Blueprint Medicines Corp. found a new U.S. commercialization home for Gavreto (pralsetinib) through an agreement with Rigel Pharmaceuticals Inc. potentially worth $117.5 million, now that Roche Holding AG has relinquished all rights. The product, a once-daily oral small-molecule kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions, received accelerated approval in 2020 by the U.S. FDA, under priority review and with orphan drug designation, to treat adults with metastatic RET fusion-positive non-small-cell lung cancer. It generated about $28 million in U.S. net product sales in 2023. The Roche deal, first signed in 2020 and worth $1.7 billion, ended on Feb. 22, one year after the Basel, Switzerland-based company said it was backing out due to strategic reasons. Roche’s Genentech unit also voluntarily withdrew Gavreto in 2023 for RET-mutant medullary thyroid cancer, an indication for which Blueprint had gained accelerated approval in December 2020. Over the four-year partnership, Blueprint realized $980 million from the Roche deal.

Tentarix joins a $64M collaboration with Abbvie

In its second big collaboration of the past six months, privately held Tentarix Biotherapeutics LP plans to discover and develop biologics for treating oncology and immunology indications with Abbvie Inc.. For the two programs, Tentarix gets up-front options payments of $64 million from Abbvie. Abbvie picks up an exclusive option to buy the programs after the candidates are nominated for an additional undisclosed payment for each program. In August, Tentarix cut a $66 million deal with Gilead Sciences Inc. to discover and develop multifunctional, conditional protein therapeutics for oncology and inflammatory diseases. A month later, Gilead participated in Tentarix’s $35 million series B.

Liquidia warns US court ruling could lead to meritless appeals

Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of the merits, another way to delay competition. So said Liquidia Technologies Inc. when it petitioned the Supreme Court for relief after it followed the IPR path to invalidate a patent that the Federal Circuit later determined it infringed because an appeal of the Patent Trial and Appeal Board’s obviousness ruling was pending. Despite Liquidia’s warnings of the harm the Federal Circuit’s ruling could have, the Supreme Court this week refused to hear the case.

Amid US drug shortages, companies told to forget profitability

As chronic drug shortages continue in the U.S., yet another congressional investigation into the problem has been launched. But instead of a wholistic search for the root causes, this one, launched by the Democratic members of the House Oversight Committee, focuses on three drug companies – Pfizer Inc., Sandoz Inc. U.S. and Teva Pharmaceuticals USA Inc. Responding to past industry statements explaining that the low price point for many generics has caused manufacturers to exit the market, further exacerbating the shortage, the committee members called on Pfizer, Sandoz and Teva to increase their production of critical generics regardless of profitability.

Kazia stops paxalisib brain cancer trial early due to promising safety and clinical results

Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.

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Also in the news

Agile, Aleta, Ansa, Astellas, Astrazeneca, Atyr, Bioxytran, Bristol Myers Squibb, Cantargia, Cardiol, Catalyst, Chromocell, Enlivex, Ensysce, Everest Medicines, Gracell, Hansa, Ikena, Immune-Onc, Immunitybio, Immunocore, Inflarx, Jcyte, Johnson & Johnson, Kane, Kazia, Lutris, Mabwell, Neurosense, Northsea, Ocular, Polpharma, Realta, Recode, Regeneron, Rejuvenate, Rhythm, Simcere, Treadwell, Viiv