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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 -
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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 -
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 -
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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 -
Christopher Furlong via Getty Images
AstraZeneca reports study success for rare disease drug acquired in Alexion deal
With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.
By Kristin Jensen • Aug. 26, 2021 -
Jeenah Moon via Getty Images
Pfizer taps McKinsey executive to lead dealmaking efforts
Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week.
By Ned Pagliarulo • Aug. 26, 2021 -
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J&J, without details, makes case for a coronavirus booster shot
A second shot given six months after the first appears to provide a bigger immune response, the company said, a finding J&J aims to take to regulators in the U.S. and elsewhere.
By Ben Fidler • Aug. 25, 2021 -
Jeenah Moon via Getty Images
Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium
The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year.
By Ned Pagliarulo • Aug. 23, 2021 -
Mario Tama via Getty Images
FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine
During a press briefing, FDA officials expressed optimism the decision could help boost vaccination rates, but warned against off-label use — particularly in children, for which clinical tests are currently underway.
By Jonathan Gardner • Updated Aug. 23, 2021 -
Mario Tama via Getty Images
J&J chief Alex Gorsky to step down early next year
Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.
By Jacob Bell • Aug. 20, 2021 -
Courtesy of Eli Lilly
FDA approves Lilly, Boehringer diabetes drug for heart failure
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.
By Kristin Jensen • Aug. 19, 2021 -
GSK, in race to catch up with rivals, wins expanded approval for cancer drug
The pharma's immunotherapy Jemperli can now be used for a wider array of cancers that are "mismatch repair-deficient," matching an indication held by Merck's top-seller Keytruda.
By Kristin Jensen • Aug. 18, 2021
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