AstraZeneca: Covid Vax 2nd Dose Showed No Increased Incidence of Thrombosis

 AstraZeneca PLC said Wednesday that analysis of its Covid-19 vaccine Vaxzevria showed no increased incidence of thrombosis with thrombocytopenia syndrome after a second dose.

The estimated rate of thrombosis with thrombocytopenia syndrome was 2.3 for every million vaccines, with incidence rates comparable to those among unvaccinated individuals, the Cambridge, U.K.-based pharmaceutical company said.

After the first dose, the rate was 8.1 per million vaccines, AstraZeneca said.

No specific risk factors or definitive cause have been identified in the safety data, the company said.

AstraZeneca said the data was published in the medical journal The Lancet, and that its database included reported cases of thrombosis with thrombocytopenia syndrome globally up to April 30 occurring within 14 days of administration of the first or second dose of its vaccine.

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Thermo Fisher 2Q Sales, Earnings Grow

 Thermo Fisher Scientific Inc.'s second-quarter sales and earnings figures came in above analysts' expectations, as the company recorded double-digit sales growth across its business segments compared with the pandemic-affected year-earlier period.

The Waltham, Mass.-based scientific-equipment company Wednesday posted earnings of $4.61 a share, a rise from $2.90 a share. Net income rose to $1.83 billion from $1.16 billion, it said.

Stripping out one-time items, the company's adjusted profit was $5.60 a share. Analysts surveyed by FactSet had forecast an adjusted profit of $5.47 a share.

Revenue climbed to $9.27 billion from $6.92 billion, the company said. Analysts had been anticipating revenue of $8.73 billion. Organic revenue growth was 28%, with a 2% contribution from acquisitions.

Life-sciences solutions sales grew 37% to $3.56 billion, and sales of lab products and services rose 29% to $3.58 billion. Analytical-instrument sales were up 41% at $1.48 billion, while specialty-diagnostics sales climbed 25% to $1.24 billion, the company said.

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XOMA Gets Orphan Drug Designation for Pancreatic Cancer Treatment

 XOMA Corp. said its NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. Food and Drug Administration.

The company said NIS793 is a potential first in class novel antibody specific for transforming growth factor beta.

An Orphan Drug Designation grants special status to a drug that treats a rare disease or condition and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these severe diseases.

Under the terms of a 2015 agreement between XOMA and Novartis AG, XOMA has the potential to earn up to $445 million in additional milestone payments. Upon receipt of regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on any net product sales that range from the mid-single digits to the low double digits.

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Asensus Surgical Shares Rise on FDA Approval of New Instruments

 Asensus Surgical Inc. shares were up 8% to $2.33 in early trade Wednesday after the company said it has received Food & Drug Administration 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System technology platform.

The medical device company said the articulating instruments offer better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the European Union.

Asensus Surgical's technology platform, the Senhance Surgical System, is a digital laparoscopic platform that uses augmented intelligence to provide unmatched performance and patient outcomes through machine learning.

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EU signs deal with GSK for supply of potential COVID drug

 

The European Union has signed a contract with GlaxoSmithKline for the supply of up to 220,000 treatments of its investigational monoclonal antibody therapy sotrovimab against COVID-19, it said on Wednesday.

The drug, which is developed together with U.S. firm Vir Biotechnology, can be used for the treatment of high-risk coronavirus patients with mild symptoms who do not require supplemental oxygen, according to the Commission.

The deal is a boost to GSK work on potential treatments for COVID-19 after the company played a limited role in the development of vaccines. Rather than making its own coronavirus shot, GSK has focused on supplying its booster to other developers and has partnered with Sanofi to develop a jab.

GSK confirmed the deal in a statement on Wednesday, saying it represented "a crucial step forward for treating cases of COVID-19" in Europe.

The drug is currently being assessed by the European Medicines Agency (EMA) under a rolling review.

It has received emergency authorisation in the United States to treat mild-to-moderate COVID-19 patients who are at high risk of developing a severe infection.

The contract has been backed by 16 of the 27 EU states, which can buy the drug only after it is approved by EMA or by national drug regulators. The price agreed for potential purchases has not been disclosed. A spokesman for the Commission declined to comment on the matter.

Monoclonal antibodies mimic natural antibodies that the body generates to fight infection.

The deal with GSK follows a contract the EU signed in April with Swiss pharmaceutical giant Roche to secure about 55,000 doses of a potential treatment based on a cocktail of monoclonal antibodies developed by Roche together with U.S. drugmaker Regeneron.

