AstraZeneca and Daiichi Sankyo said Enhertu has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. The approval by the Food and Drug Administration was based on the positive results from the randomized DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea. Enhertu is approved with Boxed Warnings for interstitial lung disease or pneumonitis and embryo-fetal toxicity. This is the second indication approved for Enhertu in the U.S. following the accelerated approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial.

Reliance Steel & Aluminum announced that Karla Lewis has been promoted to President and appointed to the company's board. Prior to being named President, Lewis served as Senior Executive Vice President and Chief Financial Officer. In concert with Lewis' promotion, Reliance also announced the promotion of Arthur Ajemyan to Vice President, Chief Financial Officer effective January 15. Ajemyan became Vice President, Corporate Controller in May 2014.

The company said, "We remain confident that our vertical integration strategy will continue to provide a competitive advantage, allowing Tronox to deliver reliable, safe, quality, low-cost, sustainable tons to our customers while outperforming our TiO2 peers. The TiO2 business continues to benefit from the global industry recovery in 2021. With the current momentum, we are very optimistic about the short-, medium-, and long-term potential for both TiO2 and Tronox as the leading integrated supplier in the industry."

The company said, "The Board intends to increase our annualized dividend to $0.32 per share from $0.28 per share, which equates to a 14 percent increase effective with the regular first quarter 2021 dividend. This reflects the confidence we have in the trajectory of the recovery in the sector and in our differentiated business model and is consistent with our previously stated goal to increase dividends as business conditions permit."

Grifols announced it will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease. "The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn't recommended. It could also help contain outbreaks in places where the vaccination hasn't begun or is still underway," the company said. Grifols expects this clinical trial, led by the researchers Oriol Mitja and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.

Partner Communications announces that on January 15, 2021, the Lod-Central District Court ruled to recognize the lawsuit against a subsidiary of the company, 012 Smile Telecom, as a class action, which concerns the claim that 012 Smile sold to its customers data browsing packages at a specified speed, which is not possible for them to achieve since the infrastructure does not support this speed. A similar decision was also given in a lawsuit against a competing company. "The causes of action for which the motion was approved are, among others, misleading acts and breach of contract," the company said in a statement. 012 Smile is studying the decision and will treat it in accordance with the dates set by law, it added.

Genkyotex SA, a subsidiary of Calliditas Therapeutics, announced "positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset." The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified, the company said. The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA, it added. The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects. The trial consisted of a single ascending dose part and a multiple ascending dose part with dosing up to 1600mg/day. Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. In that trial, setanaxib dosed at 800 mg/day achieved reductions in markers of cholestasis, including alkaline phosphatase, and in multiple non-invasive markers of liver fibrogenesis, including liver stiffness and PRO-C3 and C3M. Significant improvement in fatigue was also achieved. All doses tested in that trial were well-tolerated, with no safety signal compared to placebo. Calliditas controls 86.2% of the share capital and total number of votes of Genkyotex.