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FDA awards full approval to Paxlovid amidst hazy coverage plans
After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) …
Immuno-oncology market set to grow in billions, but access concerns remain
The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in …
Touchlight boosts DNA manufacturing capacity with latest expansion
Enzymatic DNA production company Touchlight have augmented its DNA production capabilities with a newly announced expansion to its London facilities. …
Beta Bionics’ automated insulin delivery system picks up manufacturing partner
Chronic disease tech company Convatec Group has partnered with Beta Bionics to manufacture the insulin delivery system iLet Bionic Pancrease. According …
Illegal online pharmacies gain traction as regulators lag behind
Amidst an insulin pricing crisis and consistent shortages of drugs ranging from Teva’s attention deficit hyperactivity disorder (ADHD) medication Adderall …
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After 2022 interest rate hikes spook investors, pharma M&A to resurge in late 2023
Pharma company merger and acquisition (M&A) activity in the first half of 2023 has remained relatively low, consistent with the …
Excitement associated with FDA approval of Rinvoq in Crohn’s disease
On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults …
Daiichi Sankyo receives Japan’s MHLW approval for VANFLYTA
Daiichi Sankyo has received approval from Japan’s ministry of health, labour and welfare (MHLW) for VANFLYTA (quizartinib) to treat acute …
FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA
The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for …
HanAll Biopharma and Daewoong sign deal to develop Parkinson’s therapy
HanAll Biopharma and Daewoong Pharmaceutical have entered into a co-development deal with NurrOn Pharmaceuticals to develop therapy for Parkinson’s disease …
Applied Therapeutics receives EMA orphan designation for AT-007
Applied Therapeutics has received orphan medicinal product designation from the European Medicines Agency (EMA) for AT-007 (govorestat) to treat sorbitol …
EMA accepts Sandoz’s marketing applications for biosimilar denosumab
The European Medicines Agency (EMA) has accepted two marketing authorisation applications (MAA) from Sandoz for the proposed biosimilar denosumab. The MAAs …
UK agency pilots biobank to study links between genetics and drug side effects
The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data …
Transgene and BioInvent report positive data for oncolytic virus
BioInvent International and Transgene’s partnership is looking optimistic following positive Phase 1a data on its oncolytic virus BT-001 for the …
Meningitis vaccine comes to the forefront with impressive study results
A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. …