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By PharmaCompass
2021-01-21
Impressions: 2,530 Article
With Joe Biden’s inauguration as the new President of the US, Phispers brings you news on some key appointments he made in the healthcare sector prior to taking oath.
Biden is bringing in former FDA chief David Kessler as the head of Operation Warp Speed.
A former immune oncology director at Merck was arrested for stealing trade secrets of its blockbuster cancer drug Keytruda, along with information on other drugs.
In drug approvals, the US Food and Drug Administration (FDA) gave its nod to AstraZeneca and Daiichi’s breast cancer drug Enhertu for the treatment of gastric cancer.
Pfizer announced that the FDA has approved the supplemental New Drug Application (sNDA) for Xalkori (crizotinib) for the treatment of pediatric patients with large cell lymphoma.
Regeneron signed a deal with the US government to supply its Covid-19 antibody cocktail. Fujifilm continued its CDMO expansion spree in the US by announcing a new site in Massachusetts.
And Philips bought Capsule Technologies for US$ 635 million.
Biden appoints David Kessler as Operation Warp Speed head, Janet Woodcock as interim FDA chief
This week, prior to his inauguration as the President of the United States of America, Joe Biden made some key appointments in the healthcare and pharmaceutical sector. Biden replaced Moncef Slaoui with David Kessler (former commissioner of the US Food and Drug Administration and a key adviser to his campaign) as head of the Operation Warp Speed vaccine program. Kessler is also serving as co-chair of Biden’s Covid-19 task force.
The new administration will also rename Operation Warp Speed, incoming White House press secretary Jen Psaki said on Twitter. “We are phasing in a new structure, which will have a different name than OWS,” she wrote. Biden has pledged to administer 100 million doses in the first 100 days of his administration.
Janet Woodcock, who has been in senior roles at the FDA for over three decades and has worked with Kessler, will take over as commissioner, at least temporarily. FDA commissioner Stephen Hahn will leave on Wednesday. According to news reports, former deputy FDA chief Joshua Sharfstein is Biden’s top finalist for the permanent FDA commissionership.
Biden also announced the members of his science team. Francis Collins will stay on as director of the National Institutes of Health, which he has been heading since 2009. Eric Lander, a prominent scientist who helped lead the Human Genome Project and is now president of the Broad Institute, will direct the Office of Science and Technology Policy.
Pennsylvania Health Secretary Rachel Levine is Biden's choice for assistant US health secretary. Levine would serve under Xavier Becerra, Biden’s nominee to lead the US Department of Health and Human Services. Like Becerra, Levine’s nomination must be confirmed by the US Senate. Andy Slavitt, who ran Medicare and Medicaid under President Barack Obama, will be senior adviser to the Covid-19 response coordinator, Jeff Zients.
Former Merck scientist arrested for stealing Keytruda’s trade secrets
A former immune oncology director at Merck was arrested for stealing and transmitting trade secrets around the time he left the company to join AstraZeneca in 2019. Amongst the information stolen are key secrets pertaining to Merck’s blockbuster cancer immunotherapy drug, Keytruda.
In materials published by the Department of Justice (DOJ), a Federal Bureau of Investigation (FBI) special agent has named Shafat Quadri, the former director of medical and scientific affairs, immune oncology, at Merck. He is accused of copying and removing thousands of files containing proprietary information. Quadri allegedly sent files to his personal email addresses and to an account owned by his new employer. Merck’s security system flagged up file transfers allegedly made by Quadri, prompting the company to investigate his activities. He faces up to 10 years in prison for allegedly stealing trade secrets about Keytruda and other drugs.
According to the DOJ, 57-year-old Quadri has been arrested and charged with one count of theft of trade secrets and one count of unauthorized transmission of trade secrets.
Even though the DOJ materials do not name Merck nor AstraZeneca, they do name KEYNOTE119, proprietary information on Keytruda’s clinical trial. Similarly, Quadri’s LinkedIn profile gives his employment history — he had left Merck to join AstraZeneca.
Merck introduced Keytruda in 2014. The cancer immunotherapy indicated for melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer, brought in US$ 10.4 billion in worldwide sales for Merck during the first nine months of 2020.
AstraZeneca, Daiichi’s breast cancer drug bags broader US approval
Last week, the US Food and Drug Administration approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma, who have previously received Roche’s standard-of-care Herceptin.