Apart from monoclonal treatments, the only other anti-COVID drug the EU has bought is Gilead's remdesivir, an antiviral medicine. Last year, the EU reserved half a million courses after the drug obtained a conditional EU approval.

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Bristol Myers sees return to growth for Opdivo, tops estimates

 

Bristol Myers Squibb Co reported second quarter earnings that topped Wall Street estimates, as sales of flagship cancer treatment Opdivo returned to growth after missing estimates in the previous quarter.

Excluding one-time items, Bristol Myers reported earnings of $4.3 billion, or $1.93 per share, beating analyst estimates of around $4.2 billion and $1.89 per share, according to IBES data from Refinitiv.

Bristol Myers reported second quarter revenues of $11.7 billion, 16% higher than in the same period last year, driven in part by sales of Opdivo that exceeded $1.9 billion for the quarter, 16% higher than in the quarter ended June 30, 2020.

"The highlight that is driving that strong performance is Opdivo and its return to growth," said David Elkins, Bristol-Myers' chief financial officer.

Opdivo revenues benefitted from approvals in new tumor types and its increasing use as an initial treatment for advanced lung cancer, Elkins said.

Bristol Myers' second quarter results mark a reversal from its performance last year, where a 3% decline in sales of Opdivo contributed to lower-than-expected earnings.

Bristol Myers still expects full-year earnings in the range of $7.35 to $7.55 a share

In the second quarter, Bristol Myers announced two deals with biotechs Agenus Inc and Eisai Co to develop and market new cancer drugs and it expects to do additional deals to build out its portfolio of medicines, Elkins said.

"With the financial flexibility we have, we are really focusing on replenishing and diversifying the portfolio," Elkins said. He added that Bristol Myers is more likely to engage in deals for individual products as opposed to large scale corporate M&A.

Revlimid, the blockbuster cancer drug Bristol Myers acquired in its $74 billion deal for Celgene in 2019, will lose some of its U.S. patent exclusivity in 2022, putting pressure on the company to add new products to its pipeline.

The COVID-19 pandemic continues to affect Bristol Myers but the drugmaker saw a significant improvement in the second quarter in many of its businesses, said Chief Commercial Officer Chris Boerner.

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Teva profit rise misses forecasts, sees lower 2021 sales

 

Israel-based Teva Pharmaceutical Industries reported a smaller-than-expected rise in second-quarter profit on Wednesday but reaffirmed earnings guidance for the year despite saying that the COVID-19 pandemic could hurt sales.

The world's largest generic drugmaker was optimistic it could reach a settlement this year in the United States regarding lawsuits over its role in the nationwide opioid epidemic, said CEO Kare Schultz.

"We don't have a lot of money so... there's no way we can offer a lot of money but what we can offer...is to manufacture generics" to help wean people off of addictive painkillers, Schultz told Reuters in an interview.

Teva said it expects revenue of $16-$16.4 billion for the year, $0.4 billion below its previous estimate, but kept its earnings per share forecast of $2.50-$2.70.

"Due to the effects of the pandemic, we have lowered our 2021 revenue outlook, while reaffirming our earnings and cash flow guidance," Schultz said.

The company, he said, had been cautious on overall spending this year due to the uncertainty surrounding the coronavirus crisis, so it was able to protect the bottom line.

Teva earned 59 cents per diluted share excluding one-time items in the April-June period, up from 55 cents a year ago.

Quarterly revenue was $3.91 billion, an increase of 1% or a decrease of 2% in local currency terms from the previous year, the company said, citing lower sales in North America. Teva saw growth in its two main branded drugs, Huntington's disease treatment Austedo and migraine product Ajovy.

Analysts had forecast earnings of 63 cents a share ex-items on revenue of $4.06 billion, according to I/B/E/S data from Refinitiv.

Teva, along with other drugmakers, has been accused of misleadingly marketing their pain medicines as safe, fueling the overuse of opioids in the United States.

Asked about a possible settlement on the opioid cases, Schultz told analysts the company has been in an ongoing dialogue with the Attorney General and the plaintiff lawyers.

"We are optimistic that we can reach a settlement during the coming year," he said. "We think a settlement will be to the benefit of all the Americans that suffer from substance abuse."

Teva has had extensive talks with manufacturers of COVID-19 vaccines to see if it can assist in filling, packing and distributing shots but has no indications of an imminent agreement, Schultz told Reuters.

"We have basically been in contact with all the big manufacturers of the current vaccines...and none of this has come to fruition," he said.

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