Following its FDA approval, Leqembi is expected to make $12.9bn in sales

The European Commission (EC) has again delayed the release of its new proposal for changes to Europe’s pharma legislation. The decision was previously expected on 29 March 2023, but has been announced to be “slightly later”.

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It was announced last week that the SpaceX Dragon spacecraft will make its journey to the international space station (ISS) carrying important research in the areas of life sciences and technology. The spacecraft made its launch in April, and took some of Bristol Myers Squibb’s (BMS) research with it.

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Welcome to Pharmafocus May 2023! Read on for the latest news and exciting features!

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Pharma giant AstraZeneca has been given a recommendation by the EU's Committee for Medicinal Products (CHMP) for marketing authorisation for ultomiris (ravulizumab), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMSOD) who are anti-aquaporin-4 (AQP4) antibody positive (ab+).

French pharmaceutical company Sanofi has announced that it will cut the list price of its Lantus (insulin glargine injection) 100 units/ml by 78%, beginning January 2024.

Danish pharmaceutical company Novo Nordisk has announced that it will cut its prices for insulin products by up to 75%, beginning in January 2024.

Molecular Templates has announced that the FDA has placed a partial hold on its phase 1 study for MT-0169 based on previously disclosed cardiac adverse events in two patients dosed at 50mcg/kg that triggered the dose reduction to 5mcg/kg last year. Since this reduction four patients have been dosed at 5mcg/kg and three at 10mcg/kg with no cardiac adverse events having been noted.

Seamless Therapeutics, a biotech focusing on the therapeutic potential of gene therapies, has announced it received $12.5m (€11.8m) in seed funding. The company will use the funding to accelerate research into its designer recombinases, a novel gene editing platform that will aid the treatment of severe diseases.

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AstraZeneca has announced positive high-level results from an interim analysis of the duo-o phase 3 trial assessing a combination of Lynparza (olaparib) and Imfinzi (durvalumab) alongside chemotherapy and bevacizumab. This combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy plus bevacizumab.

Chinese biopharmaceutical company CANbridge Pharmaceuticals has announced positive long-term follow-up data from its clinical studies into a glioblastoma multiforme (GBM) drug.

GSK has announced promising results from part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial for Jemperli (dostarlimab) alongside standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab, compared to chemotherapy and a placebo, in adult patients with primary advanced or recurrent endometrial cancer.

Innocare has announced that the first subject has been dosed in its clinical trial of its novel targeted protein degrader icp-490 in China. The company focuses on the treatment of cancer and autoimmune diseases, with this candidate aiming to treat multiple myeloma (MM) and non-hodgkin’s lymphoma (NHL).

US-based Nanoscope Therapeutics has announced topline results from its phase 2b restore clinical trial. Currently, patients with vision loss due to advanced retinitis pigmentosa (rp) have no treatment options.

A new drug to treat ovarian cancer is set to enter the phase 3 up-next trial imminently. Upifitamab rilsodotin is an antibody-drug conjugate (ADC), designed to destroy ovarian cancer cells. The drug has also previously been used to treat other kinds of cancer.

Abbott has announced that the FDA has approved its Epic Max stented tissue valve to treat patients with aortic regurgitation or stenosis. The device is the newest in Abbott’s Epic Surgical Valve platform which the company has been developing for decades with positive results.

NHS England has approved the use of AstraZeneca’s Lynparza (olaparib) for the treatment of patients with breast cancer and prostate cancer. This approval means men with advanced prostate cancer and women with her2-negative early breast cancer who are at high risk of the disease returning will be offered olaparib through the NHS in england. The decision has already received praise from charities and clinicians.

The FDA has approved Novartis’ combination therapy, tafinlar (dabrafenib) and mekinist (trametinib) for the treatment of BRAF v600e low-grade glioma (LGG) in paediatric patients over the age of one.

The FDA has announced that it has approved narcan, 4mg naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use. This is the first naloxone product to be approved for use without a prescription, and is the standard treatment for opioid overdose.

Merck (known as MSD globally) has announced that it has received FDA approval for keytruda in combination with padcev for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (LA/MUC) who are not eligible for cisplatin-containing chemotherapy.

