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Novo Nordisk expands site to manufacture GLP-1 drugs

Novo Nordisk announced plans to expand one of its production facilities in Chartres, France, as it scales up its serious chronic disease product portfolio. Under the Dkr16bn ($2.29bn) investment, Novo Nordisk is increasing the capacity of the manufacturing site by extending the current quality control laboratory, adding aseptic production, and finishing production processes. The company predicts that this will bring over 500 new jobs once construction is completed. According to the press release, the investment includes additional capacity for GLP-1 products such as Novo’s Ozempic (semaglutide). Novo Nordisk first launched the GLP-1 therapy Semaglutide, in the US in December 2017, under the brand name Ozempic. The drug has since been approved in the US, Canada, EU, Japan, and Australia as a treatment for T2D. Novo Nordisk later launched the therapy under the name Wegovy for the treatment of weight loss, together with diet and physical activity. Novo Nordisk is a ...
- Source: drugdu
- 101
- November 28, 2023
Health Canada approves Jazz’s cannabis derived seizure therapy

Health Canada has approved Jazz Pharmaceuticals’s Epidiolex (cannabidiol oral solution) as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC). Epidiolex is a plant-based oral cannabidiol solution. It was developed by GW Pharmaceuticals and was added to Jazz’s portfolio following GW’s acquisition in 2021. The therapy was first approved in the US as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with LGS and Dravet syndrome in June 2018. The approval in TSC came in July 2020. All three indications causes different types of serizure. LGS and Dravet syndrome are types of epileptic encephalopathy, that cause seizures. LGS is managed by two or more seizure medications whilst Dravet is treatment-resistant. TCS is a rare genetic condition that causes benign tumours to develop in different ...
- Source: drugdu
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- November 28, 2023
Surge in respiratory illnesses reported in China

Chinese authorities from the National Health Commission have reported an increase in incidence of respiratory diseases in China. This increase has been attributed to the lifting of COVID-19 restrictions and the circulation of known pathogens such as influenza, Mycoplasma pneumoniae, respiratory syncytial virus (RSV), and COVID-19. These are all common pathogens but due to changes in social mixing may not follow usual seasonal infection patterns. The UK experienced similar trends in 2022. The World Health Organization (WHO) provided an update on 23 November after speaking with Chinese health authorities from the Chinese Center for Disease Control and Prevention and the Beijing Children’s Hospital. The Chinese authorities advised that there has been no detection of any unusual or novel pathogens or unusual clinical presentations, including in Beijing and Liaoning, but only the general increase in respiratory illnesses due to multiple known pathogens. UKHSA is closely monitoring the situation and will respond ...
- Source: drugdu
- 109
- November 27, 2023
Heat shock protein protects bacteria from plasma treatment

A heat shock protein protects the cells against protein clumping. It degrades, however, over longer treatment periods. Plasmas are used, for example, in wound treatment against pathogens that are resistant to antibiotics. However, bacteria can defend themselves: They employ a heat shock protein that protects them. A research team headed by Professor Julia Bandow and Dr. Tim Dirks from the Chair for Applied Microbiology at Ruhr University Bochum, Germany, showed that bacteria that overproduce the heat shock protein Hsp33 can withstand plasma treatment more effectively than others. The researchers also demonstrated which components of the plasma activate the heat shock protein. The team published their findings in the Journal of the Royal Society Interface on October 25, 2023. All bacteria inactivated after three minutes When treated with plasma, proteins unfold, lose their natural functions and can clump together. Their clumping is toxic to cells and can lead to their inactivation. ...
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- 103
- November 27, 2023
BD hires new chief medical officer from 3M Health Care

BY JIM HAMMERAND Dr. Ron Silverman is the next chief medical officer of Becton, Dickinson & Co. [Photo courtesy of BD] Becton, Dickinson & Co. (NYSE: BDX)+ today named Dr. Ronald “Ron” Silverman as EVP and chief medical officer. He replaces BD Chief Medical Officer Dr. William Sigmund, who announced plans to retire from BD earlier this year. The change takes effect Dec. 4, 2023. Silverman comes from 3M Health Care, where he served as SVP and chief medical officer since 2021. He will lead BD’s medical affairs organization across BD’s business units, regions and central team. Franklin Lakes, New Jersey-based BD said Silverman “will use medical insights and expertise to advance BD’s pipeline of clinically relevant, innovative solutions that align with evolving patient needs, while also contributing to the safety and compliance of BD’s in-market portfolio of products.” Silverman will report to BD EVP and Chief Technology Officer Beth ...
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- November 27, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Insurers and PBMs are increasingly implementing white-bagging policies, which require oncology practices to obtain physician-administered infusions and other medications from designated specialty pharmacies often owned by or affiliated with insurers and their PBMs. By DR. JAMAL MISLEH Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified ...
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- November 27, 2023
report

After many months of shortages affecting attention-deficit/hyperactivity disorder (ADHD) drugs, it was hoped that new generics to Takeda’s Vyvanse would ease the supply situation. But according to a letter from the Association for Accessible Medicines (AAM), production limits on the drug’s active ingredient—set by the government—are at least partly to blame for the shortage that has spread to the generics. Generic drugmakers haven’t been able to obtain enough raw material to “launch their products at full commercial scale,” AAM wrote to the Drug Enforcement Administration (DEA), according to Bloomberg. The DEA sets specific restrictions on production to avoid an excess of supply that could spread to the black market due to Vyvanse’s status as a controlled substance. The agency sets its limits based on past production levels and future sales commitments, which poses a problem given that some companies are cleared to launch the generics but haven’t sold any so ...
- Source: drugdu
- 257
- November 26, 2023
FDA fast tracks Alladapt’s multi-food allergy immunotherapy

The US Food and Drug Administration (FDA) has granted a fast track designation to Alladapt Immunotherapeutics’ IgE-mediated multi-food oral immunotherapy ADP101. The FDA’s decision was based on the results from the Phase I/II Harmony trial, which investigated the immunotherapy’s use in inducing desensitisation in patients with single or multiple food allergies, including nuts, dairy, seafood and more. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling and priority reviews. In this instance the designation allows Alladapt to seek accelerated approval for oral immunotherapy in paediatric patients, aged between four and 17 years, with one or more of the 15 food allergies covered by ADP101, as per a 22 November press release. Phase I/II data The double-blind, placebo-controlled Phase I/II Harmony trial (NCT04856865) enrolled 61 paediatric patients (aged four-17 years) and 12 adult patients (aged 18-55 years). The ...
- Source: drugdu
- 212
- November 26, 2023
Simcere and Connect sign licensing agreement for anti IL-4Rα AD drug

Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
- Source: drugdu
- 188
- November 26, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 175
- November 26, 2023

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