Pharma

Novartis pays $150M for access to UCB's Parkinson's drug

UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.

By Jonathan Gardner • Dec. 2, 2021

FDA panel, after debate, narrowly backs Merck COVID pill

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.

By Jonathan Gardner • Updated Nov. 30, 2021

Explore the Trendline➔

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

GSK hires away top Pfizer vaccine scientist

Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.

By Ned Pagliarulo • Nov. 30, 2021

Vaccine makers move quickly to confront omicron threat

Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

By Ned Pagliarulo • Nov. 29, 2021

New Merck study results raise questions about its COVID pill

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.

By Ben Fidler • Nov. 26, 2021

Takeda wins US approval for new CMV treatment

The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.

By Kristin Jensen • Nov. 24, 2021

AstraZeneca, after years of delays, opens UK hub meant to recharge drug research

Formally unveiled five years after originally planned, the $1 billion headquarters will become the British drugmaker's second-largest R&D center by headcount.

By Jonathan Gardner • Nov. 23, 2021

Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

By Ben Fidler • Nov. 22, 2021

Nanomilling: an optimal solution for poorly soluble, challenging APIs

A versatile technique to ensure your drug is ready on time for your first-in-human clinical trial.

Nov. 22, 2021

A worrisome safety signal slows Merck's HIV ambitions

After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.

By Jacob Bell • Nov. 19, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Soon after the FDA's authorization, a panel of CDC advisers followed with similar recommendations for third doses in adults over 18 years old. 

By Ben Fidler • Updated Nov. 20, 2021

Gilead pays up to retain rights to Arcus cancer drugs

The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.

By Jonathan Gardner • Nov. 18, 2021

FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer

Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.

By Ben Fidler , Ned Pagliarulo • Nov. 18, 2021

Roche cuts ties with Atea after COVID-19 pill's trial failure

The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.

By Kristin Jensen • Nov. 17, 2021

Pfizer asks FDA to authorize COVID-19 pill

Study results released this month showed the pill, when given soon after symptoms start, sharply reduced the risk of COVID-19 hospitalization or death.

By Ned Pagliarulo • Nov. 16, 2021

As Congress weighs drug price restraints, ICER calls out 'unsupported' increases

In a new report, ICER highlighted AbbVie's price hikes on Humira, which the group said resulted in more than $1 billion in U.S. spending last year without any new evidence of health benefits.

By Jonathan Gardner • Nov. 16, 2021

Pfizer will allow generic drugmakers to produce promising COVID-19 pill

A licensing deal with a U.N.-backed patent group could expand supply of Pfizer's experimental drug Paxlovid in lower- and middle-income countries.

By Ned Pagliarulo • Nov. 16, 2021

Establishing an integrated evidence plan for medical affairs and beyond

Over the life of a biopharmaceutical product, there are many situations when data from randomized controlled trials (RCTs) may not be sufficient to address stakeholder questions of value, safety and effectiveness.

Nov. 15, 2021

J&J, world's largest drugmaker, plans to split in two

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand. 

By Ben Fidler , Ned Pagliarulo • Updated Nov. 12, 2021

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19. 

By Jonathan Gardner • Nov. 9, 2021

US pays $1B to nearly double supply of Merck's COVID-19 pill

The new agreement raises the financial upside of molnupiravir, which Merck believes could be a $7 billion product in 2022. But Pfizer's rival drug, which is seemingly more effective, could affect those projections.

By Ben Fidler • Nov. 9, 2021

IQVIA Omnichannel Navigator: A platform for informing smarter marketing decisions

This year, the pharmaceutical industry will spend more on its promotional activities than any year before. It’s estimated that the total U.S. promotional spend for 2021 will be around $30 billion.

By Kathryn Grimshaw • Nov. 8, 2021

How to support successful audits and inspections

Set yourself up for successful audits and inspections with the Connected Workplace.

Nov. 8, 2021

Pfizer pill for COVID-19 shows dramatic benefit in major study finding

The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.

By Jonathan Gardner • Nov. 5, 2021

Merck wins UK authorization to sell first COVID-19 pill

Molnupiravir, as the drug is known, is also under review by the FDA and other regulators. Merck expects billions in sales as countries seek to stockpile the oral treatment.

By Kristin Jensen • Nov. 4, 2021