The FDA has approved new and contraversial Alzheimer’s drug, lecanemab

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German biotech company BioNTech and the UK Government have signed a Memorandum of Understanding (MoU), which will accelerate clinical trials of personalised mRNA immunotherapies. It is hoped this acceleration will lead to up to 10,000 patients receiving such therapies by the end of 2030.

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This month's issue covers the most exciting news from developments in AI to a COVID-19 antiviral in a clinical trial.

As we welcome the new year, we look ahead at what 2023 will bring for the pharma industry.

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Molnupiravir, made by Merck, Sharp and Dohme (MSD), has been found to reduce the recovery time of COVID-19 patients, however it did not decrease mortality rates or hospital admissions.

Japan-based Sosei Heptares announced that it has joined forces with UK global biopharma company Eli Lilly to discover, develop and commercialise small molecules that modulate novel G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases.

UK-based GSK has announced a partnership with American company Wave Life Sciences, valued at up to $3.3bn. The partnership will allow GSK to use Wave’s PRISM technology – an oligonucleotide platform that combines chemistry with multiple therapeutic modalities, including editing, splicing and silencing.

GlaxoSmithKline has chosen to establish its new headquarters in London’s West End, on the corner of New Oxford Street and Earnshaw Street in the Capital’s centre. The new hub is expected to open in 2024.

UK-based point-of-care diagnostics company LumiraDx has been given $14m in grants from the Bill & Melinda Gates Foundation to support the ongoing development of its point-of-care molecular tuberculosis (TB) test system.

Unison general secretary Christina McAnea said that the ongoing ambulance strikes will continue to go ahead without a “very firm commitment” on pay, as the Government has “adamantly refused” to engage in a “proper discussion” about pay rises.

Recently, AstraZeneca announced two drug approvals in the European Union (EU), the first being Imfinzi’s approval for the treatment of biliary tract cancer, and the latter being Lynparza for prostate cancer.

Regeneron Pharmaceuticals and Sanofi have announced that the European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

ServBlock, an Irish start-up, and Irish Manufacturing Research (IMR), have been given EU funding to build a data exchange system for outsourced pharmaceutical manufacturing.

A parliamentary committee in the Gambia has recommended prosecution of the Indian pharma manufacturer Maiden Pharmaceuticals, as it has sold contaminated medicine that is believed to be linked to the deaths of at least 70 children in the Gambia.

The CDC has reported at least 23,000 hospitalisations due to influenza while this year’s flu season is at a high point, which has led to multiple manufacturers reporting shortages of a flu drug, Tamiflu.

Two US biotech CEOs have been highlighted for their roles in a conspiracy to defraud investors in CytoDyn, a company developing an investigational drug to treat human immunodeficiency virus (HIV).

BioNTech has announced the start of its new first-in-human phase 1 trial for BNT165b1, a candidate from its programme that aims to develop a multi-antigen malaria vaccine.

The FDA has approved Adstiladrin (scientific name nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)- unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

Following new rules from the FDA under the Biden administration, patients can now obtain the abortion pill mifepristone from retail pharmacies, rather than having to collect the medication in person from their healthcare provider. A prescription for the drug is still required, however this can now be filled at an instore pharmacy or by mail order.

US-based biotech companies Belharra Therapeutics and Genentech have announced a multi year partnership to lead the discovery and development of small molecule medicines in multiple therapeutic areas, including oncology, immune-oncology, autoimmune and neurodegenerative diseases.

Biotech company Guardant Health has announced that its blood test-based cancer screening technique appears to be effective: the liquid biopsy detected cases of colorectal cancer in 83% of patients who had the disease. It also correctly detected people who did not have colorectal cancer 90% of the time. However, some investors are disappointed with the technology’s ability to detect precancerous tumours.

The University of Plymouth has co-authored a new study, published in The Lancet, which shows how an asthma drug, commercially known as Relvar Ellipta, was more effective than patients’ usual care at improving their asthma control.

AstraZeneca has announced that it is set to acquire the clinical-stage biopharmaceutical company CinCor in a deal worth up to $1.8bn.

With many pharma companies preparing for President Joe Biden’s Inflation Reduction Act (IRA) to begin having an impact, and inflation continuing to soar, the cost of at least 350 drugs is expected to rise in the US throughout 2023.

After a pivotal few years, Moderna has agreed its first acquisition, worth $85m, which will allow the company access to cell-free DNA synthesis and amplification technologies. Moderna is set to acquire OriCiro Genomics K.K., gaining its expertise in DNA synthesis and amplification.

PBS Biotech, an innovative, single-use bioreactor manufacturer and process development services provider, has worked together with Avego Management and BroadOak Capital Partners to raise $22m in financing. It will be used to improve the company’s product portfolio, expand process development services and increase customer support for global cell therapy clients.

Sanofi is aiming to expand its eco-friendly and renewable energy ecosystem with plans to install solar panels on the car park, add electric vehicle charging points to the staff car park and gradually convert the corporate cars to electric vehicles over a longer period of time.

Sarepta Therapeutics is a company focused on gene therapy, RNA and gene editing, engineering precision genetic medication for rare diseases. It has announced the signing of a commercial supply agreement with Catalent that will allow the company to manufacture delandistrogene moxeparvovec (SRP-9001), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).

A recently developed AI model has been shown to predict ten-year incidences with a similar level of success to the current standard of care.

Anumana, an AI-driven health technology firm, has signed a multi year deal with Pfizer in order to develop an AI electrocardiogram (AI-ECG) for the early detection of cardiac amyloidosis.

Connected health firm Withings has unveiled its new in-home biomarker analysis platform U-Scan. It is hoped the device will utilise the “wealth of health information in daily urine.”

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Professor Henrik Van Poppel, member of the expert group for the Let's Talk Prostate Cancer initiative tells Pharmafocus about its new campaign

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Priya Singhal appointed to executive vice president and head of development at Biogen

Elligo Health appoints Dawn Saura as chief operating officer

Elaine Sun joins the board of directors at Asher Bio

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