Pharma: Page 28
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Jeenah Moon via Getty Images
EMA backs Pfizer’s RSV vaccine for use during pregnancy
The regulator’s recommendation for approval of Pfizer’s shot as a maternal immunization comes ahead of the FDA, which is currently reviewing that indication.
By Delilah Alvarado • July 21, 2023 -
Mario Tama via Getty Images
J&J shares jump on strong sales, boosted outlook
The pharmaceutical giant raised its guidance for the year as it predicts “above market” growth to continue for its prescription drug business.
By Ned Pagliarulo • July 20, 2023 -
Explore the Trendline➔
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
TrendlineAlzheimer's disease
Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.
By BioPharma Dive staff -
Permission granted by Novartis
Novartis raises drug sales forecast, plans new stock buybacks
The pharma company, which will soon split off its generic drug unit, plans to repurchase up to $15 billion of its shares through the end of 2025.
By Ned Pagliarulo • July 18, 2023 -
Permission granted by ZS
Sponsored by ZSThe rise of the new pharma marketer in an evolving commercial model
Meet the pharma marketer of the future, primed for personalization and powered by technology.
July 17, 2023 -
Courtesy of Perrigo
First nonprescription birth control pill approved by FDA
The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.
By Delilah Alvarado • July 13, 2023 -
Mario Tama via Getty Images
EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs
The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.
By Kristin Jensen • July 12, 2023 -
Takeda withdraws FDA approval application for dengue vaccine
While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the U.S. regulator in its current review cycle.
By Delilah Alvarado • July 11, 2023 -
Jonathan Gardner/BioPharma Dive
Novartis cancels BeiGene deal as questions over cancer drug target persist
The companies’ decision to end their partnership on a TIGIT-blocking drug raises new doubts over a mechanism of action that has already produced setbacks for Roche and Merck.
By Jonathan Gardner • July 11, 2023 -
Permission granted by Bristol-Myers Squibb
Bristol Myers licenses Prothena, Evotec brain drugs, inching back into neuroscience
The pharma, which had largely exited the field several years ago, will pay nearly $100 million combined to the two biotechs for rights to several experimental candidates.
By Ned Pagliarulo • July 11, 2023 -
Courtesy of Eisai
Eisai’s Ivan Cheung, who oversaw Alzheimer’s drug success, to depart
Keisuke Naito, the son of Eisai’s CEO, will replace Cheung as the company’s global Alzheimer’s disease head. The change in leadership comes days after Eisai won full U.S. approval of its drug Leqembi.
By Jacob Bell • July 11, 2023 -
Novartis to appeal district court ruling on heart drug patent
The patent is an important line of defense protecting Entresto, Novartis’ current top-selling medicine, from generic competition in the U.S.
By Ned Pagliarulo • July 10, 2023 -
Mario Tama via Getty Images
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.
By Jonathan Gardner • July 10, 2023 -
iStock / FatCamera
Sponsored by AllucentDriving big value for small biotechs in oncology drug development
Why dedicated expertise and a collaborative approach are needed to help smaller biotech companies bring new cancer treatments to light, now perhaps more than ever before
July 10, 2023 -
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Sponsored by Acceleration PointMeet Dr. Linda Traylor, VP of Medical Excellence with Acceleration Point
As the new vice president of medical excellence with global consulting and software firm Acceleration Point, she’s excited to focus on the role of technology in advancing her industry.
July 3, 2023 -
Permission granted by Novartis
Novartis, continuing revamp, sells eye drugs to Bausch + Lomb for up to $2.5B
An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.
By Jonathan Gardner • June 30, 2023 -
Sarah Silbiger via Getty Images
Ipsen gains FDA panel backing for bone drug acquired in $1.3B buyout
Despite hesitations, an advisory committee recommended use of the drug — a medicine Roche once developed for lung diseases — to treat the rare condition fibrodysplasia ossificans progressiva.
By Delilah Alvarado • June 29, 2023 -
Courtesy of Genmab A/S
Answering Roche, AbbVie and Genmab claim new study success for lymphoma drug
The companies aim to seek an FDA nod for their bispecific antibody, Epkinly, in follicular lymphoma, where it would compete with a recently approved Roche medicine.
By Jonathan Gardner • June 28, 2023 -
Permission granted by Purolite
Sponsored by PuroliteAdvances in antibody therapeutics depend on resin innovation
Chromatographic resins are important in the development of antibody therapeutics.
June 26, 2023 -
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Pfizer’s PARP drug follows Lynparza with narrow clearance in prostate cancer
As with Merck and AstraZeneca’s medicine, the agency has only cleared Talzenna for use in a subset of newly diagnosed patients who appear most likely to benefit from treatment.
By Jonathan Gardner • June 21, 2023 -
Bavarian Nordic says chikungunya vaccine succeeds in late-stage study
The shot, which the Danish company acquired from Emergent BioSolutions, spurred protective antibodies against the mosquito-borne virus in older adults.
By Delilah Alvarado • Updated June 20, 2023 -
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Sponsored by Center for Breakthrough MedicinesA right-first-time approach to development
Avoid costly delays, don't let development oversights derail your advanced therapy commercialization. Read the article.
June 20, 2023 -
Permission granted by Astellas
Astellas delves deeper into protein degrading drugs with Cullgen deal
The alliance is Astellas’ second recent partnership involving protein degraders, an emerging area of drug research the company has recently made a focus.
By Ben Fidler • June 15, 2023 -
Getty Images
Pharmaceutical supply chains raise data concerns as traceability law nears final step
Companies have had 10 years to comply with the Drug Supply Chain Security Act, but some fear the industry is not ready for a Nov. 27 deadline.
By Deborah Abrams Kaplan • June 7, 2023 -
Kena Betancur via Getty Images
Merck sues to block Medicare negotiation of drug prices
The drugmaker’s lawsuit claims the new pricing powers granted by the Inflation Reduction Act are unconstitutional and “tantamount to extortion.”
By Christopher Newman • Updated June 6, 2023 -
canva.com/Monkey Business Images
Sponsored by Acceleration PointUnlocking the impact of medical affairs: Overcoming challenges in defining and measuring success
Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.
June 5, 2023
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