Switch to PDF viewer

Back to Collection

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of adult patients with mild-to-moderate COVID-19 if they are at high risk for progression to severe COVID-19, including hospitalisation or death.

PharmaRole

#pharmarole

NICE recommends nine digital treatment options for depression and anxiety

The National Institute for Health and Care Excellence (NICE) has recommended six digitally enabled therapies for adult patients with anxiety disorders and three digitally enabled therapies for adult patients with depression for use within the NHS while further data is gathered.

PHARMATIMES

Luci.sargood@pharmatimes.com

Contents

This month's issue covers topics such as the cost of living crisis, biomolecular condensates, Alzheimer's and age-related macular degeneration.

Comment

Considering how the cost of living crisis impacts health

Pharmafocus

Www.pharmafocus.com

Report finds NHS may miss out on new drugs due to rising costs

Figures from a team at the University of York, the London School of Economics and Political Science (LSE), and the London School of Hygiene and Tropical Medicine (LSHTM) have revealed that the total cost of prescription medicines to NHS England reached a new high of £17.2bn in 2021-22, and that since 2018, NHS spending on branded medicines have been increasing by over 5% annually.

European Parliament shares goal to tackle antimicrobial resistance

The European Parliament has shared its recommendations for a ‘coordinated EU response to health threats posed by antimicrobial resistance,’ according to its press release.

FDA relaxes blood donation regulations for MSM

The US Food and Drug Administration (FDA) has released updated guidance for blood donation, which relaxes the rules for donations from men who have sex with men (MSM).

GRAIL & University of Oxford showcase first study results for multi-cancer early detection test

US-based healthcare company GRAIL and the University of Oxford, UK, have announced encouraging first prospective study results at the ASCO annual meeting 2023 for their multi-cancer early detection test for patients who were referred for diagnostic follow-up for suspicion of cancer.

Merck invests €35m in biosafety testing in Scotland

Merck has announced that it has invested €35m in biosafety testing at its sites in Glasgow and Stirling, both Scotland.

More infections from contaminated eyedrops in US increase death toll

The US centers for disease control and prevention (CDC) have released updated data regarding contaminated eyedrops. As of may 2023, 81 patients in 18 states have tested positive for VIM-GES-CRPA, a rare strain of drug-resistant pseudomonas aeruginosa.

AstraZeneca announces positive results from phase 3 trial for Tagrisso plus chemotherapy

AstraZeneca has announced positive results from the FLAURA2 phase 3 trial

Sanofi announces positive phase 2 data for MS drug frexalimab

French pharmaceutical and healthcare company Sanofi has announced positive trial data from its phase 2 clinical study into its relapsing multiple sclerosis (MS) drug.

US-based Bellerophon shares top-line data from phase 3 trial of INOpulse for fILD

Bellerophon Therapeutics has announced top-line results from its phase 3 rebuild trial evaluating the safety and efficacy of INOpulse for the treatment of fibrotic interstitial lung disease (fILD).

ISA Pharmaceuticals highlights positive clinical data at ASCO

Clinical stage biotechnology company ISA Pharmaceuticals has announced positive phase 1 data at the ASCO annual meeting for its combination therapy to treat recurrent and/or metastatic human papilloma virus type 16 (HPV16) positive oropharyngeal cancer (OPC).

SNIPR Biome reports positive findings for first-in-human, CRISPR-based microbial gene therapy

Danish CRISPR-based microbial gene therapy company SNIPR Biome has announced positive interim data from its phase 1 clinical trial with SNIPR001.

RadioMedix and OranoMed complete patient enrolment for neuroendocrine cancer trial

US-based RadioMedix and French OranoMed, two clinical stage radiopharmaceutical companies, have announced that the last patient has been enrolled in the phase 2 trial of their targeted alpha emitter therapy.

GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer

GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (SBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (DMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 60 years or older.

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its new drug application (NDA) has been accepted by the US Food and Drug Administration (FDA) for its ros1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) treatment repotrectinib.

FDA approves prescription nasal spray for opioid overdose treatment

The US Food and Drug Administration (FDA) has announced that it has approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdose in adults and paediatric patients over the age of 12.

FDA approves new insulin pump and algorithm software for enhanced automated insulin delivery

The US Food and Drug Administration (FDA) has announced that it has cleared the beta bionics ilet ace pump and the ilet dosing decision software for people over the age of six with type 1 diabetes.

FDA approves Abbott’s Assert-IQ insertable cardiac monitor

Abbott has announced that the US Food and Drug Administration (FDA) has granted its clearance for the assert-IQ insertable cardiac monitor (ICM), providing doctors with a new diagnostic option for the evaluation and long-term monitoring of people with irregular heartbeats.

FDA committee votes in favour of Pfizer’s RSV vaccine for maternal immunisation

Pfizer has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) from the US Food and Drug Administration (FDA) has voted in favour of the company’s respiratory syncytial virus (RSV) vaccine for maternal immunisation.

LaNova Medicines and AstraZeneca sign global exclusive licence agreement for preclinical ADC

Chinese biotechnology company LaNova medicines and UK-based pharma company AstraZeneca have announced that they have signed a global exclusive licence agreement for a preclinical stage antibody drug conjugate (ADC).

