The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s Aquipta (atogepant) as an option for preventing chronic and episodic migraines in adults who typically have at least four migraine days per month and where three previous preventative options have failed.

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Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).

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Considering sustainability within the pharma industry

Medincell and AbbVie have announced that they have entered into a collaboration to co-develop and commercialise up to six next-generation long-acting injectables (LAI) across multiple therapeutic areas and indications.

AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

UCB has announced that the FDA has accepted for review its supplemental biologics license application (sbla) for bimzelx (bimekizumab-bkzx), for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (hs).

Candel Therapeutics has announced that the FDA has granted orphan drug designation (ODD) to can-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer.

Sanofi has announced positive results from its phase 3 LUNA 3 study, which assessed Rilzabrutinib 400mg twice daily oral treatment in adult patients with persistent or chronic immune thrombocytopaenia (itp).

GSK has announced positive results from its phase 3 EAGLE-1 trial for Gepotidacin, a potential first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea (GC) in adolescent and adult patients.

Eli Lilly has announced positive topline results from its SURMOUNT-osa phase 3 trials, which demonstrated that tirzepatide injection (10mg or 15mg) significantly reduced the apnoea-hypopnea index (ahi) compared to placebo, therefore meeting its primary endpoints.

Novartis has announced new results from a pre-specified interim analysis of its phase 3 APPLAUSE-igan trial of Fabhalta (iptacopan),an investigational factor b inhibitor of the alternative complement pathway, in patients with iga nephropathy (igan).

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GSK has announced that the FDA has accepted for review a biologics license application (BLA) for its 5-in-1 meningococcal abcwy (menabcwy) vaccine candidate.

Roche has announced that the FDA has approved alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer (nsclc).

Pfizer has announced that the EC has granted marketing authorisation for Emblaveo (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (ciai), hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap) and complicated urinary tract infections (cuti), including pyelonephritis.

ImmunityBio has announced that the FDA has approved Anktiva (n-803, or nogapendekin alfa inbakicept-pmln) plus bacillus calmette-guérin (bcg) for the treatment of patients with bcg-unresponsive non-muscle invasive bladder cancer (nmibc) with carcinoma in situ (cis), with or without papillary tumours.

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Neurolentech has announced that it has entered into a technology access partnership with Kaerus Bioscience, with the aim of driving advancement in neurodevelopmental disorder research.

Ardena has announced that it has received good manufacturing practice (GMP) approval from the Dutch Healthcare Authority for its new analytical laboratories in its expanded facility.

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Swedish biotech startup Ironic Biotech has announced that it has successfully closed a pre-seed funding round of $1m, led by Nordic Foodtech VC. The company intends to use this funding to produce a solution to the global issue of iron deficiency and anaemia.

Curve Therapeutics has announced that its chief scientific officer, professor Ali Tavassoli, has published research in the Journal of the American Chemical Society (JACS), assessing dual hypoxia inducible factors (hif)-1 and -2 inhibitors in cancer treatment.

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AbbVie and Landos Biopharma have announced that they have entered into a definitive agreement under which AbbVie will acquire Landos for an approximate $137.5m ‒ or $20.42 per share ‒ adding to its portfolio in inflammatory and autoimmune diseases.

Johnson & Johnson (J&J) and Shockwave Medical have announced that they have entered into a definitive agreement under which J&J will acquire all outstanding shares of Shockwave Medical for $335 per share, or a total value of $13.1bn.

Vertex Pharmaceuticals and Alpine Immune Sciences have announced that they have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share, totalling an approximate $4.9bn.

Ahead of clinical trials day, Soraya Bekkali, from Alexion, AstraZeneca Rare Disease, highlights the urgent need to elevate patients’ voices to accelerate rare disease innovation

Rafal Kaminski from Angelini Pharma tells Pharmafocus about the global challenge of epilepsy as well as how his company is striving to bridge the gaps in epilepsy treatment

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Rob Conley from Beckley Psytech tells Pharmafocus about the use of psychedelic medicine for the treatment of psychiatric and neurological conditions, and how this field could develop in the future

Kabir Nath from Compass Pathways explores the need for new treatments in the mental health space, as well as assessing whether psychoactives could be the way forward

Betsy Goodfellow from Pharmafocus considers the need for sustainable practices in the pharma industry and assesses various sustainable advances that have already been made

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Calluna Pharma has announced that it has appointed Margrethe Sørgaard as senior vice president of clinical operations and pharmacovigilance.

Sakura Finetek Europe has announced the appointment of Jaap Stuut as president and general manager, effective immediately.

Harness Therapeutics has announced the appointment of Meenu Chhabra Karson as chair of its board of directors.

Single Technologies has announced that it has appointed Bob Kain as an advisor to support the commercialisation of its 3D sequencing system.

Five key facts about sustainability in the pharma industry

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