10 types of cyberattacks to know and avoid

 Hospitals are increasingly becoming victims of cyberattacks as the workforce sees major changes amid the pandemic. 

Here are 10 cyberattack terms to know and watch out for to avoid data breaches:

1. Business email compromise (BEC): Cybercriminals send an email pretending to be a well-known source like a manager or vendor, according to the FBI. They often ask victims to purchase gift cards and send them the numbers on the card or change the direct deposit routing number to a new account.

2. Password spray attack: Adversaries acquire a large list of accounts and try many common passwords until they get a hit, according to Microsoft.

3. Brute force attack: Cybercriminals conduct research to go after one user, stalking social media and personal information, according to Microsoft. They try variants of this information until they are able to guess the password.

4. Pharming: Users can correctly type in a web address, according to AARP, but will be routed to an identical website with the goal of gathering personal information.

5. Keystroke logger: A keystroke logger is a program that tracks sequences in keys touched on a keyboard to capture passwords, according to AARP.

6. Trojans: Trojans are harmful software that comes attached to useful programs and hides in those programs, according to AARP. This software forms a backdoor for cybercriminals but they don't self-replicate like other viruses.

7. Malware: Malware short for malicious software, according to the FBI. It describes software intended to damage a computer system through malicious code to perform unauthorized functions to compromise operations in a system.

8. Ransomware: Ransomware is a type of malware that limits or prevents a user's access to their system until a ransom or fee is paid, according to AARP.

9. Phishing: Phishing when cybercriminals send large numbers of authentic-looking emails — like a bank or government agency — to trick users into sending personal information, according to AARP.

10. Spear phishing: This tactic is similar to phishing, but hackers target an individual user to get information using authentic-looking emails, according to the FBI.

https://www.beckershospitalreview.com/cybersecurity/10-types-of-cyberattacks-to-know-and-avoid.html

Adcom pours fresh doubts on roxadustat’s US approvability

 “Our relationship with Fibrogen is fine,” Astrazeneca’s head of biopharmaceuticals R&D, Mene Pangalos, told Evaluate Vantage a month ago. Whether this holds true today, after yet another US setback to the companies’ chronic kidney disease project roxadustat, is anybody’s guess.

The groups’ relationship was thought to have come under pressure over Fibrogen’s handling of roxa’s US filing, a decision on which was delayed in December by a request for more analyses. Surprising news that roxa will now face a US advisory panel, revealed last night, suggests that fears over the project’s lack of safety will not easily be allayed.

Those fears had been rumbling for some time. Back in 2019 a huge analysis of roxa’s seven phase III trials was meant to dismiss the risk of serious cardiovascular events, but instead was notable for what was left out; then last year cardiac toxicity hit Akebia’s similarly acting vadadustat, raising the possibility of a class effect (Disaster strikes for Akebia, September 4, 2020).

Though the sellside rallied to Fibrogen’s defence overnight, the risk to roxadustat is real, and this morning the company’s stock opened down 28%. An ominous sign, as regards cardiac toxicity, is that the panel meeting will comprise the agency’s cardiovascular and renal drugs advisory committee.

Why?

There is no explanation for why a last-minute decision has been made to convene an adcom, whose date has yet to be set.

Perhaps the December request for more data had raised fresh issues for the FDA, or the recent experience of Akebia with vadadustat had made it especially wary. Or maybe the agency has just decided that there is sufficient doubt around this drug class that it must have the security of expert advice before deciding on approvability.

After December’s delay the FDA had set March 20 as its action date for roxa’s filing, and clearly this will now be missed. The drug, an oral HIF-PH inhibitor designed to stimulate endogenous erythropoietin production, is already sold as Evrenzo in Japan and China.

It was intended to be safer than standard-of-care injected erythropoiesis-stimulating agents (ESAs). It is now abundantly clear that this idea is on shaky ground.

Black box

Assuming that roxa is approvable, the big worry remains the precise content of a US black box warning that many analysts assume is unavoidable. The adcom therefore raises the risk that the warning will include cardiovascular toxicity, something that would likely hit roxa sales in both key target populations.

Dialysis-dependent patients are typically on ESAs, which carry cardiovascular warnings, and there would be little reason to prescribe a more expensive drug like roxa if it carried similar toxicity. Meanwhile, most dialysis-independent patients are not on ESAs because of toxicity risk, so roxa would need a clean cardiovascular profile to break into this population.

