U.S. stocks jumped at the open on Friday as an easing in U.S.-China
friction added to optimism from data showing the U.S. economy lost fewer
jobs in April than feared due to the coronavirus crisis.
The Dow Jones Industrial Average .DJI rose 231.93 points, or 0.97%, at the open to 24,107.82. The S&P 500 .SPX opened higher by 27.64 points, or 0.96%, at 2,908.83, while the Nasdaq Composite .IXIC gained 77.23 points, or 0.86%, to 9,056.89 at the opening bell.
https://www.reuters.com/article/us-usa-stocks/wall-street-gains-on-easing-u-s-china-tensions-jobs-report-idUSKBN22K1D0
Friday, May 8, 2020
Thursday, May 7, 2020
How Deere, Caterpillar kept plants running during the coronavirus outbreak
While Detroit automakers’ unionized auto factories have been idled by
the coronavirus pandemic, farm and construction equipment makers Deere (DE.N) and Caterpillar (CAT.N) have won the support of the United Auto Workers and other unions to run their facilities during the pandemic.
As U.S. states begin to lift lockdown orders and companies gear up to
restart production, the policies put in place by the two heavy
equipment makers offer a template for returning workers to idled
factories in other sectors.
Giving employees sick time without penalty, temperature screenings, staggered shifts and hiring a hygiene-auditing firm are some of the measures the two companies have taken to reassure employees to stay on production lines when many union and non-union workers balk at reporting for jobs that could expose them to the novel coronavirus that causes COVID-19.
Detroit’s auto companies had to negotiate long and hard with the United Auto Workers, which represents their hourly workers, over how and when to restart U.S. production. The UAW blocked the automakers’ plans to restart their factories on May 4.
The union this week signaled its members are ready to go back to work at General Motors Co (GM.N), Ford Motor Co (F.N) and Fiat Chrysler Automobiles NV’s U.S. factories on May 18.
By contrast, the UAW let Deere resume production at two of its facilities within days of employees testing positive for the virus.
Union officials attribute that decision to a safety policy they negotiated with the company that mandates a strict implementation of guidelines prescribed by the nation’s health protection agency and the World Health Organization.
But it was a provision for expanded benefits that sealed the deal, UAW officials say.
“One of our priorities on the health and safety issue is to make sure that our members can self-report without any kind of penalty,” said Brian Rothenberg, the UAW’s public relations director. The union is negotiating with all its employers for similar benefits in order to reduce the risk of infection in the workplace.
Deere declined to comment officially, citing the quiet period ahead of its earnings report later this month.
“The last thing we wanted was for individuals to feel compelled to come to work to get paid,” a Deere official said.
The Moline, Illinois-based company altered shift schedules to ensure employees from one shift exit before the next shift reports to work. It hired an industrial-hygiene company to audit the sanitization work at some of its larger units.
Additionally, the farm equipment maker enhanced pay provisions to cover the challenges workers face due to day care and school closings. It also waived copays, coinsurance and deductibles for its employees for coronavirus testing.
At Caterpillar, the UAW and the United Steelworkers have negotiated a similar paid sick leave policy for their members.
The heavy equipment maker is offering workers paid sick leave up to 2
weeks if they have been instructed to self-quarantine. The benefit also
can be used for taking care of immediate family members.
Production employees are allowed time off up to 10 weeks at 2/3 of their salary for child care.
Caterpillar spokeswoman Kate Kenny said the benefits are available to all employees who are unable to work from home, not just union members.
Workers are required to go for temperature checks before entering some facilities. To ensure social distancing, lunch hours have been extended at some locations and visitor access has been limited.
Caterpillar’s retail sales dropped by 20% in North America in March. In response to the virus-induced business disruption, the company is temporarily shutting down facilities and imposed indefinite or temporary layoffs.
Chief Financial Officer Andrew Bonfield said Caterpillar is managing production by segment and adjusting its workforce by facility.
The situation at Deere is also uncertain. The company will temporarily suspend production at its Davenport and Dubuque facilities in Iowa on May 11 for two weeks due to supply chain disruptions.
