Noah Higgins-Dunn
FiercePharma
New York, NY, United States
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Past articles by Noah:
Gilead, Merck and others slapped with 'pay-for-delay' lawsuits over lucrative HIV and cholesterol meds
A handful of new lawsuits claim a number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings. → Read More
Faced with generic rivals, Amarin cuts 400-plus sales reps as part of revamped Vascepa strategy
As Amarin faces generic foes in the U.S. for its heart drug Vascepa, the company is revising its game plan. It plans to reduce its U.S. sales force from about 750 reps to 300 and divert those resources to educational and promotional materials. → Read More
Do not enter: Biogen reps banned from D.C.-area neurology clinics over controversial Alzheimer's drug Aduhelm
In a stark example of the less-than-friendly reception Biogen's Alzheimer's med Aduhelm has received, the Neurology Center in Washington D.C. has gone so far as to ban Biogen reps from entering their seven office locations. → Read More
BeiGene's Brukinsa turns up heat against Imbruvica with latest lymphoma nod
BeiGene scored an accelerated FDA approval for Brukinsa, also known as zanubrutinib, in adults with relapsed or refractory marginal zone lymphoma (MZL) who have been previously treated with at least one anti-CD20-based regimen. → Read More
From Pfizer to Argenx: A look at potential blockbusters awaiting FDA decisions this year
Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Cumulatively, the meds are worth roughly $7.1 billion in sales by 2026. → Read More
Moderna taps National Resilience's new Canadian manufacturing site for COVID-19 vaccine production duties
Moderna will team up with National Resilience, founded in November 2020, to manufacture the company’s COVID-19 vaccine substance at Resilience’s newly acquired facility in Mississauga, Canada. → Read More
Teligent pulls 'super potent' topical lidocaine lot following failed stability tests
While still trying to address an FDA warning letter issued nearly two years ago, New Jersey pharma Teligent says it’s yanking a lot of its topical pain numbing treatment after stability testing found the med to be too potent. → Read More
First Biogen, now the FDA: Congressional Democrats request agency records over Aduhelm's approval
Months after high-ranking Democrats demanded Biogen answer for concerns shrouding its controversial Alzheimer’s drug Aduhelm, the pair of lawmakers are now making a similar request to the FDA itself, according to a letter sent to interim commissioner Janet Woodcock, M.D. → Read More
After criticism, Johnson & Johnson COVID-19 vaccines shipped from South Africa to Europe to be returned
Johnson & Johnson drew sharp criticism two weeks ago amid reports that doses of its single-shot COVID-19 vaccine produced in South Africa were being exported to Europe. Now, it appears that arrangement is coming to an end. → Read More
Biogen's Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises
There's "room for surprises" when it comes to the safety of Biogen's Aduhelm because of the company's tightly controlled clinical trials, which recruited a narrower group of Alzheimer's patients compared to the treatment's FDA label, RBC Capital Markets wrote on Wednesday, citing a recent study. → Read More
Johnson & Johnson scores an FDA first with nod for twice-yearly schizophrenia drug Invega Hafyera
Johnson & Johnson's Janssen scored an FDA nod on Wednesday for a 6-month formulation of its schizophrenia treatment paliperidone palmitate, making it the first and only twice-yearly injectable for the condition. → Read More
Merck, Amgen adopt double-digit price hikes in test to Big Pharma's unofficial annual limits: analyst
For years, top pharma companies limited annual drug price hikes to single digits. But now it appears some big players are starting to push the limits of pharma’s social contract, Bernstein analyst Ronny Gal points out. → Read More
Sanofi, Regeneron's Dupixent aces late-stage study in young children with atopic dermatitis
Dupixent met all of its goals in a phase 3 trial studying the treatment in children aged 6 months to 5 years old with moderate-to-severe atopic dermatitis, making it the only biologic drug with positive data in patients that young, Sanofi and Regeneron said on Monday. → Read More
Sanofi, GSK and Seqirus prep for near-record flu shot sales as COVID's delta variant cooks up 'recipe for disaster'
Sanofi, GlaxoSmithKline and Seqirus say they're prepared to match last season's record supply of U.S. flu shots, gearing up to deliver more than 190 million doses. And as the troublesome delta variant wreaks havoc, a new CDC rule means Americans may be able to get their annual flu jab at the same time as a COVID booster. → Read More
J&J, Bayer's Xarelto scores FDA nod in post-surgery artery disease as partners try to catch up with Eliquis
The FDA awarded Xarelto, coupled with aspirin, an expanded approval for patients living with peripheral artery disease, or PAD, to include those who’ve recently undergone surgery to unblock arteries in their legs because of the disease. → Read More
Giddy up: Alexion challenger Apellis could race to $4B in annual sales with Empaveli, analysts say
While Empaveli's full potential has yet to be realized, its eventual winnings could make it a thoroughbred among rival C5 inhibitors, eventually racking up over $4 billion in sales, according to Jefferies analysts. → Read More
'Our worst nightmare realized:' Investors, WHO slam J&J for exporting COVID shots produced in Africa
Johnson & Johnson is receiving fierce criticism from a group of outspoken shareholders for exporting millions of COVID-19 vaccine doses from a facility in South Africa to Europe despite glaring access inequalities, contributing to a “vaccine apartheid." → Read More
Roche warns of global Actemra shortage as delta variant drives huge spike in demand for COVID-19 patients
Roche's Genentech warned that the "unprecedented" surge in demand for its arthritis drug Actemra, used to treat severely ill COVID-19 patients, has driven a global shortage that could last for months if the pandemic continues at its current pace. → Read More
Merck's Welireg scores FDA nod in cancers spurred by rare disease—and its label is broader than expected
Belzutifan, now sold as Welireg, snared its first FDA approval on Friday for patients with a number of cancers associated with the rare disorder known as von Hippel-Lindau (VHL) disease. The agency’s decision comes a month ahead of its expected decision date, and its label is broader than what some analysts expected. → Read More
Organon shares jump as Merck's new women's health spinoff posts strong start for biosims, infertility drugs
In its first reported quarter as an independent company on Thursday, Organon pleasantly surprised investors when it reported nearly $1.6 billion in revenue, buoyed by its biosimilars business and infertility drugs. But executives warned the NuvaRing maker isn't out of the pandemic woods yet. → Read More