Trouble surfaced early in the joint FDA panel meeting to deliberate the drug-device combo esketamine 28-mg single-use nasal spray from Johnson & Johnson unit Janssen Pharmaceuticals Inc. when an agency official said U.S. gatekeepers didn't necessarily agree about the efficacy offered to support the ketamine-derived therapy for treatment-resistant depression (TRD). Read More
With a new drug application (NDA) filed at the FDA, SK Life Science Inc., part of one of South Korea's largest conglomerates, is taking a big step closer to gaining a foothold in the U.S. epilepsy treatment market. Now awaiting a Nov. 21 PDUFA date, the company's candidate cenobamate is poised to become its first-ever independent biopharma success in America. A commercial launch for the medicine, which would be initially marketed as an adjunctive therapy, could arrive as early as the first quarter of 2020. An approval would be followed by a 90-day DEA review for scheduling. Read More
While there was not much new among the solutions offered at a U.S. House committee hearing Tuesday on how to rein in prescription drug prices in the U.S., what was apparent is that a consensus toward action is growing between lawmakers regardless of political party and among the policy experts who bring varying perspectives on the problem. Read More
NEW YORK – As the U.S. House Ways and Means Committee was hearing testimony from a handful of experts Tuesday morning on how to tackle the rising cost of drug prices, a few hundred miles away panelists at the BIO CEO & Investor Conference also were discussing the need to cut patients' out-of-pocket expenses. Addressing a roomful of biopharma execs and investors in the New York Marriott Marquis in Times Square, the panel members all agreed that the Trump administration's proposed International Pricing Index (IPI) payment model, aimed at reducing reimbursement levels for the Centers for Medicare & Medicaid Services, is not the way to do it. Read More
Neurogene Inc., a New York-based company developing a pipeline of gene therapies for rare neurological diseases, has secured a $68.5 million series A financing to support its work. Investors in the adeno-associated virus (AAV)-focused startup included Samsara Biocapital, EcoR1 Capital, Cormorant Asset Management, Redmile Group and an undisclosed healthcare investment fund. Read More
Boehringer Ingelheim (Canada) Ltd., of Burlington, Ontario, and IBM Canada, of Markham, Ontario, said they plan to explore the use of blockchain technology in clinical trials, which they said marks the first application of the technology in a trial setting in Canada. Details of the transaction and alliance were not disclosed. Read More
Ico Therapeutics Inc., of Vancouver, British Columbia, said it issued 4 million units, priced at CA5 cents to a Canadian institutional investor in a non-brokered private placement. The total gross proceeds were CA$200,000 (US$150,896). Each unit consists of one common share and one common share purchase warrant exercisable at CA$0.075 for 36 months from the date of the closing of the private placement. Read More
