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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Aduhelm product image

All said and Dunn, Aduhelm overwhelms negative panel vote to win FDA go-ahead in AD

June 7, 2021
By Randy Osborne
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
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GI mojo strong as Redhill soldiers forth; PAMORA’s aura brightens

June 4, 2021
By Randy Osborne
In February 2020, when Redhill Biopharma Ltd. acquired the peripherally acting mu-opioid receptor antagonist (PAMORA) Movantik (naloxegol) from Astrazeneca plc, new prescriptions were dropping. But that picture has turned around after about nine months of promotion, with strong reimbursement trends for the product, and Redhill may have positioned itself to become a leader in the gastrointestinal (GI) space.
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Lumakras

SHP2 shore signal growing clearer with Amgen’s Lumakras in port

June 1, 2021
By Randy Osborne
Amgen Inc.’s Merdo Gordon, head of commercial global operations, said just-approved Lumakras (sotorasib) is “priced very well compared to other targeted medicines available in the market” for cancers driven by specific mutations. “Just characterizing the launch broadly, look, it’s really hard to tell because of the variability of our reach to customers right now” – a result of the COVID-19 pandemic.
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Lumakras

Amgen scores FDA approval of Lumakras in KRAS G12C-mutated NSCLC

May 28, 2021
By Randy Osborne
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
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STRIving with new approach in cancer, Effector signs Locust deal to join SPAC swarm

May 27, 2021
By Randy Osborne
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer.
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Travere’s FSGS game plan for sparsentan in U.S. askew, but EU coming through

May 26, 2021
By Randy Osborne
Bad regulatory news didn’t quash hopes for Travere Therapeutics Inc. with sparsentan, its dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors for focal segmental glomerulosclerosis (FSGS), a disease of kidney scarring.
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SBS SOS? Vectivbio finds Morse left to be done vs. Gattex with phase III apraglutide

May 25, 2021
By Randy Osborne
Vectivbio Holding AG’s IPO last month shone light on short bowel syndrome (SBS), where the company has advanced the glucagon-like peptide-2 analogue apraglutide to the phase III stage. The company aims to show an advantage over same-class Gattex (teduglutide) from Takeda Pharmaceuticals Co. Ltd., cleared by the FDA in December 2012 for adults with SBS and in May 2018 for children at least 1 year of age.
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Lung cancer illustration

Both ORRs in the water: Cullinan ASCO data near, J&J’s bispecific Rybrevant approved in NSCLC subset

May 21, 2021
By Randy Osborne
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
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Cancer cells

Black Diamond in the rough as many-faceted ASCO abstracts drop

May 20, 2021
By Randy Osborne
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
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Don’t walk away, Reneo poised to take flight in PPAR delta; Astellas too?

May 19, 2021
By Randy Osborne
Reneo Pharmaceuticals Inc.’s $93.8 million IPO last month brought renewed attention to primary mitochondrial myopathy (PMM), a genetic disorder that impairs oxidative phosphorylation, affecting mainly muscles. The San Diego-based firm sold about 6.2 million shares at $15 each, but the stock (NASDAQ:RPHM) has since taken a dive, closing May 19 at $8.83.
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View All Articles by Randy Osborne

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