Policy
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “In addition, the bill includes a strong focus on continuing the FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.”
Sorilux was approved for the treatment of patients age 12 and up.
FDA Chief of Staff Lauren Silvis indicated the FDA is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) program, and that “OTC monograph reform remains a top priority for the agency” but “it’s up to Congress to legislate the issue.”
Promore Pharma’s most important task is to develop new products aiming to improve the quality of life for patients with difficult-to-treat wounds and various types of scarring, primarily following surgery.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
Auris Medical Holding Ltd. announced that it has received written notification from the Nasdaq Hearings Panel notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550 for continued listing on The Nasdaq Capital Market.
Eisai Co., Ltd. announced today that Eisai has received approval from “Science Based Targets Initiative” for Eisai’s mid and long-term targets for greenhouse gas reduction.
Former commissioner of the U.S. Food and Drug Administration, Scott Gottlieb, although not running for office (that we are aware of), recently published commentary urging the United States to avoid making it more difficult for poor people to gain access to cutting-edge medications.
The decision, which is likely to be appealed, will allow Dana-Farber to license the technology.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.