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GSK on Friday said the settlement reflected its desire to avoid distraction related to protracted litigation in this case. It did not admit any liability and said it would vigorously defend itself in any other Zantac cases. The trial was due to start on July 24, the first test of how Zantac cancer claims would fare before a jury. Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, said the Goetz settlement could create a precedent to settle other cases. "It also removes the distraction of any protracted litigation as the company must focus on its future pipeline which is where value will be created for shareholders," she said.

Persons: drugmaker, James Goetz, Emily Field, Lucy Coutts, JM Finn, Goetz, Dado Ruvic, Boehringer Ingelheim, Zantac, Natalie Grover, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: GSK, Barclays, GlaxoSmithKline, REUTERS, Pfizer, Sanofi, Companies, Bank of America, FDA, Thomson Locations: U.S, British, California, Delaware, London, Bengaluru

CompaniesCompanies Law Firms Pfizer Inc FollowSanofi SA FollowJune 23 (Reuters) - GSK (GSK.L) reached a settlement with a U.S. citizen who alleged its discontinued heartburn drug Zantac caused cancer, the British pharmaceutical giant said on Friday, preventing the first such lawsuit from going to trial. The case, brought by California resident James Goetz in Alameda County Superior Court, was to go to trial on July 24 and would have been the first test of how Zantac cancer claims fared before a jury. The parties reached a confidential settlement and the trial will be dismissed, GSK said. Originally marketed by a forerunner of GSK Plc, Zantac was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). Last month, a Canadian court dismissed a proposed class action against Zantac over increased cancer risk.

Persons: James Goetz, Zantac, Boehringer Ingelheim, GSK's, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: Law, Pfizer, Sanofi, GSK, Alameda County Superior Court, GSK Plc, U.S . Food, Drug Administration, Thomson Locations: California, Alameda County, U.S, Zantac, Bengaluru

☆ Novo Nordisk shares slip on EMA drug safety signal
▼ + stars: | 2023-06-22 | by ( ) www.reuters.com time to read: +2 min

reported that the European Medicines Agency (EMA) had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said. EMA's safety signal had also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Lars Otto Andersen, Lange, Andersen, " Andersen, Eli Lilly, Soren Lontoft Hansen, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, Sanofi, Thomson Locations: COPENHAGEN, Novo, Denmark's Novo, Copenhagen

☆ Novo Nordisk says EMA raised safety signal on drugs, shares fall
▼ + stars: | 2023-06-22 | by ( Nikolaj Skydsgaard | ) www.reuters.com time to read: +3 min

The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. reported the EMA safety signal. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. EMA's safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Eli Lilly, Ozempic, Lars Otto Andersen, Lange, Andersen, " Andersen, Soren Lontoft Hansen, semaglutide, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Sanofi, Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, FDA, Thomson Locations: Astrazeneca, COPENHAGEN, Denmark's Novo, Copenhagen

☆ Ukraine Recovery Conferece: War-torn economy needs private investors to rebuild
▼ + stars: | 2023-06-21 | by ( Hanna Ziady | ) edition.cnn.com time to read: +5 min

Ukraine faces an enormous fundraising challenge, and it’s one that governments and development finance institutions won’t be able to meet without help from private investors. The Ukraine Development Fund is still in the planning stages and is not expected to launch until the conflict ends. But it faces a crucial test Wednesday, when it will canvas support from governments and investors attending the London conference. Attracting private investmentThe Ukraine Development Fund aims to raise so-called concessionary capital from governments and development finance institutions, and then use that to attract private investment. Sunak also unveiled a “war-risk insurance” framework Wednesday, backed by Group of Seven countries, which will help limit potential losses faced by private investors in Ukraine.