Depressed demand for construction and forestry equipment in the wake of the pandemic has led the company to lay off 159 employees indefinitely at the Dubuque facility.
“You prepare for crises, but crises would be at one factory,” the Deere official said. “This is a crisis that has upended every unit.”
https://www.reuters.com/article/us-health-coronavirus-usa-equipment/how-deere-caterpillar-kept-plants-running-during-the-coronavirus-outbreak-idUSKBN22J2R5
Giving employees sick time without penalty, temperature screenings, staggered shifts and hiring a hygiene-auditing firm are some of the measures the two companies have taken to reassure employees to stay on production lines when many union and non-union workers balk at reporting for jobs that could expose them to the novel coronavirus that causes COVID-19.
Detroit’s auto companies had to negotiate long and hard with the United Auto Workers, which represents their hourly workers, over how and when to restart U.S. production. The UAW blocked the automakers’ plans to restart their factories on May 4.
The union this week signaled its members are ready to go back to work at General Motors Co (GM.N), Ford Motor Co (F.N) and Fiat Chrysler Automobiles NV’s U.S. factories on May 18.
By contrast, the UAW let Deere resume production at two of its facilities within days of employees testing positive for the virus.
Union officials attribute that decision to a safety policy they negotiated with the company that mandates a strict implementation of guidelines prescribed by the nation’s health protection agency and the World Health Organization.
But it was a provision for expanded benefits that sealed the deal, UAW officials say.
“One of our priorities on the health and safety issue is to make sure that our members can self-report without any kind of penalty,” said Brian Rothenberg, the UAW’s public relations director. The union is negotiating with all its employers for similar benefits in order to reduce the risk of infection in the workplace.
Deere declined to comment officially, citing the quiet period ahead of its earnings report later this month.
EXPANDED BENEFITS
Under its agreement with the UAW, Deere is providing paid sick leave to cover the recommended 14 days of self-quarantine, even to workers who think they have been exposed to the virus but are not certain and have not been tested.“The last thing we wanted was for individuals to feel compelled to come to work to get paid,” a Deere official said.
The Moline, Illinois-based company altered shift schedules to ensure employees from one shift exit before the next shift reports to work. It hired an industrial-hygiene company to audit the sanitization work at some of its larger units.
Additionally, the farm equipment maker enhanced pay provisions to cover the challenges workers face due to day care and school closings. It also waived copays, coinsurance and deductibles for its employees for coronavirus testing.
At Caterpillar, the UAW and the United Steelworkers have negotiated a similar paid sick leave policy for their members.
Production employees are allowed time off up to 10 weeks at 2/3 of their salary for child care.
Caterpillar spokeswoman Kate Kenny said the benefits are available to all employees who are unable to work from home, not just union members.
Workers are required to go for temperature checks before entering some facilities. To ensure social distancing, lunch hours have been extended at some locations and visitor access has been limited.
WORKING, BUT NOT BUSINESS AS USUAL
It has not been smooth sailing for the two equipment manufacturers. Factories are hobbled by supply shortages, weakened demand and increased absenteeism among workers.Caterpillar’s retail sales dropped by 20% in North America in March. In response to the virus-induced business disruption, the company is temporarily shutting down facilities and imposed indefinite or temporary layoffs.
Chief Financial Officer Andrew Bonfield said Caterpillar is managing production by segment and adjusting its workforce by facility.
The situation at Deere is also uncertain. The company will temporarily suspend production at its Davenport and Dubuque facilities in Iowa on May 11 for two weeks due to supply chain disruptions.
Depressed demand for construction and forestry equipment in the wake of the pandemic has led the company to lay off 159 employees indefinitely at the Dubuque facility.
“You prepare for crises, but crises would be at one factory,” the Deere official said. “This is a crisis that has upended every unit.”
https://www.reuters.com/article/us-health-coronavirus-usa-equipment/how-deere-caterpillar-kept-plants-running-during-the-coronavirus-outbreak-idUSKBN22J2R5
California begins to reopen tomorrow
Retailers like clothing stores, bookstores, florists, and sporting goods (Governor Newsom’s examples) may reopen for business tomorrow with curbside pickup.
Manufacturers and logistics warehouses may reopen as well.
