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[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. Circuit Court of Appeals ruled that federal law preempts the plaintiffs' state-law claims that GSK failed to warn doctors and pregnant women that animal studies found a link between birth defects and taking Zofran. Louis Bograd, a lawyer for the plaintiffs at Motley Rice, did not respond to a request for comment. Without any newly acquired information, GSK could not legally change the label without the FDA's blessing, Kayatta wrote. For the plaintiffs: Louis Bograd of Motley RiceFor GSK: Lisa Blatt of Williams & ConnollyRead more:Zofran birth defect cases should be revived, say hundreds of plaintiffsGSK defeats 425 lawsuits alleging Zofran causes birth defects(NOTE: This story has been updated with a comment from GSK.)

☆ J&J's consumer health unit Kenvue files for IPO, moving closer to spin-off
▼ + stars: | 2023-01-04 | by ( ) www.reuters.com time to read: +2 min

Jan 4 (Reuters) - Johnson & Johnson's (JNJ.N) consumer health unit Kenvue on Wednesday filed to be listed as an independent company, bringing the healthcare conglomerate a step closer to completing the biggest shakeup in its 135-year history. The filing, for Kenvue to list on the New York Stock Exchange under the ticker symbol "KVUE", comes more than a year after Johnson & Johnson announced its plan to break up into two companies. J&J's pharmaceutical and medical equipment units, which make cancer treatments and surgical tools, had recorded nearly $80 billion in sales in 2021, far ahead of its consumer products revenues. General Electric's (GE.N) spun-off healthcare unit, GE HealthCare Technologies , debuted as an independent company on Nasdaq on Wednesday. Kenvue said J&J will continue to own at least 80.1% of the voting power of the company's shares upon completion of the offering.

In 2022, drugmakers raised prices on more than 1,400 drugs according to data published by 46brooklyn, a drug pricing non-profit that is related to 3 Axis. The median drug price increase was 4.9% last year, while the average increase was 6.4%, according to 46brooklyn. Antonio Ciaccia, president of 3 Axis, said that drugmakers have focused on launching their drugs at higher prices because of the attention paid to annual price increases. More drug prices are likely to be announced over the course of January - historically the biggest month for drugmakers to raise prices. Sanofi plans to raise prices on 14 of its drugs or vaccines.

Giuseppe Bivona and Marco Taricco, Bluebell's partners, wrote to Fink, saying they want someone else to run the company. Bluebell was founded in 2019 and has taken on companies including GlaxoSmithKline, Glencore, Vivendi and Danone, where it engineered the ouster of former CEO Emmanuel Faber. "Fink clearly has political ambitions because it is not his job as chief executive of BlackRock to dictate energy policy,” Bivona told Reuters in an interview. BlackRock did not support Bluebell's campaign to oust the CEO of chemical company Solvay or at Leonardo SpA (LDOF.MI), where Bluebell wanted to promote a liability action against the CEO. A BlackRock spokesman said it did not "support Bluebell's campaigns as we did not consider them to be in the best economic interests of our clients."

WASHINGTON, Nov 7 (Reuters) - The U.S. Supreme Court on Monday rebuffed a bid by Bristol Myers Squibb Co's Juno Therapeutics Inc to reinstate a $1.2 billion award it won in its patent fight with Gilead Sciences Inc (GILD.O) subsidiary Kite Pharma Inc over a lymphoma drug. The justices turned away Juno's appeal of a lower court's ruling throwing out the award in the litigation over Kite's biologic drug Yescarta, in a case that could have repercussions for the cutting-edge biologic drug industry. Juno and Sloan Kettering Institute for Cancer Research sued Kite in 2017 in federal court in Los Angeles, accusing it of copying technology that the institute licenses to Juno. Juno and Sloan Kettering have told the Supreme Court that the Federal Circuit's decision to invalidate the patent and other rulings against biologic patents have been "devastating for innovation." On Nov. 4, the Supreme Court took up another patent case involving biologic drugs, agreeing to hear Amgen's bid to revive patents on its cholesterol drug Repatha.

☆ GSK lifts earnings view again after forecast-beating quarter
▼ + stars: | 2022-11-02 | by ( Natalie Grover | ) www.reuters.com time to read: +2 min

[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. Shingrix generated sales of 760 million pounds ($873 million) compared with the GSK-compiled analyst consensus forecast for 685 million pounds. In July, GSK had predicted 2022 sales growth of 6% to 8% and adjusted operating profit to climb by 13% to 15%, both increases on forecasts issued in February. GSK said it had incurred a charge of 45 million pounds in the third quarter, primarily reflecting provisions for increased legal fees related to heartburn drug Zantac. Originally marketed by a forerunner of GSK, Zantac has been sold by several companies at different times, including Pfizer (PFE.N), Boehringer Ingelheim and Sanofi (SASY.PA) as well as a plethora of generic drugmakers.

