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Home » Newsletters » BioWorld

BioWorld

April 14, 2017

View Archived Issues

In the clinic

Aobiome LLC, of Cambridge, Mass., said it completed enrollment in the phase II study of lead candidate B244 in patients with elevated blood pressure. Read More

Other news to note

Biomarin Pharmaceutical Inc., of San Rafael, Calif., entered a settlement agreement with Par Pharmaceutical Inc., of Woodcliff Lake, N.J., that resolves patent litigation in the U.S. related to Biomarin's phenylketonuria therapy, Kuvan (sapropterin dihydrochloride) 100 mg oral tablets and powder for oral solution in 100 mg packets. Under the terms of the settlement, Biomarin will grant Par a nonexclusive license to its patents related to Kuvan to allow Par to market a generic version of sapropterin dihydrochloride in the U.S. for the indications approved for Kuvan beginning Oct. 1, 2020, or earlier under certain circumstances. Other details of the agreement remain confidential. Read More

Financings

Tocagen Inc., of San Diego, priced its IPO of 8.5 million shares at $10 apiece, the low end of its proposed range, to raise $85 million in gross proceeds. Read More

Regulatory front

The FDA has determined that the risk evaluation and mitigation strategy for erythropoiesis-stimulating agents, specifically relating to the use of Epogen/Procrit (epoetin alfa, Amgen Inc. and Johnson & Johnson) and Aranesp (darbepoetin alfa, Amgen Inc.) for treating anemia due to associated myelosuppressive chemotherapy, is no longer necessary to ensure the benefits of those drugs outweigh their risk of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer. Read More

CRISPR patent fight moves to EU; parties file appeal in U.S.

The European Patent Office (EPO) recently issued a broad patent for the use of CRISPR/Cas9 single-guide gene editing system to Emmanuelle Charpentier, regents of the University of California and University of Vienna. Read More

Kissing cousins enable human knockout studies

Exome sequencing of more than 10,000 individuals from an area of Pakistan with a high rate of cousin marriage has enabled researchers to identify more than 1,300 genes that were functionally absent in at least one person. Read More

Long-lasting pill design nets Lyndra $23M series A

Lyndra Inc., a company developing gelatin capsule pills that can last a week or more, has closed a $23 million series A financing it said will help it ramp up development, manufacturing and preparations for phase I studies this year. Polaris Partners, where CEO Amy Schulman is a partner, led the round. Read More

One patent down in race to oral MS generic competition

Being the first to market and having commercial success do not prove novelty, the U.S. Court of Appeals for the Federal Circuit ruled Wednesday in affirming that the Patent Trial and Appeal Board (PTAB) rightly invalidated one of four patents protecting Novartis AG's blockbuster oral multiple sclerosis (MS) drug Gilenya from generic competition. Read More

Appointments and advancements

Xenetic Biosciences Inc., of Lexington, Mass., appointed James F. Parslow chief financial officer. Read More

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