The news draws a “Yeah!!” from one well-known California resident.
Guidelines for the reopening of office buildings, dine-in restaurants, shopping malls, and others will be released early next week.
A growing number of local governments and individual businesses over the past few days have already reopened in defiance of the governor’s orders.
https://seekingalpha.com/news/3571879-california-begins-to-reopen-tomorrowGiving blood thinners to severely ill Covid-19 patients is gaining ground
Treating
Covid-19 patients with medicines to prevent blood clots might help
reduce deaths in patients on ventilators, based on new observational
data.
A team from Mount Sinai Health System in New York on Wednesday reported better results for hospitalized Covid-19 patients who received anticoagulant drugs compared to patients who didn’t. The data are preliminary and require confirmation in larger studies with a more robust design, the authors say about their study published in the Journal of the American College of Cardiology, but their findings add weight to medical guidelines.
While there are no firm data on the frequency of clotting problems in Covid-19 patients, there have been troubling anecdotal reports of patients whose lungs are peppered with tiny clots or who have suffered strokes. Last month, other Mount Sinai doctors detailed strokes in five Covid-19 patients in their 30s and 40s, an unusually young age for such a damaging cardiovascular event. Other reports of strokes have bubbled up elsewhere, including 88 patients in the original epicenter of the coronavirus in Wuhan, China, six in London, and three in Strasbourg, France.
Autopsies of 12 Covid-19 patients showed strong evidence for blood
clotting problems, including clots in the lungs and in the legs, a group
in Hamburg, Germany, reported Wednesday. In all 12 cases, the cause of death was found within the lungs or the pulmonary vascular system.
Together they add to accumulating evidence that Covid-19 leads to abnormal blood clotting and that anticoagulant medications might help.
The most recent Mount Sinai study analyzed data from more than 2,700
patients hospitalized for Covid-19. The percentage of patients who died
while not on a ventilator to help them breathe was about the same,
whether or not they received some form of anticoagulant. Time to death
was a week longer for those who were given anticoagulants: a median of
21 days compared to 14 days for those who did not receive
anticoagulants.
There was a mortality difference among sicker patients who were on ventilators in intensive care units: 63% of those given anticoagulants survived versus 29% who did not get anticoagulants. The patients were not randomly assigned to treatment or no treatment, however, meaning the study could not rule out other explanations for the apparent survival benefit.
Bleeding is a risk for patients who take anticoagulants, but the study found no significant difference between patients who did or did not receive anticoagulants.
“They interrogated their database of Covid-19 patients and came up with an interesting, thought-provoking finding that patients [on ventilators] who received full-dose, systemic anticoagulants had a lower mortality than those who did not, particularly patients in the intensive care unit,” said Jeffrey Weitz, president-elect of the International Society on Thrombosis and Haemostasis and a physician-scientist at McMaster University in Canada who was not involved in the study. “What it suggests to me is that anticoagulation alone might attenuate the disease, but it may not be the answer. We need more data and longer follow-up. Remember, this is just observational data. We don’t have a full picture on all of those patients.”
Based on the data in hand, Mount Sinai has changed its guidance on anticoagulants, said Valentin Fuster, a co-author of the study and physician-in-chief at Mount Sinai Hospital. Doctors had been giving patients anticoagulants before, using their clinical judgment. “We developed a new policy once we got these results,” Fuster said. “And that is to increase the dose of anticoagulants to the patients with Covid-19.”
Current guidelines from the American College of Cardiology for managing abnormal blood clotting in Covid-19 patients note that while most of its expert panel members recommend preventive doses of anticoagulants, a minority say they use the higher doses typically prescribed for patients with established blood-clotting problems. McMaster’s Weitz is a co-author of those guidelines. “What we’re really trying to find out is who should get it and how much,” he said about anticoagulant medication.
Anu Lala, another co-author and a cardiologist at Mount Sinai, said while the data reflect what she’s been seeing in the hospital, they demand more study.
