Pharma: Page 57
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Erik S. Lesser via Getty Images
Merck, with new breast cancer data, aims to rebound from FDA rejection
Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.
By Ben Fidler • May 13, 2021 -
Permission granted by Biogen
Biogen licenses a stroke drug from Japanese drugmaker TMS
The drug, which Biogen had an option to license, is one of two in the biotech's pipeline for a condition that has had few new treatments developed.
By Kristin Jensen • May 12, 2021 -
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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 -
Amgen asks FDA for approval of key asthma drug
Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.
By Ned Pagliarulo • May 10, 2021 -
Courtesy of BioNTech
Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
By Jonathan Gardner • May 7, 2021 -
Sarah Silbiger via Getty Images
Pharma erupts as Biden administration backs waiver of vaccine patent rights
The major shift in policy did not result in concrete action from the U.S., however, sparking ongoing criticism of unequal vaccine access.
By Jonathan Gardner , Ned Pagliarulo • May 6, 2021 -
Sean Gallup via Getty Images
Pfizer forecasts $26B in coronavirus vaccine revenue this year
The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.
By Ned Pagliarulo • May 4, 2021 -
Sarah Silbiger via Getty Images
FDA faces tough choice after panel backs speedy cancer drug approvals
The April meeting followed several immunotherapy withdrawals and led to multiple others, part of a push by the agency to review "dangling accelerated approvals."
By Ben Fidler , Ned Pagliarulo • April 30, 2021 -
Sean Gallup via Getty Images
Denying problems, AstraZeneca says US coronavirus vaccine filing due within weeks
Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.
By Jonathan Gardner • April 30, 2021 -
Merck, GSK vaccine sales hit by pandemic as competitors' business booms
Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots.
By Ned Pagliarulo • April 29, 2021 -
Jeenah Moon via Getty Images
Pfizer buys infectious disease biotech Amplyx
The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund.
By Kristin Jensen • April 28, 2021 -
Courtesy of Eli Lilly
Lilly, citing FDA feedback, won't seek speedy approval of Alzheimer's drug
The drugmaker confirmed it won't try for accelerated approval of a closely watched Alzheimer's medicine based on a single Phase 2 trial. But it's planning a lengthy new study in presymptomatic patients.
By Jonathan Gardner • April 27, 2021 -
Justin Sullivan via Getty Images
Gilead, Merck to help India access COVID-19 drugs as country's crisis deepens
Gilead will donate at least 450,000 vials of Veklury, while Merck licensed its experimental antiviral molnupiravir to five generic drugmakers in India.
By Ned Pagliarulo • April 27, 2021 -
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 -
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 -
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
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