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The Swiss firm's shares jumped 5.8% on Monday to a four-week high by 0734 GMT, after it said a panel of independent supervisors recommended stopping the trial early because an interim analysis had shown a clear benefit. Kisqali has been approved to treat hormone-driven breast cancer that has spread to other body parts, where it has taken market share from Pfizer's (PFE.N) Ibrance. Rival drug Verzenio by Eli Lilly (LLY.N) has approval in the early setting for women at high risk of recurrence after surgery. Kisqali, which saw sales gain 31% to $1.2 billion last year, is one of two new drugs with a particularly important role for the group's future sales growth. Detailed trial results will be presented at a medical conference, Novartis said, without identifying the meeting or its timing.
Sanofi and Regeneron said in a statement on Thursday a Phase III trial involving 939 current or former smokers also showed improvements in lung function, quality of life and COPD respiratory symptoms. JP Morgan analyst Richard Vosser said the trial update had "blow-out data" in store for investors, and that market consensus for 2027 Dupixent sales of 15.7 billion euros would likely be topped-up by between 1 and 2 billion euros. The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19% of the French group's overall sales of 43 billion euros, last year. Sanofi reports combined global Dupixent sales from its alliance with Regeneron. Sanofi and Regeneron on Tuesday announced the European Commission had approved Dupixent to treat severe atopic dermatitis in young children.
How GSK plans to replenish its depleted medicine cabinet
  + stars: | 2023-03-15 | by ( Maggie Fick | ) www.reuters.com   time to read: +6 min
GSK has since suffered a series of clinical trial setbacks in its cancer drugs portfolio, most recently last year involving ovarian cancer drug Zejula and blood cancer drug Blenrep. BLOCKBUSTER POTENTIALAnalysts say that despite a string of strong quarterly earnings, lingering concerns over the company's drug pipeline reflect in GSK's share price. The investor said he does not see enough GSK drugs, either on the market or in development, with potential to be a so-called "blockbusters" with annual sales exceeding $1 billion. But Wood said the overhauled R&D department has put GSK in a strong position to meet growth targets. U.S. regulatory approval on GSK's vaccine, and a rival vaccine developed by Pfizer, is expected in May.
The export-oriented FTSE 100 (.FTSE) fell 0.2% and the more domestically-focussed FTSE 250 (.FTSE) was flat by 9:25 GMT. Copper prices were in the red as top consumer China set a lower-than-expected gross domestic product target of 5%. Flutter Entertainment Plc (FLTRF.L) rose 2.4% and Aston Martin Lagonda Global Holdings Plc surged 17.8% on price target raises by brokerages. Clarkson Plc (CKN.L) added 5.1% after the shipping services provider reported a strong annual profit. Reporting by Johann M Cherian in Bengaluru; Editing by Sherry Jacob-Phillips and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
LONDON, March 2 (Reuters) - Drugmaker Viatris Inc (VTRS.O) warned on Thursday that it will stop selling some essential medicines in the UK that are already in short supply unless the British government makes changes to its voluntary medicines pricing agreement. If that level is exceeded, the government recoups the excess from suppliers of branded drugs. His colleague Viatris' Head of Europe Artur Cwiok named Germany and Portugal as countries where governments were weighing changes to drug pricing. If Viatris opted to leave that pricing scheme, it would have to pay a rate in the statutory scheme the government says will rise to 27.5%. Pharma companies AbbVie Inc (ABBV.N) and Eli Lilly and Co (LLY.N) withdrew from the pricing scheme in January.
The U.S. Food and Drug Administration's (FDA) committee is scheduled to meet on April 28. The companies' are seeking approval of the drug Lynparza in combination with other medications – abiraterone and prednisone or prednisolone – for the treatment of a type of treatment-resistant prostate cancer in adult patients. Lynparza was approved in March last year by the FDA as a treatment for patients with early-stage breast cancer with certain mutations. The drug is also approved in the United States as a standalone treatment for another form of prostate cancer. Prostate cancer is the most common form of cancer among men in the United States with about 288,300 new cases of prostate cancer in 2023, according to the American Cancer Society’s estimates.
