Spotlight On... GSK wins European regulator nod for new gene therapy; Pfizer touts another positive PhIII PCSK9 study for bococizumab; Array Bio scuttles PhIII cancer study; and more...

GlaxoSmithKline ($GSK) has won a key recommendation from the European regulator EMA today for Strimvelis (GSK2696273)--a groundbreaking new gene therapy for children living with the incredibly rare and fatal condition, severe combined immunodeficiency due to adenosine deaminase deficiency. The drug works by using a viral vector to insert working copies of the ADA gene into stem cells extracted from the bone marrow of patients. The cells are then reintroduced to the patient, who can expect to start making the gene on their own, repairing their immune system. The treatment, which Glaxo is making alongside Italian partner San Raffaele Telethon Institute for Gene Therapy and with help from Milanese biotech MolMed, should receive a final European Commission approval in around three months. Release

@FierceBiotech: EuroBiotech report: Lundbeck falls on FDA setback; BI backs cancer vax player; and more. Article | Follow @FierceBiotech

@JohnCFierce: Proving once again that the Regeneron/Sanofi team do great work together. More | Follow @JohnCFierce

> Pfizer ($PFE) has wrapped up its second positive Phase III study for its PCSK9 cholesterol drug bococizumab. The pharma giant still has to gather confirmatory data from an additional 4 late-stage studies, when it hopes to finalize an application with the FDA. If successful, Pfizer's bococizumab will follow in the footsteps of the two pioneering PCSK9 drugs from Regeneron/Sanofi and Amgen, which have been engaged in a high-profile court battle over the IP used as they compete for market share. Release

> Array BioPharma ($ARRY) has decided to fold up its Phase III ovarian cancer study for binimetinib after it failed to pass muster in an interim futility review. "While we are disappointed by this outcome, the findings from MILO have no impact on the other studies of binimetinib, including the NEMO trial, which has already met its primary endpoint, and the COLUMBUS trial, which is designed to test a highly precedented combination of mechanisms in patients with BRAF-mutant melanoma," noted Victor Sandor, the CMO for Array. Release

Medical Device News

@FierceMedDev: ICYMI yesterday: Swiss team designs robotic exoskeleton that mimics human knee stability. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: CMS Joint Replacement Model won't cut implant prices, will reform postprocedural care. More | Follow @VarunSaxena2

> Philips enrolls 5,000+ in 3 new cardiovascular studies. Story

> Cardiovascular Systems to trim 8% of its workforce in effort to return to profit. More

Pharma News

@FiercePharma: India's local rotavirus vaccine launched to combat death linked to diarrhea. More from FiercePharmaAsia | Follow @FiercePharma

@EricPFierce: Japan's Daiichi Sankyo closing an API plant in with 150 workers. More from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: FTC digs deeper into Pfizer's proposed combo with Allergan. Article | Follow @CarlyHFierce

> How are Teva and Novartis fending off copycats? By taking discounts straight to payers, analyst says. Report

> Novartis says Turkey ministry deemed bribery allegations 'unsubstantiated.' Story

Suggested Articles

As Relay looks to enter the clinic in 2020, the company is adding a trio of biopharma vets to its leadership team.

A phase 3 trial of Myovant Sciences’ relugolix in prostate cancer has met its primary endpoint, teeing the company up to file for FDA approval.

The Medicines Company, fresh from its turn at the AHA this weekend, has seen its shares jump on growing rumors that Novartis wants to acquire it.