“The very fact that there is a signal there is in line with what we seem to be observing clinically, having been on the wards for four weeks,” she said. “It opens the gate for us to do a deeper dive. There’s a lot more work to be done to prove or even really determine causality
One unknown: Did patients have an underlying cause for blood clots, such as the abnormal heart rhythm atrial fibrillation? Patients had their blood drawn when they were admitted to one of the five hospitals in the Mount Sinai system, and if they had inflammatory markers, they were put on oral, injected, or infused anticoagulants. Higher doses were given in the ICU.
In the earlier case reports on young Covid-19 patients who had strokes, there were no signs of blood-clotting disorders. J Mocco, a neurosurgeon at Mount Sinai, said that right when New York was seeing a surge in hospital admissions for Covid-19, he and colleagues in cardiology and pulmonology noticed a much higher than expected number of patients with stroke, amounting to a sevenfold increase over normal numbers. These patients were 15 years younger than typical stroke patients and they didn’t have risk factors for stroke such as irregular heartbeats or heart failure.
“I don’t want every person out there being petrified they’re going to have a stroke because of the coronavirus being out there,” he said. “But within this group of individuals, it does strongly suggest that the virus is contributory to their strokes.”
That argues for starting blood thinners sooner and looking at other measures, he said. “In some patients, we’re even trying clot-busting drugs to try to undo some of the clotting.”
Why Covid-19 patients have abnormal blood clotting isn’t known, but doctors suspect it’s related to inflammation and the ACE2 receptors the coronavirus latches onto, not only in the lungs and other organs but also on the lining of blood vessels. Inflammation and blood clotting normally go together, with a blood clot forming around the site of an infection. How this goes wrong in Covid-19 and whether it’s just one factor is still not understood.
At Mount Sinai, the next step is another observational study of 5,000 Covid-19 patients taking blood thinners to home in on why they were started on anticoagulants, followed by a randomized clinical trial based on what is learned.
“The more we learn, I think, the more we’re humbled, quite frankly,” Lala said. “We’ve got to keep going.”
A team from Mount Sinai Health System in New York on Wednesday reported better results for hospitalized Covid-19 patients who received anticoagulant drugs compared to patients who didn’t. The data are preliminary and require confirmation in larger studies with a more robust design, the authors say about their study published in the Journal of the American College of Cardiology, but their findings add weight to medical guidelines.
While there are no firm data on the frequency of clotting problems in Covid-19 patients, there have been troubling anecdotal reports of patients whose lungs are peppered with tiny clots or who have suffered strokes. Last month, other Mount Sinai doctors detailed strokes in five Covid-19 patients in their 30s and 40s, an unusually young age for such a damaging cardiovascular event. Other reports of strokes have bubbled up elsewhere, including 88 patients in the original epicenter of the coronavirus in Wuhan, China, six in London, and three in Strasbourg, France.
Together they add to accumulating evidence that Covid-19 leads to abnormal blood clotting and that anticoagulant medications might help.
There was a mortality difference among sicker patients who were on ventilators in intensive care units: 63% of those given anticoagulants survived versus 29% who did not get anticoagulants. The patients were not randomly assigned to treatment or no treatment, however, meaning the study could not rule out other explanations for the apparent survival benefit.
Bleeding is a risk for patients who take anticoagulants, but the study found no significant difference between patients who did or did not receive anticoagulants.
“They interrogated their database of Covid-19 patients and came up with an interesting, thought-provoking finding that patients [on ventilators] who received full-dose, systemic anticoagulants had a lower mortality than those who did not, particularly patients in the intensive care unit,” said Jeffrey Weitz, president-elect of the International Society on Thrombosis and Haemostasis and a physician-scientist at McMaster University in Canada who was not involved in the study. “What it suggests to me is that anticoagulation alone might attenuate the disease, but it may not be the answer. We need more data and longer follow-up. Remember, this is just observational data. We don’t have a full picture on all of those patients.”
Based on the data in hand, Mount Sinai has changed its guidance on anticoagulants, said Valentin Fuster, a co-author of the study and physician-in-chief at Mount Sinai Hospital. Doctors had been giving patients anticoagulants before, using their clinical judgment. “We developed a new policy once we got these results,” Fuster said. “And that is to increase the dose of anticoagulants to the patients with Covid-19.”
Current guidelines from the American College of Cardiology for managing abnormal blood clotting in Covid-19 patients note that while most of its expert panel members recommend preventive doses of anticoagulants, a minority say they use the higher doses typically prescribed for patients with established blood-clotting problems. McMaster’s Weitz is a co-author of those guidelines. “What we’re really trying to find out is who should get it and how much,” he said about anticoagulant medication.
Anu Lala, another co-author and a cardiologist at Mount Sinai, said while the data reflect what she’s been seeing in the hospital, they demand more study.
“The very fact that there is a signal there is in line with what we seem to be observing clinically, having been on the wards for four weeks,” she said. “It opens the gate for us to do a deeper dive. There’s a lot more work to be done to prove or even really determine causality
One unknown: Did patients have an underlying cause for blood clots, such as the abnormal heart rhythm atrial fibrillation? Patients had their blood drawn when they were admitted to one of the five hospitals in the Mount Sinai system, and if they had inflammatory markers, they were put on oral, injected, or infused anticoagulants. Higher doses were given in the ICU.
In the earlier case reports on young Covid-19 patients who had strokes, there were no signs of blood-clotting disorders. J Mocco, a neurosurgeon at Mount Sinai, said that right when New York was seeing a surge in hospital admissions for Covid-19, he and colleagues in cardiology and pulmonology noticed a much higher than expected number of patients with stroke, amounting to a sevenfold increase over normal numbers. These patients were 15 years younger than typical stroke patients and they didn’t have risk factors for stroke such as irregular heartbeats or heart failure.
“I don’t want every person out there being petrified they’re going to have a stroke because of the coronavirus being out there,” he said. “But within this group of individuals, it does strongly suggest that the virus is contributory to their strokes.”
That argues for starting blood thinners sooner and looking at other measures, he said. “In some patients, we’re even trying clot-busting drugs to try to undo some of the clotting.”
Why Covid-19 patients have abnormal blood clotting isn’t known, but doctors suspect it’s related to inflammation and the ACE2 receptors the coronavirus latches onto, not only in the lungs and other organs but also on the lining of blood vessels. Inflammation and blood clotting normally go together, with a blood clot forming around the site of an infection. How this goes wrong in Covid-19 and whether it’s just one factor is still not understood.
At Mount Sinai, the next step is another observational study of 5,000 Covid-19 patients taking blood thinners to home in on why they were started on anticoagulants, followed by a randomized clinical trial based on what is learned.
“The more we learn, I think, the more we’re humbled, quite frankly,” Lala said. “We’ve got to keep going.”
Giving blood thinners to severely ill Covid-19 patients is gaining ground
Teva CEO Kare Schultz On Drugmaker’s Outlook, Coronavirus Response
Generic drugmaker Teva Pharmaceutical Industries Ltd TEVA 10.36% reported a first-quarter earnings beat as the company managed to maintain business continuity, CEO Kare Schultz said on CNBC’s “Squawk on the Street.”
Looking forward, the company expects to see “some reversal” of the strong demand seen in March, but Schultz said full-year revenue should fall within its guidance.
While air cargo issues remain a problem, Teva is seeing improving conditions, as it has been able to increase volume outputs, but with higher transportation costs.
In the meantime, all of Teva’s facilities are operating at “full capacity,” Schultz said, and the “majority” of logistical problems have been overcome.
The CEO said he can’t at this time offer a “clarifying answer” on the efficacy of the drug in treating COVID-19. The ultimate responsibility rests with the health care professionals, he said.
Nevertheless, Teva was able to respond to the growing demand for the drug and was “quite successful” in shipping the product, Schultz said.
It is nevertheless important for all companies to increase the production of products to better prepare in the event of a second wave outbreak, he said.
https://www.benzinga.com/news/earnings/20/05/15981383/teva-ceo-kare-schultz-on-drugmakers-outlook-coronavirus-response
Teva’s ‘Very Good’ Quarter
Teva is dedicated to supplying therapies to the 200 million people who use its generic drugs and this resulted in a “very good” quarter, the CEO said.Looking forward, the company expects to see “some reversal” of the strong demand seen in March, but Schultz said full-year revenue should fall within its guidance.
