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Companies showcase innovative biotech at American Association for Cancer Research
Leading companies in the biotechnology sector have showcased their latest innovations at the American Association for Cancer Research (AACR) meeting that was held in Florida, US, between 14-19 April. The three companies below are a selection of those with positive improvements in solid-tumour treatments.
FDA approves world’s first RSV vaccine
The US Food and Drug Administration (FDA) has announced that it has approved the world’s first respiratory syncytial virus (RSV) vaccine for use in the US in individuals aged 60 or over.
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Welcome to the June issue of Pharmafocus with insights from AstraZeneca, CytoReason and Medidata
Considering climate change and how pharma is involved
Eli Lilly’s tirzepatide achieves 15.7% weight loss in adult patients
Eli Lilly has announced that tirzepatide (10mg and 15mg) achieved significant and superior weight loss compared to a placebo over 72 weeks of treatment. This data follows results from the surmount-2 trial, which met all co-primary and secondary endpoints.
FDA issues update around changes to COVID-19 vaccines’ EUAs
The FDA has announced its amendment of the emergency use authorisations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines in an attempt to simplify the vaccination programme.
Johnson & Johnson warns of dangers of Benadryl TikTok challenge
Following the death of a 13-year-old boy who took part in an online ‘challenge’ to take a large amount of the antihistamine, Benadryl (diphenhydramine), manufacturer Johnson & Johnson (J&J) has issued a statement warning of the dangers of overdosing with the drug.
Liberal states begin stockpiling abortion medications following Texas court ruling
Various liberal US states, including California and Massachusetts, have begun stockpiling abortion medications following Texas judge Matthew Kacsmaryk’s attempt to invalidate the long-standing approval of mifepristone, one of the pills used in medication abortions.
Pharmacists in England given wider prescribing powers to relieve GP pressure
NHS England has announced that pharmacists in England will be given wider prescribing powers to relieve pressure put on GPs.
Trade union Unite calls for GSK staff walkouts over pay increase disputes
UK-based trade union Unite were pushing for staff walkouts at several GSK manufacturing sites due to disputes regarding pay increases, however to date there have been no updates as to whether GSK have extended another offer.
AbbVie shares results from phase 3 trial for atogepant migraine treatment
AbbVie has shared positive results from its phase 3 elevate study, which assessed atogepant for the preventative treatment of episodic migraines in patients who have previously had two to four unsuccessful classes of oral preventive medications.
AstraZeneca and Ionis share positive results from phase 3 trial for eplontersen
AstraZeneca and Ionis have announced positive results from their phase 3 neuro-ttransform trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (attrv-pn), showing that the companies’ drug eplontersen met all primary and secondary endpoints at 66 weeks compared to an external placebo group.
Eli Lilly shares positive results from phase 3 study of donanemab for early Alzheimer’s disease
Eli Lilly has announced positive results from the trailblazer-alz 2 phase 3 trial assessing donanemab’s ability to slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
GSK announces positive data from phase 3 trial for new UTI antibiotic
GSK has shared positive data from its phase 3 trial for gepotidacin as a new oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and adolescents.
Merck’s relapsing multiple sclerosis trial put on FDA partial clinical hold over liver injuries
Merck has announced that its clinical phase 3 study evolution has been put on partial clinical hold by the US Food and Drug Administration (FDA) over liver injuries found in enrolled patients.
Vicore announces initiation of proof-of-concept study for endothelial dysfunction treatments
Vicore Pharma Holding AB has announced that it has dosed the first patient with C21 in its randomised, double-blind, placebo-controlled, cross-over clinical study of endothelial dysfunction.
AstraZeneca’s Farxiga approved to reduce risk of cardiovascular death
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Farxiga to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) hospital visits for adults with HF.
FDA approves first orally administered faecal microbiota product for preventing gut infection
The US Food and Drug Administration (FDA) has announced that it has approved the first orally ingested faecal microbiota product for the prevention of the reoccurrence of clostridioides difficile (c. Difficile) infection (CDI) following antibacterial treatment for recurrent cdi in patients aged 18 and over.
FDA approves Pfizer’s pneumococcal conjugate vaccine for infants and children
Pfizer has announced that the US Food and Drug Administration (FDA) has approved its Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) in infants and children from six weeks to 17 years of age.
Neuspera Medical receives FDA approval for peripheral nerve pain system
Medical device company Neuspera Medical has announced that it has received US Food and Drug Administration (FDA) approval for its implantable system, used to treat peripheral nerve pain.
NICE recommends Otsuka’s Lupkynis (voclosporin) in combination treatment for active lupus nephritis
Otsuka Pharmaceuticals has announced that the National Institute for Health and Care Excellence (NICE) has recommended Lupkynis (Voclosporin) in combination with Mycophenolate Mofetil (MMF) as a treatment option for adult patients with active lupus nephritis (LN).
NICE recommends two CAR T treatments for blood cancers to the Cancer Drugs Fund
The National Institute for Health and Care Excellence (NICE) has announced that it is recommending two personalised immunotherapy treatments to the Cancer Drugs Fund (CDF) for the treatment of aggressive forms of blood cancers.
3B Pharmaceuticals and Novartis enter into licensing agreement for FAP-targeting technology
German biotechnology company 3B Pharmaceuticals (3BP) and Switzerland-based Novartis have announced that they have entered into a global exclusive licensing agreement regarding fibroblast activation protein (FAP)-targeting peptide technology.
