Merck KGaA has signed an agreement with French company Biocorp SA to develop a version of its Mallya smart device for monitoring human growth hormone (HGH) treatment. Mallya is a clip-on device for pen injectors that collects the dose and time of each injection and transfers the information in real time to a companion software using Bluetooth technology. The device is CE marked (Class IIb) and was first launched in France in 2020.

With one completed med-tech merger ranking within the BioWorld Top 10 list for highest value, and two others set to join the list in coming months, 2021 is turning out to be the strongest M&A year for the industry to date.

Three is the magic number for Finnish companies Abacus Diagnostica Oy, Kaivogen Oy and Labrox Oy as they link up to develop a new diagnostic solution combining antibody and PCR testing on a single device. The three Turku, Finland-based companies said they are joining forces to form a new diagnostics powerhouse, harnessing their own unique expertise. Abacus Diagnostica develops molecular testing and rapid PCR tests while Kaivogen specializes in immunoassays and antibody tests and Labrox on laboratory instruments. All companies have previously collaborated on R&D projects.

Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer.

In a couple of deals worth more than $500 million, Everest Medicines Ltd. is picking up Asian rights to Providence Therapeutics Holdings Inc.’s mRNA candidates, including rights to a mRNA COVID-19 vaccine candidate currently in phase II testing.

DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program.

Zoll Medical Corp.’s plans to wake up the sleep apnea market segment advanced with the acquisition of Itamar Medical Ltd. for $538 million in cash. Itamar focuses on the diagnosis and treatment of sleep apnea, a common and complicating comorbidity of the cardiovascular patients served by Zoll. The deal continues Zoll’s acquisitive trend, following the purchase of Minnetonka, Minn.-based Respicardia Inc., another sleep apnea-focused company, in April and Therox Inc., of Irvine, Calif., in 2019. Zoll has operated as an Asahi Kasei Corp. subsidiary since its own acquisition by the Tokyo-based conglomerate in 2012. Zoll will acquire all outstanding shares of Itamar for $31 per American depository share (ADS) or $1.03 per ordinary share. The deal represents a more than 50% premium over the price of Itamar’s Nasdaq-listed ADS on Sept. 10. Itamar’s shares spiked 43.41% in premarket trading on news of the acquisition.

Abbvie Inc. and Regenxbio Inc. have announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy and other chronic retinal diseases. Under the terms of the agreement, Abbvie will pay Regenxbio $370 million up front, plus up to $1.38 billion in additional development, regulatory and commercial milestones. The deal gives '314 – already the most advanced gene therapy in wet AMD – another potential edge against its nearest competitor, Adverum Biotechnologies Inc.’s ADVM-022.