Xocova, a protease inhibitor like the COVID treatments developed by Pfizer Inc (PFE.N) and Merck & Co (MRK.N), was granted emergency approval by Japanese regulators in November, making it the nation's first domestically produced oral treatment for COVID. "If you kill the virus fast enough and sharp enough, the lower the probability of long COVID. According to one study by the Veterans Affairs St. Louis Health Care System, Pfizer's antiviral drug Paxlovid cuts the risk of developing many long COVID symptoms. Shionogi is hoping for Xocova sales of around $1 billion to $1.5 billion this year. "I have no regrets," Teshirogi said, adding that expectations among shareholders and the public had demanded that Shionogi devote its resources to fighting COVID.
SummarySummary Companies Rolls-Royce jumps on upbeat forecastMajor banks and healthcare stocks trade ex-divFTSE 100 down 0.3%, FTSE 250 adds 1.0%Feb 23 (Reuters) - The FTSE 100 index fell on Thursday, as banking and healthcare majors traded ex-dividend, although a surge in Rolls-Royce after it reported higher profit limited further losses. The blue-chip FTSE 100 (.FTSE) was down 0.3%, on track for its third straight session of decline. Some banks, including Barclays (BARC.L) and Standard Chartered (STAN.L), and healthcare majors AstraZeneca (AZN.L) and GSK (GSK.L) traded without entitlement for dividend payout. The exporter-heavy FTSE 100 has had a strong start to the year, helped by some positive earnings and a stir in commodity prices, hitting record highs and breaching the 8,000 barrier level. Among individual stocks, Mondi (MNDI.L) hit the bottom of the FTSE 100, falling 6.7% after reporting its full-year results.
LONDON, Feb 16 (Reuters) - Britain's agency that determines if medicines should be used in the National Health Service (NHS) said on Thursday it is speeding up how it decides if COVID-19 therapies are still effective against circulating variants. The new review process will enable the agency to update its recommendations on the cost-effectiveness of COVID treatments so they can be made available more swiftly to patients, it said. "The rapidly evolving nature of COVID-19 means we need to have a way of establishing the cost effectiveness of existing medicines against current variants in an agile way," the National Institute for Health and Care Excellence (NICE) said. It said there is no evidence of Evusheld's clinicial effectiveness against current variants and those likely to be circulating in the next 6 months. The announcement comes as demand for COVID treatments appears set to drop this year, due to population immunity from high rates of vaccination and previous infections.
The company also predicted a return to growth in China, one of its key markets, after reporting a second consecutive quarter of growth even as prices remain under pressure. Sales of its best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — came in just below estimates from Cowen analysts. Sales started to pick up in the second half of 2022 and in the fourth quarter grew by 3% at constant currency rates. Of key interest to investors is the experimental cancer drug, datopotamab deruxtecan, being evaluated in a keenly anticipated late-stage trial involving lung cancer patients. Partner Daiichi Sankyo (4568.T) this month said results of that study have been delayed to the second quarter from the first quarter of 2023.
AstraZeneca Q4 revenue just shy of analyst estimates
  + stars: | 2023-02-09 | by ( ) www.reuters.com   time to read: +1 min
Companies AstraZeneca PLC FollowLONDON, Feb 9 (Reuters) - AstraZeneca (AZN.L) on Thursday posted fourth-quarter revenue just shy of analyst estimates, with slightly lower-than-expected sales of its best-selling oncology and rare blood disorder drugs. The London-listed drugmaker, which reports its results in U.S. dollars, reported an adjusted profit of 1.38 cents per share on sales of about $11.2 billion. Analysts were expecting $1.34 per share on sales of about $11.3 billion, according to company-compiled consensus estimates. Sales of AstraZeneca's best-selling cancer drugs — Tagrisso, Imfinzi and Lynparza — generated $1.34 billion, $752 million, $689 million in the quarter respectively. Cowen analysts expected the three drugs to bring in about $1.4 billion, $760 million and $695 million respectively.
[1/2] The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. REUTERS/Rachel Wisniewski/Companies AstraZeneca PLC FollowLONDON, Feb 9 (Reuters) - Britain's business climate is deterring biopharma companies from investing in the country, AstraZeneca (AZN.L) chief Pascal Soriot said on Thursday, highlighting his company's decision to shift plans for a new manufacturing plant to Ireland. He highlighted AstraZeneca's recent decision to build a manufacturing facility in Ireland instead of the UK as evidence of Britain becoming less attractive for drugmakers. The decision, made in 2021, was also linked to the UK government's Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), a company spokesperson added. Reporting by Natalie Grover and Maggie Fick Editing by Tomasz Janowski, Barbara Lewis and Susan FentonOur Standards: The Thomson Reuters Trust Principles.
