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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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Harnessing small molecules to treat chronic inflammatory diseases
Dr Sheldon Sloan, MBE, Chief Medical Officer, Abivax, shares why the company’s microRNA small molecule treatment could provide long-term efficacy for ulcerative colitis patients, as well as the outlook for using small molecule-based drugs in autoimmune and chronic diseases.
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Lignin-based drug delivery system may improve chemotherapeutics
A sustainable drug delivery method based on the biopolymer lignin could offer applications in anti-cancer therapies, research suggests.
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Ampoules packaging market forecast to 2033
Research suggests that the ampoules packaging market will see a seven percent compound annual growth rate (CAGR) between 2024 and 2033.
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Improving stem cell transplantation success in high-risk blood cancers
The new medicine is expected to enable over 99 percent of people from a wide range of racial/ethnic groups to find a donor, research says.
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Major manufacturing investment to support API production for tirzepatide
Eli Lilly and Company has committed the largest US investment in synthetic medicine active pharmaceutical ingredient (API) manufacturing.
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New Phase III data for hidradenitis suppurativa biologic released
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.
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Development of novel water-soluble inks for 3D-printed polypills
An “innovative formulation and printing process” utilising 3D-printing could lead to scalable batch production of personalised pharmaceutical tablets, research suggests.
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Sanofi releases new data for innovative oral asthma treatment
New findings from a Sanofi trial highlight promise for the potential first advanced oral treatment for moderate-to-severe asthma.
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Progressing personalised cell therapies in oncology
Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.
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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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European authorities recognised for leading medicine regulatory oversight
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
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MSD collaboration to drive development of solid tumour combination therapy
The EGFR immune engager in combination with pembrolizumab is expected to be administered to the first patients in late 2024.
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Novel biologic could offer ulcerative colitis symptomatic remission
Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.