☆ GSK lifts 2022 forecast again after stronger than expected quarter
▼ + stars: | 2022-11-02 | by ( Natalie Grover | ) www.reuters.com time to read: +1 min

[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration/File PhotoNov 2 (Reuters) - GSK (GSK.L) on Wednesday GSK (GSK.L) on Wednesday smashed analysts' estimates for third-quarter earnings, driven by higher sales of its blockbuster shingles vaccine, Shingrix. This quarter, Shingrix blew past expectations by generating sales of 760 million pounds ($872.86 million) compared to the GSK-compiled consensus of 685 million pounds. GSK reported third-quarter adjusted profit of 46.9 pence on sales of about 7.83 billion pounds, compared with a company-compiled analyst consensus of 40.1 pence on sales of 7.32 billion pounds. Previously in July, GSK had predicted that 2022 sales would rise 6% to 8% and adjusted operating profit to climb by 13% to 15%, boosting a forecast for 2022 guidance issued in February.

☆ New GSK shines brighter with another forecast upgrade
▼ + stars: | 2022-11-02 | by ( Natalie Grover | ) www.reuters.com time to read: +3 min

Shingrix generated quarterly sales of 760 million pounds ($873 million), compared with the GSK-compiled analyst consensus forecast for 685 million pounds. GSK shares hit a 2-1/2 month high of 1,470.2 pence in early trade and were last up 1% at 1,461.3 pence. GSK said it had incurred a charge of 45 million pounds in the third quarter, primarily reflecting provisions for increased legal fees related Zantac. Originally marketed by a forerunner of GSK, Zantac has been sold by companies including Pfizer (PFE.N), Boehringer Ingelheim and Sanofi (SASY.PA), as well as many generic drugmakers. GSK reported a third-quarter adjusted profit of 46.9 pence per share on sales of about 7.83 billion pounds, topping analysts' forecasts for 40.1 pence and 7.32 billion pounds.

☆ Morning Bid: Fed up waiting
▼ + stars: | 2022-11-02 | by ( ) www.reuters.com time to read: +2 min

The market widely expects a fourth straight 75 basis-point hike, but what comes next has arguably been the bigger issue on investors' minds over the past month. With several parts of the U.S. Treasury yield curve pointing to a possible recession even as data continues to show a still-strong economy, comments from Fed Chair Jerome Powell will take the spotlight. Markets want signs of a pivot, ING economists said. In Asia, Hong Kong and China stocks continued their ascent, a day after social media rumours that China was planning a reopening from strict COVID curbs next year triggered a sharp rally. The rumour was shot down but suggests battered China shares (.SSEC) were primed for a rebound on any signs of positive news.

☆ Stock futures are flat ahead of key Fed policy decision
▼ + stars: | 2022-11-01 | by ( Tanaya Macheel | ) www.cnbc.com time to read: +2 min

Stock futures were little changed Tuesday night as investors brace themselves for the Federal Reserve's latest policy decision at the conclusion of its meeting on Wednesday. S&P 500 futures and Nasdaq 100 futures traded just below the flat line. In regular trading, the major stock averages ended the day lower after job openings in September showed a resilient labor market. "That's just not a great number for the Fed, it's still a tight job market," Greene said. In addition to the Fed policy decision, investors will also be watching for mortgage application data and ADP's employment report, both due out Wednesday morning.

☆ New RSV vaccines may soon put an end to rough seasons
▼ + stars: | 2022-10-31 | by ( Brenda Goodman | ) edition.cnn.com time to read: +15 min

The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies. In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them. Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine. The vaccines for pregnant women are meant to get newborns through their first RSV season.

☆ Top U.S. official urges caution with RSV, vaccine in development
▼ + stars: | 2022-10-28 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, Oct 28 (Reuters) - U.S. officials are working on a respiratory syncytial virus (RSV) vaccine, but until one is available people should exercise caution, especially seniors and parents of young children, the nation's top infectious disease official said. A vaccine for the infectious respiratory disease will hopefully come within the next year or two, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci told MSNBC in an interview. RSV is not a new virus but it is a leading cause of pneumonia in toddlers and the elderly and can lead to hospitalization or death. While there is a higher concentration of RSV impacting U.S. children at the moment, it can also be a serious disease for older adults, he added. "If you're an elderly person, you are vulnerable to the serious consequences of RSV," Fauci told MSNBC.

That there is no RSV vaccine for kids is not for lack of interest, experts say. But a trial gone wrong many years ago and a tricky target protein have made developing an RSV vaccine difficult. Researchers’ attempts to develop an RSV vaccine go back decades, according to Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children's Hospital. In August, Pfizer announced that its experimental RSV vaccine was nearly 86% effective in preventing severe illness in adults ages 60 and older. GSK, however, said it abandoned its efforts last year to develop a pediatric RSV vaccine, because trials suggested it wasn't effective.

