Ardena has acquired Idifarma, a contract manufacturer of niche and highly potent generic and innovative drugs, from Suanfarma; the deal enables it to expand across Southern Europe and supports its strategy to become a leading global CDMO.
Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.
Unchained Labs has acquired Freeslate, a provider of high-throughput solutions for biologics formulation development and small molecule chemistry – marking the company’s 4th acquisition in 12 months.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
Big biotech firms risk the empty pipeline pitfalls of old pharma if they protect their drugs from biosimilars rather than invest in innovation, ex-Teva CEO Jeremy Levin warns.
Novartis says it will keep biomanufacturing in-house and outsource more production of its small molecule portfolio in a strategy mirroring its Big Pharma peers.
The EMA and US FDA say the chimeric nature of antibody drug conjugates (ADC) does not make them any harder to regulate and that existing guidelines for small and large molecule drugs are sufficient.
Antibody-drug conjugates (ADCs) are fully covered by current regulations, the EMA says, though a surge of applications is not expected in the light of Roche’s recent success.
AbbVie has invested $320m (€432m) into its first Asian manufacturing facility and says it will support an emerging antibody-drug conjugate (ADC) pipeline.
Choosing the same biomanufacturing tech supplier for development and commercial systems cuts scale steps and reduces lead times according to Cobra Biologics.
Biomanufacturing is offsetting a decline in Ireland's small molecule industry caused by the patent cliff and cheaper manufacturing options in the East say industry groups.
Evotec and Apeiron Biologics are joining forces to identify small molecule modulators of DREAM (Downstream Regulatory Element Antagonistic Modulator), a novel target involved in perception of various pain mechanisms.
Anglo-German company Evotec is joining forces with Almirall to identify small molecule modulators of an ion channel target involved in respiratory diseases.
Sheffield Bio-Science takes on responsibility for global sales, distribution and development of Girus Life Sciences’ chemically defined Regocel supplements.
