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Thursday, July 25, 2019

BioCardia extends Helix collaboration with AstraZeneca

BioCardia (OTCQB:BCDA) inks an extension to its 2017 development agreement with AstraZeneca (NYSE:AZN) for its Helix biotherapeutic delivery catheter system.
In the preclinical phase of the partnership, BCDA will receive an unspecified upfront payment. The deal is exclusive for a class of biotherapeutic agents that BCDA is not developing on its own or with other parties and is time limited.
Helix has been chosen for use in 12 cell and gene therapy clinical trials to date, nine outside of BCDA.

Bristol-Myers Squibb EPS beats by $0.12, beats on revenue

Bristol-Myers Squibb (NYSE:BMY): Q2 Non-GAAP EPS of $1.18 beats by $0.12; GAAP EPS of $0.87 misses by $0.12.
Revenue of $6.27B (+10.0% Y/Y) beats by $170M.
Shares -0.51% PM.

Baxter EPS beats by $0.08, beats on revenue

Baxter (NYSE:BAX): Q2 Non-GAAP EPS of $0.89 beats by $0.08; GAAP EPS of $0.66 misses by $0.06.
Revenue of $2.84B (flat Y/Y) beats by $40M.

Roche Q2 top-line up 8%

Roche Holding (OTCQX:RHHBYQ2 results (CHF): Revenues: 30,469M (+8.4%); Pharmaceuticals: 24,194M (+10.7%); Diagnostics: 6,275M (+0.2%).
Top-selling Pharmaceuticals: Avastin: 3,659M (+7%); MabThera/Rituxan: 3,339M (-4%); Herceptin: 3,264M (-9%); Perjeta: 1,755M (+34%); Ocrevus: 1,735M (+63%); Actemra/RoActemra: 1,135M (+8%); Xolair: 972M (+1%); Lucentis: 928M (+10%); Tecentriq: 782M (+141%); Activase/TNKase: 686M (+2%).
Net Income: 8,904M (+18.5%); Non-GAAP EPS: 11.12 (13.0%).
2019 Guidance: Sales: mid- to high-single digit growth, at constant exchange rates.
https://seekingalpha.com/news/3481514-roche-q2-top-line-8-percent

Wednesday, July 24, 2019

Former U.S. pro football players may face increased risk of heart rhythm problem

Former players from the National Football League may face an increased risk of a type of irregular heartbeat that could lead to stroke, a new study suggests.
Researchers found that retired NFL players were nearly six times as likely to develop atrial fibrillation as men of the same age in the general population, according to results published in the Journal of the American Heart Association.
“We have to be aware that athletes who participate in these kinds of sports, particularly retired NFL players, do have an increased risk of atrial fibrillation compared to the general population,” said Dr. Dermot Phelan, director of the Sports Cardiology Center at the Cleveland Clinic in Ohio and the study’s senior author. “Athletes need to make sure they continue to go for annual physicals where this can be checked out.”
Atrial fibrillation occurs when the electrical impulses that spark each heartbeat fire erratically. That causes the atria, the top chambers of the heart, to almost quiver rather than pumping blood out, which can result in blood pooling and clotting. If a clot in an atrium travels to a blood vessel that leads to the brain, there can be a stroke.
The American Heart Association estimates that more than 2.7 million people in the U.S. experience atrial fibrillation - sometimes known as AFib - making it the most common irregular heart rhythm.
Studies have linked long-term participation in endurance sports such as marathon running with an increased risk of atrial fibrillation. Phelan and his colleagues suspected that a similar connection might be found in sports that require muscle strength.
To test the hypothesis, the researchers compared 460 retired pro football players to 925 men from the Dallas Heart Study, who served as the control group. Both groups of men were middle aged and about half in each group were African American.
In both groups, information on participants’ history of high blood pressure, high cholesterol, diabetes, coronary artery disease, stroke and heart failure came from self-reports and were not measured.

Overall, the retired NFL players had fewer cardiovascular risk factors, such as type-2 diabetes and high blood pressure. Most of the former players also had lower resting heart rates compared to the men from the DHS.
But 23 of the retired players, or 5%, had atrial fibrillation, as compared with five men in the control group, or 0.5%. Accounting for other AFib risk factors like heart failure, coronary artery disease, hypertension and diabetes, the researchers calculated the retired NFL players had 5.7 times the risk of developing atrial fibrillation compared to the control group.
Fifteen of the 23 NFL players with atrial fibrillation had not previously been diagnosed and had no symptoms. No new cases of atrial fibrillation were found in the control group.
“It’s known that endurance athletes - the elite ones who are middle aged and have done it for many years - are at increased risk,” Phelan said. “This is the first time this has been looked at in strength-type sports.”
It’s not clear why strength sports might lead to irregular heart rhythms, Phelan said.

