Pharma: Page 54
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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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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 -
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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 -
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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 -
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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 -
Courtesy of Eli Lilly
Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure
Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.
By Jonathan Gardner • Aug. 17, 2021 -
Shaun Anders
Sponsored by ScipherIn RA, new molecular signature test confirms who won't respond to anti-TNF therapy during any point in therapeutic journey
A new study demonstrates that PrismRA can predict the likelihood of not achieving a clinically meaningful response of at least a 50% improvement in symptoms in targeted therapy-naïve patients.
Aug. 16, 2021 -
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CDC advisers back third dose of Pfizer, Moderna vaccines for immunocompromised people
The advisory panel's vote followed the FDA's authorization last Thursday of an additional dose for people with weakened immune systems.
By Shoshana Dubnow • Aug. 13, 2021 -
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Biden embraces Medicare drug price negotiation as Democrats seek to widen health coverage
In a speech Thursday afternoon outlining his proposal, which features several familiar policy ideas, Biden emphasized price negotiation, but allowing for drugmaker profit.
By Jonathan Gardner • Updated Aug. 12, 2021 -
Merck wins approval for Keytruda combo as kidney cancer treatment
Clinical testing showed a clear benefit to using Keytruda with Merck and Eisai's Lenvima in patients with previously untreated advanced renal cell carcinoma.
By Kristin Jensen • Aug. 12, 2021 -
Maddie Meyer via Getty Images
Eyeing future outbreaks, Moderna partners with Canadian government on vaccine plant
While Canada has already secured more COVID-19 vaccine doses than it needs, the factory to be built is geared toward combating future pandemics.
By Jonathan Gardner • Aug. 10, 2021 -
Roche sets bar in early lymphoma treatment with Polivy study results
Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.
By Jonathan Gardner • Aug. 9, 2021 -
How Bayer lured a biotech away from an IPO and into a buyout
Vividion Therapeutics was headed toward an IPO earlier this year, but the company's co-founder said Bayer’s $1.5 billion offer ended up being a more attractive option.
By Shoshana Dubnow • Aug. 5, 2021 -
Amgen, expecting higher demand for its medicines, to build plant in North Carolina
The biotech is also constructing a new factory in Ohio and, between the two, expects to investment nearly $1 billion over the next few years.
By Kristin Jensen • Aug. 4, 2021 -
FDA allows Novartis gene therapy trials to resume after nearly 2 year pause
After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.
By Jonathan Gardner • Aug. 3, 2021 -
Christopher Furlong via Getty Images
AstraZeneca wins first FDA approval for systemic lupus drug in a decade
The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.
By Jonathan Gardner • Aug. 2, 2021 -
Permission granted by ZS
Sponsored by ZSData is becoming the healthcare ecosystem entry fee
Biopharmaceutical companies have an opportunity to work alongside new healthcare ecosystem entrants for mutual benefit and better customer value.
By Pratap Khedkar and Howard Deutsch • Aug. 2, 2021 -
Jeenah Moon via Getty Images
Pfizer's fast progress shines spotlight on an emerging vaccine race
The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.
By Jonathan Gardner • July 30, 2021 -
Permission granted by Albert Haught
A pharma merger's impact ripples across West Virginia as Viatris plant closes
One of the country's oldest and largest drug manufacturing plants shut down Saturday, a consequence of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come.
By Shoshana Dubnow • July 30, 2021 -
AstraZeneca still eyes US vaccine filing despite another delay
The company now expects to file for full approval by year's end and has a variant-specific shot in advanced testing. But the long-term prospects for AstraZeneca's new vaccine business are unclear.
By Ben Fidler • July 29, 2021 -
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In a first, FDA approves an 'interchangeable' biosimilar for diabetes
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.
By Jonathan Gardner • July 29, 2021 -
Drew Angerer via Getty Images
Pfizer, responding to criticism, presses case for COVID-19 booster shots
During an earnings call Wednesday, a preprint paper was released showing a waning effect for the company's vaccine over time, one of a few data points Pfizer executives used to support the need for a booster shot.
By Ben Fidler • Updated July 29, 2021
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