The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the FDA has granted accelerated approval of Talvey (talquetamab-tgvs) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous therapies.

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Regeneron Pharmaceuticals has announced positive, two-year, topline results from its pulsar trial assessing aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (WAMD).

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October Pharmafocus includes the latest news as well as fascinating articles.

Welcome to the October issue of Pharmafocus!

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Pfizer has announced that the FDA has approved Abrysvo for the prevention of respiratory syncytial virus (RSV) in infants. The vaccine will work through the immunisation of pregnant women at 32 to 36 weeks of pregnancy.

Novo Nordisk has today announced that Wegovy (semaglutide injection) is now available in the UK through a controlled and limited launch. The drug is intended to provide new treatment options to patients living with obesity.

On 9 August 2023, Astellas Pharma announced its plans to open what it has described as a “state-of-the-art life sciences facility” in Divcowest’s Cambridge Crossing neighbourhood; the facility will be located at 441 Morgan avenue in Cambridge, Massachusetts, US.

GSK has announced positive results from zoster-076 post-licence phase 4 efficacy trial for Shingrix recombinant zoster vaccine (RZV) in China.

Faron Pharmaceuticals has announced that the FDA has granted orphan drug designation to bexmarilimab for the treatment of acute myeloid leukaemia (AML).

Astellas Pharma has announced that the EMA has accepted the marketing authorisation application (MAA) for avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Roche’s Genentech has announced that the phase 3 ALINA trial assessing Alecensa, compared with platinum-based chemotherapy for the treatment of early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), met its primary endpoint of disease-free survival (DFS).

Eli Lilly has announced topline results from the libretto-531 study assessing Retevmo (selpercatinib) as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).

AstraZeneca and Daiichi Sankyo have announced results from the primary analysis of the destiny-lung02 phase 2 trial, which showed Enhertu’s (trastuzumab deruxtecan) continued strong and durable tumour responses in previously treated patients with her2-mutant (her2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).

Merck has shared topline results from its phase 3 LITESPARK-005 trial, assessing Welireg (belzutifan) for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following pd-1/l1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (vegf-tki) therapies.

Valneva and Pfizer have announced positive paediatric and adolescent immunogenicity and safety data for their lyme disease vaccine candidate, vla15, when given as a booster.

Cymabay Therapeutics has announced positive topline results from its phase 3 RESPONSE study, which assessed the safety and efficacy of seladelpar for the treatment of adult patients with primary biliary cholangitis (PBC).

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AbbVie has announced that the MHRA has granted a marketing authorisation for Aquipta (atogepant), for the prophylaxis of migraine in adult patients who have had at least four migraine days each month.

Roche has announced that the EC has approved the extension of Evrysdi’s marketing authorisation in the EU to include infants under two months with a clinical diagnosis of spinal muscular atrophy (SMA).

BMS has announced that the FDA has approved Reblozyl (luspatercept-aamt) for the treatment of anaemia without previous erythropoiesis stimulating agent use (esa-naïve) in adult patients with low- to intermediate-risk myelodysplastic syndromes (MDS) who may need regular red blood cell (RBC) transfusions.

Novartis’ Sandoz has announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics.

The FDA has announced that it has approved several first generics of Takeda’s Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/ hyperactivity disorder (ADHD) in patients over the age of six years and for moderate-to-severe binge-eating disorder (bed) in adult patients.

Amicus Therapeutics has announced that the MHRA in the UK has granted marketing authorisation to pombiliti (cipaglucosidase alfa) and opfolda (miglustat) for the treatment of adult patients with late-onset pompe disease.

Charac, an NHS-integrated pharmacy app, has raised £1.2m in debt and equity financing from the National Pharmacy Association (NPA) and pharmacy owners, bringing its total funds raised to £2.5m.

Sandoz has announced that it has entered into a development and commercialisation agreement with Samsung Bioepis, providing Sandoz the exclusive rights to commercialise the biosimilar sb17 ustekinumab in the US, Canada, EEA, Switzerland and the UK.

Tempus has announced that the FDA has granted it breakthrough device designation for its hla-loh assay as a companion diagnostic (cdx) test.

The National Institute for Health and Care Excellence (NICE) has shared draft guidance surrounding nine artificial intelligence (AI) technologies that can be used to speed up the planning of treatments for patients undergoing external beam radiotherapy for cancers including lung, prostate and colorectal.

Embark Laboratories has announced that Novo Nordisk has officially acquired the biopharmaceutical company Embark Biotech, along with its lead asset metabolic programme.

Abbott and Bigfoot Biomedical have announced a definitive agreement for Abbott to acquire Bigfoot, however this transaction is still subject to customary closing conditions and is not expected to close until the third quarter of 2023.

ImmunoGen has announced that it has entered into an exclusive collaboration with Takeda Pharmaceutical Company for the development and commercialisation of Elahere (mirvetuximab soravtansine-gynx) in Japan.

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Florian Schnappauf from Veeva tells Pharmafocus about the role of generative AI in life sciences sales and marketing and how it can help bring new medicines to market faster

Dr Martina Wiitzel from Daiichi Sankyo considers the burden of breast cancer highlighting the impact it has on women, and the advances in breast cancer care and precision medicines

Neil Ward from PacBio tells Pharmafocus about the use of whole genome sequencing in diagnosing and treating rare diseases, as well as considering other areas in which this could be utilised

Betsy Goodfellow from Pharmafocus looks at why mental health is so important during the colder, darker months

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Bristol Myers Squibb announces appointment of Dr Monica Shaw

Clinical stage biotech company Destiny Pharma has announced the appointment of Chris Tovey as chief executive officer.

Hansa Biopharma has announced the appointment of Dr Hitto Kaufmann as its new chief scientific officer effective 1 December 2023.

CN Bio has announced the appointment of Dr Tomasz Kostrzewski as chief scientific officer

Read on for five key facts about mental health.

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