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Pharmaceuticals, health and wellness

ACC: AstraZeneca’s Farxiga shows benefit in heart failure patients regardless of prior treatment

AstraZeneca’s SGLT2 diabetes med Farxiga is chugging ahead to a pioneering FDA approval in heart failure patents with or without Type 2 diabetes––a first in its class. As it awaits that nod, Farxiga has shown it can also be effective in treating heart failure patients regardless of other therapies they are receiving.  Farxiga reduced the risk […]

Coronavirus delays Bluebird Bio gene therapy Zynteglo’s EU launch, U.S. filing

First it was the manufacturing process. Now, the novel coronavirus has forced Bluebird Bio to further delay treating patients with its gene therapy Zynteglo in Europe. On Thursday, Bluebird said it’s now expecting to dose the first commercial patient with Zynteglo (LentiGlobin) in Germany in the second half of 2020, rather than in the first half of the […]

Xellia starts sterile injectable production at once vilified U.S. plant 

After nearly five years and significant investment, commercial production is again underway at a plant that was once the poster-child of pharma production quality failures. Following a January inspection, the FDA has given its nod of approval for Xellia Pharmaceuticals to start manufacturing at the sterile injectables plant in the Cleveland, Ohio suburb of Bedford. […]

India denies the export of the drug Trump keeps touting for COVID-19

The FDA suspended a drug import ban on India’s troubled Ipca to unleash its large capacity for a drug that might help against COVID-19 but the agency’s largesse may be foiled. India’s commerce department is cutting off exports of the malaria drug to the U.S. and other countries.  Shipments of hydroxychloroquine will be released if […]

Top COVID-19 aspirants chloroquine, AbbVie’s Kaletra and a flu drug disappoint in clinical tests

Malaria drug chloroquine, AbbVie’s HIV combo therapy Kaletra and an influenza med called Arbidol are among top candidates that physicians are repurposing for the treatment of COVID-19. Despite backing from officials, though, the three have disappointed separately in two Chinese clinical trials of mild patients. Hydroxychloroquine, a more tolerable form of chloroquine, didn’t top placebo at clearing […]

India investing $1.3B to cut dependence on Chinese APIs

India, like other countries, has grown dependent on cheap active pharmaceutical ingredients from China. With the COVID-19 outbreak having put pressure on prices and supplies, the country is now doing something to wean itself away from that API habit.  The government is setting up a 100-billion-rupees ($1.3 billion) fund to produce more APIs in the […]

Inside Regeneron’s R&D war room, sleepless nights and ‘esprit de corps’ in hunt for COVID-19 therapy

In a few short weeks, the novel coronavirus pandemic has upturned countries around the world, presenting new and complex workplace challenges. That shift is also true for drugmakers working to combat COVID-19.   For New York-based Regeneron––at the forefront of the COVID-19 hunt––those challenges are unprecedented and extraordinary, but it’s still mostly business as usual.  After […]

Novartis, Mylan and Teva to supply tens of millions of chloroquine tablets to fight COVID-19

As efforts to discover new COVID-19 medicines roll on, President Donald Trump and others this week focused attention on the decades-old malaria drug chloroquine. Bayer got things rolling with an initial donation of the drug, and now Novartis, Mylan and Teva are taking steps to deliver tens of millions of tablets. Chloroquine and hydroxychloroquine, a […]

GSK’s ViiV, post-FDA rejection, scores Canadian nod for once-monthly HIV regimen Cabenuva

Despite high hopes for its game-changing monthly HIV regimen Cabenuva, GlaxoSmithKline’s ViiV Healthcare went back to the drawing board after the FDA slammed the drug’s manufacturing late last year. But Canadian regulators had few concerns and now Cabenuva will be ready for launch in its first global market.  ViiV Healthcare’s long-acting Cabenuva (cabotegravir and rilpivirine) has been approved in […]

Trump talks antiviral progress amid COVID-19 pandemic, but FDA chief Hahn urges caution

In a much-anticipated press conference Thursday, President Donald Trump said the U.S. has stepped up near-term efforts to advance and make available antivirals to help patients with COVID-19 illnesses. But despite the urgency and the progress, FDA commissioner Stephen Hahn said it’s important to learn more about all potential treatments. Amid the pandemic, one drug […]

China’s CanSino pushes coronavirus vaccine into clinical testing as Moderna kicks off trial

Among a long list of biopharma companies developing vaccines against the novel coronavirus, China’s CanSino Biologics and Massachusetts-based Moderna Therapeutics are so far the frontrunners. CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology secured a quick Chinese regulatory go-ahead to start human testing of their recombinant coronavirus vaccine, […]

Tennessee’s ‘patient zero,’ a Biogen employee, comes forward to discuss ‘hysteria’ and ‘human kindness at its very best’

The novel coronavirus case count stemming from Biogen’s late-February meeting in Boston has climbed to more than 100 globally, but behind each case is a story and a family.  In Tennessee, the state’s self-described “patient zero” has decided to come forward and share his experience. Like others, 44-year-old Chris Baumgartner has witnessed “mass hysteria” in recent weeks, […]