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Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

As Novartis’ Sandoz unit prepares to go it alone, the off-patent medicines specialist is buckling up for the biosimilars long haul. Sandoz on Tuesday struck an accord with Just – Evotec Biologics to develop and manufacture biosimilar candidates over a multiyear stretch. The deal, which includes an “option for expansion,” marks the latest step in Sandoz’s quest to strengthen itself as a standalone company, the generics unit said in a release. The companies did not say how much they are paying for the deal. Last summer, Novartis telegraphed plans to spin off Sandoz. The decision came as part of a wider strategic review at the company that kicked off in October 2021. As of last August, the spinoff was expected to wrap up in the second half of 2023. Under its latest pact, Sandoz will get its hands on Just – Evotec Biologics’ drug substance development platform and manufacturing technology. Sandoz will use that ...
- Source: drugdu
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- May 15, 2023
reports

The costs for Roche to decommission and demolish its former API manufacturing plant in County Clare, Ireland, continue to climb, with the bill now reaching 57.3 million euros ($62.7 million) over a three-year period, according to local reports. In documents filed with the Companies Registration Office of Ireland, the Swiss pharma giant said it spent 11.53 million euros ($12.6 million) on winding down the facility in 2022. That’s in addition to the 23.4 million euros ($25.6 million) it shelled out dismantling the facility in the previous two years, The Irish Times reports. Roche also spent 13.18 million euros ($14.4 million) in related environmental costs last year, plus 9.1 million euros in that category through 2020 and 2021, according to the publication. “The company is continuing with its plan to decommission and demolish its assets,” Roche said in the filing, as quoted by The Irish Times. “It has successfully transitioned from a manufacturer ...
- Source: drugdu
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- May 15, 2023
Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients. The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is a recombinant human α‑Galactosidase‑A enzyme expressed in plant-cell culture that is designed for providing a long half-life. The therapy was found to have an initial half-life of 78.9 ± 10.3 hours, in clinical trials. Chiesi Global Rare Diseases head Giacomo Chiesi said: “While much progress has been made in the treatment of Fabry disease, there is still a need for new treatment options. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases. “With the FDA approval of PRX-102, we can now offer people ...
- Source: drugdu
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- May 15, 2023
Ariceum and UCB link up to take on immune-related diseases

The companies will use proprietary technology to enable the discovery of peptide-radioisotope conjugates Ariceum Therapeutics and UCB have announced a research partnership agreement to establish and develop novel systemic targeted radiopharmaceuticals for the treatment of solid tumours and immune-related diseases. An essential part of the collaboration will involve the companies utilising each other’s proprietary technology platforms to enable the discovery of peptide-radioisotope conjugates as treatments for a variety of cancers and immune-related diseases. In addition, Ariceum will gain access to UCB’s experience in order to identify novel synthetic macrocyclic peptides by incorporating its mRNA-display technology platform, ExtremeDiversity. Similarly, UCB will benefit from Ariceum’s expertise in the areas of radiochemistry and labelling technology, thereby enhancing its ability to study how this type of technology could lead to the discovery of differentiated products for immune-related diseases. Indeed, the agreement means that each company will have the opportunity to explore multiple targets. Dhaval ...
- Source: drugdu
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- May 15, 2023
NHS misses targets in England to tackle care backlogs

IMAGE SOURCE,GETTY IMAGES By Nick Triggle Health correspondent Hospitals in England have failed to hit key targets to tackle the backlogs in cancer care and routine treatment. Waiting times show too many patients were still facing long waits at the end of March. The targets were to eliminate 18-month waits for planned care, such as knee and hip replacements, and to bring 62-day cancer waits to pre-pandemic levels. NHS England said huge progress had been made, particularly on routine care. The numbers waiting more than 18 months for treatment peaked in September 2021 at nearly 125,000. By the end of March, just over 10,700 were waiting that long – but NHS England said about 4,000 of them were complex cases or patients who had been offered treatment but had chosen to wait. Half of the people were concentrated in 10 NHS trusts. Overall, there are now a record 7.3 million ...
- Source: drugdu
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- May 15, 2023
WHO declares global emergency over

