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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Gossamer shares thin on phase II data but asthma hopes find air

Oct. 13, 2020
By Randy Osborne
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based  firm closed Oct. 13 at $10.09, down $3.50, or 26%.
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CRL makes for parked Avenue; I.V. tramadol traffic stacked

Oct. 12, 2020
By Randy Osborne
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
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Psychiatric disorders illustration

Slammin’ sami, FDA panels endorse Alkermes drug but provide no home run

Oct. 9, 2020
By Randy Osborne
Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
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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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View All Articles by Randy Osborne

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