Pharma: Page 49
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Gabriel Kuchta via Getty Images
Sanofi to aid Moderna on final steps in manufacturing coronavirus vaccine
The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers.
By Ned Pagliarulo • April 26, 2021 -
Warren Little via Getty Images
GSK immunotherapy wins FDA approval, joining crowded cancer drug class
Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others.
By Ned Pagliarulo • April 23, 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 -
Tasos Katopodis via Getty Images
FDA cites Emergent for failings at plant that contaminated J&J doses
A recent nine-day inspection by agency officials found numerous breaches of manufacturing standards and inadequate training for factory employees.
By Ned Pagliarulo • April 22, 2021 -
Courtesy of Eli Lilly
Lilly to seek first approval of an autoimmune drug for hair loss
Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review.
By Kristin Jensen • April 21, 2021 -
The next 2 months in biotech and pharma will be busy. Here's what to watch.
New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • April 20, 2021 -
Jon Cherry via Getty Images
J&J to resume vaccine rollout in Europe after regulator says benefits outweigh risks
The EMA, however, recommended a warning be added to highlight a rare but serious side effect. Regulators in the U.S. are expected to soon make a similar decision.
By Ben Fidler , Jonathan Gardner • Updated April 20, 2021 -
Lisa Maree Williams via Getty Images
US clears AstraZeneca buyout of Alexion amid closer scrutiny of biopharma M&A
FTC authorization of the $39 billion deal — the sector's largest in 2020 — may ease concerns over the agency's plans to more intently inspect pharma deals.
By Jonathan Gardner • April 16, 2021 -
GSK stops studies testing closely watched cancer immunotherapy
The British pharma will halt enrollment in two studies testing feladilimab alongside Merck's Keytruda, dealing another blow to the company's cancer drug pipeline.
By Ned Pagliarulo • April 15, 2021 -
Erik S. Lesser via Getty Images
Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another
The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.
By Ben Fidler • April 15, 2021 -
Jon Cherry via Getty Images
CDC panel delays decision on J&J vaccine, extending pause over rare side effect
Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide whether vaccinations with J&J's shot should be resumed, and for whom.
By Jonathan Gardner • April 14, 2021 -
Phill Magakoe via Getty Images
The US paused use of J&J's vaccine. What happens next?
A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.
By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • April 13, 2021 -
Courtesy of Sanofi
Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy
Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired as part of a broader expansion in oncology.
By Ben Fidler • April 9, 2021 -
With new data, Merck could be first to bring immunotherapy to early kidney cancer
Keytruda has become the first drug of its kind to succeed in the so-called adjuvant setting in renal cell carcinoma, continuing an industry-wide push to establish immunotherapy in earlier lines of cancer care.
By Ben Fidler • April 8, 2021 -
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 -
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
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