The pan-European STOXX 600 (.STOXX) was up 0.8% at 0920 GMT, extending gains for a third straight session. Shares of Sweco AB (SWECb.ST), a Swedish construction and engineering company, jumped 11% to top the STOXX 600 following its upbeat fourth-quarter earnings. An over 5% gain in AstraZeneca (AZN.L) on 2023 earnings and revenue growth forecast boosted the healthcare sub-index (.SXDP). Of the 93 STOXX 600 companies that have reported earnings so far, more than half have beaten market expectations, Refinitiv data showed on Tuesday. Signs of economic resilience and better-than-feared corporate earnings have helped European stocks outperform their U.S. counterparts so far this year.
The blue-chip FTSE 100 (.FTSE) rose 0.7% to touch a record high of 7,943.68, while the midcap FTSE 250 index (.FTMC) inched up 0.1%. AstraZeneca (AZN.L) jumped 4.3%, set for its best day in nearly a year, after the drugmaker forecast earnings growth in 2023. Unilever (ULVR.L) rose 0.4% after the consumer goods giant reported quarterly underlying sales growth above expectations. Watches of Switzerland Group (WoS) (WOSG.L) slumped 13.1% after it gave its quarterly trading update. (This story has been corrected to say Watches of Switzerland Group gave quarterly trading update, not full-year in the third bullet and last paragraph.)
"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.
Earnings season continues next week, with Club holdings Linde (LIN), Emerson Electric (EMR) and Walt Disney (DIS) all set to report. Similarly, shares of Meta Platforms (META) have surged over 20% since CEO Mark Zuckerberg reassured investors Wednesday evening that 2023 would be the technology giant's "year of efficiency." The bull case is further supported by continued signs inflation is easing, a still-robust job market and the breadth of market-buying activity since the start of the year. Lastly on Wednesday, the Fed's Federal Open Market Committee raised the federal funds rate by 25 basis points, in line with expectations. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.
Feb 3 (Reuters) - Sanofi (SASY.PA) on Friday forecast moderate earnings growth this year, saying higher demand for bestselling asthma and eczema drug Dupixent would be partly offset by competition for its multiple sclerosis pill Aubagio and product launch costs. Aubagio, with 2 billion euros in sales last year, will face competition from cheaper products over the next few months after losing patent protection, Sanofi said. The company reaffirmed its target to achieve sales of Dupixent, jointly developed with Regeneron (REGN.O), of 10 billion euros this year, up more than 20% from 8.29 billion euros in 2022. Sanofi reported a 20.7% rise in fourth-quarter business operating income, or adjusted earnings before interest and tax, to 2.72 billion euros ($2.96 billion), edging past an average analyst estimate of 2.69 billion euros posted on the company's website. Revenue from Dupixent surged 42% to 2.4 billion euros during the quarter ended Dec. 31, slightly above a consensus of 2.37 billion euros.
Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Novartis shares were down 1.3% in early trade on Wednesday and have fallen about 11% since January 2020, underperforming most rivals. They were also disappointed by guidance for Sandoz's core operating income to decline by a "low double digit" percentage in 2023 due to cost inflation and investments to make it a stand-alone entity. MS drug Kesimpta, which requires fewer injections than standard therapies, is expected to become Novartis' second largest growth driver in 2023, after Entresto. Novartis shares lagReporting by Ludwig Burger; editing by Josephine Mason and Jason NeelyOur Standards: The Thomson Reuters Trust Principles.
On Wednesday, the company reported adjusted fourth quarter profit of 25.8 pence per share on sales of about 7.4 billion pounds ($9.11 billion). At 0900 GMT, GSK shares were up 0.4% outperforming the FTSE 100 which was up 0.3%. U.S. litigation over the heartburn drug Zantac has also spooked investors, hurting GSK's shares in the second half of 2022. "Nevertheless, against the backdrop of recent performance, and without any contribution from Covid-19, GSK’s 2023 guidance demonstrates some improved momentum," he said. GSK's shares have lagged most of its rivals in recent years.