At least an adcom will put to bed concerns over Fibrogen’s opaque data disclosure, since the publication of briefing documents will reveal all. Though the markets had slammed the company for this opaqueness Astra refused publicly to condemn its partner’s interaction with the FDA, Mr Pangalos insisting last month: “They’ve handled it well.”

Even a best-case scenario will now not see roxa approved in the US until late this year, and according to EvaluatePharma consensus $2.4bn of global 2026 roxa sales is at stake. Sellside firefighting notwithstanding, the markets are right to be cautious.

https://www.evaluate.com/vantage/articles/news/policy-and-regulation/adcom-pours-fresh-doubts-roxadustats-us-approvability

Medicare changes imperil Hillrom-Bardy deal

 When Hillrom arranged to buy Bardy Diagnostics for $375m up front in January it believed that Bardy’s extended cardiac-monitoring technology would be reimbursed by Medicare in the range of $250. 10 days after the deal was announced, however, the Medicare contractor Novitas cut the reimbursement rate for the four codes covering Bardy’s devices to $40-80. Having taken some time to evaluate the likely consequences of this, Hillrom yesterday concluded that it constituted a material adverse effect; it is not clear whether Hillrom intends to renegotiate terms or call the deal off completely, but Bardy has filed a complaint in Delaware’s Chancery Court so it seems that litigation will be part of the puzzle. Cardiac monitoring has recently been a hot area for deal making, with Philips buying Biotelemetry for $2.8bn in December and Boston Scientific acquiring Preventice for $925m a month later. Biotelemetry and Preventice offer similar heart monitors, and Evaluate Vantage understands that they too will be affected by this pricing change, though to a lesser extent thanks to their more diverse product ranges. The Hillrom-Bardy deal is the eighth-largest medtech acquisition announced so far in 2021.

Top 10 medtech M&A announced in 2021
Date	Acquirer	Target	Value ($m)	Focus
Jan 12	Steris	Cantel Medical	4,600	Sterilisation
Jan 21	Boston Scientific	Preventice Solutions	1,225	Cardiology - remote heart monitoring
Jan 4	Dentsply Sirona	Byte	1,040	Dental - clear aligners
Jan 19	Philips	Capsule Technologies	635	Healthcare IT
Feb 2	Veracyte	Decipher Biosciences	600	In vitro diagnostics - cancer
Jan 7	Perkinelmer	Oxford Immunotec	591	In vitro diagnostics - infection
Jan 19	Thermo Fisher Scientific	Mesa Biotech	550	In vitro diagnostics - infection
Jan 20	Haemonetics	Cardiva Medical	510	Cardiology - vascular closure
Jan 15	Hillrom	Bardy Diagnostics	375	Cardiology - remote heart monitoring
Source: EvaluateMedTech. https://www.evaluate.com/vantage/articles/news/snippets/medicare-changes-imperil-hillrom-bardy-deal

BARDA to Fund Merck to Expand Manufacturing Capacity for COVID Vax, Meds

  Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), will provide Merck with funding of up to $268.8 million to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2/COVID-19 vaccines and medicines. Merck has also entered into agreements with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the United States to produce drug substance, formulate and fill vials of Johnson & Johnson’s vaccine.

“We are steadfast in our commitment to contribute to the global response to the pandemic as part of the remarkable efforts of the entire medical and scientific community,” said Mike Nally, executive vice president, Human Health at Merck. “This funding from BARDA will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much needed medicines and vaccines for the pandemic.”

Under the terms of the BARDA agreement, Merck will adapt and make available some of the company’s existing manufacturing sites to accelerate manufacturing efforts for SARS-CoV-2/COVID-19 vaccines and medicines. This funding is in addition to Merck’s continued investment in its global vaccines manufacturing network as part of its planned capital investments of more than $20 billion from 2020 through the end of 2024.

“At Merck, we have a rich legacy in vaccine manufacturing and look forward to combining our expertise with Johnson & Johnson to help increase supply and expand access to authorized SARS-CoV-2/COVID-19 vaccines,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division.

