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Home » Newsletters » BioWorld

BioWorld

Feb. 7, 2018

View Archived Issues

Edmond De Rothschild rides wave of investor interest to exceed target of Biodiscovery V fund

LONDON – Edmond De Rothschild has closed its fifth fund, Biodiscovery V, at €345 million (US$430 million), which it said is the largest biotech and medical devices venture fund to be raised in Europe. Read More

EU Court of Justice backs EMA stance on data transparency

DUBLIN – The EMA had three big wins this week in the Court of Justice of the European Union, which has upheld its transparency policy and thrown out legal challenges from PTC Therapeutics Corp., the animal health arm of Merck & Co. Inc., and Pari Pharma GmbH. All of the companies were ordered to pay the agency's costs, as well as their own. In addition, EUCope, a Brussels-based lobby group for midsized pharma and biotech firms, which was supporting PTC's action, was also ordered to pay its own costs. Read More

Allergan's oral ubrogepant hits efficacy endpoints but elevated liver enzymes confound

Ubrogepant, the oral calcitonin gene-related peptide (CGRP) receptor antagonist from Allergan plc, hit the co-primary efficacy endpoints in ACHIEVE I, the first of two pivotal phase III trials evaluating the candidate to treat acute migraine in adults. Both 50-mg and 100-mg doses showed a statistically significant difference in the percentage of individuals treated with ubrogepant who achieved pain freedom two hours after the initial dose compared to placebo (50 mg vs. placebo, p=0.0023, 100 mg vs. placebo, p=0.0003) – response rates of about 19 percent and 21 percent, respectively, for the treatment arms compared to 12 percent for placebo. Read More

Fifth stopgap takes shape to keep U.S. government running

As the funding clock winds down yet again for the U.S. government, the House was expected to vote late Tuesday on another stopgap measure that would keep federal agencies open through March 23. Read More

Xoc says $30M series A to help carry migraine, PD drugs into clinic

Xoc Pharmaceuticals Inc., a CNS-focused startup developing drugs for migraine prevention and Parkinson's disease (PD) maintenance, has closed a tranched $30 million series A financing led by New Enterprise Associates. The Los Gatos, Calif.-based company, founded by a team of Map Pharmaceuticals Inc. alumni, said the funds will enable it to complete preclinical testing and take its two lead compounds, XC-101 and XC-130, into the clinic. Read More

China's Canbridge nabs Puma's Nerlynx for HER2+ breast cancer in $70M deal

SHANGHAI – Beijing's Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.'s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China. Read More

Financings

Sol-Gel Technologies Ltd., of Ness Ziona, Israel, closed its IPO of about 7.1 million ordinary shares at a public offering price of $12 each, which includes the exercise in full by the underwriters of their option to purchase up to 937,500 additional shares. The aggregate gross proceeds to Sol-Gel were about $86.3 million.  Read More

Other news to note

Grifols SA, of Barcelona, Spain, said the FDA approved a higher potency formulation of its Hyperrab rabies immune globulin (human) for rabies postexposure prophylaxis. The new formulation offers the potential for fewer injections. Read More

Regulatory front

The U.S. Court of Appeals for the Federal Circuit Tuesday upheld a federal district court ruling that Hospira Inc., now part of New York-based Pfizer Inc., didn't infringe two patents protecting a new way of making The Medicines Co.'s (MDCO) Angiomax (bivalirudin), but sent the case back to the lower court to determine whether the on-sale bar applies to a distribution contract MDCO had with Integrated Commercialization Solutions Inc. (ICS).  Read More

In the clinic

Trovagene Inc., of San Diego, said the first patient completed the first cycle of dosing with PCM-075, an oral PLK1-selective adenosine triphosphate competitive inhibitor, in combination with low-dose cytarabine in its phase Ib/II trial of patients with acute myeloid leukemia (AML). The open-label study will test PCM-075 in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory. Read More

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