On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...

Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients

Stock index up more than 3% in early trading on the back of hopes for remdesivir treatment

Optimism about a potential treatment for Covid-19 gave a shot in the arm to stock markets around the world, amid claims that a drug called remdesivir has spurred rapid recovery in 113 patients.

A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, found that nearly all patients suffering severe fever and respiratory symptoms were discharged within a week. A report of the study, issued by specialist healthcare publication Stat News shortly after Wall Street closed on Thursday night, spurred hopes among investors that lockdowns around the world could soon be eased.

Researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential treatment for COVID-19.

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.

The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus.

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

US Secretary of State Mike Pompeo claimed that there is evidence the COVID-19 coronavirus was created in a lab, despite US intelligence officials stating it probably occurred naturally.

President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from.

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.

A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons.

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.

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India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…

Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive…

Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has…

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…

A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,…

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.

The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.

China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January.

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.

One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday.

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.

A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme.

Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran.