Pharma

Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating. 

By Delilah Alvarado • Sept. 26, 2022

GSK names Julie Brown, former Burberry executive, its first female CFO

The U.K. drugmaker now also stands to become the first big pharmaceutical company to have women in its top two roles, with the transition planned for May 2023.

By Jonathan Gardner • Sept. 26, 2022

Explore the Trendline➔

The expanding world of RNA therapies

Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.

By BioPharma Dive staff

What biopharma companies can do to avoid a consumer communication crisis

Every challenge is also an opportunity. And these challenges offer biopharma companies an opportunity to improve communications in a way that also helps improve overall health.

Sept. 26, 2022

Health equity: the current environment and a path to improvement

Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.

Sept. 26, 2022

Novartis warns of sales hit after federal court turns back patent appeal

The Swiss company is evaluating “all available options” following the ruling, which could lead to the launch of copycat versions of its MS drug Gilenya.

By Kristin Jensen • Sept. 21, 2022

J&J opens new research hub near San Francisco

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

By Delilah Alvarado • Sept. 20, 2022

Optimizing pharmaceutical innovation

Elevate pharma product development and marketing through collaboration with physician experts

Sept. 19, 2022

Sanofi, AstraZeneca secure EMA support for RSV drug in babies

If authorized by the European Commission, the companies’ antibody medicine would become the first cleared for broad use in newborns and infants. 

By Jonathan Gardner • Sept. 16, 2022

AstraZeneca claims positive results for its “add-on” drug for rare blood disease

The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019.

By Delilah Alvarado • Sept. 16, 2022

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

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

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

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

Keeping track of changing payer formulary positioning and coverage

You need current, reliable data, but other factors are critical in assessing this information.

Sept. 12, 2022

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

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

Can 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

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

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

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

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

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

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