The Alliance for a Stronger FDA said Dec. 24 is a federal holiday and thus the U.S. federal government's budget impasse did not affect the FDA's operations that day. Nearly 60 percent of FDA employees will not be affected by the shutdown, including the Commissioned Corps, who are responsible for product safety. Read More
Intelgenx Technologies Corp., of Saint Laurent, Quebec, has filed with the SEC a prospectus related to shares of its common stock issuable upon the exercise of outstanding common stock purchase warrants and placement agent warrants to purchase a total of 9.02 million shares exercisable until Oct. 22, 2021, at $1 each. Read More
Veritas Pharma Inc., of Vancouver, British Columbia, appointed Blair Lowther corporate secretary and Peter McFadden interim chief financial officer. Read More
Adial Pharmaceuticals Inc., of Charlottesville, Va., said the holder of the sole remaining, outstanding convertible note has fully converted the balance of the note into common shares. The company has it has now completed the retirement of all outstanding debt instruments. Read More
"Let me tell you about the very rich. They are different from you and me," F. Scott Fitzgerald wrote in his short story "All the Sad Young Men," to which Ernest Hemingway had a character in "The Snows of Kilimanjaro" reply "Yes, they have more money." There is something of an analogous argument going on about longevity. Read More
More than a third of biopharma drugs issued complete response letters (CRLs) by the FDA in 2016 later received full approval, within three to 21 months. While some investors perceive the dreaded CRL as a death sentence, as evidenced by their quick stock sell-offs, BioWorld data indicate it is sometimes merely a hiccup corrected in time. Read More
Abbvie Inc. has agreed to pay Lupin Ltd. $30 million up front and as much as $947 million in milestones for an exclusive license to a molecule designed to inhibit a protein involved in both T-cell and B-cell lymphocyte activation across a range of blood cancers. The deal gives Abbvie access to a relatively new class of drugs capable of inhibiting mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT-1), which may improve response to immunotherapy according to early research. If successful, Mumbai-based Lupin would be entitled to receive a double-digit royalty on sales of any product from the collaboration and will retain commercial rights to the program in India. Read More
Approval of the home-grown Arcus delivery technology deployed by Ardsley, N.Y.-based Acorda Therapeutics Inc. with Inbrija (levodopa inhalation powder) represents "a tremendous step forward" for the device, which vaulted "the hardest, highest hurdle" in gaining FDA clearance, CEO Ron Cohen said. "You know how many questions hung over this," he told investors during a conference call. Read More
HONG KONG – Shanghai Junshi Biosciences Ltd. (HKG:1877) made a strong debut on the Hong Kong Stock Exchange, helped by China's first marketing approval of a homemade PD-1 monoclonal antibody last week. The biotech company's shares finished their first day of trading, on Dec. 24, up 22.55 percent to HK$23.75 (US$3.03). Read More
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold, while the "estrangement" previously seen between President Donald Trump and the scientific community morphed into global revulsion against a rogue research rule-breaker. Not all was well in biopharma-land, either. Read More
