Pharma: Page 45
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Novartis forecasts improving generic drug business as it weighs unit's future
The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year.
By Ned Pagliarulo • July 19, 2022 -
Drug deals, launches in focus as pharma earnings begin
Second quarter reports could bring questions on a reportedly forthcoming $40 billion takeover, GSK’s new slimmed-down look and market uptake for expected blockbusters from Lilly and Bristol Myers.
By Ned Pagliarulo , Jonathan Gardner • July 18, 2022 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 5 stories from BioPharma Dive
Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
EMA adds allergic reaction warning to Novavax's COVID-19 vaccine
The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.
By Christopher Newman • July 15, 2022 -
Novartis, BeiGene cancer drug faces delay as FDA puts off approval decision
The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.
By Ned Pagliarulo • July 14, 2022 -
FDA clears Novavax’s COVID-19 vaccine as 4th option in US
The shot is the first of its type authorized for COVID-19 by the FDA, but faces an uncertain future due to questions about its ability to fight omicron as well as the biotech’s ability to manufacture large quantities.
By Jonathan Gardner • Updated July 13, 2022 -
Merck wagers $290M on a cancer treatment from Finnish drugmaker
The treatment, developed by Orion Corporation, is in Phase 2 testing for advanced prostate cancer, and adds to Merck’s oncology pipeline
By Kristin Jensen • July 13, 2022 -
Healthcare asset manager Innoviva buys another biotech at a bargain price
Two months after acquiring Entasis Therapeutics, the firm reached a deal to buy La Jolla Pharmaceutical Co. at a fraction of what La Jolla was worth just a few years ago.
By Jonathan Gardner • July 11, 2022 -
Sponsored by Worldwide Clinical Trials
De-risking oncology trials with medical monitoring
Phase three oncology studies have approximately a 35% likelihood of leading to regulatory approval.
July 11, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
AbbVie dials back partnership on experimental Alzheimer's drug
While AbbVie is bailing on one of the two programs it paid Alector $205 million to acquire five years ago, work will continue on the second project. That drug, however, has shown safety signals.
By Jonathan Gardner • July 8, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug
The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.
By Jonathan Gardner • July 6, 2022 -
US pays Pfizer $3.2B to increase vaccine supply ahead of omicron booster push
The order will bolster the government stockpile of COVID-19 vaccines ahead of a booster rollout that the FDA now says should include shots tailored to the newest versions of omicron.
By Kristin Jensen • June 30, 2022 -
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects
Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.
By Jonathan Gardner • June 30, 2022 -
AstraZeneca, chasing immunotherapy rivals, claims study success in early lung cancer
A regimen involving its drug Imfinzi improved tumor responses when given before surgery, building on evidence that immunotherapies, already mainstays for advanced disease, could become standard treatments earlier.
By Ben Fidler • June 30, 2022 -
Novartis details plans to lay off up to 8,000 amid sweeping restructuring
The Swiss pharma confirmed it will cut as many as 1,400 jobs in Switzerland and thousands more globally under a reorganization plan first announced in early April.
By Kristin Jensen • June 29, 2022 -
Pfizer, Roivant spin out new company to advance anti-inflammatory drugs
The pharma licensed rights to two drugs, one of which is in late-stage testing for a rare autoimmune condition, to a new biotech jointly owned by Roivant.
By Jonathan Gardner • June 28, 2022 -
Sponsored by Medscape
Connect to the conversation around mental health: A spotlight on physician burnout
This year's report showed that 47% of physicians feel burned out, compared with 42% the year before.
June 27, 2022 -
Sanofi, GSK say dual-acting vaccine prevents COVID-19 from omicron in large trial
A shot the partners have been developing reduced symptomatic infections associated with the variant by 72% compared to a placebo, positioning it as a potential option, if approved, to combat omicron.
By Jonathan Gardner • June 24, 2022 -
Novartis to invest $250M in tropical disease drug research
The bulk of the investment will go toward advancing development of three antimalarial drug candidates meant to combat resistance to artemisinin, a common treatment.
By Delilah Alvarado • Updated June 23, 2022 -
Pfizer takes stake in Lyme disease partner ahead of key study
Valneva will receive $95 million from Pfizer to support development of a vaccine candidate as the French company’s COVID-19 work sputters.
By Jonathan Gardner • June 21, 2022 -
Sponsored by GoodRx
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June 21, 2022 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
Pharma under the microscope as FTC considers new ways to review acquisitions
At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.
By Jonathan Gardner • June 16, 2022 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
GSK claims first positive Phase 3 result for an RSV vaccine
The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.
By Jonathan Gardner • June 10, 2022 -
FDA advisers back Novavax's latecomer COVID-19 vaccine
Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.
By Jonathan Gardner • Updated June 7, 2022 -
Roche keeps the faith in new cancer immunotherapy despite trial setbacks
An ambitious development plan has so far resulted in two late-stage disappointments, but the Swiss drugmaker remains confident there's more to come from its combination treatment.
By Jonathan Gardner • June 7, 2022 -
Sponsored by CorEvitas
Converging data sets holds promise for creating holistic view of patient lived experience
Real-world data (RWD) and real-world evidence (RWE) are coming into increasingly widespread use across the entire pharmaceutical product development lifecycle.
June 6, 2022