Market Place
US plans to reduce drug manufacturing dependence on China, India; Cross-contamination problems at Cipla
This week, Phispers has more updates on Covid-19.
The US is preparing an executive order that will reduce the country’s drug dependence on China and India.
German biotech CureVac was in news for not just its experimental coronavirus vaccine, but also for being lured by US President Donald Trump to move its research to the US.
Germany and the EU are pledging financial support to scuttle Trump’s plans.
The US Health and Human Services (HHS) department suffered a cyber-attack on its computer system over the weekend.
Tech players like Google and Microsoft launched websites to help out people during the pandemic.
J&J saw a surge in demand of its paracetamol tablet. EMA said there is no scientific evidence that ibuprofen harms Covid-19 patients.
In the US, licensed pharmacist and physicians were allowed to create batches of hand sanitizers to scale over the supply shortfall.
And Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat Covid-19. In the only non-Covid-19 news, Indian drug maker Cipla was issued a warning letter by the FDA for serious cross-contamination problems.
White House
prepares executive order to bring drug manufacturing back to US
White House advisor Peter Navarro has said he is preparing an executive order that would reduce America’s drug dependency on other countries.
Navarro said the executive order, he hopes to finish this week, would help relocate medical supply chains from overseas to the US.
“Most Americans don’t know (that) 97 percent of antibiotics come to this country from China (and) 80 percent of the active ingredients in pharmaceuticals come from China and India,” Navarro said.
As part of the order, the Trump administration is considering offering companies “100 percent expensing” to move their operations back to the United States from China, White House economic adviser Larry Kudlow said.
Navarro also said Trump’s push for a payroll tax cut would provide enough stimulus to help Americans through the coronavirus crisis. Navarro has been championing a payroll tax cut as part of the fiscal response to the coronavirus, arguing that it would serve as a US$ 800 billion economic stimulus.
J&J’s paracetamol demand surges, France limits purchases; ‘no evidence of ibuprofen harming Covid-19 patients’
Last week, India — the world’s main supplier of generic drugs — restricted the export of some ingredients as well as medicines including paracetamol, which is also sold under the brand Tylenol in the United States. As a result, fears around shortages of some drugs wreaked havoc on supply chains.
Johnson & Johnson is seeing a spike in demand for Tylenol (an over the counter painkiller) and other self-care products, as people are stocking up essentials due to the Covid-19 scare.
J&J said it was shipping its stock in a “controlled manner” and that its manufacturing sites had ramped up production to ensure supply.
J&J said it did not anticipate a shortage of Tylenol (paracetamol) even though the drug “may have temporarily run out of stock at one location”.
However, France’s health agency ANSM issued a statement this week to limit sales of paracetamol-based drugs to prevent people from unnecessarily buying large stocks of the drug.
Taking ibuprofen for Covid-19: Reckitt Benckiser has sought to quash warnings against taking Nurofen, saying it was not aware of any evidence that the ibuprofen adversely impacted patients suffering from Covid-19.
Reckitt Benckiser’s statement followed a warning by France's health minister last week that people should not use anti-inflammatory drugs such as ibuprofen if they have coronavirus-like symptoms.
Olivier Véran, France’s health minister who is also a qualified doctor, said in a tweet on Saturday: “The taking of anti-inflammatories [ibuprofen, cortisone … ] could be a factor in aggravating the infection. In case of fever, take paracetamol. If you are already taking anti-inflammatory drugs, ask your doctor’s advice.”
Meanwhile, the European Medicines Agency (EMA) has said that there is currently no scientific evidence establishing a link between ibuprofen and worsening of Covid‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.
Pharmacists to make sanitizers: In the US, stores have run out of hand sanitizer and the FDA is worried home-made concoctions aren’t as safe to use. Therefore, the agency is encouraging licensed pharmacists and physicians to create batches of hand sanitizer to cut back on shortages due to the Covid-19 pandemic.
The FDA has said it won’t take any enforcement action against certain facilities or licensed professionals who make hand sanitizer for consumer use as long as they use high quality ingredients and follow a recipe laid out by the agency. That recipe includes suggested volumes of alcohol, glycerol, hydrogen peroxide, and sterile water.
Serious cross-contamination problems at Cipla; data-integrity issues at Windlas
Two months after Indian drugmaker Cipla informed the bourses that its finished pharmaceuticals manufacturing facility in Goa had been classified as Official Action Indicated (OAI) by the US Food and Drug Administration (FDA), the warning letter issued to the facility was posted on the FDA website.
The site was inspected in September 2019, following which the FDA investigators had issued a 38-page Form 483.
The warning letter highlights severe cross contamination concerns at the Goa site. It follows both the inspection as well as a review of Cipla’s responses.
During the inspection, FDA investigators observed residue on manufacturing equipment which when tested by Cipla confirmed the presence of multiple active ingredients. After the inspection, Cipla also tested reserve samples of selected batches to assess the potential for cross contamination and the testing confirmed the presence of active ingredients from a previous product in batches of the next product.
In its warning letter, the FDA also states that there is no assurance that the scope of Cipla’s evaluation into this cross-contamination problem was comprehensive.
Following the inspection, Cipla also informed the FDA of its decision to suspend production in its sterile units where the FDA had raised concerns over atypical High Efficiency Particulate Air (HEPA) filter failures and the firm’s failure to perform adequate smoke studies to evaluate whether unidirectional flow existed in Cipla’s aseptic operations.
At the time of the inspection, Cipla’s Goa unit generated 25 to 30 percent of its US business.
