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Home » Newsletters » BioWorld

BioWorld

Aug. 12, 2019

View Archived Issues

Regulatory actions for Aug. 9, 2019

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Clinical data for Aug. 9, 2019

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Earnings

Melinta Therapeutics Inc., of Morristown, N.J., reported revenue of $16 million and $12 million, respectively, for the three-month periods ended June 30, 2019, and 2018. Read More

Financings

Agile Therapeutics Inc., of Princeton, N.J., said the underwriters of its public offering of common stock have exercised in full their option to purchase an additional 1.89 million shares at 95 cents each, bringing the total number of shares sold to 14.52 million and total gross proceeds to approximately $13.8 million. Read More

Other news to note

Neoleukin Therapeutics Inc., of Seattle, completed its merger with Aquinox Pharmaceuticals Inc., of Vancouver, British Columbia. Aquinox will be renamed Neoleukin and now trades under the new ticker symbol NLTX on the Nasdaq.  Read More

Mexican distributor of Indian measles vaccines sanctioned under forgery charges

BOGOTA, Colombia - Grupo Laboratorios Imperiales Pharma SA de C.V. (Laboratorios Imperiales), from Jiutepec, Mexico, the distributor of measles-rubella (MR) and measles, mumps and rubella (MMR) vaccines manufactured by Serum Institute of India Pvt. Ltd., was banned from signing public contracts with Mexico's public entities for 27 months and fined MX$1.088 million (US$55,478) after it breached two public contracts with the country's Secretariat of Health to provide the country with vaccines. Read More

Okogen begins phase II trial in Australia with topical ranpirnase to fight adenoviral conjunctivitis

PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial. Read More

Bempeg goose egg likely not, but Nektar hitch nips stock as more clarity due

Analysts had questions aplenty for Nektar Therapeutics Inc. about cancer drug candidate bempegaldesleukin ("bempeg," NKTR-214) after the firm made known some apparent manufacturing problems with the compound, a CD122-preferential interleukin-2 pathway agonist designed to stimulate the patient's own immune system and fight various cancer types. Read More

Kala readies for 2020 refile of dry eye NDA following anticipated CRL

Kala Pharmaceuticals Inc. said it would look to data from a third phase III trial of its dry eye disease candidate, KPI-121 0.25%, to satisfy the request, in an FDA complete response letter (CRL), for efficacy data from an additional trial to support its NDA. The study, called STRIDE (Short Term Relief In Dry Eye) 3, is already underway with Kala targeting a top-line readout by year-end to support a resubmission in the first half of 2020. Read More

British scientists pan PM Johnson's fast track visa plan

LONDON - The great and good of British science have given a less than lukewarm reception to government plans to preserve the status of U.K. research by setting up a new fast track visa system to attract top scientists post-Brexit. Read More

Something's fishy as Amarin's Vascepa dealt adcom

The advisory committee meeting (adcom) that slowed progress for Amarin Corp. and its pending supplemental new drug application (sNDA) for expanding the labeling of Vascepa (icosapent ethyl) was a shock not only to the company but to investors, too, as the stock (NASDAQ:AMRN) took a battering Friday. Read More

Big changes are coming to BioWorld! Your opinion is requested

We're working to enhance BioWorld's news services by moving to a brand-new platform later this year. Upgrades will include: same-day news delivery, improved functionality, easier accessibility on all devices, more analysis and dynamic data visualization. We value your opinion on these changes. Please take 2 minutes to complete this short survey to help guide our work: https://www.surveymonkey.com/r/Q5TK8JL Read More

Bench Press: BioWorld looks at translational medicine

The blood-brain barrier prevents many drugs from entering the brain. Unfortunately, the same cannot be said for tumor cells. The brain is one of the most frequent locations for cancer metastases, which are then extremely challenging to treat. Now, researchers at the University of California at Los Angeles have developed an encapsulation technique that allowed the delivery of the monoclonal antibody Rituxan (rituximab) to brain metastases of a mouse xenograft model of non-Hodgkin lymphoma.  Read More

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