NeuroRPM has announced that it has received clearance from the FDAfor its neuroRPM device, which uses AI and existing Apple Watch technology to monitor symptoms of Parkinson’s disease, offering continuous, day-to-day tracking of symptoms.

AbbVie has announced new 52-week data from a study assessing the efficacy of new IL-23 inhibitor, skyrizi (risankizumab). Patients with moderate to severe psoriasis plaques had seem suboptimal responses to treatment with secukinumab or ixekizumab, both IL-17a inhibitor therapies, for over six months before switching to the new treatment.

Kite has announced the primary overall survival (OS) analysis results of a phase 3 study into yescarta for the treatment of adult patients with relapsed/refractory large b-cell lymphoma (r/r LBCL) within 12 months of completion of first-line therapy. The results showed a statistically significant improvement following treatment with yescarta compared to the previous standard of care (SOC).

Oxford Nanopore Technologies and Swiss company 4bases have announced a collaboration making 4bases' kits with Oxford Nanopore’s sequencing technology. These will be used to enable same day sample-to-answer results for brca1 and brca2 gene analysis.

Swiss biotech company Roche has announced a collaboration with US pharmaceutical company Eli Lilly to develop Roche’s elecsys amyloid plasma panel (EAPP), which will be used to test for Alzheimer’s disease before symptoms arise.

Janssen, part of Johnson & Johnson, has announced new long-term data from its CHRYSALIS study, which assessed rybrevant (amivantamab) in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease continued to progress while receiving platinum-based chemotherapy.

Avaxzipen, a biotech company focusing on the development of a novel needle-free vaccine delivery platform, has announced that it will present data at the world vaccine congress (wvc) in washington, us. The company plans to present a poster stating: “needle-free, injectable solid dose vaccine delivery generates equivalent immune response with different antigens and animal models.”

BioNTech and OncoC4 have entered a strategic collaboration for the co-development and commercialisation of a novel checkpoint antibody for multiple solid tumour indications. BioNTech will receive an exclusive worldwide license from oncoc4 for its anti-ctla-4 monoclonal antibody candidate, onc-392.

Pharma giant Pfizer has signed a definitive merger agreement valued at $43bn to buy biotech firm Seagen. US-based Seagen discovers, develops and commercialises cancer medicines through pioneering antibody-drug conjugates (ADCs) technology. It currently has four approved medicines in its portfolio, including three ADCs: adcetris (brentuximab vedotin) for lymphoma; padcev (enfortumab vedotin) for bladder cancers; and tivdak (tisotumab vedotin) for cervical cancer.

Théa Open Innovation (TOI) and Galimedix have announced that they have signed a licensing agreement granting TOI exclusive rights for the development and commercialisation of GAL-101, Galimedix’s treatment for dry age-related macular degeneration (AMD), glaucoma and other ophthalmic indications with high unmet medical need, in Europe, the Americas, the Middle East and Africa.

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Michael Earl, director of pharmaceutical services at Owen Mumford, considers the benefits of connectivity and how this can be best utilised by pharma companies

Betsy Goodfellow and James Spargo from Pharmafocus explore the investigation around contaminated cough syrups following a timeline that includes products manufactured by Maiden Pharmaceuticals, Marion Biotech and other companies

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Optibrium has announced the appointment of Dr Hamed Tabatabaei Ghomi as head of research, this is the latest appointment in a series of senior level hires. Ghomi brings with him experience of strategic and industrial research in the bioinformatics space, as well as a positive academic record.

The Janssen pharmaceutical companies, part of Johnson & Johnson (J&J), has announced the appointment of Roz Bekker as the new managing director of Janssen UK and Ireland.

Ingenza has announced the appointment of Steve Jones as chief financial officer (CFO). Jones has over 25 years of industry experience, and has previously held senior financial roles across a range of business sectors.

Syncona ltd has announced the appointment of roel bulthuis as managing partner and head of investments. Bulthuis has over 20 years of experience in life sciences venture capital, business development and investment banking, that he brings with him to his new role.

Following the investigations into the substandard cough syrups sold in The Gambia, Uzbekistan and Indonesia, here are some key health facts and statistics about these countries.

International Clinical Trials: www.samedanltd.com