPA) said (Chinese) on Friday it had inspected all of the other 45 vaccine makers between July 23 and Aug. 9 and found no quality or safety problems.

Among the 45 manufacturers, 38 were complying with GMP practices and other regulations, while the other seven have ceased production for more than three years and have no products currently on the market, said the agency.

The drug regulator said teams made “comprehensive” inspections on all those companies, including on equipment maintenance, quality control, production and material management, with a stress on the authenticity of production records and laboratory results.

Changsheng was found to have systematically fabricated production data for its rabies vaccines and had earlier provided about half a million doses of ineffective DTaP vaccines for children.

Italian CDMO buys India API plant that supplies Novartis

CDMO Olon is continuing its expansion binge with a deal to buy an API plant in India that supplies ingredients to Novartis.

The Italian generic drug and API maker said Tuesday that it is buying an API manufacturing facility in Mahad, India, that supplies ingredients to Sandoz, the generics division of Novartis. Olon said that as part of the purchase agreement, it has committed to a long-term supply contract to supply the Sandoz products manufactured in Mahad. Sandoz closed a plant in Mahad in 2016.

It said no jobs would be lost and that Olon intends to invest in the site, which also provides drugs to the Indian healthcare system. Terms of the deal were not disclosed.

“By acquiring a manufacturing base in India, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new generic products for the Indian market,” Olon CEO Paolo Tubertini said in a statement. “It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements. (cr: FiercePharma)

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Merck’s Keytruda threatens Pfizer, Merck KGaA’s Bavencio with Merkel cell ‘priority’ tag

Merck is getting ready to take on Pfizer and Merck KGaA’s Bavencio in a rare form of skin cancer, and the FDA just sped up the showdown.

The FDA has tapped the New Jersey drugmaker’s immuno-oncology standout Keytruda for a priority review in Merkel cell carcinoma, an aggressive cancer that affects about 2,500 new patients each year in the U.S. The designation will speed Keytruda’s trip down the regulatory pathway, and if approved, it’ll bear a green light in patients with recurrent locally advanced or metastatic forms of the disease. The agency expects to make a decision by Dec. 28, Merck said.  (See more details on FiercePharma)

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US FDA announces impurity screening for all ARB drugs

After experiencing the “toxin gate” of valsartan, the US Food and Drug Administration (FDA) is testing whether all of this class of drugs also contains toxic substances.

According to FDA Director Scott Gottlieb and Janet Woodcock, who is responsible for the FDA’s Center for Drug Evaluation and Research, due to the uncertainty, the FDA is testing all angiotensin II receptor antagonist (ARB) drugs to determine if all such drugs contain the carcinogenic nitrosodimethylamine and ensure that the contaminated drug is The United States is all off the shelves. The FDA said that they attach great importance to drug safety issues and the action will be closely managed by the FDA’s leadership.

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Gilead steals new commercial chief from Amgen to tackle big sales challenges

Gilead has some big commercial challenges looming, and it’s tapped the leader who will spearhead them.

The big biotech appointed longtime Amgen veteran Laura Hamill to its top commercial post, it said Tuesday. The move comes after an “extensive search” that began when James Meyers announced in February that he would retire.

To take the Gilead post, Hamill will leave behind her position as Amgen SVP of U.S. business operations, a job she’s held since early 2016. Before that, she spent 16-plus years climbing the Amgen ladder, taking on projects that included launching anti-inflammatory blockbuster Enbrel. (See more details on FirecePharma)

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