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Home » Newsletters » BioWorld

BioWorld

May 6, 2019

View Archived Issues

Clinical data for May 3, 2019

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Bench Press: BioWorld looks at translational medicine

Researchers have linked the hormone oxytocin, which stimulates social and pair bonding, to the increased risk of aortic tear in women with Marfan syndrome.  Read More

Regulatory actions for May 3, 2019

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Prion may be answer to Alzheimer's amyloid riddle

"The molecular genetics for APP" – amyloid precursor protein – "still unequivocally demonstrate that APP and Abeta are crucial for disease pathogenesis" in Alzheimer's disease (AD), Carlo Condello told BioWorld. Read More

Other news to note

Geovax Labs Inc., of Atlanta, said it implemented a 1-for-500 reverse stock split of its common stock with a market effective date of May 2. Read More

Earnings

Pacira Biosciences Inc., of Parsippany, N.J., reported revenues of $91.3 million in the first quarter, a 22.4% increase over the $74.6 million reported for the same period last year.  Read More

Financings

Novus Therapeutics Inc., of Irvine, Calif., said it closed its registered direct offering of 3.44 million shares at $3.095 each, priced at-the-market, to health care-focused institutional investors led by Orbimed, BVF Partners LP and Armistice Capital.  Read More

Regulatory front

The founder and four former executives of Insys Therapeutics Inc. were convicted by a federal jury in Boston in connection with bribing medical practitioners to prescribe Subsys, a sublingual spray formulation of fentanyl intended for cancer patients experiencing breakthrough pain, and for defrauding Medicare and private insurance carriers.  Read More

Effectiveness of big biotech's pipelines varies; M&A to blame?

About one in four drugs made it from being a new molecular entity (NME) in 2013 to approval in five years, according to a report on the pipeline progress for eight large biotechs analyzed by SVB Leerink analyst Geoffrey Porges. Externally acquired NMEs had a higher conversion rate, with 32% making it to market, compared to 21% of internally developed drugs. Read More

Third U.S. biosimilar nod offers good news for Samsung Bioepis, though sales delayed – for now

HONG KONG – Samsung Bioepis Co. Ltd.'s recent FDA approval to market biosimilar Eticovo (etanercept-ykro) in the U.S., marking another significant step forward for the growing South Korean drugmaker, may not bring any real benefits for almost a decade. But the U.S. nod sets the stage for Bioepis to potentially nab a significant share of the etanercept biosimilar market in the future. Read More

THOR: IL-2 bids' Marvel? Dark world of combos lit by nascent not-alpha try

Synthorx Inc. has rolled out intriguing data over the past couple of months and more is due ahead at the American Society of Clinical Oncology (ASCO) meeting in early June, when the San Diego-based firm unveils how synthetic biology can be used to reprogram the therapeutic activity of interleukin-2 (IL-2). Read More

Gilead's Q1 earnings driven by U.S. HIV volume growth as new CEO takes the helm

Gilead Sciences Inc. missed its top-line numbers for the first quarter of the year but was bolstered by strong volume growth of its HIV franchise in the U.S. Its weakness came from lower sales for hepatitis C virus (HCV) drugs, down 21% from last year. Read More

Acacia's Barhemsys hit with second CRL; CMO troubles persist

LONDON – Acacia Pharma Group plc has been hit with a second complete response letter (CRL) for its postoperative nausea and vomiting (PONV) product, Barhemsys, with the FDA still unhappy following re-inspection of the contract manufacturer's site. Read More

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