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Pfizer reports success in trial of all-in-one meningitis vaccine
The company is planning an FDA submission as it works to expand its vaccine business beyond top-selling shots for COVID-19 and pneumonia.
By Jonathan Gardner • Sept. 15, 2022 -
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Pfizer brings mRNA flu vaccine into Phase 3 testing
The trial, expected to enroll 25,000 adults, is the second late-stage test of an mRNA flu shot to begin this year, following the June start of a Moderna study.
By Delilah Alvarado • Sept. 14, 2022 -
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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 -
Novartis funnels $300M into early biologic drug manufacturing
The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline.
By Christopher Newman • Sept. 12, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Amgen data supports KRAS cancer drug, but survival benefit remains in question
Results from the company’s Phase 3 study show Lumakras outperformed chemotherapy. But that effect didn’t translate into patients living longer.
By Ned Pagliarulo • Sept. 12, 2022 -
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Sept. 12, 2022 -
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Bristol Myers gets FDA approval for new type of psoriasis drug
Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.
By Jonathan Gardner • Updated Sept. 12, 2022 -
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Moderna says US COVID-19 vaccine market could be worth $13B a year
The high end of the company’s estimates assumes a $100 price per dose and that half of all U.S. adults will receive a yearly booster.
By Christopher Newman • Sept. 9, 2022 -
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Deep DiveCan biosimilars, after years of limited impact, finally make a mark in the US?
Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.
By Jonathan Gardner • Sept. 7, 2022 -
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CDC backs updated COVID shots from Pfizer, Moderna
One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.
By Delilah Alvarado • Sept. 2, 2022 -
Courtesy of Novartis
Novartis’ Bradner steps down as research head amid company shake-up
Jay Bradner, a well-known physician scientist who pushed to make Novartis more accessible to biotech startups, will be replaced by Merck executive Fiona Marshall in November.
By Ben Fidler • Sept. 1, 2022 -
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FDA clears updated COVID-19 boosters from Pfizer, Moderna
The new shots, which are designed to better target circulating strains of omicron, could be available within days.
By Delilah Alvarado • Aug. 31, 2022 -
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Pfizer lures first chief marketing officer from Verily
Drew Panayiotou led marketing efforts at Alphabet’s life sciences arm Verily, and his appointment is Pfizer’s third senior-level hire this year.
By Christopher Newman • Aug. 31, 2022 -
AstraZeneca, matching Lilly, reports positive heart failure data for diabetes pill
The new data position AstraZeneca to significantly expand use of Farxiga in heart failure and compete with Lilly and Boehringer Ingelheim’s rival drug Jardiance.
By Jonathan Gardner • Aug. 29, 2022 -
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Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology
The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.
By Jonathan Gardner • Aug. 26, 2022 -
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Pfizer follows GSK with positive Phase 3 results for RSV vaccine
In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.
By Delilah Alvarado • Aug. 25, 2022 -
Novartis begins plans to spin off generic drug business
After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.
By Jonathan Gardner • Aug. 25, 2022 -
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Safety worries spur Novartis to suspend drug dosing in Huntington’s trial
Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.
By Jonathan Gardner • Aug. 24, 2022 -
Permission granted by Gilead Sciences
Gilead breaks through with first approval for new HIV drug
European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.
By Jonathan Gardner • Aug. 22, 2022 -
Courtesy of Sanofi
Sanofi ends development of breast cancer drug in another blow to pipeline
The French drugmaker’s shares fell by more than 6% after the once promising treatment, called amcenestrant, failed its second major trial this year.
By Kristin Jensen • Aug. 17, 2022 -
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UK approves Moderna’s two-pronged COVID-19 booster
Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus.
By Jonathan Gardner • Aug. 15, 2022 -
Novartis bid to repurpose rare disease drug for cancer falls short in third trial
A study testing Novartis’ canakinumab as an adjuvant lung cancer treatment missed its main goal, closing off an opportunity for an expanded approval.
By Ned Pagliarulo • Aug. 15, 2022 -
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Aug. 15, 2022 -
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Pfizer’s new pneumococcal vaccine meets study goal in children
Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.
By Delilah Alvarado • Aug. 12, 2022 -
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Amgen’s low tax rates draw attention of top Democratic senator
Ron Wyden, D-Ore., is probing how Amgen paid an average effective tax rate of 12% over the past four years, well below the U.S. statutory rate of 21%.
By Ned Pagliarulo • Aug. 12, 2022 -
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GSK, Pfizer, Sanofi shares drop amid Zantac litigation concerns
The companies could face liability related to their sales of the heartburn drug, which was withdrawn from the market in the U.S. and other countries after impurities related to a likely carcinogen were detected.
By Ned Pagliarulo • Updated Aug. 11, 2022
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