Top Regulatory News Stories – Week Ending January 12, 2018

The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids.

Roche said that the EU approved Ocrevus for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis, a form of the neurological disease that previously was without an approved medicine.

The FDA has approved expanded use of AstraZeneca’s cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene. This is the first time a PARP inhibitor has been approved to treat breast cancer and the first time any drug has been approved to treat certain patients with metastatic breast cancer associated with the same genetic mutation.

An FDA expert committee has voted against Aradigm’s inhaled formulation of ciprofloxacin. Most of the panel felt Aradigm failed to provide substantial evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in patients with chronic lung infections.

 Amgen announced that the FDA has approved the sBLA for XGEVA® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Ipsen announced Health Canada approval of DYSPORT THERAPEUTIC (abobotulinumtoxinA) for the treatment of lower limb spasticity in children aged two and older

Amicus Therapeutics submitted an NDA to the FDA for the oral precision medicine migalastat HCl (“migalastat”) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations.

Spruce Biosciences announced that the EMA has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia (CAH).

INSYS Therapeutics reported that the U.S. FDA has allowed Fast Track designation to the firm’s cannabidiol oral solution for the cure of Prader-Willi syndrome.

The FDA granted Fast Track Designation to Renova Therapeutics’ RT-100 AC6 gene transfer for the treatment of heart failure

The FDA issued a breakthrough therapy designation to Novartis’ Kisqali (ribociclib) for treatment of pre- or perimenopausal women with advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

Merck and development partner Eisai received Breakthrough Therapy Designation from the FDA for the combination treatment the companies are developing for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

In other news…

Takeda forged a collaborative agreement with Denali Therapeutics for three Alzheimer’s disease programs in a deal that could be worth up to $1 billion when regulatory and clinical milestones are factored into the equation.

Pfizer is axing its neurosciences division, laying off 300 and discarding neuroscience development programs.

Shire announced that they are creating a separate neurosciences division for future investments:

Celgene said it will acquire San Diego-based Impact Biomedicines and its late-stage blood disease drug fedratinib in a deal worth up to $7 billion.

Forty Seven has added Roche to its partner list for its CD47-targeted immuno-oncology candidate, with Roche’s Genentech unit agreeing to sponsor two trials of the antibody in combination with its PD-L1 inhibitor Tecentriq.


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