Pharma: Page 58
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FDA pushes back decisions on skin disease and arthritis drugs from Pfizer, Lilly
The delays offer further evidence regulators remain wary of the safety issues surrounding so-called JAK drugs like Pfizer's Xeljanz and Lilly's Olumiant.
By Kristin Jensen • April 7, 2021 -
Courtesy of AstraZeneca
AstraZeneca's coronavirus vaccine possibly linked to rare blood clots, EMA says
Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.
By Ben Fidler • Updated April 7, 2021 -
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Brian Tucker / BioPharma Dive/BioPharma Dive
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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 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test
An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.
By Ben Fidler • April 5, 2021 -
Permission granted by University of Maryland School of Medicine
Pfizer vaccine data show durable protection, hint at efficacy against virus variant
Updated Phase 3 study results could position Pfizer to file for full approval of its vaccine and might have implications for its plans to develop a booster shot.
By Ben Fidler • April 1, 2021 -
Courtesy of Merck & Co.
FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer
Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.
By Ben Fidler • March 30, 2021 -
Permission granted by Bristol-Myers Squibb
FDA approves first CAR-T cell therapy for multiple myeloma
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.
By Ned Pagliarulo • March 27, 2021 -
Pfizer and Lilly's pain drug hits setback in negative committee vote
In a Thursday meeting, advisers to the Food and Drug Administration concluded the companies didn't have a strong enough plan to mitigate the risks associated with tanezumab.
By Jacob Bell • March 26, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets late-stage win in test of new type of immunotherapy
When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals.
By Jonathan Gardner • March 25, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US stops rollout of Lilly's first COVID-19 antibody over variant concerns
Treatments from Lilly and Regeneron that combine two different antibodies should be used instead, according to health officials.
By Kristin Jensen • March 25, 2021 -
Dufour, Tia. (2020). "White House Coronavirus Update Briefing" [Photograph]. Retrieved from Flickr.
Moncef Slaoui, who led US Warp Speed effort, accused of sexual harassment
Slaoui was fired as board chair of Galvani Bioelectronics following an investigation by the company's majority shareholder GlaxoSmithKline, which said the claims were substantiated.
By Ned Pagliarulo • Updated March 24, 2021 -
AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas
A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad.
By Ben Fidler • Updated March 22, 2021 -
Permission granted by Roche
Roche immunotherapy notches a win in early lung cancer, pressuring Merck
New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.
By Jonathan Gardner • March 22, 2021 -
José Baselga, prominent cancer researcher, dies at 61
The head of AstraZeneca's oncology R&D changed the paradigm of breast cancer care by helping bring the targeted treatments Herceptin and Perjeta to patients.
By Jacob Bell • March 22, 2021 -
Courtesy of AstraZeneca
EU, UK throw support behind AstraZeneca's vaccine amid reports of rare blood clots
The two drug regulators each believe the benefits of the shot outweigh the risks after investigating rare and unusual clotting events that have led more than 20 countries to halt vaccinations.
By Ben Fidler • March 18, 2021 -
Retrieved from C-SPAN on February 24, 2021
Becerra confirmed as HHS secretary
The 50-49 vote in the Senate was almost entirely along party lines. The only Republican to cross the aisle was Sen. Susan Collins of Maine.
By Shannon Muchmore • March 18, 2021 -
Kendall Davis/BioPharma Dive
Gilead, still aiming at NASH, broadens an alliance with Novo
With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.
By Jonathan Gardner • March 18, 2021 -
Courtesy of Walmart
Biden administration hikes Medicare reimbursement for coronavirus vaccines
The increased payout by Medicare is intended to speed up distribution of the three currently available shots.
By Shannon Muchmore • March 16, 2021 -
Brian Tucker/BioPharma Dive
FTC joins overseas antitrust regulators in reexamination of pharma M&A
Rebecca Kelly Slaughter, the commission's acting chair, indicated future reviews could look beyond measures of company size and market share.
By Jonathan Gardner • March 16, 2021 -
Courtesy of Eli Lilly
Lilly lays out 2-year plan to gain approval for Alzheimer's drug
Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.
By Jonathan Gardner • March 15, 2021 -
Courtesy of AstraZeneca
AstraZeneca says 'no evidence' linking vaccine to clots after multiple countries pause rollout
The drugmaker defended its shot following reports of blood clots among vaccine recipients, noting more than 17 million people in the U.K. and Europe have now received it.
By Ben Fidler • March 15, 2021 -
Detailed Lilly data give mixed picture of Alzheimer's drug's benefit
Highly anticipated results from a Phase 2 study of donanemab showed treatment slowed disease progression on one measure, but mixed data on other scales could temper optimism in its potential.
By Jonathan Gardner • March 13, 2021 -
Alex Wong via Getty Images
The top drugs that could be impacted by an obscure provision in the pandemic relief law
Elimination of the so-called penny rule in Medicaid could force drugmakers to pay larger rebates on a number of top medicines, including some HIV, diabetes and anti-inflammatory drugs.
By Jonathan Gardner • March 12, 2021 -
Permission granted by Johnson & Johnson
Vaccine factories churn out millions more doses, speeding US rollout of coronavirus shots
The U.S. is now averaging more than 2 million doses given each day, a pace that will help President Joe Biden meet his target of 100 million shots in 100 days well ahead of schedule.
By Ned Pagliarulo • March 11, 2021 -
Courtesy of Eli Lilly
Lilly builds case for COVID-19 drug cocktail with new data
A low-dose combination of Lilly antibodies for COVID-19 reduced deaths and hospitalizations in a Phase 3 trial, a finding that could boost its use.
By Kristin Jensen • March 10, 2021 -
Taking a page from Celgene, Takeda builds and buys a cancer biotech
An agreement to acquire Maverick Therapeutics for up to $525 million has roots in a plan hatched by Takeda to emulate elements of Celgene's dealmaking strategy.
By Ben Fidler • March 9, 2021
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