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Pharmaceuticals, health and wellness

FiercePharmaAsia—Biocon, Mylan’s Lantus copy; Samsung rides COVID-19 demand; Adlai Nortye’s C round

Mylan and Biocon will launch Semglee, their biosimilar of Sanofi’s Lantus, at a discount. Samsung Biologics’ $2 billion “Super Plant” expansion is the result of increased demand partly due to COVID-19, the CDMO’s CEO said. China’s Adlai Nortye, with a PI3K drug bought from Novartis leading its pipeline, collected $100 million in its latest financing. […]

AstraZeneca signs on Albany Molecular to help boost COVID-19 shot production

British drugmaker AstraZeneca is on a mission to lock in as many manufacturing partners as possible to support a planned global rollout for its COVID-19 vaccine frontrunner. A New York CDMO has now jumped on board, and it will commit its Southwestern facility to help pick up the slack. New York-based Albany Molecular Research will […]

CDC sets its sights on November COVID-19 vaccine deliveries: report

With investigators recruiting participants for late-stage COVID-19 vaccine trials, officials are working behind the scenes at the federal, state and local levels to deliver the first doses by November 1, McClatchy reports. That timeline appears to be ahead of when the shots can definitively prove safety and efficacy.  Last week, CDC director Robert Redfield sent an “urgent” […]

FDA flags Mylan ingredients plant in ongoing fallout from global blood pressure med recalls

Generics maker Mylan ran afoul of the FDA late last year for lax testing protocols that could have led to active pharmaceutical ingredients (API) tainted with a probable carcinogen. Learning its lesson, Mylan battened down operations at another of its Indian API plants—but the FDA still found issues.  The FDA cited Mylan for failing to […]

Gilead’s Veklury wins expanded FDA nod for moderate COVID-19 patients despite mixed data

Amid daily headlines about COVID-19 vaccines and trends, Gilead’s Veklury, also known as remdesivir, remains the only antiviral drug authorized to treat the illness. With a new move from the FDA, the medicine’s emergency green light is a little broader—despite some lingering questions about its efficacy. Under the expanded emergency use authorization (EUA), all hospitalized […]

ESC: Novartis’ Entresto racks up a heart failure study win—but it’s a mixed one

As the bestselling drug in the heart failure space, Novartis’ Entresto suffered a stinging setback last year in a novel indication—but there were some signs of hope. Now, a new Entresto study is again showing promise in that patient population, but it’s not a resounding win.  Entresto had split success in improving symptom severity and […]

ESC: Pfizer, BMS’ Eliquis tops Xarelto, vitamin K drugs for site-specific bleeding risks in French real-world study

Pfizer and Bristol Myers Squibb’s anticoagulant superstar Eliquis has raced out to blockbuster sales in recent years and a big-time lead over its its warfarin alternative competitors. Looking to pad that lead, the partners are building a body of real-world evidence for their drug, and in one French study the results are mostly promising. Eliquis topped […]

ESC: Eli Lilly, Boehringer’s Jardiance cuts CV events by 25% in Farxiga-matching heart failure trial

AstraZeneca put the rest of the SGLT2 inhibitor class on notice when its Farxiga scored an FDA heart failure nod in patients with or without diabetes. One of its competitors, Eli Lilly and Boehringer Ingelheim’s Jardiance, is fast on Farxiga’s heels, though, and it’s ready to bring its pivotal trial win in front of physicians.  Jardiance, added […]

FDA pulls J&J’s Invokana boxed warning after reviewing amputation risks—but the sales damage is done

Sales of Johnson & Johnson’s diabetes drug Invokana have suffered since the FDA slapped a boxed warning on its label detailing the product’s amputation risks. But in an about-face, the agency now says it’s removed that warning. The FDA this week scrapped the boxed warning—which has graced Invokana’s label since 2017—after reviewing data from three clinical […]

Liability risks emerge as an obstacle in Europe’s COVID-19 vaccine negotiations: Reuters

With all eyes on the hunt for COVID-19 vaccines, Europe’s supply negotiations with drugmakers have hit snags over potential liability for side effects, Reuters reports.  While some companies are in “advanced discussions” to supply tens or hundreds of millions of doses to European countries, only AstraZeneca has completed an agreement—for 400 million doses. That deal provides AstraZeneca some protection, according to […]

Biogen conference likely linked to ‘tens of thousands’ of COVID-19 cases, researchers say

It’s been some months since Biogen’s February management conference has been in the news, but as the pandemic drags on, researchers are now linking the early “superspreading event” with tens of thousands of cases in the U.S.—if not more. The company’s February management conference has been connected to cases in numerous states and countries, and now researchers say it’s associated with about 20,000 cases […]

FiercePharmaPolitics—Is the ‘deep state’ running the FDA? Trump tweet sparks pushback amid COVID-19 fight

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.  It was a contentious weekend at the FDA after attacks from President Donald Trump and his allies, who’ve claimed “deep state” employees within the agency are undercutting their fight against the COVID-19 pandemic. It’s worth […]