Daiichi Sankyo and AstraZeneca’s Enhertu is the first HER2-directed therapy approved for gastric cancer in the US in a decade. This application was granted priority review and the FDA approved it approximately six weeks ahead of the FDA goal date.
Previously treated HER2-positive stomach cancer now becomes Enhertu’s second US approval. It was originally approved in third-line HER2-positive breast cancer.
Crizotinib bags FDA nod for kids with large cell lymphomas: Pfizer Inc announced that the FDA approved the supplemental New Drug Application (sNDA) for Xalkori (crizotinib) for the treatment of pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30 percent of cases of NHL in young people. The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
Regeneron signs deal with US govt to supply 1.25 million doses of its antibody cocktail
Regeneron’s antibody cocktail — which was given to former US President Donald Trump when he was down with Covid-19 in early October — could bring in over US$ 2 billion in revenues for the company in 2021.
After previously agreeing to supply the US government with 300,000 doses of its antibody cocktail, Regeneron signed a much larger supply deal for up to 1.25 million doses this week. Regeneron’s antibody cocktail is authorized for Covid-19 patients with mild to moderate cases who are at a risk of progressing to severe disease.
If the company is able to supply all doses, the deal will be worth around US$ 2.63 billion. Under the agreement, the government will pay Regeneron for any doses it is able to produce by the end of June. The government can also purchase any additional doses past that point at its discretion.
Trials of Covid jabs underway for kids: In the US, Pfizer and Moderna are testing their Covid-19 vaccines on children. The adolescent trial of the Pfizer-BioNTech vaccine has completed enrollment, with 2,000 volunteers between the age of 12 and 15 years taking part in the trial.
Moderna gave its first doses to young volunteers in December and hopes to receive initial data from its 3,000-strong trial on 12 to 18-year-olds by summer, so that it can bag an approval before the start of the 2021 school year. According to Moncef Slaoui, chief scientific adviser to America’s Operation Warp Speed program, Moderna has been struggling with enrollment.
“It’s been a real challenge,” Slaoui said last week. After four weeks, Moderna and its partners at the National Institutes of Health had “only recruited about 800 subjects in the trial,” he said.
At Oxford, the university plans to recruit about 120 children in the age groups 12-to-18 years and 6-to-11 years. AstraZeneca will then run a larger trial for children in the US. Children over 12 years will receive the same dose as adults in the Pfizer, Moderna and Oxford trials.
Fujifilm continues CDMO expansion spree in US; Philips buys Capsule Technologies
Over the last few weeks, Fujifilm has announced three CDMO projects in the US. Earlier this month, Fujifilm had announced an over US$ 2 billion investment to establish a new large-scale cell culture production site in the US to accelerate the growth of its biopharmaceutical CDMO business. Soon after that, it said it would invest US$ 40 million to establish a new viral vector manufacturing plant in the greater Boston area. Both the plants will be run by its subsidiary contract development and manufacturing organization (CDMO) — Fujifilm Diosynth Biotechnologies.
Last week, it announced yet another investment in the US. Fujifilm Corporation and the Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM) have secured US$ 76 million in financing, and have signed a lease for a 40,000 square-foot site in Watertown, Massachusetts. The center, slated to begin operations in early 2022, will help advance R&D in cell and gene therapy, gene editing, immunotherapy, and biotechnology, while also looking to develop talent in the field of biopharma manufacturing in the Greater Boston area.
Thermo Fisher buys Novasep’s viral vector division: At the recently-concluded JP Morgan healthcare conference, Thermo Fisher announced it has acquired Henogen, Novasep’s viral vector manufacturing division, for about US$ 878.2 million (€725 million) in cash.
Novasep recently signed a multi-year deal with AstraZeneca to support the large-scale production of adenovirus vectors for the latter’s Covid-19 vaccine. Henogen provides contract manufacturing services from formulation to packaging across two locations in Belgium and maintains over 75,000 square feet of production space and about 400 employees.
Philips acquires Capsule Technologies: In order to expand its leadership in patient care management solutions for hospitals, Philips has acquired Capsule Technologies, a leading provider of medical device integration and data technologies for hospitals and healthcare organizations. Philips will acquire Capsule for a cash consideration of around US$ 635 million (€530 million). Founded in 1997, Capsule is headquartered in Massachusetts and serves over 2,800 hospitals and healthcare organizations in 40 countries across the world. In 2020, the company achieved sales of over US$ 100 million.
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