Pharma

Lilly antibody drug doesn't help hospitalized COVID-19 patients in NIH study

The results could raise doubts about the ability of synthetic antibody drugs to help patients already very sick with COVID-19.

By Ben Fidler • UPDATED: Oct. 27, 2020 at 11:45 a.m.

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Regulatory-driven material control with SAP

Learn about material segmentation, a unique approach for characteristics-based planning and execution.

By Stephen Cloughley, Senior Director, SAP Life Sciences IBU • Oct. 26, 2020

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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

Purdue, reaching $8B settlement with US, pleads guilty to charges over opioid sales

Under a deal reached with the Department of Justice, Purdue faces fines and a forfeiture worth more than $5 billion — the largest penalties ever for a drug company.

By Jacob Bell • Oct. 21, 2020

Sponsored by ZS

Patients and physicians brace for flu season amid COVID-19

ZS surveyed more than 500 patients and 500 physicians to gather their perspectives on COVID-19's potential impact on flu vaccination rates.

J&J halts studies of coronavirus vaccine due to participant's illness

The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review. 

By Ned Pagliarulo • UPDATED: Oct. 13, 2020 at 11:15 a.m.

Mallinckrodt, beset by opioid drug suits, files for bankruptcy

The drugmaker aims to resolve billions of dollars in opioid-related claims and a federal lawsuit over Medicaid rebates, liabilities it says would be "otherwise unmanageable."

By Ned Pagliarulo • Oct. 12, 2020

Pfizer stumbles again in early breast cancer study, clearing path for Eli Lilly

The latest setback for Pfizer's top-selling Ibrance leaves Lilly's Verzenio, for now, as the only drug in its class to be proven to stave off breast cancer recurrence after surgery.

By Ben Fidler • Oct. 09, 2020

Merck research chief Roger Perlmutter to retire, leaving immunotherapy legacy

Under his leadership, Merck developed a once overlooked cancer drug into Keytruda, now a top-selling medicine and foundational treatment for more than a dozen types of tumors. 

By Ned Pagliarulo • Oct. 02, 2020

AstraZeneca restarts another coronavirus vaccine trial, but US delay lingers

The company is now cleared to resume testing of its experimental shot in multiple countries, but a Phase 3 trial in the U.S. remains halted as an FDA investigation reportedly widens.

By Ben Fidler • Oct. 02, 2020

Pfizer pushes deeper into China with stake in cancer biotech

The $200 million investment in CStone Pharmaceuticals puts Pfizer in charge of selling a cancer immunotherapy in the world's second largest drug market.

By Jacob Bell • Sept. 30, 2020

Ironwood lays off one-third of staff after heartburn drug falls short in study

The company will halt further work on its only fully owned drug and focus instead on expanding sales of its marketed product Linzess.

By Jonathan Gardner • UPDATED: Sept. 29, 2020 at 2:25 p.m.

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

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