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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Amag: All hands Andexxa to prep for Vyleesi launch as reverser nears key test

June 21, 2019
By Randy Osborne

Diamedica kidney phase I results bolster case; target next stages in second half

June 21, 2019
By Randy Osborne
Minneapolis-based Diamedica Therapeutics Inc. shares (NASDAQ:DMAC) closed Thursday at $4.94, up $1.12, or 29%, after trading as high as $5.93 as Wall Street made known its appreciation of positive interim data from the phase Ib study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD).
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Amag: All hands Andexxa to prep for Vyleesi launch as reverser nears key test

June 20, 2019
By Randy Osborne
As the weekend PDUFA date for bremelanotide approaches, investors in Waltham, Mass.-based Amag Pharmaceuticals Inc. hope an approval will revive the stock, on the slide since last summer. Generating interest at the same time, though, is ciraparantag, brought in-house via the buyout in December of Perosphere Pharmaceuticals Inc., of Danbury, Conn. 
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Mass spec(ulation) blots DMD gene therapy space as PPMD data come soon

June 19, 2019
By Randy Osborne
Last week at the Goldman Sachs Healthcare Conference in Rancho Palos Verdes, Calif., Sarepta Therapeutics Inc. CEO Douglas Ingram noted that "more than a kid a day dies" from Duchenne muscular dystrophy (DMD) in the U.S., adding that officials at his Cambridge, Mass.-based firm "feel an enormous obligation to move heaven and earth to get this [gene] therapy to the community if it's possible" and quickly.
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Combinations locked? Bid for new pairings via Pfizer propels $11.4B Array grab

June 18, 2019
By Randy Osborne
Pfizer Inc. wasn't shy about talking specifics with regard to synergy in its merger with Array Biopharma Inc., for which the pharma giant has agreed to pay $48 per share in cash – a 62% premium to Friday's closing price of $29.59 – in a deal with an enterprise value of about $11.4 billion. The boards of both companies have approved the merger, expected to finish in the second half of this year.
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Tipi of the iceberg? Study takes KIR with biomarker strategy; Kura bid proven

June 17, 2019
By Randy Osborne
Kura Oncology Inc. CEO Troy Wilson told BioWorld that, based on powerful interim data with tipifarnib (often called "tipi" by researchers) in relapsed or refractory peripheral T-cell lymphoma (PTCL), to amend the ongoing phase II study – which has been rejiggered once already – into a registrational experiment is "a possibility. I think that would not be our preference, but you could do that."
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'Suite' series B nets $60M for Prelude; new overture in cancer-focused PRMT5

June 13, 2019
By Randy Osborne
Prelude Therapeutics Inc. founder and CEO Kris Vaddi said the new $60 million in series B money – which brings to $95 million the amount raised since the firm's inception in 2016 – should pull the current phase I research through proof-of-concept stage, targeting protein arginine methyltransferase 5 (PRMT5) in cancer.
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Liver-fat NASH bid fizzles, Cymabay stock in tailspin; propose ALTernative read

June 12, 2019
By Randy Osborne
Cymabay Therapeutics Inc.'s chief scientific officer, Charles McWherter, told BioWorld that the concept of liver enzyme scores as a powerful indicator of efficacy vs. liver fat reductions in nonalcoholic steatohepatitis (NASH) "is not an entirely made-up idea, just because we got this result" in the phase IIb study of peroxisome proliferator-activated receptor (PPAR) delta agonist seladelpar. "If you had to choose between reducing fat, which can be harmful or can be inert, or showing evidence of improving the underlying lesions and injury" as a way of showing a drug's worth in NASH, he said, researchers might choose the latter as "more proximal to the injury," McWherter said. As Newark, Calif.-based Cymabay's chief medical officer, Pol Boudes, put it, "the fat story is not the end of the story" in NASH.
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Merck to run victory LAP in TGF-beta? Tilos buyout value could reach $773M

June 11, 2019
By Randy Osborne
Tilos Therapeutics Inc. CEO Barbara Fox told BioWorld that the relationship with Merck & Co. Inc. "went pretty deep pretty fast," culminating in the pharma giant's decision to take over her firm for as much as $773 million. "We never intended to do this," she said. "We always assumed we were going to raise a series A, take these [candidates] forward independently, get some clinical proof of concept and look for partnerships later."
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Xeris room enough? Lilly trying easier glucagon too; both struck by FDA delays

June 10, 2019
By Randy Osborne
View All Articles by Randy Osborne

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