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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Coronavirus vaccine illustration

COVID-19 vaccine race growing ‘titer’ as Novavax unveils phase I data

Aug. 5, 2020
By Randy Osborne
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
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Not sleepy or hollow, hopes for Legend high despite loss of head

Aug. 4, 2020
By Randy Osborne
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
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Peanut allergy
Newco news

Time sensitive? Allergy overdue for something new, Iggenix bags $10M series A

Aug. 4, 2020
By Randy Osborne
Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said.
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Child pushing away bowl of peanuts

Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch

Aug. 4, 2020
By Randy Osborne
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
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It’s the EPITs: CRL latest peanut allergy snafu for DBV, shares going to hull

Aug. 4, 2020
By Randy Osborne

DHODH enzyme makes catalyst grist for Immunic, others in MS-plus

Aug. 3, 2020
By Randy Osborne
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
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Target with off-center arrow

Red pill, blue pill? Neoantigen matrix proving tricky as Wall Street hacks Genocea results

July 30, 2020
By Randy Osborne
Unraveling the eagerly awaited data from Genocea Biosciences Inc.’s phase I/IIa study with neoantigen cancer vaccine GEN-009 turned out less than simple, and the rollout of results – characterized by the company as positive, albeit early – were followed by a haircut for shares (NASDAQ:GNCA), which closed at $3.45, down $1.52, or 31%.
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Collagen degree: Bigger-wound treatment by Abeona key in RDEB?

July 29, 2020
By Randy Osborne
Like many companies, New York-based Abeona Therapeutics Inc. faltered clinically as a result of the COVID-19 virus, which delayed enrollment in the phase III study with EB-101 gene therapy in recessive dystrophic epidermolysis bullosa (RDEB), but the company earlier this month disclosed the restart of patient enrollment in the experiment called Viital.
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Two ways about it? Spectrum sorts for cohorts’ purport after NSCLC win

July 28, 2020
By Randy Osborne
The bad cohort 1 news from Spectrum Pharmaceuticals Inc. in late April with poziotinib in the phase II Zenith20 study turned itself around in a stock-boosting way as the Henderson, Nev.-based firm unveiled data from cohort 2.
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Gland opening: MBX series A draws $34.6M as players reunite for endocrine push

July 27, 2020
By Randy Osborne
As Carmel, Ind.-based MBX Biosciences Inc., taking aim at rare endocrine diseases, disclosed $34.6 million in a series A financing, CEO and co-founder Kent Hawryluk told BioWorld that “everyone on the leadership team we’ve worked with in prior lives, so to speak,” adding that he’s “excited to have the band back together.”
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