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Home » Newsletters » BioWorld

BioWorld

April 29, 2016

View Archived Issues

Other news to note

Bioq Pharma Inc., of San Francisco, expanded its license and supply agreement with Sandoz, a division of Basel, Switzerland-based Novartis AG, under which Sandoz has the right to exclusively market an additional ready-to-use infusible sedative, AS-2, in the U.S. Under the agreement, Bioq is responsible for developing and supplying the unit dose infusion pharmaceutical, and Sandoz is responsible for obtaining regulatory approval, marketing and commercializing the product. Financial terms were not disclosed. Read More

Financings

Theravance Biopharma Inc., of Dublin, said it intends to offer 4.25 million shares in a public offering and plans to grant underwriters a 30-day option to purchase up to 637,500 additional shares. Share price has not yet been disclosed. Leerink Partners and Evercore ISI are acting as the joint book-running managers. Proceeds are expected to support general corporate purposes, which may include research activities, preclinical and clinical development, manufacture of preclinical, clinical and commercial-drug supplies, working capital and acquisitions of technology or drug candidates. Shares of Theravance (NASDAQ:TBPH) closed Thursday at $21.16, down $2.41, or 10.2 percent. Read More

Regulatory front

The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response said it will support the collection of blood samples from people in the continental U.S. and Puerto Rico who have been infected with Zika virus, in an effort to speed the development of diagnostic tests. Under a six-month, $692,000 project funded by the Biomedical Advanced Research and Development Authority, Clinical Research Management Inc., of Hinckley, Ohio, will collect blood samples from people who have had confirmed Zika virus infection, in coordination with state and local health departments and the Centers for Disease Control and Prevention. Read More

CFDA: Foreign firms now included in China's priority review channel

HONG KONG – In a first release of its kind, the CFDA posted two lists of drugs set for fast lane approval through the Center for Drug Evaluation (CDE). This is the first time drugs by foreign companies have been given priority since the launch of a pilot priority review process proposed earlier this year. The project is part of a strategy to clear a backlog of applications. Read More

Mixed bag for biopharma as Q1 earnings pour in

Celgene Corp. coasted through currency exchange headwinds. Vertex Pharmaceuticals Inc. focused on its emerging pipeline after soft Orkambi sales. And Gilead Sciences Inc. fell shy of analyst expectations. Amgen Inc. saved the day with higher-than-expected profits and raised guidance. Read More

Keeping the fountain of youth, well, young

Stem cells are something like the body's fountain of youth, enabling tissues to repair and regenerate themselves. The thing is, though, that fountain of youth is aging along with the rest of the body. Read More

Abbvie Rova-T draftee in SCLC 'solid' wager: $10B takeover as platform Stemcentrx clicks

The world must wait until June to find out more about Stemcentrx Inc.'s lead, late-stage asset, rovalpituzumab tesirine (Rova-T), an antibody-drug conjugate (ADC), but Abbvie Inc. already has decided to bet high, taking over the company in a deal that could be worth almost $10 billion. Read More

Makers of blockbuster biologics ready for biosimilar competition

Up until now, only one biologics company has had to compete with a biosimilar in the U.S. But they've all been getting ready for the day biosimilars arrive in their space. Read More

In the clinic

Novo Nordisk A/S, of Bagsvaerd, Denmark, reported top-line results from the sixth and last global phase IIIa trial, SUSTAIN6, assessing long-term cardiovascular and other safety outcomes of GLP-1 analogue semaglutide vs. placebo, both in addition to standard of care. Read More

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