Tower Mains Weekly Newsletter
Regulatory Updates
FDA signs MRA between US and Switzerland relating to GMP
On 12th January, the US Food and Drug Administration (FDA) signed a Mutual Recognition Agreement (MRA) between the US and Switzerland, allowing the FDA and Swissmedic to share each other’s GMP inspectional findings, reducing unnecessary costs and avoiding the need for duplicative efforts. In addition to covering good manufacturing practice inspections of facilities making human drugs, the MRA with Swissmedic also includes veterinary drugs
MHRA guidance updates
- On 16th January, the Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance on how it regulates medicines, medical devices, and blood components for transfusion in the UK. Click to view source
- On 16th January, a link to ‘Horizon Scanning Case Study: What is an Actionable Horizon Scanning Signal (AHSS)?’ was added to guidance on how the MHRA provides developers of innovative products access to scientific expertise, regulatory guidance and an enhanced advice and its signposting service. Click to view source
Optimising dosage of human prescription drugs and biological products for treatment of oncologic diseases
On 17th January, the FDA published draft guidance intended to assist sponsors in identifying the optimal dosage for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to applying for approval for a new indication and usage.
Industry Updates
FDA approves first generic doramectin topical solution for the treatment of certain parasites in cattle
On 11th January, the FDA approved DectoGard, the first generic doramectin topical solution for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle. DectoGard is an antiparasitic drug that contains the same active ingredient in the same concentration and dosage form as the approved brand name drug product, Dectomax, which was first approved for use in cattle on September 16, 1997.
Bayer to drive drug discovery with Google’s Cloud’s high performance compute power
On 11th January, Bayer AG and Google Cloud announced a partnership to drive early drug discovery that will apply Google Cloud’s Tensor Processing Units (TPUs), which are custom-developed accelerators designed to run innovative machine learning models and computationally intensive workloads, to help accelerate and scale Bayer’s quantum chemistry calculations. The theory of quantum mechanics applied to computer-aided drug discovery enables the in-silico modelling of biological and chemical systems with high accuracy, and consequently has the potential to help identify novel drug candidates.
FDA approves drug combination treatment for adults with asthma
On 11th January, the FDA approved the Airsupra inhalation aerosol for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older. AstraZeneca’s Airsupra is a combination of albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid) and is the first combination of an inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the US.
EMA issues highlights from the latest PRAC meeting
On 13th January, the European Medicines Agency (EMA) published meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 9th – 12th of January 2023. Highlights include the alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors, the recent fatal cases of acute liver failure reported in patients treated with Zolgensma, and the latest PRAC statistics.
US-based Moderna joins UK’s leading pharmaceutical industry body
On 13th January, the Association of the British Pharmaceutical Industry (ABPI) announced that Moderna has become its newest member, building on the wider long-term commitment by the US-based company to expand its footprint and investment in the UK.
AstraZeneca acquires Neogene Therapeutics
On 16th January, AstraZeneca announced it has completed the acquisition of Neogene Therapeutics Inc., a global clinical-stage biotechnology company pioneering the discovery, development, and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). Neogene will operate as a wholly owned subsidiary of AstraZeneca, with operations in Amsterdam, the Netherlands, and the US.
Professor Tom Clutton Brock MBE new Chair of MHRA Interim Devices Working Group
On 16th January, the MHRA announced the appointment of Professor Tom Clutton Brock MBE as Chair of the MHRA Interim Devices Working Group. The Interim Devices Working Group will provide independent, external expert input and advice on the safety, performance, benefits, and risks of devices in use in the United Kingdom healthcare system, prior to the launch of the statutory committee under the Medicines and Medical Devices Act 2021.
Issue Number: WN00095
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