Pharma

Trump forges ahead with drug import plan, but impact in doubt

Under the proposed plan, states would be permitted to import lower-priced products from Canada and drugmakers from around the globe. But participation is uncertain, as is the plan's effect on drug prices.

By Jonathan Gardner • Sept. 25, 2020

J&J begins largest Phase 3 study of a coronavirus vaccine

The trial, which launched Wednesday in the U.S., South Africa and several South American countries, will enroll as many as 60,000 participants.

By Ned Pagliarulo • Sept. 23, 2020

Explore the Trendline➔

Trendline

Inside the global race for a coronavirus vaccine

Some 29 vaccine candidates are now in clinical studies. Early results from five leading efforts are encouraging, suggesting researchers are on the right track despite rapid acceleration of testing.

By BioPharma Dive staff

FDA sets back Novartis plans to expand use of SMA gene therapy

The agency has asked the company to run a new study of the Zolgensma formulation that it aims to bring to older patients with spinal muscular atrophy.

By Ben Fidler • Sept. 23, 2020

FDA decision on Bristol Myers cell therapy could come down to the wire

An FDA decision on Bristol Myers' myeloma treatment ide-cel could come four days before a key deadline related to the pharma's buyout of Celgene. 

By Jonathan Gardner • Sept. 22, 2020

With Eli Lilly data, another drug emerges to stop breast cancers from returning

The highly anticipated results could change how some patients with the most common form of breast cancer are treated — and drive up the costs of care. 

By Ben Fidler • Sept. 20, 2020

Arrowhead shares soar on liver disease data from four patients

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

By Jonathan Gardner • Sept. 16, 2020

Lilly offers first evidence that its antibody drug may help treat COVID-19

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear. 

By Ben Fidler • Sept. 16, 2020

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

By Jonathan Gardner • Sept. 15, 2020

AstraZeneca, Oxford vaccine study allowed to restart in UK

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

By Ben Fidler • Sept. 12, 2020

GSK inhaler locks down a coveted approval in asthma

The approval helps differentiate Trelegy Ellipta, a three-drug treatment for COPD and, now, asthma, in the crowded respiratory drug market.

By Jacob Bell • Sept. 10, 2020

Sanofi's hemophilia drug comes into focus as delays hit a key competitor

With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ. 

By Jacob Bell • Sept. 10, 2020

Sponsored by ZS

The voice of the customer, and how pharma can respond

ZS surveyed more than 500 physicians, 500 patients and 30 healthcare administrators to gather their current thoughts on care delivery, telemedicine and pharma's potential role during the COVID-19 pandemic.

By Yasasvi Popuri, Jay Lichtenstein & Ganesh Vedarajan • Sept. 10, 2020

Merck takes aim at Pfizer with pneumonia vaccine data

Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product. 

By Jonathan Gardner • Sept. 09, 2020

Deep Dive

How biotech and pharma companies pay their CEOs, and their workers

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees.

By Ned Pagliarulo • Sept. 09, 2020

Merck details cough drug data, raising questions about its potential

Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use. 

By Jonathan Gardner • Sept. 08, 2020

Coronavirus vaccine makers vow to wait for data before seeking approval

In an unusual letter, the heads of nine top vaccine developers pledged to "stand with science" and only move forward with approval applications if warranted by clinical results.

By Ben Fidler • Sept. 08, 2020

Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine

The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing. 

By Ben Fidler • Sept. 03, 2020

Sanofi ends research of arthritis drug as coronavirus treatment

Kevzara failed to shorten hospital stays among patients severely sick with COVID-19, study results showed, further dimming hopes that drugs similar to it could help combat the disease.

By Jonathan Gardner • Sept. 01, 2020

AstraZeneca, vowing it won't cut corners, begins large US study of coronavirus vaccine

Amid reports the U.S. might fast-track AstraZeneca and the University of Oxford's experimental shot, the company pledged to "follow the science."

By Ben Fidler • Sept. 01, 2020

Vir, GSK push coronavirus antibody drug straight into mid-stage tests

The two companies, chasing rival treatments from Eli Lilly, Regeneron and more, aim to produce their first study results by the end of the year.

By Jonathan Gardner • Aug. 31, 2020

CanSino said to seek early authorization of coronavirus vaccine

The reported talks between CanSino and several countries highlight the urgency with which governments are operating to secure supply of experimental coronavirus vaccines.

By Jonathan Gardner • Aug. 28, 2020

Moderna's vaccine may have an edge when immunization programs roll out

A rival shot from Pfizer and BioNTech needs to be stored at colder temperatures and doesn't last as long in a refrigerator, which may limit its use.

By Jonathan Gardner • Aug. 26, 2020

Moderna says its coronavirus vaccine sparks immune response in older people

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

By Jonathan Gardner • Aug. 26, 2020

AstraZeneca's coronavirus antibody drug cocktail begins human tests as rivals slip

The British pharma has started a Phase 1 trial amidst reports that competing programs from Regeneron and Eli Lilly haven't met their projected timelines.

By Ben Fidler • Aug. 25, 2020

Novartis set to take on Roche as FDA clears first at-home, injectable MS drug

Kesimpta, a new multiple sclerosis drug from Novartis, works the same way as Roche's blockbuster Ocrevus, but patients can take it without leaving home.

By Ben Fidler • Aug. 20, 2020