Pharma: Page 46
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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 -
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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 -
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 -
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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 -
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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 -
Sarah Silbiger via Getty Images
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 -
Elizabeth Regan/BioPharma Dive
An AstraZeneca spinout scores a buyout option from Arena
The potential acquisition marks a fast turnaround for Aristea, one of several biotechs formed from programs AstraZeneca decided not to advance internally.
By Jonathan Gardner • July 27, 2021 -
Justin Sullivan via Getty Images
Regeneron, AstraZeneca team up on targeted drugs for obesity
After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. AstraZeneca aims to help the biotech make a drug based on its findings.
By Jonathan Gardner • July 27, 2021 -
Merck rebounds to win a milestone immunotherapy approval in early breast cancer
The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease.
By Ben Fidler • July 27, 2021 -
Sean Gallup via Getty Images
BioNTech, WHO hatch plan to bring mRNA vaccines to Africa
Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent.
By Jonathan Gardner • July 26, 2021 -
John Moore via Getty Images
Drug distributors, J&J agree to pay $26B in major opioid settlement with states
The long-negotiated deal could resolve the vast majority of lawsuits against the companies for their alleged role in contributing to the opioid epidemic.
By Kristin Jensen • July 22, 2021 -
Mario Tama via Getty Images
Pfizer, BioNTech ink vaccine supply deal for Africa in step toward addressing criticism
The companies aim to deliver 100 million doses per year to 55 African countries in an effort to shrink the wide gap between high- and lower-income countries in coronavirus vaccinations.
By Jonathan Gardner • July 21, 2021 -
Jon Cherry via Getty Images
J&J predicts faster coronavirus vaccine sales amid debate over boosters
The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.
By Ned Pagliarulo • July 21, 2021 -
Erik S. Lesser via Getty Images
Merck to take on Pfizer with FDA OK of next-gen pneumonia vaccine
Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.
By Jonathan Gardner • July 19, 2021 -
FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
Merck details an immunotherapy 'milestone' in early breast cancer
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
By Ben Fidler • July 15, 2021 -
Christopher Furlong via Getty Images
AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition
The go-ahead from British regulators was the last hurdle standing in the way of the two companies wrapping up their $39 billion deal announced last year.
By Kristin Jensen • July 14, 2021 -
Courtesy of Eli Lilly
Lilly wagers up to $1B on a biotech's plan for a new type of insulin
Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.
By Jonathan Gardner • July 14, 2021
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