se

FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




se

Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

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.




se

First French case of COVID-19 occurred in December, a month earlier than previously thought

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.




se

Roche’s COVID-19 antibody test approved for emergency use in the US

Ramps up capacity for testing across the country




se

US clears emergency use of Gilead’s remdesivir

Move comes after drug showed preliminary efficacy in clinical trial in late April




se

Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo

Drug has shown “clinically meaningful responses” for basal cell carcinoma




se

Novo Nordisk trumpets NASH data with semaglutide

Results could unlock another big market for the company’s star drug




se

Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets

Click to view a price quote on LCI.




se

Rick Simpson Oil (RSO): Benefits, Effects and Research

Click to view a price quote on TLRY.




se

AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients

AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.




se

Key nose cells identified as likely COVID-19 virus entry points

Two specific cell types in the nose have been identified as likely initial infection points for COVID-19 coronavirus. Scientists discovered that goblet and ciliated cells in the nose have high levels of the entry proteins that the COVID-19 virus uses to get into our cells. The identification of these cells by researchers from the




se

Loss of smell associated with milder clinical course in COVID-19

Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published findings that olfactory impairment suggests the resulting COVID-19 disease is more likely to be mild to moderate, a potential early indicator that could help health care providers determine which patients may require hospitalization.




se

Researchers identify four possible treatments for COVID-19

While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments.




se

Supercomputer simulations present potential active substances against coronavirus

Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world,




se

Positive Phase III data for Lupin’s trichomoniasis candidate

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



  • Antibiotics and Infectious diseases/Drug Trial/India/Lupin/Pharmaceutical/Research/Solosec/Symbiomix Therapeutics/Women's health

se

EU-led coronavirus fundraiser targets initial 7.5 billion euros

A pledging conference led by the European Union (EU) has set an initial target of 7.5 billion euros ($8.1…



  • Anti-virals/Antibiotics and Infectious diseases/Coronavirus/EIB Group/Europe/Focus On/Government Affairs/Health Medical Pharma/Pharmaceutical/Public health

se

China and COVID-19 offer test case for blockchain

The COVID-19 pandemic did not stop China from launching its national blockchain-based service network…



  • China/Coronavirus/Digital Pharma/Focus On/GlobalData/Pharmaceutical

se

Ferring in sight of finish line with first microbiome-based drug

Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland

se

BRIEF—Merck invests in AI chip start-up SynSense

Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly…



  • China/Companies
  • mergers and acquisitions/Digital Pharma/Germany/Merck KGaA/Pharmaceutical/Switzerland/SynSense

se

Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar

Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…



  • Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane

se

Bausch Health and partners settle Xifaxan IP litigation

Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and…



  • Alfasigma/Bausch Health Companies Inc./Canada/Deals/Legal/Licensing/Nephrology and Hepatology/Patents & Trademarks/Pharmaceutical/Salix Pharmaceuticals Ltd/Sandoz/Switzerland/USA/Xifaxan

se

Assessing the long-term impact of COVID-19 on clinical research

The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a…



  • Anti-virals/Cell and Gene Therapy/Coronavirus/CRA/Feature/Focus On/Global/In Depth/Pharmaceutical/Regulation/Research/Vaccines

se

Recordati 1st-qtr revenues rise 12% as income leaps more than 20%

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…



  • Financial/Italy/Pharmaceutical/Recordati/Signifor

se

jCyte out-licenses rare vision disorder treatment for $252 million

US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…



  • Biotechnology/Deals/Japan/jCell/jCyte Inc/Licensing/Ophthalmics/Rare diseases/Santen/USA/Vision disorder

se

Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

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.




se

Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.




se

Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.




se

Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials

German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.




se

GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.




se

FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.




se

Roche's Kadcyla wins NICE backing in early breast cancer use

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.




se

Gilead hit with Iranian cyberattack for role in COVID-19 response: report

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.




se

U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths

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.




se

Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.




se

China reports one new coronavirus case, 15 asymptomatic cases

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




se

FDA commissioner in self-quarantine after exposure to person with COVID-19

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.




se

Thailand reports four new coronavirus cases, one new death

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.




se

China to reform disease prevention system

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.




se

Singapore reports 753 new coronavirus cases, taking total to 22,460

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




se

Russia records more than 10,000 new coronavirus cases in past day

Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.




se

Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi

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.




se

Indonesia reports 533 new COVID-19 cases, biggest in a day

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.




se

Malaysia reports 54 new coronavirus cases and one new death

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




se

Slovakia records no new coronavirus cases for first time since March 10

Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed.




se

Portugal's low-income households struggle to survive pandemic

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.




se

Half of Spaniards will see lockdown eased from Monday as death toll falls

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.




se

FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.




se

Puerto Rico Senator Jorge De Castro Font Pleads Guilty to Honest Services Wire Fraud and Conspiracy to Commit Extortion

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.



  • OPA Press Releases

se

Twentieth Member of Casino-cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.



  • OPA Press Releases

se

Foreign National Sentenced to Five Years in Prison for Smuggling East Africans to the United States

A Ghanian man was sentenced today in the District of Columbia for his role in smuggling East Africans into the United States. Mohammed Kamel Ibrahim, a/k/a Hakim, 27, a native of Ghana and naturalized citizen of Mexico, was sentenced to five years in prison by U.S. District Judge Ricardo M. Urbina after pleading guilty to one count of conspiracy and three counts of bringing aliens to the United States for profit.



  • OPA Press Releases