Pharmaceutical Processing World Archives - Page 41 of 64

Novo Nordisk settles U.S. securities class action suit

Novo Nordisk (NYSE:NVO) has agreed in principle to settle securities class action litigation in the Federal District Court of New Jersey. The Bagsværd, Denmark–based company would pay $100 million in the settlement.

That amount includes plaintiffs’ attorneys’ fees, expenses and settlement costs.

The lawsuit alleged that the company made misleading statements regarding the price of its insulin.

The agreement contains no admission of liability or wrongdoing. The company stressed in a statement that it believes the “plaintiffs’ claims are without any merit.”

“While we are confident in the facts and merits of our position, we believe that resolving this matter is the right business decision for Novo Nordisk and our shareholders,” said Tomas Haagen, general counsel at Novo Nordisk.

Purchasers of American Depository Receipts initially filed the lawsuit in 2017.

Novo Nordisk, along with Eli Lilly and Sanofi-Aventis, has faced litigation ove…

CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

ATA Freight expands in India to serve growing pharma industry

The international logistics company ATA Freight is opening a new facility in Hyderabad due to growing demand from India’s quickly-growing pharmaceutical industry.

The Hyderabad facility will primarily cater to the pharmaceutical industry.

“ATA Freight already has a strong footprint in India’s pharmaceutical industry, serving many of the area’s leading pharma manufacturers,” said ATA freight chief operating officer Matt Goker. “We are also responding to the growing need from pharma companies in the Telangana region [in south-central India].”

The Telangana region is home to a high concentration of pharma companies.

India is also home to Serum Institute of India, which is the world’s largest manufacturer of vaccines.

India ranks third in the world in terms of pharmaceutical product volume.

ATA Freight has more than 30 facilities in total. Outside of India, it has sites in the U.S., Russia, Turkey, China and Mexico.

Lonza bolsters drug manufacturing services in Switzerland

Contract development and manufacturing organization Lonza has announced a series of expansion projects during the pandemic. Most recently, the Basel-based company revealed plans to expand its drug product manufacturing services on its home turf in Switzerland.

Included in the expansion will be an installation of a new aseptic fill and finish line in the city of Stein in northern Switzerland. The filling line will enable the company to process various drug types such as monoclonal antibodies, bioconjugates and viral vectors. The company aims to finish the expansion by 2023.

The company is also beefing up its drug product services in nearby Basel. Specifically, its investments in Stücki Technologiepark in Basel will increase its offerings for early and late clinical stages. The expansion will also add to its capabilities related to integrated drug substances and drug products. Lonza aims to finish this expansion in 2024.

In late August, the company unveile…

FDA authorizes Pfizer boosters with caveats

The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a third dose in individuals who face a high risk of infection or developing severe COVID-19. Those groups include people at least 65 and those aged 18 to 64 with a high risk of developing severe COVID-19.

The EUA also covers individuals aged 18 to 64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

According to Acting Commissioner Dr. Janet Woodcock, the EUA will apply to “health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others.”

The latter recommendation deviates somewhat from those presented at the most recent Vaccines and Related Biological Products Advisory Committee (VRBAC) meeting, which recommended boosters to those with high occupational risk to the virus, including medical …

Single dose of Janssen’s COVID-19 vaccine offers durable protection, but a booster amplifies it

Drawing from de-identified insurance claims data, Johnson & Johnson (NYSE:JNJ) has announced that a single dose of its Ad26.COV2.S vaccine was 79% effective in preventing COVID-19 infections and is 81% effective in preventing hospitalizations associated with the novel coronavirus.

The company also released results from its Phase 3 ENSEMBLE 2 trial, which tested the impact of a booster dose on immunity. The booster was 94% effective when administered two months after the initial injection and led to a four- to six-fold rise in antibodies. When administered six months after the prime dose, the vaccine resulted in 12-fold higher antibody levels four weeks after the booster dose was administered.

Janssen’s ENSEMBLE 2 study also found that a second dose of its vaccine was generally well-tolerated. The side effect profile from the second dose was generally similar to that of the first dose.

The single-dose results were summarized in a MedRxiv preprint stud…

Former top IT person at Mylan pleads guilty to insider trading

A former information technology (IT) executive at Mylan today pleaded guilty to conspiracy to commit securities fraud and aiding in the preparation of a false tax return.

Dayakar Mallu, who at the time of the fraud served as VP of global operations information technology at Mylan, admitted to the charges in court in the Western District of Pennsylvania, according to a U.S. Dept. of Justice news release.

