Pharma: Page
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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 -
Sponsored by Scipher
In 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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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 -
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 -
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 -
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 -
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 -
Sponsored by ZS
Data 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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