Market Place
Pfizer’s NC facility damaged by tornado may worsen drug shortages; Biogen to cut 1,000 jobs
Pfizer’s manufacturing facility in Rocky Mount, North Carolina, suffered significant damage due to last week’s tornado. The company has notified hospitals of the possibility of supply disruptions of over 30 drugs produced at the plant.
After bagging two drug approvals during the last quarter, Biogen has embarked on a ‘Fit for Growth’ cost-cutting program wherein 1,000 employees will be laid off to save US$ 1 billion.
FDA has okayed Daiichi Sankyo’s Vanflyta for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML). And Emergent’s anthrax vaccine — Cyfendus — was granted FDA approval in adults.
Meanwhile, Mirati’s Krazati received the European Medicines Agency’s (EMA) negative opinion for lung cancer. And Gilead has halted a late-stage trial of a combination of two drugs to treat a rare type of blood cancer.
In regulatory news, Biocon’s Malaysia facility and Aurobindo’s Telangana facility in India received FDA’s Form 483s.
Pfizer warns of supply disruptions after tornado damages its NC facility
Pfizer’s manufacturing facility in Rocky Mount, North Carolina, suffered significant damage from a tornado, completely destroying the warehouse that stored raw materials, packaging supplies, and finished medicines awaiting release. The production facilities at the site did not report of major damage. Pfizer notified hospitals of the possibility of supply disruptions of over 30 drugs produced at the plant, including crucial drugs used in surgery and critical care. FDA is closely working with Pfizer to assess the damage and is taking mitigation steps to avoid immediate supply shortages.
Ends agreement with Syros: Pfizer has decided to terminate its license agreement with Syros Pharmaceuticals, which involved working together on innovative therapies for sickle cell disease and beta-thalassemia. This decision also marks the end of Syros’ three year old partnership with Global Blood Therapeutics (GBT), a sickle cell disease drugmaker that Pfizer acquired for US$ 5.4 billion in August 2022.
Biogen to cut 1,000 jobs as part of its US$ 1 billion expense saving program
During the last quarter, Biogen had bagged two FDA approvals — Leqembi for Alzheimer’s disease and Qalsody for ALS. Now, Biogen plans to shift its resources to these areas of higher value creation. Therefore, the company plans to cut 1,000 jobs, out of a worldwide employee strength of 8,725, as part of its “Fit for Growth” cost-cutting program that seeks to achieve US$ 1 billion in gross operating expense savings. Approximately US$ 300 million of this will be reinvested in product launches and R&D programs.
Mirati’s lung cancer drug Krazati receives EMA’s negative opinion
Mirati Therapeutics’ Krazati (adagrasib), a non-small cell lung cancer (NSCLC) KRAS inhibitor, received a negative opinion on its application for conditional marketing authorisation from the EMA’s Committee for Medicinal Products for Human Use (CHMP). It expressed concerns about the lack of comprehensive data and uncertainties regarding the medicine’s effectiveness.
UK reviews safety data of diabetes, weight loss meds sold by Novo, Astra, Sanofi, Lilly
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing a class of drugs known as GLP-1 receptor agonists used for weight management and to treat diabetes after some patients reported suicidal or self-harming thoughts. Similar action was taken by the European Union two weeks back. The drugs being reviewed are Novo’s Ozempic and Saxenda, AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide and Eli Lilly’s dulaglutide.
Gilead halts late-stage blood cancer trial: Gilead Sciences has decided to halt a late-stage trial of the combination treatment of magrolimab and azacitidine for the treatment of a rare but severe form of blood cancer, known as higher-risk myelodysplastic syndromes (HR-MDS), in adults. The decision came after an analysis revealed that the drug combination would not be effective for treating the condition.
Bavarian Nordic ends RSV vaccine trial: Bavarian Nordic will discontinue its late-stage trial for respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV, intended for adults aged 60 and above. The vaccine did not meet all the primary objectives of preventing lower respiratory tract disease caused by RSV. Based on this outcome, Bavarian Nordic will discontinue its RSV program.
Verrica Pharma’s Ycanth bags FDA nod for viral skin infection
Verrica Pharmaceuticals’ Ycanth (cantharidin) has bagged an FDA approval, making it the first approved drug-device combination product for the treatment of Molluscum contagiosum, a viral skin infection that affects both adults and children. Ycanth is expected to be available by September. Prior to the approval, the drug had faced rejections in 2020, 2021 and 2022.
FDA okays Daiichi’s Vanflyta for newly diagnosed leukemia: Daiichi Sankyo’s Vanflyta (quizartinib) was granted FDA approval for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. This is an aggressive form of leukemia. Vanflyta will be available in the coming weeks. In 2019, an FDA advisory panel had voted 8-3 against Vanflyta’s approval, as they believed the safety risks for AML patients outweighed the potential efficacy benefit. The drug got approved in Japan in May 2023.
FDA approves Emergent’s anthrax vaccine: Emergent BioSolutions has bagged FDA approval of its anthrax vaccine, Cyfendus, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in adults aged between 18 to 65 years. Emergent has been supplying Cyfendus to the US Department of Health and Human Services since 2019 under pre-emergency use authorization status.
Biocon’s Malaysia facility, Aurobindo’s India facility receive FDA’s Form 483
FDA has issued a Form 483 with six observations to Biocon Biologics’ Malaysia insulin facility. The inspection of the facility was conducted from July 10 to 20. The company said the observations were primarily related to enhancing operational procedures and strengthening training programs.
FDA has also issued a Form 483 with three observations to Aurobindo Pharma’s Unit III formulation manufacturing facility in Telangana, India. The inspection of the facility was conducted from July 14 to 21, and has ended with three observations. The company said the observations were procedural in nature.
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