Merck continues to be actively involved in discussions with governments, public health agencies, and other industry colleagues to identify additional areas of pandemic response where Merck can make a meaningful impact.

https://www.merck.com/news/merck-to-help-produce-johnson-barda-to-provide-merck-with-funding-to-expand-mercks-manufacturing-capacity-for-covid-19-vaccines-and-medicines/

AstraZeneca's Covid-19 Vaccine Piles Up in Europe Amid Government Curbs

 Europe's reluctance to distribute millions of doses of AstraZeneca PLC's Covid-19 vaccine is coming under pressure after the French government authorized use of the shot for some older people.

The French government announced it would allow people with comorbidities between the ages of 65 and 74 to receive the vaccine developed by Oxford University and AstraZeneca. New data from the U.K. on Monday showed just one dose of the vaccine was effective in preventing disease and deaths among adults aged 70 and older who had received it.

France's move was a sharp departure from a month ago when President Emmanuel Macron told reporters that the vaccine was quasi ineffective for people older than 65 years, without providing evidence to back up his claim. The comments helped sow doubts across the European Union that still persist.

Germany, Italy and other large European countries continue to restrict older people from receiving AstraZeneca's vaccine, citing a lack of data about its efficacy with that age group. And France's restrictions remain in place for older people without comorbidities.

The result: Doses of the company's vaccine have piled up as European governments refuse to distribute the shots to younger people until older cohorts and people with priority, such as medical staff, have received a vaccine.

France has administered only a quarter of the 1.6 million shots it began receiving from AstraZeneca last month, according to French officials. Italy has used only 26% of its supply while Spain has administered 43% of its shots.

In Germany, which has used less than a third of its nearly 1.5 million AstraZeneca doses, some states such as Bavaria and Saxony have decided to donate doses to neighboring countries badly hit by the virus instead of letting them languish in storage.

"Too many vaccines are still laying around in the refrigerators, " said German Health Minister Jens Spahn said last week.

The restrictions on administering the AstraZeneca vaccine risk undercutting a major plank in the continent's plans to accelerate a rollout that has been slow compared with the U.S. and U.K. So-called mRNA vaccines developed by Moderna Inc. and the alliance of Pfizer Inc. and BioNTech SE are in limited supply in Europe. They also have storage requirements that are colder than the AstraZeneca vaccine, making them harder to administer in pharmacies and other accessible locations.

In March, France plans to administer a total of six million shots -- more than half of them coming from AstraZeneca. About three million people, less than 5% of France's population, have so far have received a single dose of any vaccine.

In the U.K., where AstraZeneca's vaccine has been widely deployed, more than 20 million people, or 30% of its population, have received at least one vaccine shot. That has allowed the government to lay out step-by-step plans for an almost complete reopening of its economy by June 21. Hospitalizations and deaths among older people, the first to get vaccinated, have begun to fall significantly more rapidly than among the unvaccinated population.

Canada's government on Monday recommended the Oxford-AstraZeneca shot be given to adults regardless of age, going against the recommendation of a national vaccine-advisory committee that earlier Monday had cited insufficient data about the shot's effectiveness in older people. Canadian government officials said they considered the shot safe and effective for adults of all ages.

A test for the vaccine is expected soon after late-stage human trials wrap up in the U.S. AstraZeneca has said it expects results from those trials -- with around 30,000 volunteers in the U.S., Chile and Peru -- by the end of this month, meaning a U.S. verdict on the vaccine could come as soon as April.

Governments across Europe now face the challenge of overcoming public skepticism toward the AstraZeneca vaccine. That has become more ingrained in recent weeks as many younger healthcare workers have publicly refused the company's vaccine because of concerns over efficacy and reports of side effects.

Alain Fischer, an immunologist overseeing France's vaccination campaign, publicly defended the vaccine's efficacy and safety last week in an effort to turn the tide of public opinion.

"I find it deeply unjust," Dr. Fischer said. "This vaccine gets relatively bad press in France."

AstraZeneca's European rollout stumbled the moment it left the gates. On Jan. 29, the European Medicines Agency, the EU's drug regulator, endorsed the vaccine's use in people 18 and older while warning the shot hadn't been sufficiently tested in people over 55.

Earlier that day Mr. Macron met with a group of reporters inside the Élysée Palace who questioned whether he was mistaken in backing the EU's strategy of collectively procuring vaccine supplies instead of going it alone like the U.K.

