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Remdesivir: five Australian hospitals to receive experimental coronavirus drug

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

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The promise of an Oxford vaccine reveals how a new Britain could thrive | Will Hutton

The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks


There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

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FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.




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‘Excess deaths’ in England among the highest in Europe

English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis.




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Italy to relax COVID-19 lockdown in early May

Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic.




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EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

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.




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Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.




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Men most likely to exhibit the worst COVID-19 symptoms, according to a new study

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.




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More than half of US states will relax lockdowns by the end of the week

Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns.




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AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine

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.



  • Research and Development
  • Manufacturing and Production

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Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.




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UK testing experimental treatment for use in COVID-19 patients

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.




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Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal

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.




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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.




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FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.




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AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine

AZ has pledged to make the vaccine at cost for the duration of the pandemic




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Oxford COVID-19 vaccine programme opens for clinical trial recruitment

University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still.




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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.




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AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.

The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford.




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Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine

Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today.

Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus.




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Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…



  • Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK

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ALK Abello outperforms expectations in strong 1st-qtr

Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner…



  • Acarizax/ALK Abello/Denmark/Financial/Immunologicals/Itulazax/Pharmaceutical

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Portola agrees to takeover bid from Alexion

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



  • Alexion Pharmaceuticals/AndexXa/Anticoagulants/Biotechnology/Cardio-vascular/Companies
  • mergers and acquisitions/Hematology/Ondexxya/Portola Pharmaceuticals/USA

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FDA approval for Farxiga in new indication in heart failure patients

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…



  • AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA

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Alexion exceeds earnings estimates but drops guidance

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…



  • Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA

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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

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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

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Dr Reddy's gets FDA nod for migraine drug Elyxyb

Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker…



  • Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA

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Teva soars as 1st-qtr beats expectations

Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,…



  • Ajovy/Analgesia/Austedo/Copaxone/Financial/Generics/Israel/Musculoskeletal/Rare diseases/Teva Pharmaceutical Industries/Treanda

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B-MS’ quarterly financials exceed estimates

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…



  • Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA

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Japan grants ‘exceptional’ approval for remdesivir in COVID-19

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

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Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 




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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.




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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.




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AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes

AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. 




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Amgen ramps up Otezla expansion effort with positive data in mild psoriasis

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.




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Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs

Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year.




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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.




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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.




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Factbox: Latest on the worldwide spread of the coronavirus

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.




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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

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LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments

Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry.



  • OPA Press Releases

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Former Oak Ridge Complex Employee Pleads Guilty to Unlawful Disclosure of Restricted Atomic Energy Data

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).



  • OPA Press Releases

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Defendant Pleads Guilty to Conspiring to Export Military Aircraft Parts to Iran

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. 



  • OPA Press Releases

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Former NFL Player, Ex-Casino Owner and Nevada Businessman Indicted in Massive Tax Fraud Scheme

A Las Vegas federal grand jury has returned an indictment charging Alan Rodrigues, a former pit boss and casino owner from Henderson, Nev.; Weston Coolidge, a businessman from Las Vegas; and Joseph Prokop, a former National Football League punter from Upland, Calif., with a tax fraud scheme for their promotion of a fraudulent tax product through the now defunct National Audit Defense Network (NADN).



  • OPA Press Releases

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Justice Department Sues Ypsilanti, Mich., Landlords for Sexual Harassment

The Department today filed suit against Ronald D. Peterson and Glen E. Johnson, the owner and rental manager, respectively, of 11 single family homes in Ypsilanti, Mich., alleging a pattern or practice of sexual harassment of female tenants.



  • OPA Press Releases

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Former Shipping Executive Sentenced to 48 Months in Jail for His Role in Antitrust Conspiracy

A former high-level shipping executive was sentenced today to serve 48 months in jail and to pay a $20,000 criminal fine for his role in an antitrust conspiracy involving the transportation of goods to and from the continental United States and Puerto Rico by ocean vessel. This is the longest jail sentence ever imposed for a single antitrust charge.



  • OPA Press Releases

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Former Mendenhall, Miss., Police Chief Pleads Guilty to Using Excessive Force

Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., pleaded guilty today to a felony civil rights violation, admitting that he used excessive force when he repeatedly stomped on the head of an arrestee.



  • OPA Press Releases

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Brothers Plead Guilty to Conspiring to Steal Military Optics from U.S. Marine Corps and Export Them Overseas

Timothy Oldani, 24, of Scott Depot, W.Va., and Joseph Oldani, 21, of Camp Lejeune, N.C., both pleaded guilty today in the Southern District of West Virginia to conspiring to steal military optics from the U.S. Marine Corps and illegally export them from the United States.



  • OPA Press Releases

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Federal Court Bars Maine Resident from Preparing Tax Returns for Others

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.



  • OPA Press Releases