Pharma: Page 48
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Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy
Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.
By Ned Pagliarulo • June 3, 2021 -
David Paul Morris via Getty Images
Former FDA official Abernethy joins Google health spinoff
The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.
By Jonathan Gardner • June 3, 2021 -
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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 -
ICER, vocal critic of drug company pricing, turns scrutiny to insurers
The watchdog group plans to examine how cost sharing can hurt access to care, but it won't assess some of the most controversial insurer practices.
By Jonathan Gardner • May 25, 2021 -
Sarah Silbiger via Getty Images
J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies
Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.
By Jonathan Gardner • May 24, 2021 -
Courtesy of Eli Lilly
Coronavirus variants threaten to undermine another Lilly COVID-19 drug
One month after Lilly's first coronavirus antibody was pulled from market, the U.S. government stopped distributing its other treatment in two states.
By Ben Fidler • May 24, 2021 -
Sean Gallup via Getty Images
Pfizer, BioNTech to send EU up to 1.8B coronavirus vaccine doses
The deal, which the companies and the bloc have been negotiating for weeks, will significantly expand on the current contract for 600 million shots.
By Kristin Jensen • May 20, 2021 -
Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs
Study abstracts for drugs from Allogene, EQRx, Sanofi and Lilly drew early interest and helped set the stage for the meeting.
By Ben Fidler , Ned Pagliarulo • May 20, 2021 -
Permission granted by Bristol-Myers Squibb
Closely watched Bristol Myers immunotherapy shows benefit in melanoma
Study results prove, for the first time, that a drug blocking the protein LAG-3 can improve on another immunotherapy.
By Ned Pagliarulo • May 19, 2021 -
Win McNamee via Getty Images
Humira patents take center stage as House panel targets AbbVie pricing
CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said.
By Jonathan Gardner • May 18, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target
The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers.
By Ned Pagliarulo • May 18, 2021 -
Novartis challenge to Amgen's Enbrel patents ends at Supreme Court's door
The top court declined to hear Novartis' appeal of an earlier federal ruling in Amgen's favor, likely preventing biosimilar competition until 2029.
By Ned Pagliarulo • May 18, 2021 -
Kena Betancur via Getty Images
Deep DiveTrump tax law cut what US drugmakers owed. Now they fear an increase.
The 2017 law saved pharmaceutical companies billions of dollars, BioPharma Dive found. Executives are now fiercely opposing tax hikes proposed by President Biden, claiming they've since boosted domestic investment.
By Jonathan Gardner • May 17, 2021 -
Courtesy of Sanofi
Sanofi, GSK say revamped coronavirus vaccine is strong enough for final test
The two drugmakers, set back last December after an earlier version underperformed, reported positive results from a Phase 2 study.
By Ned Pagliarulo • Updated May 17, 2021 -
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 -
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
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