Carly Helfand
FiercePharma
Washington, DC, United States
Contact Carly
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Past articles by Carly:
AstraZeneca's PD-L1 med Imfinzi strikes out again in head and neck cancer
After AstraZeneca’s Imfinzi in late 2018 failed a trial in head and neck cancer, the company pinned its hopes on the phase 3 Kestrel study, figuring the drug might be able to show a benefit in patients with high levels of the PD-L1 biomarker. But that study didn’t pan out. → Read More
JPM: Regeneron execs say 'it's a problem' how few COVID-19 patients are getting antibody treatments
To Regeneron, there’s no question about it: “We as a society have to do a much better job” of getting antibody therapies—such as the company’s own—to patients, R&D chief George Yancopoulos said Monday at the J.P. Morgan Healthcare Conference. → Read More
JPM: Merck is 'not complacent, but we're not desperate' for deals, CEO says
Merck CEO Ken Frazier gets why investors are worried about what will happen when megablockbuster cancer drug Keytruda eventually loses patent protection. He just doesn’t think they need to be as worried as they are. → Read More
2021 forecast: Love 'em or hate 'em, virtual medical meetings are here to stay—even after live ones return
If you didn’t fall in love with virtual medical meetings in 2020, let’s just say you’re not alone. But while the industry is eager to get back to live conferences, some aspects of the virtual experience will follow us into 2021 and beyond—even after in-person meetings resume. → Read More
The top 15 highest-paid biopharma CEOs of 2019
While the list of the best-paid biopharma CEOs of 2019 includes some of the world's largest drugmakers, you'll also find smaller companies among them. And the CEO at No. 1 could be a surprise. → Read More
Calling vaccine makers: Moderna, NIH need a partner to produce their coronavirus shot
Moderna and the NIH put their coronavirus vaccine R&D into high gear. But the partners need a manufacturer, and no major pharma has stepped up. Why? Companies might not want to sacrifice capacity for their own profit-making vaccine prospects. → Read More
Wockhardt selling plant and piece of its business to Dr. Reddy’s for $260M
India’s Wockhardt, which has had its financial fortunes dampened for several years by manufacturing issues, has decided to improve its cash flow by selling a plant and portfolio of products to a competitor, a move that will raise more than $250 million. → Read More
Sanofi CEO Hudson singles out his digital ambitions in big executive shakeup
Sanofi bid farewell to four top executives as new CEO Paul Hudson rejigs and simplifies the company's management structure. Part of the plan? Separating the roles of chief medical officer and chief digital officer, so Sanofi can accelerate its bid to incorporate AI and other new technologies companywide. → Read More
Chinese firm copies Gilead's remdesivir, the most promising drug against the new coronavirus
Gilead's experimental remdesivir has emerged as the most promising candidate against the deadly new coronavirus. But some unexpected confusion has cropped up about its China patent—the latest being a Chinese firm claiming it's successfully copied the drug and started mass production. → Read More
Teva's global cutback spree is done. Now it's aiming to grow with Ajovy, Austedo
Teva's multibillion-dollar restructuring plan is finally coming to an end with the drugmaker running lighter to the tune of around 13,000 employees and 23 manufacturing sites. Now, it's charting a new path to growth—and hoping to ride CGRP med Ajovy and Huntington's therapy Austedo to get there. → Read More
ESMO: Lilly's Verzenio looks for an edge with gold-standard data in tough-to-treat patients
It’s tough to be a third-to-market drug, particularly when you’re trailing a first-up launch like Pfizer’s blockbuster Ibrance. But with some new data showing Verzenio can help tough-to-treat breast cancer patients live significantly longer, Eli Lilly’s hoping for a kick-start for its contender. → Read More
AACR: Astellas pads Xospata's AML lead with chemo-beating survival data
Astellas is looking to snap up share with Xospata before a head-to-head rival hits the acute myeloid leukemia scene, and some new survival data could help speed that process along. → Read More
AACR: Merck's Keytruda, up for new FDA nod, spurs lengthy responses in small cell lung cancer
Merck & Co. is awaiting an FDA decision for Keytruda in previously treated small cell lung cancer, and it has new numbers to boost its case. Almost one-fifth of patients in a pooled analysis responded to the PD-1 inhibitor, and those who did saw prolonged benefits. → Read More
Between Merck and Pfizer, the race is on in kidney cancer—but analysts are calling it early
The race is on between two Big Pharmas to snag a new indication in kidney cancer, but thanks to new data from Merck & Co., it may not matter who gets there first. → Read More
With safety data, Bayer could challenge Erleada, Xtandi in prostate cancer: analyst
For years, Johnson & Johnson and the Pfizer-Astellas team have been the only players in their class of prostate-cancer fighters. But Bayer is waiting in the wings, and stellar new safety data could make it a threat. → Read More
Swayed by discounts, NICE finally backs Roche's Perjeta for post-surgery breast cancer
Looks like the third time was a charm for Roche’s Perjeta when it comes to stepped-up use in England. Thanks to new discounts, the cost-effectiveness watchdogs at NICE recommended the drug for use after surgery in certain HER2-positive breast cancer patients. → Read More
Merck aims for prostate cancer dominance with 3 new phase 3 Keytruda studies
If Merck gets its way, it won’t be long before the prostate cancer treatment landscape looks pretty different. The company is adding a trio of late-stage studies to its Keytruda program, hoping they'll deliver some new combo approvals. → Read More
Mylan's 'aggressive' generic Advair discount isn't as big as it looks: analysts
Mylan has set its list price for its copy of GlaxoSmithKline’s Advair at a 70% discount to the brand. But the move likely isn’t as dramatic as it seems, analysts say. → Read More
Big Keytruda survival win sets Merck up to steal Bristol-Myers Squibb's kidney cancer share
Bristol-Myers Squibb investors have been dreading positive kidney cancer results from archrival Merck for months. And now that they’re here, they might do even more damage to Bristol-Myers’ market share than some industry watchers expected. → Read More
Pfizer, Astellas chase new Xtandi nod with big survival numbers in prostate cancer
When it comes to using Xtandi in hormone-sensitive prostate cancer, Pfizer and Astellas are “really excited,” executives have said. And new data shows the partners have reason to be. → Read More