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Alzheimer’s drug Leqembi expected to generate $12.9bn in sales by 2028

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

European Commission delays release of major changes to pharma legislation

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”.

Magazine.pharmafile

Magazine.pharmafile.com

Bristol Myers Squibb works with SpaceX to study biomanufacturing in space

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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Contents

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

SAMEDAN IPT

IPTonline.com

AstraZeneca’s NMOSD treatment recommended marketing

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+).

Sanofi to cut insulin prices by 78% starting January 2024

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.

Novo Nordisk to cut insulin prices by up to 75% in 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 announces hold for phase 1 study

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 launches with $12.5m in financing

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.

PHARMATIMES

Www.pharmatimes.com/croy

AstraZeneca reports positive results of drug combination in late-stage ovarian cancer trial

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.

CANbridge Pharmaceuticals reports positive long-term data for glioblastoma multiforme drug

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

GSK shares promising clinical trial results for endometrial cancer therapy

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 announced first subject dosed

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).

Nanoscope Therapeutics announces positive results from phase 2b trial in retinitis

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.

Promising ovarian cancer drug enters phase 3 trial

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 gains FDA approval for Epic Max tissue valve for the treatment of aortic valve disease

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.

AstraZeneca’s Lynparza approved by NHS England

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.

FDA approves Novartis’ Tafinlar and Mekinist combination

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.

First over-the-counter opioid overdose treatment approved by FDA

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 receives FDA approval for Keytruda in combination with Padcev to treat bladder cancer

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 announces FDA clearance for AI monitoring app for Parkinson’s disease on Apple Watch

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 shares results from study for new psoriasis therapy

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’s Yescarta CAR T-cell therapy shows statistically significant improvement in overall survival

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 and 4bases collaborate on kit for BRCA1 and BRCA2 gene analysis

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.

Roche and Eli Lilly collaborate on Alzheimer’s disease blood test

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 reports new Rybrevant data for patients with advanced non-small cell lung cancer

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 announces positive data for multiple diseases with novel needle-free vaccine

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 to partner for development and commercialisation of novel checkpoint antibody

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.

Pfizer signs $43bn deal to buy Seagen

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 & Galimedix announce partnership for development & commercialisation of GAL-101

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.

FLYPHARMA EUROPE

Www.flypharmaeurope.com

Connected drug delivery devices: considerations for developing digitised combination products

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

The cough syrup investigation: a timeline

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

PharmaRole

Pharmarole.com

Optibrium appoints Dr Hamed Tabatabaei Ghomi as head of research

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.

Roz Bekker appointed managing director of Janssen UK and Ireland

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.

Steve Jones appointed as Ingenza’s chief financial officer

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 appoints Roel Bulthuis as managing partner

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.

Five health facts about The Gambia, Uzbekistan and Indonesia

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.

SAMEDAN

International Clinical Trials: www.samedanltd.com

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