Pharma
-
J&J puts focus on cancer drugs in push to reach 2025 sales target
The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.
By Christopher Newman • Updated Jan. 24, 2023 -
Lilly to boost diabetes drug production with $450M factory investment
The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.
By Jonathan Gardner • Jan. 24, 2023 -
Explore the Trendline➔
luismmolina via Getty ImagesTrendlineThe expanding world of RNA therapies
Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.
By BioPharma Dive staff -
Sponsored by Allucent
Big passion for small biotech and its potential to address complex diseases
A conversation with Teresa Nunes, chief medical officer of Allucent.
Jan. 23, 2023 -
Why Wall Street shrugged at Lilly’s Alzheimer’s setback
Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.
By Jacob Bell • Jan. 20, 2023 -
BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca
The drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.
By Jonathan Gardner • Jan. 20, 2023 -
FDA rejects Lilly Alzheimer’s drug, citing insufficient data
The drugmaker had sought an accelerated approval based on data from a small mid-stage trial. Results from a larger study are due in the second quarter.
By Ned Pagliarulo • Jan. 20, 2023 -
Roche says Tecentriq immunotherapy reduces risk of liver cancer recurrence
While the company did not reveal specific study data, the results could help Tecentriq become the first drug approved for adjuvant liver cancer treatment.
By Jonathan Gardner • Jan. 19, 2023 -
Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK
The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.
By Delilah Alvarado • Jan. 18, 2023 -
Gene therapy safety
EMA weighs new safety guidance for Novartis’ gene therapy Zolgensma
The discussions come months after two patients died from acute liver injury following treatment with the spinal muscular atrophy therapy.
By Delilah Alvarado • Jan. 13, 2023 -
Novo Nordisk diabetes pill wins FDA approval for first-line use
The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.
By Jonathan Gardner • Jan. 13, 2023 -
California files suit against PBMs over insulin prices
The state filed suit Thursday against pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx, alleging they worked with drugmakers to drive up the price of insulin.
By Hailey Mensik • Jan. 13, 2023 -
JPM23: Takeda tests Bristol Myers, Prime weighs spinoffs and Sanofi faces down a competitor
Prime Medicine’s CEO pondered how best to advance an expansive pipeline, while executives at the two pharmas talked up their rival autoimmune disease drugs at the J.P. Morgan Healthcare Conference.
By Ben Fidler , Jacob Bell , Gwendolyn Wu , Delilah Alvarado • Jan. 11, 2023 -
Bristol Myers, Bayer forecast blockbuster future for rival blood thinners
The companies forecast that annual sales of two experimental anticoagulants they’re respectively developing could exceed $5 billion later this decade.
By Christopher Newman • Jan. 11, 2023 -
AstraZeneca, Avillion get FDA approval for new ‘rescue’ drug for asthma
Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.
By Kristin Jensen • Jan. 11, 2023 -
Looking past Humira, AbbVie boosts sales forecasts for successor drugs
Competition to Humira will weigh on AbbVie, but the pharma has laid out ambitious expectations for fast growth from its medicines Skyrizi and Rinvoq.
By Jonathan Gardner • Jan. 11, 2023 -
JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies
Arrakis CEO Michael Gilman discussed platform companies’ central challenge, while Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted at greater dealmaking to come for their companies.
By Jacob Bell , Ben Fidler , Jonathan Gardner • Jan. 10, 2023 -
Novavax’s Erck to depart after 12 years as CEO
The longtime company head is retiring after a trying year for the COVID-19 vaccine developer. John Jacobs, most recently CEO at Harmony Biosciences, will succeed him.
By Delilah Alvarado • Jan. 9, 2023 -
Arrowhead reports positive data from liver drug, but company’s shares slide
The biotech and partner Takeda also announced a Phase 3 study of the RNA medicine that is longer than anticipated, pushing out analysts’ timelines.
By Jonathan Gardner • Jan. 9, 2023 -
5 questions facing the pharma industry in 2023
Drug price reforms and regulatory scrutiny present challenges for large drugmakers, although successes in Alzheimer’s and obesity have brought new opportunities, too.
By Christopher Newman , Jonathan Gardner • Jan. 9, 2023 -
Trio of biotech buyouts jumpstarts J.P. Morgan healthcare meeting
AstraZeneca is acquiring CinCor Pharma, while Ipsen and Chiesi announced deals to buy rare disease drugmakers Albireo and Amryt Pharma, respectively.
By Ned Pagliarulo • Jan. 9, 2023 -
Sponsored by Cognizant
Harmonizing site and sponsor platforms to accelerate study startup and monitoring
Tech overload is among the greatest challenges sites have when they take on new clinical trials and the average clinical research center has to manage multiple platforms daily.
Jan. 9, 2023 -
Eisai, in pricing new Alzheimer’s drug, tries to sidestep controversy
The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness.
By Ned Pagliarulo • Jan. 6, 2023 -
Pfizer pares back early-stage research in rare disease, cancer
The drugmaker said it is considering licensing out some assets to shorten development timelines, and will stop work on early viral-based gene therapies.
By Jonathan Gardner • Jan. 6, 2023 -
Kenvue, J&J’s consumer health unit, files for an IPO in step toward split
The IPO, which one estimate said could raise as much as $5 billion, is likely to be one of the largest new stock offerings in recent years.
By Delilah Alvarado • Jan. 5, 2023 -
FDA sets decision date for Alvotech’s Humira biosimilar
Along with the review deadline, Alvotech also disclosed the FDA had turned back an application for interchangeability as the agency needs to reinspect a manufacturing facility.
By Jonathan Gardner • Dec. 22, 2022