Teva Supply Chain Update
One of Teva’s drugs, propofol, experienced shipping delays due to the COVID-19 pandemic. Part of the problem stems from a reduction in air traffic, less air cargo availability and some countries placing new restrictions on imported goods.While air cargo issues remain a problem, Teva is seeing improving conditions, as it has been able to increase volume outputs, but with higher transportation costs.
In the meantime, all of Teva’s facilities are operating at “full capacity,” Schultz said, and the “majority” of logistical problems have been overcome.
Teva And The Hydroxychloroquine Controversy
Teva is one of the few makers of the anti-malaria drug hydroxychloroquine, which has come under its fair share of controversy.The CEO said he can’t at this time offer a “clarifying answer” on the efficacy of the drug in treating COVID-19. The ultimate responsibility rests with the health care professionals, he said.
Nevertheless, Teva was able to respond to the growing demand for the drug and was “quite successful” in shipping the product, Schultz said.
Teva CEO On Coronavirus Second Wave Concerns
The coronavirus could return for a “second wave” in the fall season, but it is “too early to say” what, if any, actions hospitals are taking now to prepare themselves, Schultz said.It is nevertheless important for all companies to increase the production of products to better prepare in the event of a second wave outbreak, he said.
https://www.benzinga.com/news/earnings/20/05/15981383/teva-ceo-kare-schultz-on-drugmakers-outlook-coronavirus-response
FDA approves new heart failure use for AstraZeneca’s Farxiga
The FDA has approved a new use for
AstraZeneca’s Farxiga (dapagliflozin) to reduce risk of cardiovascular
death and hospitalisation with heart failure, in adults with reduced
ejection fraction heart failure, with or without type 2 diabetes.
AZ is building a metabolic and cardiovascular franchise around Farxiga, which was first approved in type 2 diabetes and was added to the company’s portfolio of drugs after the company bought out Bristol-Myers Squibb’s share of a diabetes joint venture in 2013.
An SGLT-2 class drug, Farxiga has become one of the company’s most important products in terms of sales, generating $407 million in Q1 this year, up 16%.
With this new indication Farxiga has become the first drug in the class to be approved by the FDA to treat patients with heart failure with reduced ejection fraction (HFrEF).
AZ’s big rivals Eli Lilly and Boehringer Ingelheim are also attempting to develop their class competitor Jardiance (empagliflozin) to prevent heart failure, but suffered a setback in December when the drug failed to improve exercise ability in two phase 3 studies.
Approval for Farxiga was based on positive results from the phase 3 DAPA-HF trial, which showed Farxiga achieved a statistically significant and clinically meaningful reduction of death or hospitalisation for heart failure compared with placebo.
DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% in patients with HFrEF.
During the trial duration, one CV death or hospitalisation for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga.
The FDA had granted a faster priority review in January, where the regulator committed to making a decision within six months.
In October the FDA approved Farxiga to reduce risk of hospitalisation for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
The FDA is also evaluating data from the phase 3 DAPA-CKD trial, which tested the drug in chronic kidney disease and was stopped early because of efficacy.
AZ is also developing Farxiga in heart failure patients with reduced ejection fraction.
There is a potential threat of generic competition for Farxiga in the US – the FDA has tentatively approved a cheaper copy but it is unable to launch until a patent dispute is resolved in courts.
AZ is building a metabolic and cardiovascular franchise around Farxiga, which was first approved in type 2 diabetes and was added to the company’s portfolio of drugs after the company bought out Bristol-Myers Squibb’s share of a diabetes joint venture in 2013.
An SGLT-2 class drug, Farxiga has become one of the company’s most important products in terms of sales, generating $407 million in Q1 this year, up 16%.
With this new indication Farxiga has become the first drug in the class to be approved by the FDA to treat patients with heart failure with reduced ejection fraction (HFrEF).
AZ’s big rivals Eli Lilly and Boehringer Ingelheim are also attempting to develop their class competitor Jardiance (empagliflozin) to prevent heart failure, but suffered a setback in December when the drug failed to improve exercise ability in two phase 3 studies.