Persons: London CNN —, Rishi Sunak’s, Antony Blinken, Sergei Chuzavkov, Volodymyr Zelensky, Stefan Weiler, JPMorgan’s, Weiler, It’s, ”, Brandon Hall, ” Hall, Yan Dobronosov, ” Zelensky, Sunak, ” Sunak, Lenna Koszarny, — Jo Shelley Organizations: London CNN, Conference, Citi, Sanofi, Philips, Bank, World Bank, BlackRock, JPMorgan, Ukraine Development Fund, CNN, Fund, London, BlackRock’s, Group of, Private, Horizon Locations: Russia, Ukraine, London, United States, Russian, Kyiv, Ukrainian, Europe, East, Africa, Kupiansk

☆ Sanofi says arbitration court rejects Boehringer's Zantac claims
▼ + stars: | 2023-06-20 | by ( Ludwig Burger | ) www.reuters.com time to read: +1 min

FRANKFURT, June 20 (Reuters) - Sanofi (SASY.PA) said on Tuesday that the International Chamber of Commerce rejected rival drugmaker Boehringer Ingelheim's (BI) claims to be indemnified by Sanofi in cancer lawsuits linked to heartburn drug Zantac in the United States. Shares in France's Sanofi, which added that the decision cannot be appealed, gained 2.4% shortly after the 0700 GMT market open, reaching a three-week high. Sanofi and Boehringer had sought arbitration to determine whether liability in lawsuits was transferred to the French group after it acquired the marketing rights from Boehringer in a 2017 deal. Sanofi reiterated that it regarded its defence of the underlying litigation as very strong. "There is no reliable scientific evidence that Zantac causes the alleged injuries in the cases brought against GSK, Pfizer, BI, Sanofi, and others in the U.S. litigation," the company said.

Persons: drugmaker Boehringer, Boehringer, Sanofi, Ludwig Burger, Kirsten Donovan, Emma Rumney Organizations: Sanofi, International Chamber of Commerce, GSK, Pfizer, BI, Thomson Locations: FRANKFURT, United States, Boehringer, U.S

Germany's DAX index (.GDAXI) fell 0.3% by 0750 GMT, retreating farther from a record high hit on Friday. The continent-wide STOXX 600 index (.STOXX) edged 0.1% lower. The chemicals index (.SX4P) slid 1.7%, leading sectoral declines. London's FTSE 100 index (.FTSE) rose 0.2%. Reporting by Shreyashi Sanyal in Bengaluru; editing by Eileen SorengOur Standards: The Thomson Reuters Trust Principles.

Persons: DAX, Boehringer's Zantac, Stuart Cole, drugmaker, Boehringer, Jerome Powell, Shreyashi Sanyal, Eileen Soreng Organizations: Europe Sanofi, Equiti, People's Bank of China, Sanofi, International Chamber of Commerce, Global Auto Holdings, Bank of, Investors, . Federal, Thomson Locations: Europe, China, United States, British, Bengaluru

☆ Drugmakers aim to strike down Medicare drug-price negotiations at Supreme Court
▼ + stars: | 2023-06-20 | by ( Spencer Kimball | ) www.cnbc.com time to read: +10 min

And Bristol Myers Squibb is trying protect its blood thinner Eliquis, which brought in $11.8 billion in sales last year, or about 25% of the company's $46 billion total revenue for 2022. Long legal battle aheadMerck, the chamber and Bristol Myers Squibb filed their lawsuits ahead of two key deadlines. Bristol Myers Squibb did not either. If circuit court decisions on the matter contradict one another, the Supreme Court would step in to decide the issue, Bagby said. Bristol Myers Squibb made an identical argument in its complaint.

