Launches

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

While Celltrion has delivered an unimpressive first quarter of 2021, the company has pointed to plans to launch high-margin products in new markets. The Korean firm said that it was looking to launch its subcutaneous Remsima SC infliximab formulation in Canada and Australia in 2021, while it is also aiming to launch its Yuflyma (adalimumab) in more than 70% of the EU adalimumab market.

Teva has launched the first US generic version of Absorica (isotretinoin), expanding its dermatological portfolio. The company has also launched generic erythromycin tablets in the US. Meanwhile, in its recent environmental, social and governance progress report, Teva has launched a plan to increase access to medicines globally by 2025.

After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024. 

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.    

Ordspono, a bispecific antibody newly approved in the EU to treat follicular lymphoma and diffuse large B-cell lymphoma, joins Libtayo in Regeneron’s growing oncology portfolio.

Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis. 

 Johnson & Johnson’s drug for treatment-resistant depression got off to a slow start when it launched in 2019, but strong sales growth has put it on a blockbuster trajectory this year. 

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.

US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.

The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.

The US FDA updated labeling for Astellas’ drug for hot flashes after a postmarketing report of a single patient with signs and symptoms of liver injury taking the medicine. 

Apple is introducing new health features in conjunction with its launch of the Series 10 Apple Watch and AirPods Pro 2 earbuds, which soon will be able to monitor for potential sleep apnea and function as a clinical-grade hearing aid, respectively, pending regulatory clearances in the US and other countries around the globe.

Dexcom announced the launch of Stelo, the first non-prescription continuous glucose monitoring system to hit the US market, but is likely going to face competition soon from Abbott.

Merck & Co. won European Commission approval for Winrevair on top of other medicines for pulmonary arterial hypertension and expects an initial EU launch in Germany.

Estee Lauder Companies’ TOM FORD signs Academy Award-winning actress Angelina Jolie as the face of its Runway Lip Color Campaign launching 3 September. Dolly Parton introduces her first beauty range, Dolly Beauty, through Scent Beauty. More cosmetics and personal-care news in brief.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.