Scientists at MIT and McMaster University use AI to find new antibiotic to fight superbug

Scientists at McMaster University and the Massachusetts Institute of Technology (MIT) have utilised artificial intelligence (AI) in order to discover a new antibiotic, which, it appears, could be used to fight a drug-resistant ‘superbug’ that often circulates among vulnerable hospital patients.

Servier and Aitia enter into R&D collaboration for pancreatic cancer using Digital Twins

French pharmaceutical company Servier and US-based causal AI and digital twins company Aitia have announced a collaboration to create digital twins as an aid to help treat pancreatic cancer. This collaboration builds on a previous multiple myeloma one that was announced in 2022.

Asieris Pharmaceuticals and UroViu announce strategic collaboration

US-based biopharmaceutical company Asieris pharmaceuticals and single-use endoscopic platform creator UroViu have announced that they have entered into a strategic collaboration to integrate the detection and treatment of bladder cancers.

US-based Nemours Children’s Health selected to conduct first gene therapy for Morquio A syndrome

Nemours Children’s Health, based in Delaware, US, has been chosen by the foundation for the National Institutes of Health (NIH) accelerating medicines partnership bespoke gene therapy consortium (AMP BGCT) to conduct a first-of-its-kind gene therapy clinical trial for Morquio A syndrome.

Lonza to acquire Synaffix to strengthen ADC development

Global manufacturer for the pharmaceutical, biotech and nutraceutical markets, Lonza, has announced that it has acquired Synaffix, a biotech company focused on the commercialisation of its clinical stage technology platform for the development of antibody-drug conjugates (ADCs).

Astellas and Sony enter collaborative research agreement

Sony and Astellas Pharma have announced that they have entered into a collaborative research agreement in an attempt to discover a novel antibody-drug conjugate (ADC) platform in oncology, which will be based on Sony’s polymeric material, Kiravia backbone.

Pharmanovia & Stealth BioTherapeutics enter licensing agreement for novel Barth syndrome treatment

Pharmanovia and Stealth BioTherapeutics have announced that they have entered into a new licensing agreement for the marketing and further development of elamipretide as a treatment for Barth syndrome in Europe and the Middle East and North Africa.

FLYPHARMA CONFERENCE EUROPE

Www.flypharmaeurope.com

What are biomolecular condensates, and will they be a breakthrough in diabetes treatment?

Ameet Nathwani at Dewpoint Therapeutics considers the current treatment landscape for both type 1 and type 2 diabetes, as well as evaluating the use of biomolecular condensates as a potential treatment option

PMEA

Alzheimer’s disease & age-related macular degeneration–how are they linked &what are the treatments?

Alexander Gebauer from Galimedix Therapeutics talks to Pharmafocus about the link between the two diseases and what the treatment landscape for both could look like in the future

The impact of the cost of living crisis on health

Betsy Goodfellow from Pharmafocus looks at the reasons for the current cost of living crisis and the resulting impact on health

PharmaTimes

Www.pharmatimes.com

Simon Sinclair appointed as chief medical officer of Ondine Biomedical

Ken Mariash appointed as Sinaptica’s chief executive officer

Sinaptica Therapeutics has announced the appointment of Ken Mariash Jr as chief executive office.

Immodulon appoints Josefine Roemmler-Zehrer as chief medical officer

Immodulon, a late-stage clinical company developing highly differentiated cancer immunotherapies to prime a patient’s own immune system, has announced that it has appointed Dr Josefine Roemmler-Zehrer as chief medical officer.

Engimmune Therapeutics appoints Annalisa D’Andrea to board of directors

Swiss biotech Engimmune Therapeutics has announced that it has appointed Dr Annalisa D’Andrea to its board of directors as a non-executive director.

Five facts about income and health

Read on for five key facts about the link between income and health

Pharmafile

Www.pharmafile.com

Pharmafocus

Appointments

Immodulon appoints Josefine Roemmler-Zehrer as chief medical officer

Roemmler-Zehrer brings with her a strong track record of experience in clinical and medical affairs, with specific experience in drug development and leadership roles at pharmaceutical companies such as Celgene, Amgen and Ipsen. She has been involved in several successful product development programmes including Celgene’s Abraxane for pancreatic cancer and non-small cell lung cancer and Ipsen’s Cabometyx in renal cell carcinoma and thyroid cancer. She has also led teams spanning various disciplines in multiple therapeutic areas including oncology, inflammation, rheumatology, dermatology, neurology and rare diseases.

Gertjan Bartlema, chief executive officer of Immodulon, stated: “I am delighted to welcome incoming Josefine to the new leadership team at Immodulon as we prepare to advance our lead asset IMM-101 into a pivotal trial. Josefine brings a wealth of global experience in clinical and medical affairs from leading pharmaceutical companies and will be instrumental in our efforts to unlock the full potential of IMM-101. We look forward to benefiting from Josefine’s insights and leadership as we finalise the design of our pivotal trial in pancreatic cancer and advance our mission to improve the lives of patients suffering from this difficult-to-treat cancer.”

Commenting on her appointment, Roemmler-Zehrer added: “I am so pleased to be joining Immodulon at this pivotal time in the company’s development. I have been excited and inspired by the new management’s energy and commitment to bring IMM-101, a new, transformative, broad-spectrum immunotherapy to patients with pancreatic cancer. Pancreatic cancer has the highest mortality of any solid tumour and patients have few meaningful treatment options. I believe that IMM-101 can make a major contribution in addressing this fatal disease.”