Persons: Richard A, Gonzalez, Pascal Soriot, Giovanni Caforio, Jennifer Taubert, Johnson, Kenneth C, Frazier, Albert Bourla, Olivier Brandicourt, Win Mcnamee, Drugmaker Merck, Drugmaker, Bristol Myers Squibb, PhRMA, Eli Lilly, Merck, Bristol Myers, Robin Feldman, Nicholas Bagley, Bagley, Gretchen Whitmer, Chris Meekins, Raymond James, Antonin Scalia, Brett Kavanaugh, Neil Gorsuch, Meekins, Long, Xavier Becerra, Randolph Daniel Moss, Barack Obama, Judge Thomas M, Rose, George W, Bush, Kelly Bagby, Bagby, Amgen, Donald Trump, Karine Jean, Pierre, Biden, Jean, we'll, Becerra, Feldman Organizations: Senate, AbbVie Inc, AstraZeneca, Myers Squibb Co, Janssen Pharmaceuticals, Johnson, Merck & Co, Inc, Pfizer, Sanofi, Getty, U.S . Chamber of Commerce, Bristol Myers Squibb, Washington , D.C, Southern, Southern District of, Democratic Party, U.S, Merck, Bristol, Pharmaceutical Research, Manufacturers of America, CNBC, Medicare, University of California College of, Justice Department, Michigan Gov, Bristol Myers, Human Services, Centers, Services, AARP Foundation, HHS, AARP, Specialty Pharmacy, Reuters, Supreme, Appeals, Democratic, U.S . Sixth, Republican, Third, White Locations: America, Washington , DC, Bristol, U.S, Washington ,, Southern District, Southern District of Ohio, New Jersey, Commerce's Dayton , Ohio, San Francisco

☆ FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV
▼ + stars: | 2023-06-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the U.S. that can protect all infants from RSV. Nirsevimab is a monoclonal antibody made by AstraZeneca. Infants hospitalized with RSV often require oxygen support, intravenous fluids and are sometimes placed on a ventilator to support their breathing. There is another monoclonal antibody used against RSV called palivizumab. Nirsevimab is not considered a vaccine because it is a monoclonal antibody.

Persons: Infants, Biden, Palivizumab, Nirsevimab Organizations: Food and Drug Administration, FDA, AstraZeneca, Sanofi, Children Locations: U.S, Nirsevimab, United States, Canada, Europe, United Kingdom

☆ Sanofi: smoker's lung drug benefit was swift and sustained in trial
▼ + stars: | 2023-05-22 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

May 22 (Reuters) - The benefits of Sanofi (SASY.PA) and Regeneron's (REGN.O) anti-inflammatory drug Dupixent set in quickly during a trial to treat "smoker's lung" and lasted for the duration of the 1-year study, French drugmaker Sanofi said late on Sunday. The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial. Sanofi presented details on the successful study at the American Thoracic Society congress in Washington over the weekend. "Within two weeks we saw improvement in lung function and improvement in quality of life," said Naimish Patel, Sanofi head of global development for immunology and inflammation. "We will take these results to regulators and have a discussion about what can be done ahead of the read-out of the second trial," Patel said.

☆ Sanofi Wins Supreme Court Patent Dispute With Amgen
▼ + stars: | 2023-05-18 | by ( Jan Wolfe | ) www.wsj.com time to read: 1 min

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☆ Fact Check-Tdap vaccine use in pregnancy proven safe in studies, not ‘an experiment’
▼ + stars: | 2023-05-18 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

TDAP TRIALSThe Tdap vaccine can help prevent three diseases: tetanus, diphtheria, and pertussis, which is also known as whooping cough (here). Whooping cough can be “extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death,” according to the CDC (here). FDA-approved vaccine package-insert documentation for Adacel (here) and Boostrix (here) shows that neither manufacturer states the vaccine has not been tested in clinical trials. In 2017, about 49% of all pregnant women in the U.S. received a Tdap vaccine during their pregnancy (here). Clinical trials and population data have shown the Tdap vaccine to be safe and effective in pregnancy.

