GSK has announced that the MHRA has authorised its Arexvy respiratory syncytial virus (RSV) vaccine for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60.

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Ministers have opened a new vaccine research centre at the UKHSA Porton Down campus in Wiltshire, intended to prepare for 'disease x', the next possible pandemic pathogen.

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Welcome to this issue of Pharmafocus!

Research innovations in rare diseases and improving patient access

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On 3 August 2023, the FDA approved Merck’s Ervebo vaccine for children over 12 months.

Ionis Pharmaceuticals has announced that it has entered into a new collaboration and licence agreement with Novartis, aiming to discover, develop and commercialise a novel medicine for patients with lipoprotein(a) or lp(a)-driven cardiovascular disease (CVD).

The WHO has shared a medical product alert for an additional contaminated cough syrup medicine identified in Africa.

Alnylam Pharmaceuticals has announced that it has entered a strategic agreement with Roche for the development and commercialisation of zilebesiran, Alnylam’s investigational RNAi therapeutic for the treatment of hypertension in patients with high cardiovascular risk.

GSK has announced that the FDA has granted fast track designation for its investigational vaccine for gonorrhoea, which is currently in an ongoing phase 2 trial assessing the efficacy of the vaccine in healthy adults aged 18 to 50 who are considered at risk of contracting gonorrhoea.

Astellas Pharma and Mitsui Fudosan have announced that Astellas plans to establish a tumour microenvironment (TME) open innovation hub, intended to open in October 2023.

Eli Lilly has announced results from its two phase 3 tirzepatide studies in adult patients with obesity or who are overweight with weight-related comorbidities, excluding type 2 diabetes.

As of 31 July 2023, the NIH launched the first trials of its ‘researching COVID to enhance recovery’ (RECOVER) initiative.

Novo Nordisk has shared results from the select cardiovascular outcomes trial, which show that a once-weekly subcutaneous dose of Wegovy (semaglutide 2.4mg) reduced the risk of major adverse cardiovascular events (mace) by 20% in overweight or obese adults over the age of 45 with established cardiovascular disease (CVD) and no prior history of diabetes.

Pfizer has announced new data from its phase 2 study, which assessed its hexavalent capsular polysaccharide conjugate group b streptococcus vaccine candidate, gbs6, in development for maternal vaccination in order to protect infants against invasive GBS disease.

AstraZeneca has announced results from its tropion-lung01 phase 3 trial for its trop2-directed antibody drug conjugate, developed in collaboration with daiichi sankyo.

Merck, also known as MSD outside of the US and Canada, has announced positive results from the phase 3 KEYNOTE-756 trial, which assessed Keytruda in combination with chemotherapy for the treatment of patients with high-risk, early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (er+/her2-) breast cancer.

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GSK has announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DMMR) or microsatellite instability-high (MSI-H).

Japanese Eisai and US-based biotechnology company Biogen have announced that the FDA has given their Alzheimer’s disease drug Leqembi (lecanemab-irmb) full approval through the approval of a supplemental biologics license application.

FDA has announced that it has approved the Opill (norgestrel) tablet for non-prescription use to prevent pregnancy.

Bristol Myers Squibb has announced that NICE has recommended Sotyktu (deucravacitinib) for use on the NHS in England as a new treatment option for adult patients with moderate-to-severe plaque psoriasis.

The FDA has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adult patients with type 1 diabetes.

GSK has announced that ViiV healthcare has received a positive opinion from the EMA's CHMP, recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention.

Sanofi has shared new data from the phase 3 xtend-kids study, which assessed Altuviiio (antihemophilic factor (recombinant), fc-vwf-xten fusion protein) once-weekly prophylaxis in patients under the age of 12 with previously treated severe haemophilia A.

The American Heart Association has announced that it will fund seven new scientific research studies to learn more about the link between migraines, strokes and cardiovascular disease (CVD).

Recent studies have discovered that human neonatal cardiac-derived mesenchymal stem cells can induce wound-healing and reduce inflammation in the digestive system, caused by Crohn’s disease.

Lupin Healthcare, has announced the UK launch of its carbon-neutral pressurised metered dose inhalers (PDMI) for the treatment of adult and paediatric patients with asthma.

Clinical stage biotech company Recursion has announced a $50m investment by NVIDIA, intended to accelerate the development of its AIfoundation models for biology and chemistry, working in collaboration with NVIDIA to optimise and distribute these ai models to biotechnology companies through NVIDIA's cloud services.

A team of scientists at the Max Planck Institute (MPI) for informatics, Germany, and the University of California, US, have developed a process of 3d printing pills in unusual shapes, allowing a time-controlled release as the object’s shape means it will dissolve in a predetermined manner.

Alexion has announced that it has entered a definitive purchase and licence agreement with Pfizer.

Biogen and Reata Pharmaceuticals have announced that they have entered a definitive agreement under which Biogen will acquire Reata for approximately $7.3bn, or $172.50 per share.

Eli Lilly and Versanis Bio have announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical company focusing on the development of new medicines to treat cardiometabolic diseases.

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Jonathan Bowen from Sanofi UK and Ireland explains how indication-based agreements can remove barriers to patient access to combination cancer therapies

Giles Partington, Lindsay Govan, Paddy O’Hara, Emily Foreman and Jennifer Visser-Rogers from Phastar consider how data can be used to improve research innovations in rare diseases

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Veeva talks to Pharmafocus about the best ways that biopharma companies can boost their engagement

Betsy Goodfellow from Pharmafocus considers the importance of community pharmacies as part of primary care in the UK and the significance of their closure

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Reacta appoints Kevin Hawkins as new head of regulatory affairs

Cytovation, a clinical stage immune-oncology company with a focus on targeted tumour membrane immunotherapies, has announced that it has appointed Olav Hellebø to its board of directors.

The Helmholtz Centre for Infection Research (HZI), Germany, has appointed professor Josef Penninger as scientific director.

The biotechnology company foghorn therapeutics has announced the addition of the new chief medical officer, Alfonso Quintás-Cardama, who will be replacing Sam Agresta after his retirement on 11 September 2023.

Read on for five facts about rare diseases

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