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manufacturing
This page shows the latest manufacturing news and features for those working in and with pharma, biotech and healthcare.
Pfizer goes big on gene therapy with $500m facility spend
The new manufacturing plant will be located at Pfizer’s facility in Sanford, North Carolina, where it already produces vaccines including its blockbuster childhood immunisation Prevnar 13 and several experimental shots, ... The $500m investment in
Latest news
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Amgen wins Enbrel patent case, knocking back Sandoz's biosimilar plan
Sandoz did not dispute that its biosimilar infringes on the patents, which cover the Enbrel active ingredient and manufacturing process, but argued that they were invalid.
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Von der Leyen elected new European Commission president
On 1 July, a new supplementary protection certificate (SPC) manufacturing waiver was introduced, relaxing the regulations governing the manufacturing of generics and biosimilars in Europe. ... This allows the two sides to rely on each other’s
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BioNTech raises €290m for mRNA cancer vaccine platform
Some of the proceeds of the second round will also go towards bolstering its manufacturing capabilities, according to the company, which has also been adding to its capabilities and pipeline with
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Europe urged to adapt faster to gene therapy challenges
restricted.”. Slow uptake, coupled with manufacturing cost and capacity problems could hobble the field’s development. ... However next-generation antibodies with comparable efficacy but with lower costs and complexity in manufacturing could undercut
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Amicus forms gene therapy manufacturing partnership with Catalent
The agreement will also see the development of an Adeno-Associated Virus (AAV) manufacturing platform, supporting the manufacturing of Amicus’ preclinical gene therapy programmes. ... capabilities. Thermo Fisher will supply Amicus with immediate access
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Latest Intelligence
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Streamlining clinical trials – why better data use is key
She told us sponsors should apply QbD manufacturing principles in a clinical setting.
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Biotech profile: Tom Evans, CEO, Vaccitech.
We have all the skills internally to oversee the regulatory, clinical and manufacturing aspects to take us through the large phase 2 trials that we are presently conducting. ... As many of the safety and manufacturing issues surrounding our MVA-NP M1
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Women Leaders in UK Healthcare: Liz Henderson
Prior to this, Liz was Executive Vice President, Head of Global Manufacturing &Supply for the Biopharma business of Merck. ... Liz’s career spans more than 20 years in manufacturing and supply in the healthcare and life sciences industries.
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The trials and tribulations of rare opportunities
Manufacturing success. In some respects, making supplies for a rare disease study may be more straightforward than one for a common disease, according to Keefer, who said the smaller batch sizes ... Manufacturing and distributing gene therapies is
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Gene therapy market access Q&A
reality in terms of manufacturing costs/margins and volumes is very different from that of conventional drugs. ... What’s going to unlock the long-term sustainability of the field – evolution in cell and gene manufacturing platforms or novel payment
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Latest appointments
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Ipsen hires general manager, Laura Hamill joins Gilead and Orchard expands leadership team
During her 16-year stint with Amgen, Hamill worked in a number of executive roles, including general and regional management, US reimbursement and access, and manufacturing.
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BMS appoints new commercial leader, Davies joins Eisai and more
Officially joining the biopharma on 1 October, Schuermans will play a part in bringing together Sobi’s manufacturing operations/biological development and supply, quality, supply chain, procurement and environment and safety ... Commenting on her
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Building trust in our industry
This year, a trust score of 63 puts healthcare on a par with the energy and telecommunications industries but below manufacturing, retail and transportation and well adrift of technology, the most
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Pharnext appoints COO
He has also held a number of leadership roles with Sanofi in sales, marketing, finance, supply chain and manufacturing.
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Zelluna Immunotherapy appoints chief technology officer
Miguel Forte, chief executive officer of Zelluna, said: “Zelluna appointed Arjan specifically for his wide-ranging knowledge in key areas of cell therapy product manufacturing. ... He will play a big part in the execution of Zelluna’s manufacturing
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Latest from PMHub
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Rare Disease Day 2019: A patient perspective on primary sclerosing cholangitis
This is often due to the lack of knowledge about the diseases and the high costs of running clinical trials and manufacturing drugs for a relatively small number of patients.
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Lucid Group continues their expansion into the north west of England with new premises
Macclesfield has long been a regarded as a key hub for scientific research, development and manufacturing in the UK.
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Solaris Health looks at the gene therapy revolution
The only approved manufacturing centre for Strimvelis is in Milan, Italy, and due to the 6‑hour shelf life of Strimvelis, the treatment is only available at Hospital San Raffaele Telethon
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Training the next generation of biotech leaders
Each breakthrough is reliant on complex and highly specific technology, making the manufacturing and reproduction of these therapies challenging. ... UCL is working with students and an industry consortium to transform the manufacturing process for
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