WASHINGTON, May 18 (Reuters) - The U.S. Supreme Court on Thursday ruled against Amgen Inc (AMGN.O) in its bid to revive patents on its cholesterol-lowering drug Repatha over a legal challenge by French rival Sanofi SA (SASY.PA). Amgen sought to patent a group of antibodies that help reduce so-called "bad" cholesterol. In 2014, Amgen sued Sanofi and Regeneron for patent infringement over their rival drug Praluent, which works by a similar mechanism as Repatha. The justices said that Supreme Court precedent weighed against Amgen. President Joe Biden's administration, arguing in support of Sanofi, told the justices that Amgen had not disclosed the information needed to make to make its patents valid.

☆ GOP law cut Big Pharma tax rates by 40%, Senate report says
▼ + stars: | 2023-05-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A Republican law has slashed the average tax rates of big pharmaceutical companies by more than 40% since it was enacted in 2017, Senate Finance Committee Democrats said in a report Thursday. That provision allowed U.S.-based pharmaceutical companies to access lower tax rates on their foreign income, the report said. Pharmaceutical companies report 75% of their taxable income overseas, the report said. The report said the average rate fell to 11.6% in 2019 and 2020, which resulted in billions of dollars in tax savings for pharmaceutical companies. Wyden also obtained similar information about other U.S. pharmaceutical companies, including Abbott Laboratories , Amgen , Bristol Myers Squibb and Merck .

Both sides blame each other for high drug prices. Senator Bernie Sanders, who chairs the Senate Health, Education, Labor, and Pensions (HELP) Committee, is a fierce critic of both industries and will likely grill the executives. Optum Rx CEO Heather Cianfrocco will say manufacturers alone set the drug prices and abuse patent protections to stifle competition, her written testimony shows. Lilly, Novo Nordisk, and Sanofi all said in March they were cutting list prices by more than 70% for some insulin products. Uninsured people often have to pay full list prices, an average of $900 a month, forcing many to ration or skip doses.

☆ Eli Lilly CEO vows not to raise insulin prices again, while Novo Nordisk and Sanofi hedge
▼ + stars: | 2023-05-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders, the committee's chair, asked Ricks and the CEOs of Novo Nordisk and Sanofi to commit to "never increase the price of any insulin drug again." Meanwhile, Novo Nordisk CEO Lars Fruergaard Jørgensen said the Danish company is committed to limiting price increases to "single digits." Net price refers to the amount insurers pay for an insulin drug after discounts and rebates. Sanofi said it plans to cut the price of its most popular insulin drug, Lantus, by 78% and reduce the list price of its short-acting insulin, Apidra, by 70%. At the hearing, Sanders called those actions "good news" and a result of public pressure.

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

☆ Regeneron's Eylea drug misses sales estimates as competition heats up
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +1 min

The drug recorded sales of $2.28 billion in the quarter, missing expectations of $2.43 billion, according to an average of six analysts' estimates polled by Refinitiv. The company has also been leaning on its anti-inflammatory drug Dupixent - a treatment currently approved for five indications including asthma and atopic dermatitis, or eczema. Quarterly sales of Dupixent, recorded by Regeneron's partner Sanofi (SASY.PA), rose about 37% to $2.49 billion, above expectations of $2.38 billion. Regeneron's total revenue of $3.16 billion beat estimates of $3 billion. Excluding items, the company reported a profit of $10.09 per share, above estimates of $9.56.

☆ Novo Nordisk rivals see room to compete in $100 billion weight-loss drug market
▼ + stars: | 2023-05-04 | by ( Michael Erman | ) www.reuters.com time to read: +6 min

The company has two oral GLP-1 drugs in mid-stage trials, and aims to choose one for a late-stage trial this year. He forecasts GLP-1s or similar drugs topping $100 billion in annual sales early in the 2030s, with Lilly's product accounting for more than $50 billion in sales. Smaller biotechs are also vying for a piece of the obesity market and hope large pharmaceutical companies will pay up for partnerships. "I don't know if it's $90 billion or $80 billion or $50 billion. The current GLP-1 drugs can cause nausea and vomiting.

