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Home » Newsletters » BioWorld

BioWorld

July 31, 2019

View Archived Issues

Fumarate's GI mojo arms new Biogen MS prospect

What the phase III multiple sclerosis (MS) win scored by Biogen Inc. and partner Alkermes plc might mean in the marketplace for diroximel fumarate – tested against their approved MS therapy Tecfidera (dimethyl fumarate) – became fodder for speculation as investors weighed the fine points of side-effect profiles and would-be reimbursement hitches. Read More

Elixiron secures $10.5M, eyes first and best-in-class immunotherapies

TAIPEI, Taiwan – Budding Taiwanese startup Elixiron Immunotherapeutics Inc. closed a $10.5 million series A1 financing to further expand its technology platform and drive its drug candidates toward clinical development. Read More

Foamix secures $64M to support commercial prep for acne, rosacea candidates

Foamix Pharmaceuticals Ltd., an Israeli specialty pharma developing foam-based formulations of minocycline for moderate-to-severe acne and rosacea, has secured up to $64 million in financing from Perceptive Advisors and Orbimed, its two largest shareholders. The funds, comprised of loans and proceeds of a registered direct offering, are expected to support potential commercial launches for FMX-101 and FMX-103, pending FDA approval, the company said. Read More

Ireland looking to play catch-up in cell, gene therapies manufacturing

DUBLIN – Every technology shift has its winners and losers. Ireland, long a key location for small-molecule and biologics manufacturing, is now gearing up to ensure it is on the right side of the divide as the rollout of cell and gene therapies (CAGT) gathers momentum. There are no guarantees that the same technological and economic factors that contributed to its success during earlier eras of pharmaceutical and biopharmaceutical manufacturing will apply to the coming era of regenerative medicine. But the country's inward investment agency, IDA Ireland, is betting that its long-established relationships with the top tier of biopharma companies and its longstanding expertise in meeting FDA manufacturing requirements will help in the battle to win new investment projects. Read More

Alteogen, Cristália to develop persistent growth hormone for children

HONG KONG – Daejeon, South Korea-based Alteogen Inc. said that it has signed a licensing agreement with Brazil's Cristália Produtos Químicos Farmacêuticos Ltd. to jointly develop and commercialize Alteogen's ALT-P1, a persistent growth hormone for children. Read More

Aussie radiopharma Telix raises AU$40M as it advances to late-stage trials

PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia. Read More

Other news to note

Cytori Therapeutics Inc., of Austin, Texas, has changed its name to Plus Therapeutics Inc. Its ticker symbol on the Nasdaq Capital Market and for its series S warrants is now PSTV. The company plans a 1-for-50 reverse stock split on Aug. 5. The number of outstanding shares of its common stock is anticipated to change from about 22.2 million to approximately 400,000. Read More

Regulatory front

Holding an inter partes review (IPR) of a patent granted before the 2012 implementation of the America Invents Act, which invented the IPR, is not an unconstitutional taking under the Fifth Amendment, the U.S. Court of Appeals for the Federal Circuit ruled Tuesday in Celgene Corp. v. Laura Peter.  Read More

Earnings

Incyte Corp., of Wilmington, Del., said for the second quarter, net product revenues of Jakafi (ruxolitinib) were $410 million as compared to $346 million for the same period in 2018, representing 18% growth. Read More

Financings

Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it intends to complete a non-brokered private placement offering, where some of the corporation's directors, officers, consultants and employees, as well of certain of their associates, will purchase an aggregate of 870,000 units at CA0.30 each for aggregate gross proceeds of CA$261,000 (US$197,750).  Read More

Clinical data for July 30, 2019

Read More

Regulatory actions for July 30, 2019

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