Boehringer Ingelheim and Ginkgo Bioworks collaborate over $406m undruggable targets deal
German pharmaceutical company Boehringer Ingelheim (BI) and cell programming and biosecurity platform builder Ginkgo Bioworks have announced a partnership to discover and develop novel therapeutic molecules. The companies are focusing on treatments for diseases considered ‘undruggable’ with high unmet patient needs.
Diabeloop announces collaboration with Novo Nordisk for connected diabetes treatment
Automated insulin delivery company Diabeloop has announced its collaboration with global healthcare company Novo Nordisk.
National Institutes of Health awards grant for gammaCore clinical
Bioelectronic medicine and wellness company Electrocore has announced that the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Emory University and the Georgia Institute of Technology, both US, a three-year, $6m grant as part of the NIH Helping to End Addiction Long Term (HEAL) initiative.
RetinAI and Boehringer Ingelheim partner over AI treatments for geographic atrophy
Swiss data management software company RetinAI and US-based Boehringer Ingelheim (BI) have announced a partnership to improve patient outcomes in geographic atrophy (GA) with AI. GA is a progressive form of age-related macular degeneration and a leading cause of sight loss.
Thermo Fisher and Pfizer collaborate on NGS-based cancer tests
Scientific equipment provider Thermo Fisher and US pharmaceutical firm Pfizer have announced a collaboration to advance next-generation sequencing (NGS)-based cancer testing.
Gilead acquires XinThera to strengthen pipeline in oncology and inflammation
Gilead sciences has announced the acquisition of all outstanding shares of XinThera, a privately owned biotech company based in San Diego, US. This acquisition aims to strengthen Gilead’s clinical development pipeline through the addition of XinThera’s oncology and inflammation assets.
GSK enters into £1.6bn deal to acquire Bellus Health
UK-based GSK has announced its plans to acquire Bellus Health, a Canadian late-stage biopharmaceutical company that focuses on treatments for refractory chronic cough (RCC). The acquisition will give GSK access to Camlipixant, Bellus’ first-in-class treatment for RCC.
Sobi acquires CTI BioPharma Corporation for $1.7bn
Swedish Orphan Biovitrum (Sobi) has announced that it had entered into a ‘plan of merger’ with CTI Biopharma Corp (CTI), a biopharmaceutical company focused on blood-related cancers and rare diseases, by means of a tender offer valued at $1.7bn.
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The climate crisis: what is it and is pharma to blame?
Stefan Woxström at AstraZeneca Europe and Canada tells Pharmafocus about the link between climate change and human health, as well as considering how the pharma industry has contributed to the climate crisis
Why modelling patient heterogeneity is crucial in drug development
Prof Shai Shen-Orr at Cytoreason explores the need for patient heterogeneity in drug development, and suggests why this is so central to successful drug development
How regulators are keeping pace with technology
Fiona Maini from Medidata Solutions, speaks about pharmaceutical regulation and the opportunities and policy challenges posed by digitalisation and a rapidly evolving industry
Could climate change along with pandemics equal a recipe for disaster?
Betsy Goodfellow from Pharmafocus considers the effects of climate change and how this could impact future pandemics
Ishwaria Subbiah appointed SCRI’s executive director for Cancer Care Equity & Professional Wellness
Oncology research organisation, Sarah Cannon Research Institute (SCRI) has announced that Ishwaria Subbiah MD MS, has been appointed to the role of executive director of cancer care equity and professional wellness.
LEON appoints Dr Setu Kasera as CSO
LEON has announced the appointment of Dr Setu Kasera as its new chief scientific officer (CSO) effective 15 June 2023.
Patrick Johnson appointed to Aviceda Therapeutics’ board of directors
Private clinical-stage biotech, Aviceda Therapeutics has announced that it has appointed Patrick Johnson to its board of directors.
Alex C Sapir appointed as Fulcrum Therapeutics’ CEO
Clinical stage biopharmaceutical company, Fulcrum Therapeutics, has announced the appointment of Alex C Sapir as CEO and president effective 1 July 2023.
Five facts about climate change and health
Five facts about climate change and health
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Page 14 - The climate crisis: what is it and is pharma to blame?
Stefan Woxström at AstraZeneca tells
about the link between climate change and human health
Page 16 - Why modelling patient heterogeneity is crucial in drug development
Prof Shai Shen-Orr at CytoReason explores the need for patient heterogeneity and why this is so central to successful drug development
Page 18 - How regulators are keeping pace with technology
Fiona Maini from Medidata speaks about pharmaceutical regulation and the opportunities and challenges of digitalisation and a rapidly evolving industry
Page 20 - Could climate change along with pandemics equal a recipe for disaster?
Betsy Goodfellow considers the effects of climate change and how this could worsen, or even trigger, future pandemics
– FDA issues update around changes to COVID-19 vaccines’ EUAs
– Eli Lilly shares positive results from phase 3 study of donanemab for early Alzheimer’s disease
– Merck’s relapsing multiple sclerosis trial put on FDA partial clinical hold over liver injuries
– NICE recommends two CAR T treatments for blood cancers to the Cancer Drugs Fund
– 3B Pharmaceuticals and Novartis enter into licensing agreement for FAP-targeting technology
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