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Home » Authors » Randy Osborne

Articles by Randy Osborne

Soft-diamond special: Investors Jazzed as Xywav Coltrane pulls into phase III station for IH

Oct. 8, 2020
By Randy Osborne
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
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Opioid antagonism unlikely for Alkermes at adcom? Weight and see

Oct. 7, 2020
By Randy Osborne
As expected, weight mitigation and opioid-related risks turned up as the main concerns in briefing documents for the joint advisory panel meeting Oct. 9 to mull the approvability of Alkermes plc’s ALKS-3831.
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Assay what? No lifileucel BLA for Iovance TIL agency signs off

Oct. 6, 2020
By Randy Osborne
Exploring new regulatory territory, Iovance Biotherapeutics Inc. hit a snag that will delay the submission of the BLA for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel (LN-144), in metastatic melanoma.
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Blue heart and data grid

Myosins for givin’: $13.1B takeover by BMS blesses Myokardia, points at Cytokinetics pipeline

Oct. 5, 2020
By Randy Osborne
Cytokinetics Inc. as a competitor for Myokardia Inc.’s cardiovascular drug, mavacamten, didn’t come up until near the end of the conference call related to the $13.1 billion buyout of the latter company by Bristol Myers Squibb Co., but the prospect is on Wall Street’s mind.
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BMS takes Myokardia with HCM therapy for $13.1B; Cytokinetics next?

Oct. 5, 2020
By Randy Osborne

COVID, the metamorphosis? Humanigen, Gilead bids Roman across mechanism landscape

Oct. 2, 2020
By Randy Osborne
Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir).
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Vial and syringe with DNA

Finding neo: Vaccibody nets Roche in potential $715M cancer vaccine deal

Oct. 1, 2020
By Randy Osborne
Michael Engsig, CEO of Oslo, Norway-based Vaccibody AS, said the company’s deal with Roche Holding AG lets his firm “fully set in motion” the plan to explore infectious diseases as well as cancer, and Chief Scientific Officer (CSO) Agnete Fredriksen pointed out that “an exceptional cross-functional team” has been put in place to get the job done. Vaccibody signed the new contract with Basel, Switzerland-based Roche’s Genentech arm to develop and sell DNA-based individualized neoantigen vaccines for cancers. The tie-up brings as much as $715 million for Vaccibody.
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Antibodies attacking SARS-CoV-2 virus

Spike jones: Wall Street credits Regeneron COVID-19 data, wants to see more

Sep. 30, 2020
By Randy Osborne
As his firm unveiled early data with its spike protein-targeting COVID-19 therapy, Regeneron Pharmaceuticals Inc.’s chief scientific officer, George Yancopoulos, said that, even if researchers come up with a drug that works, coming up with efficient point-of-care diagnostics remains “a major societal imperative.”
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GERD illustration

Ironwood GERDs its loins for Linzess press after phase III bomb

Sep. 29, 2020
By Randy Osborne
Ironwood Pharmaceuticals Inc. CEO Mark Mallon said the company will seek to grow Linzess (linaclotide) and “continue to scan the environment” for more prospects in gastrointestinal conditions after the phase III fizzle in one of two identical experiments with IW-3718 in refractory gastroesophageal reflux disease.
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Bag of euros

Biopharm America: European money spigot wide open in pandemic

Sep. 28, 2020
By Randy Osborne
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
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