Akcea obtains NICE approval for stage 1 or 2 polyneuropathy in adult patients with hATTR

Akcea Therapeutics’ Inotersen has received recommendation from NICE, meaning the therapy will now be made available to NHS patients in England and Wales for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).  hATTR is a serious condition caused by “the abnormal formation of the TTR protein

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European Commission approval for AbbVie’s psoriasis treatment

AbbVie has announced that the European Commission (EC) has approved its interleukin-23 (IL-23) inhibitor Risankizumab, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. The EC gave approval following results from four Phase III studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance which assessed more than 2,000 patients

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FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

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Janssen’s advanced or metastatic bladder cancer treatment approved by FDA

FDA has granted accelerated approval to Janssen’s erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer. Which enables the drug to be used to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. The

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AZ’s breast cancer treatment gains approval from European Commission

AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from

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FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

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