REUTERS/Dado Ruvic/Illustration/Oct 26 (Reuters) - GSK Plc (GSK.L) came closer to securing its first drug approval since its consumer health spin-off in July as an expert panel of the U.S. health regulator backed an approval for its drug to treat anemia in some patients with chronic kidney disease (CKD). The advisers to the Food and Drug Administration on Wednesday voted 13-3 in favor of the oral drug for patients on dialysis, although GSK was expecting approval for a broader CKD population. The panel, hesitant about backing the drug for patients not on dialysis, voted 11-5 against it for that group, citing increased safety risks such as heart failure. read moreGSK's drug, daprodustat, is the first from the HIF-PH inhibitor class to win U.S. FDA panel's endorsement. The FDA, which usually follows the recommendations of its expert panel, is expected to make its final decision on the drug by Feb. 1.

☆ Unilever is losing its CEO Alan Jope as the company finds itself at an inflection point. Insiders have questioned the massive reorganization and the entrenched 'too nice' culture he presided over.
▼ + stars: | 2022-09-28 | by ( Alex Bitter | Ellen Thomas | ) www.businessinsider.com time to read: +9 min

Editor's note: On Sunday, Unilever said that CEO Alan Jope will retire at the end of 2023. It looks at some of the challenges that Jope and Unilever faced in streamlining its structure through the reorganization, including a culture that is 'too nice' at times. Two of the five divisions remain focused on food products, an area that CEO Jope said Unilever considered spinning off. One former Unilever executive pointed to Fernando Fernandez, who will assume the top job at the company's new beauty and wellbeing division. Fernandez has been Unilever's executive vice president for Latin America since 2019 and held other jobs with the company in the region before that.

Unilever logo is displayed on Dove soap boxes in this illustration taken on January 17, 2022. Unilever's search begins at a time of soaring food and energy prices which are hitting household budgets and hurting consumer confidence. The move was met with disapproval from shareholders, some of whom also criticised Unilever for prioritising sustainability over core growth. "This may signal more welcome future change at Unilever," Tineke Frikee, fund manager at Unilever investor Waverton Asset Management, said. A Unilever spokesperson said the company is "fully committed to the organisational changes" and that Jope is "completely committed to delivering against that strategy."

☆ Unilever CEO Alan Jope to retire at end of 2023
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterUnilever logo is displayed on Dove soap boxes in this illustration taken on January 17, 2022. REUTERS/Dado Ruvic/IllustrationSept 26 (Reuters) - Unilever (ULVR.L) CEO Alan Jope plans to retire at the end of 2023, the maker of Dove soap and Knorr stock cubes said on Monday, roughly two months after activist investor Nelson Peltz joined the board. The British consumer goods maker said its board would start a formal search for his successor, considering both internal and external candidates. Register now for FREE unlimited access to Reuters.com RegisterThe move was met with disapproval from shareholders, some of whom also criticised Unilever for prioritising sustainability over core growth. ($1 = 0.9410 pounds)Register now for FREE unlimited access to Reuters.com RegisterReporting by Yadarisa Shabong in Bengaluru and Richa Naidu in London; Editing by Saumyadeb Chakrabarty and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.

☆ GSK picks Burberry's Brown as CFO
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +2 min

Register now for FREE unlimited access to Reuters.com RegisterGSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration/SummarySummary Companies Brown to join GSK in April, start as CFO in MayCFO Iain Mackay to retireSept 26 (Reuters) - GSK (GSK.L) named luxury fashion brand Burberry's (BRBY.L) Julie Brown as its new chief financial officer on Monday to succeed Iain Mackay, at a time when the British drugmaker is sharpening focus on its core business. The change comes after GSK spun off its large consumer business, Haleon (HLN.L), to focus on prescription drugs and vaccines. Burberry had said on Friday that Brown would step down as its CFO and chief operating officer in April to take up a role outside the luxury industry. Register now for FREE unlimited access to Reuters.com RegisterReporting by Amna Karimi and Pushkala Aripaka in Bengaluru; Editing by Subhranshu Sahu and Louise HeavensOur Standards: The Thomson Reuters Trust Principles.

☆ GSK Taps Burberry Executive As CFO
▼ + stars: | 2022-09-26 | by ( Jennifer Williams-Alvarez | Mark Maurer | ) www.wsj.com time to read: +3 min

Pharmaceutical firm GSK PLC hired the finance chief of British luxury fashion group Burberry Group PLC to lead its finances as it works to develop new medicines after the recent spinoff of its consumer-health business. Brentford, U.K.-based GSK, a maker of cancer and asthma medications, on Monday named Julie Brown as chief financial officer and executive director, effective next spring. Ms. Brown serves as chief operating and financial officer at Burberry, a role she has held since 2017. “Julie is a highly experienced CFO with a tremendous understanding of the biopharma sector,” Emma Walmsley, chief executive officer at GSK, said in a release. Burberry on Friday said a search is under way for the successor of Ms. Brown.

