GSK FIRES EXECUTIVE AFTER RAISING RACE COMPLAINTS

GSK was reported to have dismissed an executive from its African consumer healthcare division for refusing to submit to a performance plan that was initiated a week after he reported alleged racial discrimination to a confidential integrity hotline, company documents show, Bloomberg reports. The executive, who was fired on 3rd October, filed a 17-page report ...

ITALY SUSPENDS BATCHES OF NOVARTIS FLU VACCINE AFTER THREE DEATHS

Italy’s drug regulator suspended two batches of Novartis’ Fluad influenza vaccine after three people died within 48 hours of receiving the shot, Bloomberg reports. A fourth person had a “serious adverse event” after getting the Basel, Switzerland-based company’s vaccine, the Italian Pharmaceutical Agency said in a statement. The suspension of the two batches is a ...

NOVARTIS SAYS HEART-FAILURE DRUG GRANTED FASTER REVIEW IN EU

Novartis’ new heart failure drug was granted a speedier evaluation by the European health regulator, shortening the review by 60 days, the Swiss drug maker said 28th November, Reuters reports. Basel-based Novartis in August reported data for LCZ696, which found the drug cut the risk of both cardiovascular death and admissions to hospital by a ...

ALEXION SAYS SOLIRIS GRANTED ORPHAN DRUG STATUS BY JAPAN’S MHLW

Alexion has said that Soliris (eculizumab) has been granted orphan drug designation by Japan’s Ministry of Health, Labour and Welfare for the treatment of patients with neuromyelitis optica or NMO, a life-threatening, ultra-rare neurologic disorder, RTTNews.com reports. In patients with NMO, chronic, uncontrolled complement activation results in severe damage to the central nervous system, predominantly ...

IPSEN SAYS FDA ACCEPTS SBLA FOR DYSPORT FOR REVIEW

Ipsen said the FDA has accepted for review its supplemental Biologics License Application or sBLA for Dysport (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients, RTTNews.com reports. The regulatory filing was based on a clinical Phase III study involving nearly 250 adult patients with upper limb spasticity. The international, multi-centre, double-blind, randomized, ...

TAKEDA TO FOCUS OSAKA PLANT ON SPECIALTY MANUFACTURING FOR LEUPLIN

Takeda has said that it has decided to focus its Osaka Plant towards becoming a specialty manufacturing site for Leuplin, one of the company’s main products, RTTNews.com reports. It will transfer the manufacturing of solid products to its plants at Hikari and Oranienburg, a process that will be completed during fiscal year 2018, in order ...

MEDTRONIC WINS CONDITIONAL EU APPROVAL FOR $43BN COVIDIEN ACQUISITION

US medical device maker Medtronic has gained EU regulatory approval for its $43 billion takeover of Covidien after agreeing to sell its Irish rival’s drug-coated balloon catheter business, Reuters reports. The deal will put Medtronic on roughly the same footing as global leader Johnson & Johnson and take it a step closer to moving to ...

VALEANT CEO TOUTS R&D OUTPUT WITH NEW DERMATOLOGY APPROVAL

Less than two weeks after losing longtime acquisition target Allergan, which happily sold itself to Actavis to dodge Valeant’s hostile bid and the R&D cuts it feared would come along with it, the Canadian pharma is talking up the productivity of its own labs, fiercepharma.com reports. On 25th November, Valeant announced the FDA had approved ...

EUROPEAN CARDIOLOGISTS WARN OVER AF DIAGNOSIS DELAYS

Despite an increase in the number of non-valvular atrial fibrillation patients compared to five years ago, nearly all European cardiologists think there is a delay in patients reaching diagnosis, pharmatimes.com reports. That is the claim contained in the European analysis of a global cardiology survey sponsored by Daiichi Sankyo, maker of the anticoagulant edoxaban, in ...

ALMOST HALF-MILLION SIGN UP IN FIRST WEEK FOR OBAMACARE

Around 462,000 people signed up for 2015 Obamacare coverage in the first week the federal enrollment system was open for business, the US government has announced, confirming a turnaround for the programme in its second year, Bloomberg reports. The government released the first of what it said would be weekly snapshots of health insurance sign-ups ...