This week, the FDA also shared the warning letter issued to another Indian finished formulation manufacturer Windlas Healthcare, which was placed on an import alert by the FDA on January 21, 2020.
An August 2019 inspection of the firm revealed several data-integrity violations. When the FDA investigators arrived at Windlas just 30 minutes after announcing their inspection, they observed numerous employees in the process of moving off-site cartloads of trash bags containing shredded and torn documents and binders. Upon closer examination, the investigators discovered batch reconciliation forms, cleaning and dispensing logs, training assessments, and scale balance printouts. The inspection also revealed that failing API batches had been used to manufacture and ship drug products to the United States.
Cyberattack hits HHS in US amid Covid-19 crisis; Google, Microsoft launch websites
In the US, the Health and Human Services Department suffered a cyber-attack on its computer system on Sunday, March 15. The HHS is a key part of the federal response to the fast-spreading coronavirus outbreak.
While the cyberattack is being seen as a campaign of disruption and disinformation that was aimed at undermining the response to the coronavirus pandemic, the HHS Secretary Alex Azar said there was “no data breach.”
National Security Council spokesman John Ullyot said HHS networks “are functioning normally at this time” and that officials are investigating the matter.
According to reports, the attack, which involved overloading the HHS servers with millions of hits over several hours, didn’t succeed in slowing the agency’s systems significantly.
“We had no penetration into our networks, we had no degradation of the functioning of our networks,” Azar said at a White House briefing on the coronavirus on Monday afternoon.
Covid-19 websites: Microsoft has launched a new interactive Bing map to provide information on the spread of Covid-19. The map shows the amount of cases on a per country basis, broken down by the number of currently active cases, recovered cases, and fatal cases.
Microsoft says the tool is pulling data from a collection of sources including the World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), the European Centre for Disease Prevention and Control (ECDC), and Wikipedia.
Although the number of cases the tool is pulling are consistent with those published by the WHO, Microsoft’s Covid-19 tracker appears to be having trouble surfacing relevant news stories.
Microsoft isn’t the only tech company providing tools on the pandemic. Verily – a sister company to Google under the corporate umbrella of Alphabet – launched a website on Sunday allowing residents of two northern California counties to enter symptoms and, if eligible, make an appointment for coronavirus testing.
However, the rollout of this website has been marred by confusion and limitations. Privacy concerns are also circling the service.
By Monday morning, the website had reached capacity, and users were informed that no more testing appointments were available.
US President Donald Trump had announced last week that Google had 1,700 engineers working on a website that would “be very quickly done, unlike websites of the past, to determine whether a test is warranted and to facilitate testing at a nearby convenient location”.
Pfizer opens up
tools and capabilities to battle Covid-19
US-headquartered drug behemoth Pfizer has issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19.
“In this troubling time, Pfizer is committed to doing all we can to respond to the COVID-19 pandemic,” Dr. Albert Bourla, Chairman and CEO, said in a statement.
Pfizer said it is openly sharing its drug development talents, tools and expertise with any company working on promising anti-Covid-19 candidates. It is also calling on the entire biopharma industry to do the same.
“Pfizer is working to advance our own potential antiviral therapies and is engaged with BioNTech on a potential mRNA coronavirus vaccine,” Bourla said.
Pfizer is making five promises that will help scientists more rapidly bring forward therapies and vaccines to protect humankind from this escalating pandemic. One of its promises includes offering its manufacturing capabilities. “Once a therapy or vaccine is approved it will need to be rapidly scaled and deployed around the world to put an end to this pandemic. As one of the largest manufacturers of vaccines and therapeutics, Pfizer is committed to using any excess manufacturing capacity and to potentially shifting production to support others in rapidly getting these life-saving breakthroughs into the hands of patients as quickly as possible,” a Pfizer statement said.
Pfizer is also reaching out to federal agencies to build a cross-industry rapid response team of scientists, clinicians and technicians able to move into action immediately when future epidemics surface.
Germany, EU try
to stop US from luring away vaccine firm CureVac
German biotech CureVac AG has been developing a Covid-19 vaccine. Florian von der Muelbe, CureVac’s chief production officer and co-founder, had told Reuters last week the company had started with a multitude of coronavirus vaccine candidates and was now selecting the two best to go into clinical trials. CureVac hopes to have an experimental vaccine ready by June or July to then seek the go-ahead from regulators for testing on humans.
Alongside, there was news that US President Donald Trump had offered funds to lure CureVac to the United States, and the German government was making counter-offers to tempt it to stay back.
Reports by Welt am Sonntag and Reuters had alleged that Trump had met CureVac’s then-CEO Daniel Menichella earlier this month (who has since left CureVac), and had tried to lure the company over to the US to continue working on its Covid-19 mRNA vaccine, albeit for use only in the US.
Reports say that Berlin is trying to stop Washington from persuading CureVac to move its research to the United States, prompting German politicians to insist no country should have a monopoly on any future vaccine.
A German Health Ministry spokeswoman said: “The German government is very interested in ensuring that vaccines and active substances against the new coronavirus are also developed in Germany and Europe.”
“In this regard, the government is in intensive exchange with the company CureVac,” she added.
Meanwhile, in a call to CureVac this week, European Commission president Ursula von der Leyen, EU Research Commissioner Mariya Gabriel and European Investment Bank vice-president of innovation Ambroise Fayolle, pledged financial support “to scale up development and production of a vaccine against the coronavirus in Europe.”
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