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Pharmaceuticals, health and wellness

Pfizer, AstraZeneca COVID vaccines probed in Europe after reports of heart inflammation, rare nerve disorder

Europe’s drug regulator says it’s evaluating an assortment of potential side effects following inoculation with leading COVID-19 vaccines, including heart inflammation, facial swelling and a rare nerve-degenerating disorder. Yet in most circumstances, it’s not clear whether the vaccines are to blame.  In AstraZeneca’s case, the European Medicines Agency’s safety committee, known as PRAC for short, said […]

Fierce Pharma Asia—BeiGene touts Q1, PARP inhibitor nod; Astellas culls muscle disease pact

BeiGene’s first-quarter sales jumped 104% year over year to $106 million as it started to benefit from demand surging on new national reimbursement coverage. The Chinese biotech also won a local go-ahead for a PARP inhibitor to challenge incumbents Lynparza and Zejula. Astellas walked away from a muscle disease pact with Cytokinetics after a midstage trial flop. […]

Moderna CEO says he’s not losing any sleep over Biden’s support for COVID-19 vaccine waiver

Moderna shares plummeted overnight alongside fellow COVID-19 drugmakers after the Biden administration came out in favor of temporarily waiving intellectual property rights for their vaccines. But to Moderna CEO Stéphane Bancel, the newly U.S.-backed measure is not a concern.  “I didn’t lose a minute of sleep over the news during the night,” Bancel told analysts following the company’s […]

Eli Lilly faces employee complaints, FDA troubles at factory making COVID-19 drug: report

Quality control problems have already plagued one COVID-19 vaccine manufacturer in Baltimore, Maryland. Now, it appears they’re threatening to trip up a major pandemic therapeutic supplier as well.  Eli Lilly employees have accused an executive at the drugmaker’s Branchburg, New Jersey, manufacturing site of altering FDA-required documents in an effort to downplay serious quality control […]

Moderna plans major expansion at Massachusetts manufacturing site to help boost COVID-19 vaccine supply

With plans to boost COVID-19 vaccine production into the billions of doses next year, Moderna is making major renovations at its Massachusetts manufacturing site that will more than double its size.  The mRNA developer on Tuesday said it plans to renovate its manufacturing site in Norwood, Massachusetts, from “a production and lab space to an industrial technology […]

Activist-investor target Alkermes clears Alex Denner’s Sarissa Capital to fill board seat

Activist investor Alex Denner has made a name for himself sparring with drugmakers. Now, he’s put the pressure on neuroscience and oncology specialist Alkermes, which has already been working its way through a board shakeup for about two years.  Alkermes has agreed to let Denner’s Sarissa Capital Management, which owns a 5% stake in the company, appoint […]

AstraZeneca’s diabetes drug Farxiga nabs coveted kidney disease nod, way ahead of rival Jardiance

AstraZeneca’s diabetes med Farxiga stormed the heart failure market with a first-in-class approval last year—and in chronic kidney disease, it just left would-be rival Jardiance in the dust.  The FDA late Friday approved Farxiga, also known as dapagliflozin, to treat chronic kidney disease even in patients without diabetes. With that CKD approval in hand, Farxiga […]

Amid JAK safety uncertainty, AbbVie says latest data support its key launch Rinvoq

As AbbVie plans for its post-Humira future, its immunology drugs Rinvoq and Skyrizi are carrying big expectations. However, the drugmaker and its investors been forced to hold their breath while the FDA works overtime to review data on a handful of new indications for Rinvoq.  In response to an FDA request, AbbVie has provided the federal agency […]

AbbVie CEO summoned to Congress—again—to answer questions on Humira pricing, patenting

Accused of forming a patent thicket around its top-seller Humira and cancer blockbuster Imbruvica, AbbVie has faced repeated pressure from the House Committee on Oversight and Reform to lay out its pricing and patenting strategies. With that information now in hand, the committee is putting AbbVie’s helmsman in the hot seat. AbbVie CEO Richard Gonzalez […]

After $600M sales hit from pandemic, Merck’s open to ‘all forms’ of M&A deals, incoming CEO says

With Merck’s sales dragging from the pandemic and the company becoming increasingly reliant on immuno-oncology superstar Keytruda, the pharma giant’s executive team unveiled a willingness to flex its M&A muscle. “We are open to any opportunity to add a meaningful asset,” president and soon-to-be CEO Rob Davis said on a Thursday call with investors. “We […]

Despite big sales drop, GlaxoSmithKline is betting on a strong return later this year with help from Shingrix

GlaxoSmithKline is weathering several challenges amid the COVID-19 pandemic, including lackluster sales and pressure from activist shareholders to revamp the company. Undeterred, GSK is pushing forward and, like other drugmakers, betting on a strong recovery in the second half of the year.  GSK reported sales of £7.42 billion ($10.28 billion) during the first quarter, an 18% decline […]

Gilead, Merck step in to help India’s drug manufacturers fight surging COVID-19 outbreak

India is in the midst of one of the world’s grimmest COVID-19 outbreaks so far, but for weeks the country has struggled to meet local demand for life-saving drugs and vaccines. Now, drugmakers reliant on India for their own production needs are stepping in to help.  Gilead Sciences on Monday said it would help local manufacturers boost production of its […]