The new study is a “good initial observation, but we will have to have more objective evidence of (other health conditions) and risk factors plus long-term monitoring of atrial fibrillation for there to be a clear correlation,” said Dr. Johanna Contreras, an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai and director of heart failure at Mount Sinai St Luke’s in New York City.
One issue with the study is that “there are many other factors that can increase the incidence of atrial fibrillation, like age, smoking, alcohol use, steroid use, poor sleeping hygiene, and sleep apnea,” Contreras said. “There was also no objective verification of diabetes, hypercholesterolemia and hypertension, which are associated with an increased incidence of atrial fibrillation.”
SOURCE: bit.ly/2LDWpIk Journal of the American Heart Association, online July 24, 2019.
https://www.reuters.com/article/us-health-profootball-atrial-fibrillatio/former-u-s-pro-football-players-may-face-increased-risk-of-heart-rhythm-problem-idUSKCN1UJ2Y3

White House reported preparing order that would cut drug prices for Medicare

U.S. President Donald Trump is considering a sweeping executive order that would cut prices on virtually all branded prescription drugs sold to Medicare and other government programs, according to two industry sources who had discussions with the White House.
The order under discussion would be much broader than the Administration’s previously disclosed proposal to lower prices on physician administered, or Part B, drugs by tying prices to lower costs in other countries.
The administration is now looking at ways to use this or a similar method to lower prices in Medicare’s much larger Part D, which is for widely used prescription drugs patients take at home, such as for cholesterol and blood pressure, the sources said.
The White House declined to comment, and it was unclear how far along the any such plan was from being undertaken. The U.S. Department of Health and Human Services, also declined to comment.
Americans pay the highest prices for prescription drugs in the world as most other developed nations have single-payer systems in which the government negotiates drug prices for its people.
The U.S. government in 2016 spent around $29 billion on prescription drugs in Medicare’s Part B, which includes most injectable drugs, and nearly $100 billion in Part D, which covers as pills and other drugs usually dispensed in pharmacies.
Trump is also considering extending the pricing controls to the U.S. Department of Defense, which runs the Tricare health plan for military personnel and their families, as well as the Department of Veterans Affairs, the sources said.

Executive orders often go through various drafts and incarnations, and sometimes competing versions of the same order are floated within the Trump White House. In addition, some executive orders do not end up being signed.
The drug pricing executive order could come as soon as the next few weeks, the sources said.
U.S. Senators Chuck Grassley and Ron Wyden – the top Republican and Democrat on the U.S. Senate Finance Committee – earlier this week announced a proposal to lower prescription drug prices that could save $100 billion in costs to government healthcare programs.
The White House could delay the executive order if the Senate bill looks likely to garner bipartisan support, the sources said.
If implemented, the executive order could significantly increase the number of drugmakers whose sales could take a hit. AbbVie, Eli Lilly and Co and Pfizer Inc all have substantial exposure to Medicare Part D. Companies with major exposure to Part B include Merck & Co, Bristol-Myers Squibb Co and Roche
In early July, Trump said his administration was working on a drug pricing executive order with a “favored-nation clause, where we pay whatever the lowest nation’s price is.” Trump has called the lower prices paid by other nations “global freeloading.”
Trump, a Republican, has struggled to deliver on a pledge to lower drug prices before the November 2020 election. Healthcare costs are expected to be a major focus of the campaign by Trump and Democratic rivals vying to run against him.

The Trump administration earlier this month scrapped an ambitious policy that would have required health insurers to pass billions of dollars in rebates they receive from drugmakers to Medicare patients.
Also in July, a federal judge struck down a Trump administration rule that would have forced pharmaceutical companies to include the wholesale prices of their drugs in television advertising.

Lilly’s hypoglycemia treatment wins FDA approval

The U.S. Food and Drug Administration approved Eli Lilly and Co’s treatment for severe hypoglycemia, the health regulator said on Wednesday.
Hypoglycemia is a condition in which blood sugar falls to dangerously low levels.

Severe hypoglycemia typically occurs in people with diabetes who are using insulin treatment, the FDA said and noted that the therapy, Baqsimi, is approved to treat the severe form of the condition in patients with diabetes aged four and older.
Baqsimi is a powder that is administered into the nose. It is the first glucagon therapy approved for the emergency treatment of the condition, without using an injection, the agency said.

“This new way to administer glucagon may simplify the process, which can be critical during an episode,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The FDA said that injectable glucagon has been approved for use in the United States for several decades.