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BioWorld - Saturday, May 10, 2025
Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Chess board and pieces, blocks spelling out M&A

Bruton soup’s on: Merck paying $2.7B for Arqule, Aptose bubbles as Lilly data cool at ASH

Dec. 9, 2019
By Randy Osborne
Arqule Inc. CEO Paolo Pucci said the firm was “limited in what we can comment [on] for the time being” in connection with Merck & Co. Inc.’s deal to pay about $2.7 billion in cash for the company. “There is no better model for bringing a drug faster into the hands of patients and caregivers than the example of Keytruda. I will leave it at that.” Merck’s Keytruda (pembrolizumab), a human PD-1-blocking antibody was first approved in September 2014 for advanced melanoma. The label has been widely expanded since. 
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‘Fergene’ therapy in BCG-stubborn bladder cancer, Instiladrin instills phase III confidence

Dec. 6, 2019
By Randy Osborne
The “remarkably appealing” route of administration and every-three-month dosing put Ferring Pharmaceuticals SA’s nadofaragene firadenovec (rAd-IFN/Syn3, also known as Instiladrin) in strong position for approval in high-grade Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC).  
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Man running up rising arrows

Borealis keys to palace: Aurinia’s Aurora phase III bid with voclosporin lights up LN

Dec. 5, 2019
By Randy Osborne
In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study. 
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Antibody

Two’s companies: Crowd in bispecifics still growing as methodology sorted

Dec. 4, 2019
By Randy Osborne
Bispecific: It might sound to some like a self-contained contradiction, as in “doubly singular” or “twice particular.” But if the word “specific” is taken in its primary meaning as “clearly defined or identified,” then the matter becomes clear – and, in the case of bispecific antibodies, it’s becoming clearer by the year.
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Hands holding puzzle pieces with digital globe overlay

Non-andante, Audentes: Gene therapy pace picking up with $3B Astellas buyout

Dec. 3, 2019
By Randy Osborne
Audentes Therapeutics Inc. CEO Matthew Patterson early last month characterized results with lead compound AT-132 in X-linked myotubular myopathy (XLMTM) as “unprecedented in neuromuscular disease,” and the value apparently wasn’t lost on Tokyo-based Astellas Pharma Inc., which signed a deal worth about $3 billion to take over the company. Shares of Audentes (NASDAQ:BOLD) closed at $58.93, up $30.32, or 106%, on word of the buyout – which pairs the two firms’ gene therapy expertise and is slated to close in the first quarter of next year – at a cost of $60 per share in cash.
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Astellas buying Audentes for $3B to create gene-therapy powerhouse

Dec. 3, 2019
By Randy Osborne

<p>Shares of Audentes Therapeutics Inc. (NASDAQ:BOLD) were trading pre-market at $58.97, up $30.36, or 106% on word of the takeover by Astellas Pharma Inc., which is paying $60 per share in cash for an equity value of about $3 billion.</p>


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Former FDA commissioner Frank Young

Buoyed by optimism and love of family, former FDA chief Frank Young leaned into storms

Nov. 27, 2019
By Randy Osborne
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS crisis and public furor over drug tampering, said his son, Jonathan Young, co-founder and chief operating officer of South San Francisco-based Akero Therapeutics Inc.
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Former FDA commissioner Frank Young

Buoyed by optimism and love of family, former FDA chief Frank Young leaned into storms

Nov. 27, 2019
By Randy Osborne
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS crisis and public furor over drug tampering, said his son, Jonathan Young, co-founder and chief operating officer of South San Francisco-based Akero Therapeutics Inc. Post-FDA, Frank Young would help grapple with the opioid epidemic as well – a scourge that began with the passage of the Compassionate Pain Relief Act (CPRA), passed the year he was appointed. Young, 88, died Nov. 24 of B-cell lymphoma. 
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‘Tacrolimust’ hold bright future, Asahi price: $1.3B for Veloxis with Envarsus kidney transplant formulation

Nov. 26, 2019
By Randy Osborne
Veloxis Pharmaceuticals A/S’ board chairman, Michael Heffernan, said investors will find out in “the next four weeks” more details related to the $1.3 billion takeover by Tokyo-based Asahi Kasei Corp., which gets control of Envarsus XR, an improved formulation of tacrolimus for prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus and for use in de novo kidney transplant patients.
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GBT’s Oxbryta gains nod in SCD; one-two punch for patients with Novartis win

Nov. 26, 2019
By Randy Osborne

Less than two weeks after giving the go-ahead to Novartis AG for Adakveo (crizanlizumab) to reduce the frequency of vaso-occlusive crises (VOCs) in adult and pediatric patients ages 16 and older with sickle cell disease (SCD), the FDA cleared – well ahead of its Feb. 26, 2020, PDUFA date – Oxbryta (voxelotor), from Global Blood Therapeutics Inc. (GBT), for SCD in adults and pediatric patients ages 12 and up. 


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