With its reactive aldehyde species (RASP) inhibitor reproxalap a winner in phase IIb results against dry eye disease (DED) and already undergoing study at the phase III stage in allergic conjunctivitis (AC), Aldeyra Therapeutics Inc. might be able to pull off a dual NDA submission.
Wall Street apparently wasn't much pleased with the boxed warning on Verastem Inc.'s first approved product, trimming shares (NASDAQ:VSTM) by 19.6 percent, or $1.74, so they closed Tuesday at $7.15, even though analysts pointed out that the side effects with Copiktra (duvelisib) can be handled by doctors.
Investors will have to wait until November to find out the details of Amarin Corp. plc's cardiovascular (CV) outcomes trial with Vascepa, but Wall Street heard enough Monday to increase the share value of the Dublin-based company by 315 percent, or $9.41, closing at $12.40.
With Blueprint Medicines Corp. due to start screening patients soon for the phase II Pathfinder trial that will test avapritinib in systemic mastocytosis (SM), investors are weighing the chances of several players in the disease and mulling how success might most rightly be judged.
This summer, Adverum Biotechnologies Inc. drew Wall Street's eyeballs to a potential gene therapy for wet age-related macular degeneration (AMD) when the company made known that its IND had become active for ADVM-022 (AAV.7m8-aflibercept).
Days after a court decision torpedoed four patents protecting Acorda Therapeutics Inc.'s Ampyra (dalfampridine) – clearing the way for generic versions of the only drug approved in the U.S. for improving walking in people with multiple sclerosis – the company learned that the FDA has extended the PDUFA date for its NDA related to Inbrija (levodopa inhalation powder) to treat off-period symptoms in people with Parkinson's disease (PD) on a carbidopa/levodopa regimen.
BOSTON – To explain best practice in making cross-border investments, especially those in China, Biopharm America panelists quickly seized upon the metaphor of groping to form a romantic relationship.
BOSTON – During a panel talk at Biopharm America on how collaborations between pharmaceutical firms and venture capital (VC) are changing the industry, New York-based Pfizer Inc.'s Anthony Berry said that "oftentimes we might look to join [as a limited partner (LP)] in a fund that might have a specific niche or opportunity" representing "a complement to what we're doing, not necessarily in direct competition with something we might be doing on our own." Such moves "certainly help us get a firsthand look at those companies from a different perspective than just being shopped around from the outside."
BOSTON – The intersection of gene therapy with rare disease drug development was one topic explored by panelists at Biopharm America, who surveyed new business models, fretted over reimbursement, and took stock of the favorable (so far) regulatory climate.
BOSTON – To explain best practice in making cross-border investments, especially those in China, Biopharm America panelists quickly seized upon the metaphor of groping to form a romantic relationship.
