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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Scant backlash from NASH crash as Genfit scores $539M-plus Ipsen deal in PBC

Dec. 17, 2021
By Randy Osborne
Genfit SA’s global development and commercialization deal with Ipsen Pharma SA for phase III-stage elafibranor in primary biliary cholangitis (PBC) – plus a separate arrangement for rights to an asset earlier in development from Genoscience Pharma SA – represent “the logical next steps in the implementation of a strategy that we outlined to you about 18 months ago,” Genfit CEO Pascal Prigent said during a conference call with investors.
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Brain-DNA illustration

NfL data could mean Uniqure bound for HD playoffs; Street awaits gene therapy’s efficacy readout

Dec. 16, 2021
By Randy Osborne
Wall Street didn’t much like Uniqure NV’s decision to hold off reporting efficacy measures in the phase I/II trial with one-time gene therapy AMT-130 for the treatment of Huntington’s disease (HD), but safety findings proved encouraging and analysts held out hope.
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Antibody

Mythic draws $103M series B to write new story for ADCs

Dec. 15, 2021
By Randy Osborne
Mythic Therapeutics Inc. officially launched with an oversubscribed series B round that garnered $103 million to design smarter, safer antibody-drug conjugates (ADCs) by way of a technology originated by the company and dubbed Fatecontrol. Co-founder and CEO Alex Nichols said that, after about 40 years’ worth of development – and despite fairly recent wins – ADCs have been hampered by “toxicity and poor therapeutic index [that] have stopped them from reaching what we would consider to be their full potential.”
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Angion’s HGF mimetic in peril after phase II failure

Dec. 10, 2021
By Randy Osborne
Angion Biomedica Corp. CEO Jay Venkatesan said his firm is ransacking phase II data for “a clear and consistent trend” toward benefit with ANG-3777 before going to the next stage of development with the hepatocyte growth factor mimetic for patients undergoing cardiac surgery involving cardiopulmonary bypass who are at risk for developing acute kidney injury. A decision is due early next year.
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Aduhelm product image
A look back as we head into 2022

Top Trends of 2021: Controversy much alive over Biogen’s Aduhelm; picture unclear for other AD prospects

Dec. 9, 2021
By Randy Osborne
In 2021, no drug approval garnered as much attention and debate as Biogen Inc.’s Aduhelm (aducanumab). The FDA’s surprise, accelerated approval of Aduhelm for Alzheimer’s disease flew in the face of the recommendation by an advisory committee, causing a stir that included the resignation of three adcom members, along with publicly made claims that the company’s relationship with regulators had become too cozy.
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Partner talks percolate as FDA clears Daré gel for BV

Dec. 8, 2021
By Randy Osborne
Daré Bioscience Inc.’s investors will have to wait a while for details regarding a commercialization partnership centered on Xaciato (2% clindamycin phosphate gel, formerly known as DARE-BV1) as a single-dose treatment of bacterial vaginosis (BV) in females 12 years of age and older. Approved Dec. 7, Xaciato is expected to launch next year.
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Odyssey’s epic series A reaps $218M for ‘been there, done that’ dream team

Dec. 7, 2021
By Randy Osborne
Odyssey Therapeutics Inc. launched with a whopping $218 million series A round, the year’s second-largest, to fuel work by almost 100 employees recruited in the past few months, mostly from big pharma firms.
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Abdominal pain illustration

Partner not in the cards, Ardelyx going solitary with Ibsrela

Dec. 3, 2021
By Randy Osborne
CEO Michael Raab said that would-be partners for Ardelyx Inc.’s Ibsrela (tenapanor), cleared in September 2019 to treat irritable bowel syndrome with constipation, “don't understand and don't approach the market in the manner that we will,” which is why the company has chosen to launch the sodium/hydrogen exchanger 3 inhibitor on its own in 2022.
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HBV vaccine cleared, VBI says the price is (or will be) right

Dec. 1, 2021
By Randy Osborne
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
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Soraya hope in resistant ovarian cancer: Immunogen unveils top-line phase III data with ADC

Nov. 30, 2021
By Randy Osborne
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
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View All Articles by Randy Osborne

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