KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of metastastic breast cancer.

While Chugai’s satralizumab may not be odds on to win the race for approval, it may beat Alexion’s Soliris on ease of use with a regimen of subcutaneous application once a month versus Soliris’ fortnightly IV.

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.

October has been a very good month for Ionis. Following US approval of Tegredi, it has now signed a potentially lucrative deal with existing partner Roche for another antisense drug, this time to tackle advanced dry AMD.

Big pharma and little biotechs are getting ready to pack their bags for Germany where over 2,000 abstracts will be presented at ESMO and the fine details on some major oncology studies will be closely watched.

Yutiq, for posterior uveitis, will compete with two existing steroid products and should launch during the first quarter of 2019. EyePoint’s Dexycu, although approved in February, is still in scale-up and probably will launch a bit later.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Highlighting key late-stage drugs that could reach their first markets during 2019, including first-in-class products, medicines likely to become standards of care, and products introduced for major new indications.

Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.