Pharma
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Novartis gets second trial win for blockbuster hopeful
The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.
By Kristin Jensen • Dec. 8, 2022 -
Sarah Silbiger via Getty Images
MEI, Kyowa stop lymphoma drug trials after FDA meeting
The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors.
By Jonathan Gardner • Dec. 6, 2022 -
Explore the Trendline➔
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
TrendlineCOVID-19 vaccines and the pandemic's third year
The urgency of the pandemic’s first two years is giving way to questions of how to sustain public health responses and prepare for what could come next. In the U.S., health officials are urging booster shots and preparing for private sector distribution of vaccines.
By BioPharma Dive staff -
Elizabeth Regan / Industry Dive
J&J drops out of hunt for Horizon, leaving Sanofi and Amgen to bid
The two remaining suitors said they would make cash bids if they move forward with offers, for which they must declare “firm intent” by Jan. 10 under Irish takeover rules.
By Christopher Newman • Dec. 5, 2022 -
Mario Tama via Getty Images
J&J’s Duato to replace departing Gorsky as board chair
The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.
By Delilah Alvarado • Dec. 2, 2022 -
Brian Tucker / BioPharma Dive
Large pharmas probe takeover of Horizon Therapeutics
The Dublin-headquartered drugmaker confirmed it is in "highly preliminary" talks with Amgen, J&J and Sanofi, although it cautioned no offer may ever materialize.
By Ned Pagliarulo • Updated Nov. 30, 2022 -
iStock via Getty Images
Roche pulls Tecentriq in bladder cancer, completing sweep of ‘dangling’ accelerated approvals
The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.
By Jonathan Gardner • Nov. 29, 2022 -
XH4D via Getty Images
Sponsored by CognizantIs your gross-to-net strategy ready for uncertainty?
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Nov. 28, 2022 -
Md Ariful Islam via Getty Images
Novartis, research group to advance new kind of malaria drug into late-stage test
The Swiss pharma and the Medicines for Malaria Venture plan to start a Phase 3 trial of a non-artemisinin combination treatment next year.
By Delilah Alvarado • Nov. 23, 2022 -
Courtesy of Merck & Co.
Merck to buy blood cancer biotech Imago for $1.35B
The deal is Merck’s second notable acquisition in the past year and a half, part of a strategy to diversify its pipeline beyond the top-selling Keytruda.
By Christopher Newman • Nov. 21, 2022 -
Courtesy of Merck KGaA
Merck KGaA outlines plan to rev up drug R&D
The German company aims to, on average, launch a new medicine or major treatment indication every 18 months in a bid to boost its pharma business.
By Ned Pagliarulo • Nov. 21, 2022 -
Courtesy of Teva Pharmaceutical
Teva taps Sandoz veteran to take over CEO post from Schultz
Richard Francis will take over for the retiring Kåre Schultz on Jan. 1. He’ll face major challenges at Teva, including opioid settlements, biosimilar launches and reducing the company’s debt.
By Jonathan Gardner • Nov. 21, 2022 -
Spencer Platt via Getty Images
Pfizer, BioNTech start study testing next COVID-19 vaccine
The new candidate is meant to provide broader immunity over a longer period of time and is part of the companies’ strategy to stay ahead of a shifting coronavirus threat.
By Delilah Alvarado • Nov. 17, 2022 -
Regeneron
Regeneron teams up with CytomX to develop dual-targeting cancer drugs
Regeneron will pay CytomX $30 million to try to create bispecific antibody drugs that are safer and have a wider reach than existing treatments.
By Christopher Newman • Nov. 17, 2022 -
Q&A // Emerging biotech
Eli Lilly’s Julie Gilmore on finding up-and-coming companies and backing small biotechs
Only a small fraction of the companies Lilly evaluates get into its incubator, according to Gilmore. Here’s how the big pharma selects them.
By Gwendolyn Wu • Nov. 15, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Trial failures end latest hope for Roche’s Alzheimer’s drug
Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials.
By Delilah Alvarado , Ben Fidler • Nov. 14, 2022 -
Buena Vista Images via Getty Images
Sponsored by LumanityCrossing the new real world data landscape
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Nov. 14, 2022 -
Courtesy of GSK Flickr page
Under FDA pressure, GSK limits use of ovarian cancer drug
The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology.
By Jonathan Gardner • Nov. 11, 2022 -
Carl Court via Getty Images
EMA backs restrictions on certain immune-regulating drugs
Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications.
By Christopher Newman • Nov. 11, 2022 -
zorazhuang via Getty Images
Pharma earnings outline drug law’s looming impact on sales, development
While many companies are still unsure of the Inflation Reduction Act's effects, some have begun to warn investors about the likelihood of lower sales and reduced profitability.
By Christopher Newman • Nov. 9, 2022 -
National Cancer Institute \ USC Norris Comprehensive Cancer Center
Ipsen drug shows benefit in pancreatic cancer, lifting shares of ghost company
Adding Onivyde to chemotherapy helped patients live longer, a finding that could result in increased payouts to shareholders in the drug’s developer, Merrimack, which laid off all of its employees in 2019.
By Jonathan Gardner • Nov. 9, 2022 -
Amgen Inc.
Early data hint at benefit for Amgen’s obesity drug
Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.
By Jonathan Gardner • Nov. 8, 2022 -
Courtesy of Novavax
Novavax details trial results for omicron-targeting booster shots
A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.
By Delilah Alvarado • Nov. 8, 2022 -
Courtesy of Viatris
Viatris to buy two eye drug developers in deals worth up to $750M
The generics company is acquiring Oyster Point Pharma and the privately held Famy Life Sciences in a move aimed at creating an ophthalmology business.
By Delilah Alvarado • Updated Nov. 7, 2022 -
Courtesy of GSK
GSK myeloma drug comes up short in confirmatory test
The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.
By Ned Pagliarulo • Nov. 7, 2022 -
iStock.com/PeopleImages
Sponsored by flipMD from GoodRxflipMD by GoodRx helps physicians create hybrid careers to reduce burnout
Using flipMD, organizations can find, vet, connect with and source practicing board-certified physicians from all specialties for contract, project-based or full-time assignments.
Nov. 7, 2022
