While U.S. lawmakers continue their debate on reducing spending for prescription drugs, government payers are exploring innovative reimbursement ideas to cover gene and cell therapies that could cost millions of dollars for a cure or a durable effect against rare diseases.
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
DUBLIN – Michael Greve, one of Germany’s most successful internet entrepreneurs and investors, is personally committing €300 million (US$362 million) to building a portfolio of biotechnology firms focused on different aspects of aging. His investment vehicle, Kizoo Technology Capital GmbH, of Karlsruhe, has already provided seed funding to more than a dozen early stage firms. Greve is now ready to invest in follow-on rounds, particularly in four core companies he described as “category openers” in rejuvenation biotech. “We are really super focused, because there are so many things we could do,” he told BioWorld.
With the massive amounts of capital raised by global public and private biopharmaceutical companies last year generating approximately $134 billion – a total that was almost double the previous record of about $69 billion raised in 2015 – it is not surprising that financing for the regenerative medicine and advanced therapy sector also set an annual record.
Humacyte Inc., which develops universally implantable, bioengineered human tissue at commercial scale, has agreed to go public via a merger with Alpha Healthcare Acquisition Corp. (AHAC), a blank-check company led by Rajiv Shukla. Upon closing of the deal, AHAC will be renamed Humacyte Inc. and will be led by Humacyte’s current CEO, Laura Niklason. The combined company’s stock is expected to list on the Nasdaq Capital Market under the ticker symbol HUMA.
As it waits on initial data from its two lead programs, in sensorineural hearing loss and multiple sclerosis, Pipeline Therapeutics Inc. raised $80 million in a series C crossover round to progress its pipeline of small-molecule drugs for neuroregeneration and to position it for a potential IPO.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. received marketing clearance from Australia’s Therapeutic Goods Administration (TGA) for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The approval validates the Celgro platform technology and clears the way for further approvals in nerve and tendon repair, Orthocell CEO Paul Anderson told BioWorld.