Mr. Macron, a longtime champion of the EU, fired back: "The real problem with AstraZeneca is that it hasn't worked the way we expected. Because we've had very little information." So far, he said, "everything seems to indicate that it's quasi ineffective for people older than 65 years old, some say 60 years and above."

Amid the confusion, national health authorities across the continent began issuing their own guidance. Spain cut off access for anyone older than 55 years. Italy restricted people 55 years and up from receiving AstraZeneca's shot, saying they needed more data for that age group, before bending to public pressure and placing the restriction at 65 years and up.

Germany's standing vaccination committee, a panel of experts that issues guidance on vaccination, went against the EMA's guidance, recommending the shot only for people younger than 65. The committee said it based the decision on the lack of trial data about the vaccine's efficacy on the elderly, not because of any doubt about its overall quality.

This week the German committee said it would reconsider its original recommendation and possibly open the vaccine for general use. The committee's chief, Thomas Mertens, said elderly people could expect to receive the shot soon. The initial guidance wasn't intended to criticize the vaccine itself, he said, adding: "The whole thing somehow did not turn out that well,"

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-Doses-of-AstraZeneca-s-Covid-19-Vaccine-Pile-Up-in-Europe-Amid-Government-Restric-32586204/

MorphoSys Licensing Partner GSK Shared Prelim Otilimab Study Results in Pulmonary COVID Related Disease

 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical

company and a leader in antibody, protein and peptide technologies, announced today that its licensing partner 
GlaxoSmithKline plc (LSE/NYSE: GSK) reported preliminary results of the OSCAR (Otilimab?in Severe COVID-19 Related 
Disease) study using otilimab (formerly MOR103/GSK3196165) for the treatment of severe pulmonary COVID-19 related 
disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and 
the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially 
significant findings. 
This event of the first patient dosed in the expanded study triggers milestone payments of a total of EUR16 million to 
MorphoSys. 
Otilimab is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage 
colony-stimulating factor) that was generated by MorphoSys and outlicensed to GSK in 2013. GSK is also developing 
otilimab for the treatment of rheumatoid arthritis in the ongoing Phase 3 ContRAst trials. 
"The preliminary study results with otilimab are encouraging news for patients 70 and older with severe COVID-19 
related pulmonary disease," said Dr. Malte Peters, Chief Research and Development Officer of MorphoSys AG. "We are 
pleased that our licensing partner GSK is expanding the study in order to further explore otilimab as a potential 
treatment option for this group of older adults suffering from severe forms of COVID-19." 
About the OSCAR study 
This global, randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept phase 2a OSCAR study 
(NCT04376684) assessed the efficacy and safety of a single intravenous infusion of otilimab 90 mg given over an hour or 
placebo in addition to standard of care in 806 hospitalised adults (ages 18 to 79 years) with severe COVID-19 related 
pulmonary disease. Standard of care permitted the use of corticosteroids (including dexamethasone), remdesivir, and 
convalescent plasma according to local hospital/institutional policies. Study participants were enrolled at 130 sites 
around the world, including in the United States, Europe, Asia, Russia, South Africa and South America. All 
participants had a positive SARS-CoV-2 test result; been hospitalised due to a diagnosis of pneumonia; had new onset of 
oxygenation impairment requiring high-flow oxygen, non-invasive ventilation or mechanical ventilation <48 hours before 
dosing; and had increased biological markers of systemic inflammation. 
Participants were considered 'alive and free of respiratory failure' if they were off significant oxygen support 
measured using a GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) 
scale 2020. A full analysis is ongoing and will be made available in an upcoming pre-print publication when available. 

https://www.marketscreener.com/quote/stock/MORPHOSYS-AG-436425/news/PRESS-RELEASE-MorphoSys-s-Licensing-Partner-GSK-Shared-Preliminary-Results-From-OSCAR-Study-with-Ot-32586349/

Amgen: BLINCYTO Ups Survival In Pediatric Acute Lymphoblastic Leukemia

 Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with BLINCYTO were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with BLINCYTO, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the BLINCYTO group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

https://www.prnewswire.com/news-releases/blincyto-blinatumomab-demonstrated-significantly-prolonged-event-free-survival-compared-with-consolidation-chemotherapy-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-301238918.html