IMAGE SOURCE,GETTY IMAGES Image caption, Monkeypox is caused by the monkeypox virus, a member of the same family of viruses as smallpox BBC By Michelle Roberts Digital health editor Monkeypox is no longer a global public health emergency, the World Health Organization (WHO) has said, almost a year after the threat was raised. The virus is still around and further waves and outbreaks could continue, but the highest level of alert is over, the WHO added. The global health body’s chief Tedros Adhanom Ghebreyesus called on countries to “remain vigilant”. It can be passed on by close contact with someone who is infected. What is monkeypox? Its official name is Mpox and it is caused by the monkeypox virus, a member of the same family of viruses as smallpox, although it is much less severe. Initial symptoms include fever, headaches, swellings, back pain, aching muscles. Once the fever breaks ...
- Source: drugdu
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- May 15, 2023
ImmunityBio gets manufacturing-related FDA snub on cancer drug, shares crash

ImmunityBio was hit with a complete response letter from the FDA for its bladder cancer prospect, sending the California-based company’s stock into a steep slide Thursday. The company’s stock fell more than 50% in overnight trading after it announced in a Securities and Exchange Commission filing Wednesday that it received a CRL from the agency on its application for its drug Anktiva in combination with a vaccine mainly used against tuberculosis, Bacillus Calmette-Guérin. The treatment is designed for patients with BCG-unresponsive, non-muscle invasive bladder cancer. Shares in the overnight session tumbled to $3.39 from Wednesday’s closing price of $6.22. “The deficiencies relate to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations,” ImmunityBio said in the filing. “Satisfactory resolution of the observations noted at the pre-license inspection is required before the [application] may be approved.” ImmunityBio said it has requested a meeting with the FDA to address the agency’s concerns. The ...
- Source: https://seekingalpha.com/news/3969942-immunitybio-stock-crashes-after-fda-snub-cancer-therapy
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- May 14, 2023
Cytiva and Pall Life Sciences complete integration

Cytiva and the life sciences business of Pall Corporation have completed their integration and are now united as one business under the Cytiva brand. With nearly 16 000 associates in 40 countries, and more than 300 years’ heritage of trusted expertise, the new Cytiva supports customers in solving major biotechnology challenges and plays a critical role in advancing and accelerating therapeutics for the benefit of patients everywhere. In January 2023, the life sciences business of Pall separated from Pall Corporation. Pall’s biotech portfolio is now a product family in Cytiva’s bioprocess business. The Pall medical portfolio will remain a market brand and part of Cytiva. Pall Corporation continues to operate as a Danaher operating company serving customers across a wide range of industrial applications. “The biotechnology industry is at the start of a new era. New modalities are emerging, there is greater emphasis on local manufacturing, and we are accelerating ...
- Source: https://www.news-medical.net/news/20230512/Cytiva-and-Pall-Life-Sciences-complete-integration-to-create-a-global-innovation-and-solutions-leader-in-biotechnology.aspx
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Despite rough quarter, Bayer’s duo of Nubeqa and Kerendia continue to excel

As Bayer presented its first-quarter earnings, much of the focus centered on the company’s struggling agricultural sector, which has been hindered by the poor performance of its glyphosate-based weedkillers. Somewhat under the radar is Bayer’s pharma business, which could use a boost as well. On the company’s list of best-selling medicines, seven of the top 10 posted a sales decline from the first quarter of last year. That list doesn’t include the aging eye treatment Eylea, which was up 2% on the quarter. Still, the drug posted a sequential (PDF) sales decline of 4% from the fourth quarter of last year. It all adds up to lots of pressure to perform for Bayer’s most promising new treatments—prostate cancer drug Nubeqa and kidney disease therapy Kerendia. Bayer’s small dose of good news on Thursday is that both are progressing nicely. The company has projected the drugs will generate 3 billion euros ($3.2 billion) each at peak. During the ...
- Source: https://www.fiercepharma.com/pharma/rough-quarter-bayers-duo-nubeqa-kerendia-continue-excel
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Sobi to acquire CTI BioPharma for approximately $1.7bn

Swedish Orphan Biovitrum (Sobi) has said it will acquire CTI BioPharma for approximately $1.7bn, marking a notable expansion to the Swedish drugmaker’s rare haematology pipeline. The deal will grant Sobi access to the US biopharma’s recently-approved Vonjo (pacritinib), a novel oral kinase inhibitor for patients with myelofibrosis and severe thrombocytopenia. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) in February last year to treat adults with intermediate or high-risk primary or secondary myelofibrosis with low platelet counts. This was based on positive results from a phase 3 trial of Vonjo in patients with myelofibrosis. Results showed that 29% of patients receiving Vonjo had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy. Sobi said Vonjo will be ‘highly complementary’ to Doptelet (avatrombopag), its oral thrombopoietin receptor agonist which also addresses rare haematological platelet disorders. Guido ...
- Source: https://www.pmlive.com/pharma_news/sobi_to_acquire_cti_biopharma_for_approximately_$1.7bn_1491454
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