Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.

Company Updates

Key Considerations for a Good Lab Investigation

When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause, and prevent recurrence.

Our Senior Associate, Anna Lothian, has compiled some of her top tips to help you maximise the effectiveness of your laboratory investigations. To read, click on this link.

Regulatory Updates

FDA guidance updates

  • Processes and Practices Applicable to Bioresearch Monitoring Inspections. On 5th June, the US Food and Drug Administration (FDA) published draft guidance to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct. Click to view source
  • Standardised Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions. On 5th June, draft guidance was published applying to electronic submissions of data and information from the major studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by the Center for Biologics Evaluation and Research (CBER), as well as supplemental applications containing new clinical study reports. Click to view source

Industry Updates

The Francis Crick Institute announces boost for tech bio companies seeking investment

On 30th May, the Francis Crick Institute announced its start-up accelerator KQ Labs and the UK Bioindustry Association (BIA) have launched TechBio, a new programme to support growing companies working at the interface of biology and data technologies.

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Valneva receives EMA’s positive CHMP opinion for its chikungunya vaccine

On 31st May, Valneva SE, a speciality vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorisation of IXCHIQ®, a single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

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Pfizer receives positive CHMP opinion for new gene therapy treatment for haemophilia B

On 31st May, Pfizer Inc. announced that the EMA’s CHMP has adopted a positive opinion for Durveqtix, a gene therapy for the treatment of severe and moderately severe haemophilia B in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. Durveqtix is delivered as a single infusion that aims at enabling the body to produce factor IX itself and prevent and control bleeding.

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EMA issues latest CHMP meeting highlights

On 31st May, the EMA issued highlights from the CHMP meeting held on the 27th-30th May. Highlights include 14 new medicines recommended for approval and the latest CHMP statistics.

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World Health Assembly agreement reached on package of amendments to improve the International Health Regulations

On 1st June, the World Health Assembly agreed on a package of critical amendments to the International Health Regulations (2005) (IHR) and made concrete commitments to completing negotiations on a global pandemic agreement within a year, at the latest, and possibly in 2024. These critical actions have been taken to ensure comprehensive, robust systems are in place in all countries to protect the health and safety of all people everywhere from the risk of future outbreaks and pandemics.

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EpiEndo and AlveoliX achieve milestone in ulcerative colitis treatment

On 4th June, EpiEndo Pharmaceuticals, a clinical-stage biopharmaceutical company, and AlveoliX, an innovator in organ-on-chip technology, announced significant advancements in their joint project, the EpicoliX Project, to develop a novel treatment for ulcerative colitis (UC). This includes a new gut-on-chip model developed to mimic the colon epithelium of UC patients and used to screen and select lead compounds from EpiEndo’s libraries that indicate promising effects on the gut epithelium.

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Alchemab advances a novel antibody with potential in Parkinson’s disease

On 6th June, Alchemab Therapeutics, an antibody discovery company identifying naturally occurring antibodies from individuals resilient to disease, announced that it has been awarded a grant of $595,000 by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support its Parkinson’s disease (PD) program. The grant will fund research performed at Alchemab following its identification of antibodies that target prostaglandin biology in Parkinson’s disease (PD), a potentially unique approach to treatment. Alchemab is researching the therapeutic effects of its resilient patient-derived antibody in PD.

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Amgen’s trial brings new hope for IgG4-RD patients

On 6th June, Amgen announced a breakthrough in the treatment of Immunoglobulin G4-related disease (IgG4-RD) with its phase 3 clinical trial of UPLIZNA® showing an 87% reduction in disease flares. The trial, known as MITIGATE, met all primary and key secondary endpoints, including a reduction in the annualised flare rate and achieving flare-free, treatment-free complete remission. Based on these results, Amgen is planning to file for approval in the US followed by other key markets.

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Issue Number: WN00165

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