Between 2017 and 2019, Mallu conspired with others to trade the securities of Mylan — the maker of the EpiPen — ahead of corporate announcements concerning drug approvals, financial earnings and a merger. Mallu placed trades in the company’s securities and shared trading profits with his co-conspiratory through cash transactions in India, with the trading resulting in more than $8 million in unrealized profits and losses avoided.

According to the DOJ release, Mallu ultimately realized net profits and losses avoided totaling more than $4.2 million as…

Report: U.S. set to buy hundreds of millions of Pfizer’s COVID-19 vaccine to share

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

The Biden administration reportedly plans to purchase and share with the world hundreds of millions of doses of Pfizer’s COVID-19 vaccine.

The Washington Post reported today that the U.S. has plans to make another large purchase of COVID-19 vaccines, although details of the deal have not been made clear. Neither the White House nor Pfizer have offered comment or confirmation regarding the deal, according to the report.

It seems likely that the apparent purchase comes ahead of the U.N. General Assembly next week because of an increased focus on vaccine access in lower-income countries, according to The Post. Additionally, the report noted that the White House intends to host a virtual summit on global vaccinations alongside the U.N. General Assembly next week.

The Hill said that Biden and his administration remain under…

Panasonic acquires autonomous supply chain firm Blue Yonder

Panasonic (TYO: 6752) has announced that it has wrapped up its acquisition of Blue Yonder, a supply chain management company established in Scottsdale, Arizona.

Both companies had similar plans for developing autonomous supply chain technology. The partnership will pair Panasonic’s sensing technology with the edge computing and machine learning capabilities of Blue Yonder.

Having acquired a 20% stake in the company in July 2020, Panasonic now owns 80% of Blue Yonder shares.

Blue Yonder’s most recent valuation was $8.5 billion.

Supply chain disruptions have grown more common during the pandemic, forcing many manufacturers including in the pharmaceutical industry to rethink their logistics strategy.

Part of the promise of autonomous supply chains is their resilience.

“Panasonic’s resources and Blue Yonder’s innovation will accelerate the development of the tools customers need to anticipate and prevent disruptions and breathe aut…

Schott expands Chinese glass tubing plant

Schott’s pharmaceutical glass tubing site in Jinyun, China [Image courtesy of Schott]

Schott recently announced that it has completed the next expansion stage at its pharmaceutical glass tubing site in Jinyun, China.

The company completed construction at the site in just 15 months despite the COVID-19 pandemic, with production starting in November 2020. The plant is meant to create a solid production base for high-quality borosilicate glass tubing in the local Chinese market. The tubing is for pharma containers that store vaccines (e.g., against COVID-19) and other drugs.

“Right on schedule with our planning, we have doubled our melting capacity. It’s another big milestone for pharma tubing in China. The expanded infrastructure will enable a reliable local supply of glass tubing, which is needed urgently to serve the increased demand for pharmaceutical packaging,” Patrick Marksc…

Catalent to make Phathom Pharmaceuticals stomach acid blocker if it wins FDA approval

Catalent announced today that it entered into a commercial supply agreement with Phathom Pharmaceuticals for its acid blocker.

The commercial supply agreement covers Phathom’s lead compound, vonoprazan, which is a novel, orally active-potassium competitive acid blocker (P-CAB) for treating gastrointestinal diseases, according to a news release.

Phathom currently has vonoprazan in late clinical-stage development for treating gastric acid-related diseases and disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori (H. pylori) bacterial infection. The company owns rights for developing and commercializing vonoprazan in the U.S., Europe and Canada.

Under the agreement, Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, Kentucky, should the drug receive FDA approval.

“As Phathom readies for the …

Steris launches two new vaporized hydrogen peroxide biodecontamination systems

The VHP 100i (left) and 1000i (right) systems [Image courtesy of Steris]

Steris has launched the next generation of its vaporized hydrogen peroxide (VHP) biodecontamination systems to achieve 6-log bioburden reduction in good-manufacturing-practice pharmaceutical, medical device and research environments.

It’s possible to integrate the new VHP 100i and 1000i systems into a facility’s building automation and HVAC systems, running a decontamination cycle at programmed intervals or at the push of a button. The result, according to Steris, is easy and frequent decontamination of rooms, isolators, filling lines, RABs, pass-through chambers and more.

“The new VHP systems incorporate input received at thousands of VHP customer sites on five continents,” said Andrea Conroy, VP of marketing for Life Science Equipment and Service at Steris, said in a Sept. 9 news release. “They are engineered to streamline…