☆ R.S.V. Vaccine Approved for Older Adults
▼ + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

☆ Sanofi Q1 profit buoyed by better-than-expected Dupixent sales
▼ + stars: | 2023-04-27 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

SummarySummary Companies Adj EPS still seen up by "low single digit" percentage in 2023Q1 operating profit, Dupixent sales beat consensusEstablished MS pill Aubagio hit by U.S. generic competitionApril 27 (Reuters) - French drugmaker Sanofi (SASY.PA) on Thursday posted better-than-expected earnings for the first quarter as continued gains from anti-inflammatory drug Dupixent more than offset declining sales from an established multiple sclerosis drug. It reported an 8.7% rise in quarterly business operating income, or adjusted earnings before interest and tax, to 3.33 billion euros ($3.7 billion), ahead of an average analyst estimate of 3.14 billion posted on the company's website. Revenue from eczema and asthma drug Dupixent, jointly developed with Regeneron (REGN.O), surged more than 43% to 2.32 billion euros, above a consensus of 2.27 billion euros. Finance chief Jean-Baptiste de Chatillon said in a media call that, for now, there would be no new annual peak sales estimate for the product, which Sanofi has put at more than 13 billion euros. ($1 = 0.9049 euros)Reporting by Ludwig Burger; Editing by Jacqueline WongOur Standards: The Thomson Reuters Trust Principles.

☆ Big Tech earnings, crucial inflation call — here comes the biggest week of earnings season
▼ + stars: | 2023-04-22 | by ( Zev Fima | ) www.cnbc.com time to read: +9 min

Stocks stuck to a holding pattern this week as investors brace for an incoming wave of Big Tech earnings and the Fed's favorite inflation reading. Earnings reports have generally been better than expected so far this first quarter. Humana (HUM) reports before the bell Wednesday; Meta Platforms and Pioneer Natural Resources (PXD) report after the bell Wednesday. ET: Personal Spending & Income (includes PCE Price Index) Club trades this week Just one trade: We added 150 shares of Coterra Energy (CTRA) on Wednesday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.

☆ Eli Lilly, Novo Nordisk and Sanofi CEOs to testify before Senate on lowering insulin prices
▼ + stars: | 2023-04-21 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

In this photo illustration, an insulin pen manufactured by the Novo Nordisk company is displayed on March 14, 2023 in Miami, Florida. Those companies — Eli Lilly, Novo Nordisk and Sanofi — had announced in March that they will slash prices of their most widely used insulin products by 70% or more. The companies' versions of insulin cost at least $275 before the announced price slashes, Sanders noted. Novo Nordisk said its CEO looks forward to "a productive and collaborative discussion about this important issue." PBMs have come under criticism for inflating drug prices and not passing on all the discounts they negotiate to consumers.

☆ Senate legislation would cap insulin at $35 per month for people with private insurance
▼ + stars: | 2023-04-21 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

In this photo illustration, insulin pens manufactured by the Novo Nordisk company are displayed on March 14, 2023 in Miami, Florida. Bipartisan Senate legislation introduced Friday would cap the price of insulin at $35 per month for people with private insurance. Biden's Inflation Reduction Act, which became law last year, capped the price of insulin at $35 a month for seniors on Medicare. More than 2 million patients with diabetes who take insulin are privately insured, according to the Health and Human Services Department. In March, Eli Lilly, Novo Nordisk and Sanofi announced they would slash prices of their most widely used insulin products in response to growing public pressure to address rising costs.

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. Sanofi in 2009 acquired the rights to Auvi-Q, an epinephrine auto-injector intended to compete with EpiPen. Injection of epinephrine is used to treat serious and sometimes life-threatening allergic reactions to foods, medications, bee stings and other causes. Circuit Court of Appeals last July agreed, noting that the exclusive contracts in question were "a normal competitive tool within the epinephrine auto-injector industry." The 10th Circuit added that Sanofi could have competed on those terms, but instead chose initially to market Auvi-Q as a more expensive, premium product.

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