Pharma: Page 53
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US buying 500M more doses of Pfizer coronavirus vaccine for donation to world
Under pressure to help other countries access vaccines, Biden is doubling his administration's planned donation to 1 billion doses, although delivery will extend through September of next year.
By Ned Pagliarulo • Sept. 22, 2021 -
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Second dose of J&J's coronavirus vaccine increases protection, company says
Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.
By Shoshana Dubnow • Sept. 21, 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 -
Seagen, Genmab win speedy FDA approval for cervical cancer drug
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.
By Jonathan Gardner • Sept. 21, 2021 -
Novartis pushes further into gene therapy for the eye with deal for Swiss startup
The large drugmaker has acquired Arctos Medical and its preclinical research into optogenetics, an area Novartis already showed interest in with its buyout of Vedere Bio last year.
By Ned Pagliarulo • Updated Sept. 23, 2021 -
Antonio Masiello via Getty Images
Pfizer says coronavirus vaccine is safe and spurs immune response in children
The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
By Jonathan Gardner • Sept. 20, 2021 -
ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
By Ned Pagliarulo • Updated Sept. 21, 2021 -
Permission granted by Whiskey Junction
Sponsored by IQVIAWhy 'hidden' thought leaders and their networks can make (or break) your launch
Finding the right thought leaders is not as simple as searching for KOLs or identifying high-volume prescribers.
By John Eichert, Senior Principal, Thought Leader Network CoE; Jennifer Millard, Vice President, Field Medical Affairs Deployment Services; and Bruce West, Senior Principal, Thought Leader Network CoE • Sept. 20, 2021 -
Takeda wins FDA approval for targeted lung cancer drug
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.
By Kristin Jensen • Sept. 16, 2021 -
Permission granted by University of Maryland School of Medicine
New data from Israel, Pfizer show potent effect from third coronavirus shot
The much-anticipated data arrive ahead of an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.
By Jonathan Gardner • Sept. 15, 2021 -
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FDA staff tight-lipped on booster shot views ahead of consequential meeting
In a briefing document, agency reviewers did not appear to take a strong line either for or against the broad authorization of boosters for the general public.
By Shoshana Dubnow • Sept. 15, 2021 -
Permission granted by IQVIA
Sponsored by IQVIAOvercoming inertia: Adopting omnichannel marketing for pharma
Pharmaceutical companies are increasingly attracted to the idea of replacing the current multichannel marketing focus with an omnichannel marketing approach. But the industry is struggling to break out of its own silos.
By Andrew Burkus, Principal, Omnichannel Marketing, IQVIA • Sept. 13, 2021 -
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Biden pushes forward on Medicare price negotiation
But opposition from the drug industry and congressional Republicans could make the Democrats' signature proposal an uphill battle.
By Jonathan Gardner • Sept. 10, 2021 -
Courtesy of Sanofi
Sanofi drug for rare skin disease, acquired in buyout, fails in late-stage trial
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
By Jonathan Gardner • Sept. 9, 2021 -
Courtesy of Eli Lilly
Lilly joins RNA editing race with ProQR deal
An agreement with the Dutch biotech, which could be worth as much as $1.3 billion, expands Lilly's work in genetic medicine research.
By Kristin Jensen • Sept. 9, 2021 -
Roche bets big on off-the-shelf cancer cell therapy with Adaptimmune deal
Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion.
By Jonathan Gardner • Sept. 7, 2021 -
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Sponsored by Reed TechOver-the-counter drug product monographs: What you need to know
Register for our OTC-focused webinars to get a deeper look at five OTC drug monographs.
Sept. 7, 2021 -
Sean Gallup via Getty Images
Settling lawsuit, AstraZeneca and European Commission agree on coronavirus vaccine delivery
The U.K.-based drugmaker fell behind on its promise to supply 300 million doses by the end of June to countries in the trading bloc. Now, it's set to reach that target by March 2022.
By Jonathan Gardner • Sept. 3, 2021 -
Mario Tama via Getty Images
FDA panel to discuss boosters as Moderna seeks OK for additional shot
The advisory committee will meet Sept. 17 to weigh an additional dose of Pfizer's shot, just three days before the Biden administration aims to broadly roll out boosters to Americans.
By Shoshana Dubnow • Sept. 2, 2021 -
Jeenah Moon via Getty Images
Pfizer, marking fast research pace, starts key trial of RSV vaccine
The pharma company is in a tight race with rivals, including GSK, to become the first with an approved shot for the infectious disease.
By Kristin Jensen • Sept. 2, 2021 -
Novartis finalizes deal to make new heart drug widely available in England
An agreement between Novartis and England's national health system is an important commercial step for Leqvio, the cholesterol-lowering medicine the Swiss drugmaker acquired in its $10 billion buyout of The Medicines Co.
By Shoshana Dubnow • Sept. 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Pfizer, Merck launch large new trials of oral COVID-19 drugs
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
By Kristin Jensen • Sept. 1, 2021 -
Do, Thao; Subramaniam, Sriram. (2016). "HIV on Bridges Between Infected Immune Cell and Uninfected Brain Cell" [Image]. Retrieved from Flickr.
After coronavirus success, J&J hits setback with HIV vaccine
While the HIV shot is still in testing, its failure in a mid-stage study in young women may lead to yet another discontinuation of a promising project.
By Jonathan Gardner • Aug. 31, 2021 -
Courtesy of Eli Lilly
FDA restarts distribution of Lilly's COVID-19 drug in 22 states
Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly's therapy will be available again.
By Shoshana Dubnow • Aug. 30, 2021 -
Spencer Platt via Getty Images
Pfizer drug bests Sanofi, Regeneron's Dupixent in head-to-head study
Abrocitinib, a JAK inhibitor Pfizer's developing, outperformed Dupixent in treating moderate or severe eczema. Hanging over the study's success, however, is an ongoing review by the FDA of the drug's class.
By Ned Pagliarulo • Aug. 30, 2021 -
FDA scrutiny, Merck approval lead Roche to pull Tecentriq in breast cancer
While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication.
By Jonathan Gardner • Aug. 30, 2021
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