Friday, November 1, 2019 Daily Archives

Systems Compliance: A Risk-Based Approach to Software Management

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This webcast features: Martin Laferriere, Director, IT Systems Compliance, Avid Bioservices Software systems risk management and evaluations should be part of your validation process. It is possible to reduce testing by documenting your risk, actual use, regulation impact, evaluating vendor(s), etc. The approach to managing the risk evolves through audits and prior experience and can tailor the management and approach to system quality within each organizations. In my experience and observations, an efficient system risk management is essential, and it…

November 1, 2019

GSK Q3: Shingrix shines but adjuvant will drive future vaccines

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GSK says the adjuvant platform used in Shingrix will be the “backbone†of its future vaccine strategy. The shingles vaccine pulled in sales of £535 million ($693 million) for the third quarter. For the quarter, GlaxoSmithKline (GSK) reported group sales of £9.4 billion, up 11% on the previous year. Its vaccines unit grew 15% year-on-year to £2.3 billion with its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster), Shingrix, pulling in £535 million – up 76% year-on-year.…

November 1, 2019

Amgen takes $2.7bn stake in BeiGene to up presence in China

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Amgen will look to commercialize several of its biologics and advance 20 oncology candidates in China as it acquires roughly 20% of local drugmaker BeiGene. During Amgen’s third quarter 2019 financial call this week, CEO Bob Bradway noted his firm’s excitement of having recently launched its first product in China – cardiovascular disease monoclonal antibody Repatha (evolocumab). “We expect this to become an important market for us through time,†he told investors. Days later, and the biopharma firm has struck…

November 1, 2019

From Mylotarg to Polivy: Ebbs and flows, successes and woes of ADCs

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Interest in antibody drug conjugates (ADC) is surging with more combined MAb and warhead candidates entering clinical trials than ever before. The biopharmaceutical industry has had a difficult few years with ADCs. There have been successes like Besponsa (inotuzumab ozogamicin) – which Pfizer cited as a driver in 2018 – and Roche and Seattle Genetics’ Polivy (polatuzumab vedotin-piiq) which won fast-track approval in the US this year. Likewise, Kadcyla (trastuzumab emtansine) – also made by Roche – has been cleared…

November 1, 2019

Abzena and MilliporeSigma up services on ADC outsourcing demand

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The high clinical failure rate of antibody-drug conjugates (ADCs) and the tendency to outsource development have driven both Abzena and MilliporeSigma to launch new service offerings. The first ADC, Wyeth’s Mylotarg (gemtuzumab ozogamicin) was approved in 2000, but nearly 20 years on there are only a handful of such therapies on the market. However, ADCs remain a viable and financially tempting oncology treatment and according to MilliporeSigma there more than 300 projects in development. Writing in ADC Directory earlier this…

November 1, 2019

Avacta teams with ADC Therapeutics on Affimer conjugates

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Avacta Group and cancer drug developer ADC Therapeutics SA have entered into a collaboration agreement. The partnership – financial terms of which were not made public – will develop drugs combining ADC Therapeutics’ pyrrolobenzodiazepine-based cytotoxic warheads with Avacta’s Affimer targeting platform. ADC Therapeutics will cover all Avacta’s costs during the project. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization. Matt Vincent, Avacta’s VP of Therapeutics Business Development, told us:…

November 1, 2019

Manufacturing assessments critical in ADC development, says AZ

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Manufacturing is key to bringing ADCs to the clinic faster says AstraZeneca, which stresses the importance of carrying out developability assessments. When a new molecule enters AstraZeneca’s portfolio, one of the first things the Anglo-Swedish biopharma firm does is carry out a developability assessment to understand the challenges in bringing the candidate through the clinic. Like other drug developers, the firm has a series of processes to move a project from lead optimization to candidate profiling, before moving into the…

November 1, 2019