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BioWorld - Wednesday, December 17, 2025
Home » Newsletters » BioWorld

BioWorld

Dec. 28, 2016

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Regulatory front

The U.S. Department of Justice arrested Iat Hong, of Macau, Sunday in Hong Kong on insider trading and hacking charges. According to indictments unsealed this week, Hong, Bo Zheng, of Changsha, China, and Chin Hung, of Macau, all face U.S. charges stemming from an alleged scheme to hack the networks and servers of at least seven major New York law firms to gain access to the email of attorneys involved in high profile M&As and then trading on the stolen insider information. Read More

In the clinic

Mylan NV, of Hertfordshire, U.K., and Biocon Ltd., of Bangalore, India, said results of the HERITAGE study, published in the Journal of the American Medical Association, confirm the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab (Herceptin, Roche Holding AG). Read More

Other news to note

Pharmacyte Biotech Inc., of Laguna Hills, Calif., said recent research at the Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University's Feinberg School of Medicine published in Child's Nervous System further support the company's efforts to develop a targeted cannabinoid-based chemotherapy for brain cancer utilizing its Cell-in-a-Box technology. Read More

Financings

Rasna Therapeutics Inc., of New York, said it closed a private placement to accredited investors of an aggregate 3.4 million shares of common stock at 60 cents per share for gross proceeds of about $2 million. Read More

Last minute gift from the FDA: Nusinersen wins approval in SMA

Biogen Inc. plans to make newly approved spinal muscular atrophy (SMA) drug Spinraza (nusinersen) available within a week of its FDA nod late Friday, marking the first drug indicated for SMA, a genetic disease characterized by a loss of motor neurons in the spinal cord and lower brain stem that causes death in infants and toddlers. Read More

Ribociclib ups survival in postmenopausal Asian women with advanced breast cancer

HONG KONG – The cyclin-dependent kinase (CDK) 4/6 pathway inhibitor, ribociclib (LEE011, Novartis AG), in combination with Femara (letrozole, Novartis AG), significantly improved progression-free survival (PFS) in postmenopausal Asian women with advanced breast cancer, in a subanalysis of the MONALEESA-2 trial. Read More

Hong Kong's Uni-Bio teams up with Sun-Novo in diabetes treatment

HONG KONG – Looking to tap into the drastically underserviced market for diabetes treatments in China, biopharma company Uni-Bio Science Group plans to develop and introduce new diabetes drugs by partnering with a local CRO. Read More

Biopharma logs $37.3B in 2016, with 38 IPOs and Moderna's record private raise

Biopharmaceutical financings have taken a strong stance in 2016, coming in third for the most money raised in a single year since BioWorld began tracking financings 20 years ago. Read More

Unafraid for CASCADE: Seagen's hold in AML dams up early trials but phase III going ahead

Much talked-about at this year's ASH meeting, the CD33-targeting antibody-drug conjugate SGN-CD33A (33A) from Seattle Genetics Inc. faltered as the FDA put clinical holds on phase I and phase I/II trials in acute myeloid leukemia, though enrollment in the phase III CASCADE study continues. Read More

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