Approval for Farxiga was based on positive results from the phase 3 DAPA-HF trial, which showed Farxiga achieved a statistically significant and clinically meaningful reduction of death or hospitalisation for heart failure compared with placebo.
DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% in patients with HFrEF.
During the trial duration, one CV death or hospitalisation for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga.
The FDA had granted a faster priority review in January, where the regulator committed to making a decision within six months.
In October the FDA approved Farxiga to reduce risk of hospitalisation for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
The FDA is also evaluating data from the phase 3 DAPA-CKD trial, which tested the drug in chronic kidney disease and was stopped early because of efficacy.
AZ is also developing Farxiga in heart failure patients with reduced ejection fraction.
There is a potential threat of generic competition for Farxiga in the US – the FDA has tentatively approved a cheaper copy but it is unable to launch until a patent dispute is resolved in courts.
FDA approves new heart failure use for AZ’s Farxiga
Concerns over Bristol-Celgene merger payout as FDA extends drug review
Bristol-Myers Squibb’s risky three-drug bet with former
shareholders in Celgene is still on – but it could be a close-run thing
after the FDA extended the review of a cancer cell therapy close to key
deadline.
Shareholders in Celgene accepted a “contingent value right” (CVR) to sweeten the $74 billion merger with BMS in November.
Each Celgene share entitled the holder to one CVR that can be publicly traded and pays out $9 if three big drugs from Celgene’s pipeline are approved by the FDA in time for certain deadlines.
The first of the three drugs – Celgene’s multiple sclerosis drug Zeposia (ozanimod) – was approved in March.
That leaves two complex cancer CAR-T cell therapies outstanding, and the FDA just extended the review period for one of them after BMS had to submit further data to support the filing.
The three-month extension of the review for lisocabtagene maraleucel (liso-cel) gives a new FDA action date of 16th November this year, around six weeks before the deadline of 31st December mandated by the CVR.
Liso-cel is a CAR-T (chimeric antigen receptor T-cell) therapy designed to target the protein CD19, a protein expressed during the formation of B-cells and maintained following their transformation into cancer cells.
Formerly known as JCAR017 it was originally developed by Celgene’s Juno unit, and is under review by the FDA for relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The value of the CVR slipped following the announcement, as investors got spooked by the tightness of the deadline.
While the FDA seems to be approving drugs on time at the moment, there are concerns that the ongoing COVID-19 pandemic could cause further delays as staffers at the regulator turn their attention to drugs and vaccines to fight the coronavirus.
The final drug in the CVR “bet” is bb2121, another CAR-T that Celgene developed in partnership with bluebird bio, which must get approved before 31st March next year.
Shareholders in Celgene accepted a “contingent value right” (CVR) to sweeten the $74 billion merger with BMS in November.
Each Celgene share entitled the holder to one CVR that can be publicly traded and pays out $9 if three big drugs from Celgene’s pipeline are approved by the FDA in time for certain deadlines.
The first of the three drugs – Celgene’s multiple sclerosis drug Zeposia (ozanimod) – was approved in March.
That leaves two complex cancer CAR-T cell therapies outstanding, and the FDA just extended the review period for one of them after BMS had to submit further data to support the filing.
The three-month extension of the review for lisocabtagene maraleucel (liso-cel) gives a new FDA action date of 16th November this year, around six weeks before the deadline of 31st December mandated by the CVR.
Liso-cel is a CAR-T (chimeric antigen receptor T-cell) therapy designed to target the protein CD19, a protein expressed during the formation of B-cells and maintained following their transformation into cancer cells.
Formerly known as JCAR017 it was originally developed by Celgene’s Juno unit, and is under review by the FDA for relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The value of the CVR slipped following the announcement, as investors got spooked by the tightness of the deadline.
While the FDA seems to be approving drugs on time at the moment, there are concerns that the ongoing COVID-19 pandemic could cause further delays as staffers at the regulator turn their attention to drugs and vaccines to fight the coronavirus.
The final drug in the CVR “bet” is bb2121, another CAR-T that Celgene developed in partnership with bluebird bio, which must get approved before 31st March next year.
Concerns over BMS and Celgene merger payout as FDA extends drug review
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