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Home » Authors » Randy Osborne

Articles by Randy Osborne

IRD of paradise? J&J pact worth up to $440M, leaves Meiragtx Parkinson's pipeline plus

Feb. 1, 2019
By Randy Osborne
Meiragtx Holdings plc CEO Alexandria Forbes told BioWorld that the "very strong financial position" conferred by her firm's deal with New Brunswick, N.J.-based Johnson & Johnson arm Janssen Pharmaceuticals Inc. means that more money can go to the Parkinson's disease (PD) program. "We haven't given guidance about how long our cash is going to last," she said, but the London-based firm now has "multiple years" worth of resources.
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Film at eleventh hour: FDA Sunovion CRL asking more info but no further studies

Feb. 1, 2019
By Randy Osborne
Sunovion Pharmaceuticals Inc. stayed mostly mum on details regarding the FDA's complete response letter (CRL) related to the NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson's disease (PD).
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Mallinckrodt stopper knot arimoclomol wins in NPC, Orphazyme readies to file

Jan. 31, 2019
By Randy Osborne
If there's a small hitch in the phase II/III data rolled out by Orphazyme A/S with arimoclomol against the lysosomal storage disease Niemann-Pick type C (NPC), it's that the trial missed a co-primary endpoint chosen by the FDA, and the firm plans to take the results with the heat-shock protein (Hsp) amplifier to regulators in the U.S. and EU in the first half of next year.
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Many-FACITed effort has Triphase, Celgene, OICR in $980M leukemia play

Jan. 30, 2019
By Randy Osborne
Toronto-based Triphase Accelerator Corp. and its majority shareholder, Fight Against Cancer Innovation Trust (FACIT), disclosed a new epigenetics deal with Celgene Corp. for what's described as a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers, including leukemia.
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PD action in the 'off'-ing: Sunovion's decision near, Acorda to unleash Inbrija

Jan. 28, 2019
By Randy Osborne
Investors and others in the field of Parkinson's disease (PD) are weighing the odds of two major players in treating "off" episodes: Sunovion Pharmaceuticals Inc. with apomorphine sublingual film (APL-130277), for which the FDA set Tuesday as the PDUFA date; and Acorda Therapeutics Inc., of Ardsley, N.Y., preparing to launch Inbrija (levodopa inhalation powder) this quarter. Off periods are times when PD symptoms return because of low dopamine levels between doses of oral carbidopa/levodopa.
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What you know can HER2: Breast paradigm changes, Street mulls Nerlynx odds

Jan. 25, 2019
By Randy Osborne
In December, when Puma Biotechnology Inc. disclosed data with the breast cancer drug Nerlynx (neratinib), a kinase inhibitor that irreversibly binds to EGFR, HER2 and HER4, questions that were already on the burner bubbled harder regarding the drug's future, especially given the shifting treatment setup in HER2-positive disease.
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HAE changing its Attune, oral effort garners $23M; ATN-249 'best in class'?

Jan. 24, 2019
By Randy Osborne
CEO Andrew McDonald told BioWorld that Attune Pharmaceuticals Inc. made 1,200 compounds – "a tour de force, from a medicinal chemistry perspective" – in order to find two that worked the way the company wanted as oral plasma kallikrein inhibitors in the prophylactic treatment of hereditary angioedema (HAE).
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CRL for TNBC BLA: Soupy Immunomedics situation, still regarded as alpha bet

Jan. 22, 2019
By Randy Osborne
Company watchers remained upbeat as analysts during a conference call Friday pressed Immunomedics Inc. for details about the complete response letter (CRL) regarding the BLA related to antibody-drug conjugate (ADC) sacituzumab govitecan for metastatic triple-negative breast cancer (TNBC).
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Tune folate-breaking news: Immunogen's ADC findings in ovarian cancer due soon

Jan. 22, 2019
By Randy Osborne
Investors awaiting word from Immunogen Inc. in the first half of this year regarding the phase III trial called Forward-1 in platinum-resistant ovarian cancer continue to debate the odds of success with antibody-drug conjugate (ADC) mirvetuximab soravtansine. Previously known as IMGN-853, mirvetuximab soravtansine targets folate receptor alpha (FRa).
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Narrowed Spectrum to let pair of cancer drugs drive; Acrotech sale adds $160M

Jan. 18, 2019
By Randy Osborne
When he took the position about a year ago, CEO Joe Turgeon of Spectrum Pharmaceuticals Inc. saw "right off the bat, when I met with my senior staff" that the company needed to change, he told BioWorld. "We had these important products, but they were small niche products, and we were classified as a specialty pharma company."
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