BioSpace's Global Biopharma Roundup: Feb. 28

World Map made out of colorful Pills

German drug giant Bayer and its developmental partner Orion Corporation, based in Finland, completed a rolling submission to the U.S. Food and Drug Administration (FDA) for darolutamide, a treatment for non-metastatic castration-resistant prostate cancer (nmCRPC).

The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with nmCRPC showing a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT). Darolutamide plus ADT has shown a favorable safety profile compared to placebo plus ADT. Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC.

The rolling submission announcement was just some of the pharma and biotech news coming from outside the United States this week. BioSpace collected several news stories from companies across the globe to share.

Themis Bioscience – Austria-based Themis snagged fast track designation from the FDA for its lead vaccine candidate MV-CHIK for the prevention of Chikungunya, a debilitating disease with global outbreak potential. MV-CHIK is the first candidate from Themis’ innovative immunomodulation platform based on the measles vector, one of the safest and most efficacious vaccines available, and has already been tested in over 600 study volunteers in the U.S., European Union and Central America, the company said. Themis called their Chikungunya vaccine the most advanced candidate in development. It has completed Phase II trials.

“The FDA decision to grant fast track designation to MV-CHIK, recognizes the urgency to prevent this disease and will greatly support our pivotal Phase III development efforts this year. It will also allow us to work more closely with the FDA and expedite our efforts to provide a vaccine product to the population as soon as possible,” Erich Tauber, CEO of Themis Bioscience, said in a statement.

Axonics Modulation Technologies – The California-based Axonics won CE mark approval for its 1.5 Tesla and 3T MRI system. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe, the company said. Axonics CEO Raymond W. Cohen said without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, which results in an additional surgery for the patient and additional costs to patients and the healthcare system. Earlier this month Axonics submitted complete test data to the FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S.

AbCellera – Vancouver-based AbCellera expanded its collaboration with Denali Therapeutics to discover antibodies as therapies for neurological indications. AbCellera will generate panels of antibodies for up to eight drug targets nominated by Denali using AbCellera’s high-throughput, ultra-deep single-cell immune profiling capabilities. This multi-target deal expands the scope of the initial collaboration, announced last year that successfully produced potent lead candidates now in preclinical development. Carl Hansen, CEO of AbCellera, said the partnership with Denali exemplifies the company’s commitment to “providing partners with industry-leading discovery innovation to deliver numerous, diverse, and high-quality antibody candidates, meaning faster timelines and more robust shots on goals.”

Synaptive Medical – Toronto-based Synaptic Medical expanded its presence in Asia by providing hospitals in Thailand and Vietnam with its BrightMatter and Modus V product suite, a set of neurosurgery tools designed to unite surgical planning, imaging and navigation for more integrated brain and spine surgery and potentially improved patient outcomes. The Synaptive BrightMatter product suite and Modus V robotic arm provide surgeons with a highly detailed imaging, navigation and robotic platform that allows them to see the patient’s brain with unprecedented detail before and during surgery. The platform allows surgeons to see the brain in new ways, which can potentially minimize damage to structures associated with key brain functions such as movement, speech and vision.

Sunstar Suisse SA – In January, Sunstar acquired BMG Pharma S.p.a. and its cancer supportive care product GelX. BMG Pharma will invest the proceeds from the deal into the “rapid development completion” of a number of new patent-protected products with topical, subcutaneous dermatology, osteoarthritis and oral care applications, which it will be able to offer to its network of global marketing partners.

Proteostasis Therapeutics – Boston-based Proteostasis has been invited to join the HIT-CF Europe, a pan European strategic initiative which seeks to validate a personalized therapy approach for cystic fibrosis patients with extremely rare genetic mutations. HIT-CF is a consortium of researchers, doctors, pharmaceutical companies and patient representatives, which aims to provide better treatment for people with CF. Meenu Chhabra, president and CEO of Proteostasis, said the company is honored to participate in the HIT-CF Europe consortium and “join forces with key thought leaders to explore the potential of a personalized medicine approach as a possible new frontier for CF therapy.”

MeiraGTx – London-based MeiraGTx raised $80 million through the sale of a block of ordinary shares. The company will use the proceeds from the private placement to advance its pipeline of gene therapy assets through clinical development, as well as for general business purposes. The financing was led by JJDC, Inc., the investment arm of Johnson & Johnson, which made a $40 million equity investment in the company through the private placement. Other participants included Perceptive Advisors, OrbiMed Advisors and 683 Capital Management.

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