Amicus Therapeutics Inc. minced no words on the failure of its phase III study of SD-101 in epidermolysis bullosa (EB), the object of a potential $847 million take-out of Scioderm Inc., but John Crowley, Amicus chairman and CEO, was equally quick to defend the merits of the acquisition on a conference call Wednesday.

Following the failure of Inotek Pharmaceuticals Corp.'s trabodenoson to move the needle in treating glaucoma, the company has found a new way forward: a proposed merger with New York-based gene therapy startup Rocket Pharmaceuticals Ltd. Led by former Novartis AG cell and gene therapies unit veteran Gaurav Shah, the combined company is developing a pipeline of gene therapies based on lentiviral virus and adeno-associated virus (AAV) platforms, with a focus on treating rare diseases. (See BioWorld, July 11, 2017.)

LONDON – Governments across Europe have realized that biosimilars need a tailor-made framework and are disentangling their pricing policies from those applied to generic medicines, according to a review of policies in 31 countries.

HONG KONG – Chinese biotech company Harbour Biomed Therapeutics Ltd. has entered a collaboration and licensing agreement with South Korea's Hanall Biopharma Co. Ltd. for novel biologics. Under the agreement, Harbour, of Shanghai, will have the rights to develop, manufacture and commercialize HL-161 and HL-036 for the Greater China market, which includes the territories of Hong Kong, Macau and Taiwan.

PERTH, Australia – New listings of higher-priced innovative drugs on Australia's government-subsidized Pharmaceutical Benefit Scheme (PBS) illustrate the government's commitment to list new innovative drugs, and pharma companies will see improved commercial opportunities in Australia, according to a recent BMI Research report.

DUBLIN – Proqr Therapeutics NV has spun out a startup firm, Amylon Therapeutics NV, to take forward an RNA-based drug development program focused on rare beta-amyloid-related disorders. The new company has raised an undisclosed level of seed funding from a group of institutional and private investors and has appointed Thomas de Vlaam, formerly therapeutic area lead for CNS indications at Proqr, as CEO.

The FDA released a draft guidance providing nonclinical study recommendations for the development of microdose radiopharmaceutical diagnostic drugs. The draft is intended to provide recommendations for a pathway to marketing authorization, the FDA said in a notice slated for publication in Wednesday's Federal Register. Comments should be submitted by Nov. 12.

India Globalization Capital Inc., of Bethesda, Md., reported in vitro data compiled from genetically engineered cell lines showing that, at varying concentrations of tetrahydrocannabinol (THC), the production of amyloid beta 40 protein decreases by as much as 50 percent over a 48-hour period.

Amgen Inc., of Thousand Oaks, Calif., and UCB SA, of Brussels, Belgium, disclosed detailed results from the phase III Arch study showing that 12 months of sclerostin binder Evenity (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, nonvertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone.

Synthetic Biologics Inc., of Rockville, Md., said it closed a privately placed stock purchase transaction for the sale of redeemable convertible preferred stock to an affiliate of MSD Partners LP for aggregate gross proceeds of $12 million.