Companies GSK plc FollowAstraZeneca PLC FollowFeb 1 (Reuters) - GSK (GSK.L) on Wednesday beat fourth-quarter profit and sales forecasts helped by sales of its blockbuster shingles vaccine Shingrix. That beat the 21.2 pence per share on sales of about 7.1 billion pounds expected by analysts in a company-compiled consensus. Shingrix generated 769 million pounds over the quarter, topping the 748 million in the GSK-compiled consensus estimates. GSK, now solely focused on vaccines and medicines, on Wednesday forecast 2023 adjusted operating profit to climb by 10% to 12% on sales up 6% to 8%. The company said that it also does not expect any significant COVID-19 pandemic-related sales in 2023, after the its COVID solutions unit generated 2.4 billion pounds last year.
LONDON, Feb 1 (Reuters) - GSK (GSK.L) chief executive Emma Walmsley on Wednesday made replenishing the drugmaker's pipeline of vaccines and therapies her number-one priority. But analysts say there is not enough in the medicine cabinet to keep the momentum going even beyond the next few years. Meanwhile, analysts say the market for Shingrix will eventually become saturated, further limiting the company's growth prospects. GSK shares lagR&D SPENDGSK's spending on R&D has long lagged behind its peers, something activist investor Elliott highlighted in a 2021 letter pressuring the company to make sweeping changes. Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, there is hope the company will eventually deliver a streamlined and specialist portfolio of blockbuster drugs.
Morning Bid: Mind the gap
  + stars: | 2023-01-31 | by ( ) www.reuters.com   time to read: +3 min
The IMF cited "surprisingly resilient" demand in the United States and Europe, easing of energy costs and the reopening of China's economy. Still, it would be wise for investors to be mindful of a gap between expectations and reality. Flash GDP numbers are due from the euro zone, along with growth data for France and Italy. The Bank of England is set to raise rates by 50 bps to 4.0%, respectively. Money market bets show that the U.S. Federal Reserve is set to raise its policy rate by 25 basis points to 4.50%-4.75% on Wednesday.
Jan 30 (Reuters) - Drug manufacturers can limit healthcare providers' use of outside pharmacies for dispensing drugs under a federal drug discount program, a federal appeals court ruled Monday. The case centers on the federal 340B program, in which drugmakers provide discounts to eligible healthcare providers that serve low-income populations. Drugmakers are required to participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid. Sanofi, Novo Nordisk and AstraZeneca all continued to allow 340B providers without in-house pharmacies to use a single contract pharmacy. HHS ordered them to stop, saying the new policies were not allowed under the 340B program.
Resources lift FTSE 100 to mid-2019 highs
  + stars: | 2023-01-09 | by ( Shashwat Chauhan | ) www.reuters.com   time to read: +2 min
SummarySummary Companies FTSE 100 up 0.2%, FTSE 250 adds 0.4%Game developers fall on bleak outlookAstraZeneca down after $1.8 bln CinCor Pharma dealResources shares rise on China reopening optimismJan 9 (Reuters) - UK's exporter-heavy FTSE 100 hit a more than three-year high on Monday, led by commodity-linked stocks, as China's reopening of its borders reinforced hopes for a rebound in the world's second-largest economy. The blue-chip FTSE 100 (.FTSE) gained 0.2%, hitting its highest since July 30, 2019, while the more domestically focused FTSE 250 mid-cap index (.FTMC) rose 0.4%. Industrial metal miners (.FTNMX551020) gained 1.4%, while oil majors Shell (SHEL.L) and BP (BP.L) also advanced as oil prices climbed on China demand prospects after Beijing opened on Sunday borders that have been all but shut since the start of the COVID-19 pandemic. Despite surging inflation and risks of a global recession, the FTSE 100 outperformed major global markets last year due to high exposure to commodity prices. Reporting by Shashwat Chauhan in Bengaluru; Editing by Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.
AstraZeneca to buy U.S.-based CinCor Pharma in $1.8 bln deal
  + stars: | 2023-01-09 | by ( ) www.reuters.com   time to read: 1 min
Jan 9 (Reuters) - AstraZeneca (AZN.L) said on Monday it will buy U.S.-based clinical-stage biopharmaceutical firm CinCor Pharma Inc (CINC.O) in a deal valued at about $1.8 billion to strengthen its pipeline of heart and kidney drugs. AstraZeneca said it will pay $26 per CinCor share in cash, a premium of nearly 121% to the stock's closing price on Friday. The offer also includes a non-tradable contingent value right of $10 per share in cash payable upon a specified regulatory submission of CinCor's baxdrostat, which is being developed to treat cardiorenal diseases. Including this, the offer represent a 206% premium to CinCor's shares close on Friday. Reporting by Radhika Anilkumar in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.
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