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Home » Newsletters » BioWorld

BioWorld

Feb. 27, 2018

View Archived Issues

PTAB: Tribal immunity doesn't block Restasis inter partes review proceedings

In the latest chapter of the continuing saga of six Restasis (cyclosporine) patents, a U.S. Patent Trial and Appeal Board (PTAB) edited out sovereign immunity claims rising from Allergan plc assigning its patents to the Saint Regis Mohawk Tribe and then licensing them back in perpetuity. Read More

Regulatory front

The EMA published its first report Monday that summarizes the agency's actions over the past two years to support the implementation of the "3Rs" principles for more ethical use of animals in drug testing across the EU. Read More

In the clinic

Endocyte Inc., of West Lafayette, Ind., said that, following a successful end-of-phase II meeting with the FDA, the company is launching the Vision trial, a phase III registration study with the radioligand therapy 177Lu-PSMA-617 in patients with prostate cancer. Read More

Obseva showcases IVF drug's success in top-line phase III data

Obseva SA, the developer of a pill intended to improve pregnancy and live birth rates for women undergoing in vitro fertilization (IVF), reported top-line success in a phase III trial of the experimental therapy nolasiban. Read More

Arca seeks FDA covenant; ex-U.S. results skew study, Gencaro golden otherwise

Wall Street took a separate view, but Arca Biopharma Inc. CEO Michael Bristow said he is "very pleased with the outcome of this trial," a phase IIb experiment testing beta blocker and mild vasodilator Gencaro (bucindolol hydrochloride) compared with Toprol XL (metoprolol succinate, Astrazeneca plc). Read More

BIA says industry still lacking details on post-Brexit transition

LONDON – A pivotal week for the Brexit negotiations kicked off on Monday with the U.K.'s main opposition Labour party shifting its official stance to come out in favor of a soft Brexit, saying it wants the U.K. to remain a member of EU agencies and be part of the customs union. Read More

Prokarium raises $10M for Salmonella-based oral vaccine pipeline

DUBLIN – Prokarium Ltd. secured $10 million in new funding to take forward an oral vaccine vector technology based on an attenuated strain of Salmonella enterica. The cash will fund the company for the next two years, enough to move two if not three programs into the clinic. Read More

Pre-revenue biotech startups go public in Hong Kong under new listing rules

HONG KONG – Biotech companies that have not yet generated any revenue can seek listing on the Main Board of the Hong Kong Stock Exchange (HKEX). The exchange proposed the new policy Friday as part of the effort to lure more firms to go public, bolstering Hong Kong's biotech development. Read More

Diacarta earns $45M series B for its liquid biopsy cancer platform

Molecular diagnostics company Diacarta Ltd. raised $45 million in its most recent series B funding, and will apply the capital to expand its liquid biopsy cancer detection platform. The cash flow will be used toward Diacarta's XNA technology platform to detect cancer at an early stage, and to expand globally. Read More

Financings

Strongbridge Biopharma plc, of Trevose, Pa., said the underwriters of its public offering of 5 million ordinary shares have partially exercised their option to purchase an additional 255,683 ordinary shares from the company at $6.75 per share. Read More

Other news to note

Xencor Inc., of Monrovia, Calif., signed four commercial license agreements with Selexis SA, of Geneva, extending the firms' previous agreement through which Selexis is providing Xencor with access to its Suretechnology platform, as well as cell line development-related services that include personnel, laboratory equipment and laboratory space. Read More

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