Novartis AG won FDA clearance for Leqvio (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower LDL-C, given twice per year after the initial dose and another at three months. Less frequent dosing compared to other available therapies in the space could help with adherence, Novartis said. Leqvio will be available in early January 2022 at a wholesale acquisition cost of $3,250 per dose, for annualized price of $6,500.

Access key ingredient in Paxlovid vs. molnupiravir

The FDA went from zero to two oral anti-COVID-19 drugs in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both drugs are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of developing severe disease, including hospitalization and death. Released in blister packs containing nirmatrelvir tablets and ritonavir tablets that are to be taken together for five days, Paxlovid has broader conditions of use than molnupiravir, which is restricted to adults and is limited to situations where other FDA-authorized treatments are inaccessible or not clinically appropriate. That “inaccessible” clause could give Merck a short-term advantage in the U.S., even though Paxlovid can be used in individuals as young as 12.

ITM is made in China with potential $589M+ radiopharmaceutical deal

DUBLIN – ITM Isotope Technologies Munich (ITM) SE has secured its first radiopharmaceutical licensing deal in China, a pact with Grand Pharmaceutical Group Ltd. involving two radiopharmaceutical candidates, as well as a companion diagnostic for one of them. The Garching, Germany-based firm has secured what it called a “significant” – though undisclosed – up-front payment and could earn up to €520 million (US$589 million) more in aggregate regulatory and commercial milestones.

Bridgebio’s acoramidis misses its phase III primary endpoint

Top-line results from Bridgebio Pharma Inc.’s ongoing phase III study of acoramidis are no holiday gift for the company. The clinical trial for treating symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) missed its primary endpoint. The mean six-minute walk distance decline for the acoramidis and placebo arms was 9 meters and 7 meters, respectively. Both were similar to healthy elderly adults and less than previously untreated ATTR-CM cohorts, the company said. The study’s independent data monitoring committee, however, recommended continuing based on unblinded data reviews. The Palo Alto, Calif.-based company’s stock (NASDAQ:BBIO) plunged on the news, with shares trading 70% lower at midday.

Ji Xing acquires rights to heart failure treatment from Cytokinetics in $400M deal

RTW Investments LP-backed Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to Cytokinetics Inc.’s omecamtiv mecarbil in a deal worth up to $400 million. Ji Xing is granted the rights to develop and commercialize the drug for treating heart failure with reduced ejection fraction (HFrEF). RTW Investments has also agreed to buy 511,182 shares of Cytokinetics common stock at a price per share of $39.125.

Cstone’s PD-L1 antibody wins NMPA approval in NSCLC

China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy. It marks the first anti-PD-L1 plus chemotherapy to receive the green light as the first-line treatment of metastatic non-squamous and squamous NSCLC patients worldwide, according to Suzhou-based Cstone. The company told BioWorld that it is aiming for 2022 National Reimbursement Drug List inclusion to “maximize patient accessibility.”

Blaming COVID-19, Canada again delays start date for major drug pricing changes

Biopharma is getting another reprieve as Canada is once again delaying the implementation of major changes to its Patented Medicines Regulations. Set to take effect Jan. 1, the implementation of the drug pricing changes has now been pushed back to July 1 to allow “industry, the governments and other parties within the drug reimbursement and distribution system to continue to focus their efforts on responding to the unprecedented challenges presented by the COVID-19 pandemic,” Canadian Health Minister Jean-Yves Duclos said Dec. 23. The announcement marks the fourth time the 2017 changes have been delayed.

Holiday notice

BioWorld's offices were closed in observance of Christmas. No issues were published Thursday, Dec. 23 or Friday, Dec. 24.

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