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BioWorld - Monday, April 6, 2026
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MHRA to stay aligned with EMA post-Brexit, says U.K. government

July 18, 2017
By Nuala Moran
LONDON - The U.K. government has given the industry formal notice that it aims to keep the Medicines and Healthcare products Regulatory Agency (MHRA) involved in and aligned with the EMA when the U.K. leaves the EU.
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Financings

July 18, 2017
Targovax ASA, of Oslo, Norway, said it had allocated 323,268 shares (Oslo:TRVK) to subscribers in its subsequent offering, which expired July 14. Øystein Soug, the company's CEO and primary insider, and his close associate Abakus Invest AS have received their full allocations of subscribed shares and will now hold 109,598 shares, representing about 0.2 percent of the votes and shares in the company following the completion of the offering.
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Kolon Life Science's Invossa receives approval amid efficacy skepticism

July 18, 2017
By Haky Moon
HONG KONG – After more than a decade of development, Maryland-based Tissuegene Inc. and its Asia licensee, Kolon Life Science Inc., received a bittersweet go-ahead from the South Korean authorities to market gene therapy drug Invossa-K.
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'Signal of intent' as U.K. government discloses funding for advancing AAR

July 18, 2017
By Nuala Moran
LONDON – The U.K. government announced an £86 million (US$112.3 million) funding package to promote the uptake of digital health and other novel technologies, as the first step in taking forward the Accelerated Access Review (AAR), an independent report that made 18 recommendations to promote a step change in the speed at which the National Health Service (NHS) adopts innovation.
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Regulatory front

July 18, 2017
Although numerous generic drug companies have filed ANDAs referencing Millennium Pharmaceuticals Inc.'s Velcade (bortezomib), it could be a while before a generic version hits the market.
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Appointments and advancements

July 18, 2017
Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, named Lars Peter Brunse executive vice president and chief production officer.
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Evenity eventually? FDA complete response letter lengthens romosozumab's road to approval

July 18, 2017
By Cormac Sheridan
DUBLIN – To no one's great surprise, UCB SA and Amgen Inc. confirmed Monday that they had received a complete response letter from the FDA for their BLA for Evenity (romosozumab), which is in development for osteoporosis in postmenopausal women.
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Clarus completes transformation to distance runner with $910M biopharma fund

July 18, 2017
By Marie Powers
Clarus Ventures, which has been shifting iteratively from traditional venture investing to structured financings, completed its transformation with the close of Clarus IV LP, which topped its $750 million goal by attracting $910 million in assets. The size of the fund pushed the firm, which has offices in Cambridge, Mass., and South San Francisco, beyond $2.6 billion in assets invested across 50 private and public life sciences companies.
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In the clinic

July 18, 2017
Cancer Prevention Pharmaceuticals Inc., of Tucson, Ariz., said it launched a phase II trial at Vanderbilt University Medical Center to test CPP-1X in patients with precancerous gastric lesions who are at high risk for gastric cancer.
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Other news to note

July 18, 2017
Valeant Pharmaceuticals International Inc., of Laval, Quebec, said certain affiliates of the company entered an agreement to sell its Obagi Medical Products skincare business for $190 million in cash to Haitong International Zhonghua Finance Acquisition Fund I LP.
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