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Pharmaceuticals, health and wellness

Merck looks for leg up on Bristol with Keytruda’s latest colorectal cancer win

Merck’s Keytruda went up against chemo in a head-to-head colorectal cancer battle—and won. The immuno-oncology star trumped various chemo regimens at keeping cancer from progressing in previously untreated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that had either spread to other parts of the body or couldn’t be surgically removed, […]

Zantac, generics ordered off the market after FDA finds they’re a ticking time bomb

Sixteen years after it was approved, the FDA has ordered that heartburn drug Zantac and its generics be removed from the market, saying they have been exposing consumers to the risk of cancer.  The move comes six months after an independent lab warned the FDA of a potential carcinogen in ranitidine drugs and nearly three […]

Chinese APIs flowing but India ban hinders U.S. approval of hydroxychloroquine

The production of Chinese active pharmaceutical ingredients (APIs) slipped by 10% to 20% during the early days of the COVID-19 outbreak in China but is quickly recovering. The bottleneck in the global supply chain for APIs is now shipping, particularly ocean freight.  This is the assessment of Chinese officials who held a press conference Tuesday. […]

AstraZeneca’s Imfinzi gets FDA green light to challenge Roche in small-cell lung cancer

Move over, Roche. There’s a new small-cell lung cancer therapy on the scene, and it belongs to AstraZeneca. Monday, the FDA cleared the British drugmaker’s Imfinzi—in tandem with standard-of-care chemo—for use in previously untreated patients with extensive-stage small cell lung cancer. About 15% of all lung cancer cases are small cell, a fast-growing form of […]

ACC: Amgen’s Repatha cuts cholesterol in rarely studied HIV patients

Amid Amgen’s pricing war with Sanofi and Regeneron’s Praluent, PCSK9 cholesterol fighter Repatha has been looking for a leg up in a wide-ranging clinical program involving dozens of trials. Now, in rarely studied HIV patients, Repatha has posted positive data in lowering cholesterol levels. Repatha cut LDL-C levels from baseline by 56.9% compared with placebo […]

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 […]