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To the layperson, dry eye disease (DED), technically xerophthalmia, often is dismissed as an innocuous nuisance that can be treated with over-the-counter eye drops. But Anat Galor, an ophthalmologist in Miami and clinical expert with the American Academy of Ophthalmology (AAO), said the disease name "is a little bit of a misnomer" for a chronic indication that encompasses a variety of symptoms and can have serious consequences for patients.
Despite the allure of the public markets, Alector LLC elected to continue its upward trajectory of private financings, hauling in $133 million in an oversubscribed series E – the target was raised twice before the round closed – that pushed its five-year fundraising efforts to about $215 million.
Orilissa (elagolix) became the latest potential blockbuster to pass FDA scrutiny and the first drug in more than a decade approved to treat moderate to severe pain associated with endometriosis.
A month ahead of its Aug. 21 PDUFA date, Tibsovo (ivosidenib, formerly AG-120) received full FDA approval Friday to treat adults with relapsed or refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The oral drug, developed by Agios Pharmaceuticals Inc., became the first FDA-approved therapy in the targeted indication and the first in the class green-lighted with an FDA-approved companion diagnostic, the Abbott Realtime IDH1 test.
With the clock ticking on a Nov. 20 PDUFA date, Swedish Orphan Biovitrum AB (Sobi) swooped in to acquire global rights to emapalumab (NI-0501) from developer Novimmune SA in exchange for CHF50 million (US$50.3 million) up front in cash and additional payments totaling CHF400 million (US$402.3 million) over an eight-year period.
Shares of Mersana Therapeutics Inc. (NASDAQ:MRSN) sank to a historic low after the company reported an FDA partial clinical hold on the phase I study of XMT-1522 following the death of a trial participant deemed by the investigator as "possibly drug-related."
On the heels of an FDA orphan drug designation for lead compound PU-H71 in myelofibrosis, privately held Samus Therapeutics Inc. moved the small molecule into a phase Ib dose-escalation study in patients with the bone marrow disorder. PU-H71 is designed to target the epichaperome, a protein complex present in more than half of the cancers tested by the company, a spinout of Memorial Sloan Kettering Cancer Center (MSKCC).
"We're enjoying the one-two punch," Mark Goldsmith, president and CEO of Revolution Medicines Inc., told BioWorld after the Redwood City, Calif.-based firm inked an oncology partnership with Sanofi SA covering its SHP2 program. In return for an exclusive license for global commercialization of any approved products targeting SHP2, the Paris-based pharma agreed to provide Revolution with $50 million up front and up to $500 million in development and regulatory milestone payments and to fund R&D for the joint SHP2 program, which remains, for now, under Revolution's direction.
Clinical trial protocols have grown ever more complex, and that craving to capture larger and more diverse data points has begun to affect the efficiency of therapeutic development, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD).
