The US Food and Drug Administration has agreed to give Alkermes Plc’s candidate drug for the adjunctive treatment of major depressive disorder a ‘fast track’ designation which means the company can have more frequent interactions with the regulator.
The market for initial public offerings for biotechnology companies in the US is likely to remain open for some time as investors position themselves to take advantage of the demand for new medical therapies.
Hutchison MediPharma Ltd (HMP), the R&D unit of Hutchison China MediTech Ltd, has secured a licensing agreement for an early-stage oncology compound with Eli Lilly and Company – its third deal for a molecule in its six-compound clinical portfolio. The deal was announced on 9 October.
The Dutch biotech company, Pharming Group NV, has raised €12 million in a private share placement, sweetened with warrants, with existing and new institutional investors. The proceeds will support the manufacture of Ruconest, which is awaiting FDA approval.
The German vaccine developer CureVac GmbH has secured a licensing agreement with Janssen Pharmaceuticals (Johnson & Johnson Inc) to develop an influenza vaccine based on its messenger RNA technology. Financial terms were not disclosed.
Pharmalink AB, a Sweden-based specialty pharmaceutical company, has raised SEK96 million (€11.1 million) in a Series C round to advance the clinical development of products to treat patients with cancer and renal disease.
The fortunes of biotech, at least in the US, have shifted. Gone is the gloom and in its place has arrived something close to euphoria, driven by a wave of initial public offerings (IPOs).
Merck & Co Inc has announced a further contraction of its business in order to become better focused and more flexible. The plan includes new redundancies of about 8,500, in addition to pending, previously announced staff cuts.
The US Food and Drug Administration has approved Brintellix (vortioxetine), an inhibitor of serotonin reuptake, for the treatment of major depressive disorder (MDD). The developers are H. Lundbeck A/S and Takeda Pharmaceutical Company Ltd.
Cell Medica Ltd has further extended its global footprint with the opening of a manufacturing facility in Germany which will support the commercial launch of its lead cell product for the prevention and treatment of cytomegalovirus infections.