Mackay, 60, will be retiring next year after serving as GSK's finance chief for nearly four years, following an eight-year stint as group finance director at the bank HSBC. Register now for FREE unlimited access to Reuters.com RegisterBrown, also 60, will join GSK in April and take up the job in May. She also served in several finance roles at AstraZeneca (AZN.L), which last year also appointed a female CFO, Aradhana Sarin. With Emma Walmsley as GSK's chief executive officer, Brown's appointment also creates a rare, all-female top management at a blue-chip (.FTSE) British company and a global pharma major. Brown will receive an annual base salary of more than 900,000 pounds at GSK, the company said.

Register now for FREE unlimited access to Reuters.com RegisterGSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration/SummarySummary Companies Brown to join GSK in AprilIain Mackay to retire in MaySept 26 (Reuters) - Britain's GSK (GSK.L) has appointed its first female chief financial officer, Julie Brown, to succeed Iain Mackay, as the drugmaker focuses on its core pharmaceuticals business. With Emma Walmsley as GSK's chief executive, Brown's appointment also creates a rare, all-female top management at a blue-chip (.FTSE) British company and a global pharma major. Mackay, 60, will retire next year after almost four years as GSK's finance chief, before which he completed an eight-year stint as group finance director at HSBC. She also served in several finance roles at AstraZeneca (AZN.L), which last year appointed a female CFO, Aradhana Sarin.

☆ GSK poaches Burberry CFO Julie Brown to create all-female top team, Sky News reports
▼ + stars: | 2022-09-24 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterGSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/IllustrationSept 24 (Reuters) - British drugmaker GSK plc has poached Burberry Group's (BRBY.L) finance chief to create a rare all-female executive leadership team, Sky News reported on Saturday. GSK could announce as soon as Monday morning that it has recruited Julie Brown to replace Iain Mackay, who has served as its chief financial officer since 2019, the report added. On Friday, Burberry announced that its finance chief Julie Brown will step down in April 2023 after more than five years in the role. Register now for FREE unlimited access to Reuters.com RegisterReporting by Jaiveer Singh Shekhawat in Bengaluru Editing by Peter GraffOur Standards: The Thomson Reuters Trust Principles.

☆ GSK poaches Burberry CFO Julie Brown to create all-female top team - Sky News
▼ + stars: | 2022-09-24 | by ( ) www.reuters.com time to read: +1 min

☆ Cerebral is trying out an unusual clinical trial for a depression drug that has other companies wary. Here’s why.
▼ + stars: | 2022-01-14 | by ( Megan Hernbroth | ) www.businessinsider.com time to read: +6 min

The mental-health startup Cerebral partnered with Alto Neuroscience for a clinical trial. The mental-health startup Cerebral is teaming up with Alto Neuroscience on an upcoming home-based clinical trial for the biopharmaceutical company Alto's depression-drug candidate, according to federal records. The idea behind the partnership is that Cerebral is a mental-health company treating patients with depression, the condition for which Alto is developing treatments. Cerebral Chief Medical Officer David Mou told TechCrunch in December that the startup provided patients for the trial "within an hour." How Alto is running the trialThe trial with Cerebral does not include a control group, according to the filing.

☆ Sanofi mizează pe lansarea unui vaccin anti-COVID în decembrie
▼ + stars: | 2021-07-06 | by ( Publika.Md - Aici Sunt Știrile | ) www.publika.md time to read: +1 min

Vaccinul anti-COVID-19 dezvoltat de producătorul francez de medicamente Sanofi, împreună cu firma farmaceutică britanică GlaxoSmithKline, va fi disponibil din decembrie. Testele clinice din faza a doua au arătat că vaccinul a generat un răspuns imun solid, având o eficacitate de la 95 până la 100%. Noul vaccin se află în faza a treia a testării clinie, la cere participă peste 35.000 de persoane. Anterior, președintele Comisiei Europene, Ursula von der Leyen, a declarat că vaccinurile precum cele create de Sanofi "chiar au potențial". Până acum, producătorii acestuia au încheiat acorduri de achiziție cu SUA, UE, Canada și Marea Britanie, precum și cu programul COVAX al Organizației Mondiale a Sănătății.

Persons: Anunţul, Ursula von Organizations: France Inter, Comisiei Europene, Organizației Mondiale a Sănătății Locations: Ursula von der, SUA, UE, Canada

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