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☆ AstraZeneca, AI biologics firm Absci tie up on cancer drug - FT
▼ + stars: | 2023-12-03 | by ( ) www.reuters.com time to read: +1 min

The AstraZeneca logo is pictured outside the AstraZeneca office building in Brussels as part of the coronavirus disease (COVID-19) vaccination campaign, Belgium, January 28, 2021. REUTERS/Johanna Geron/File Photo Acquire Licensing RightsCompanies Absci Corp FollowAstraZeneca PLC FollowDec 3 (Reuters) - Anglo-Swedish drugmaker AstraZeneca (AZN.L) has signed a deal worth up to $247 million with U.S. artificial intelligence (AI) biologics firm Absci (ABSI.O) to design an antibody to fight cancer, the Financial Times reported on Sunday. The collaboration aims to harness Absci's AI technology for large-scale protein analysis to find a viable oncology therapy, a leading focus of AstraZeneca, the report said. Absci and AstraZeneca did not immediately respond to a Reuters requests for comment. Absci applies generative artificial intelligence to design optimal drug candidates based on target affinity, safety, manufacturability and other traits.

Persons: Johanna Geron, Sean McClain, Absci’s, Shivani Tanna, William Mallard Organizations: AstraZeneca, REUTERS, U.S, Financial Times, Thomson Locations: Brussels, Belgium, Swedish, Bengaluru

Many of the patents at issue in the Food and Drug Administration's Orange Book listing of approved products were for devices such as asthma inhalers and epinephrine autoinjectors, the FTC said. "Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs," FTC Chair Lina Khan said on X, formerly known as Twitter. The Orange Book identifies drugs and products that the FDA has deemed safe and effective. The FTC says companies sometimes improperly list patents in the Orange Book that can delay market entry of lower priced generics. AbbVie was informed the FTC would dispute four patents in the Orange Book having to do with Restasis Multidose, eye drops used for chronic dry eye.

Persons: Andrew Kelly, Lina Khan, Boehringer Ingelheim, Mylan, AbbVie, Restasis, Diane Bartz, Patrick Wingrove, Bill Berkrot Organizations: Food and Drug Administration, FDA, REUTERS, AstraZeneca, GSK, U.S . Federal Trade Commission, Food, FTC, pharma, Thomson Locations: White Oak , Maryland, U.S, WASHINGTON, Israel, Viatris

☆ AstraZeneca to invest $245 mln in Cellectis to boost gene therapy prospects
▼ + stars: | 2023-11-01 | by ( ) www.reuters.com time to read: +1 min

The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. Cellectis' gene-editing technology and manufacturing capabilities to design novel cell and gene therapy products will help strengthen AstraZeneca's growing offering in the space, it said. AstraZeneca said that as part of the deal, it will pay Cellectis $105 million by the end of this year. That includes an $80 million equity investment, which will be followed by another $140 million in early 2024, which will give AstraZeneca a stake of about 44% in the French company. The Anglo-Swedish pharma company said it had exclusive rights to 25 genetic targets, of which up to 10 candidate products could be explored for development.

Persons: Rachel Wisniewski, Aby Jose Koilparambil, Savio D'Souza Organizations: AstraZeneca, REUTERS, Swedish pharma, Thomson Locations: North America, Wilmington , Delaware, U.S, Swedish, Bengaluru

☆ AstraZeneca seeks to calm CEO speculation after shares drop
▼ + stars: | 2023-09-11 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. The company initially declined to comment on the Mail on Sunday report, but later issued a statement saying: "We do not comment on market rumours. AstraZeneca shares closed down 3.2% after earlier touching their lowest since July 19. The Times' article focused on the retirement of Mene Pangalos, the long-time biopharmaceuticals head of research at AstraZeneca, which was announced in July. Reporting by Maggie Fick and Samuel Indyk; Editing by Tomasz Janowski and Mark PotterOur Standards: The Thomson Reuters Trust Principles.

Persons: Brendan McDermid, Pascal Soriot, Soriot, Mene Pangalos, Pangalos, Pascal, Maggie Fick, Samuel Indyk, Tomasz Janowski, Mark Potter Organizations: AstraZeneca, New York Stock Exchange, REUTERS, Reuters, Times, Thomson Locations: British

☆ AstraZeneca shares fall 4% to 7-1/2 week low
▼ + stars: | 2023-09-11 | by ( ) www.reuters.com time to read: +1 min

The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsCompanies AstraZeneca PLC FollowLONDON, Sept 11 (Reuters) - Shares in London-listed drugmaker AstraZeneca (AZN.L) fell more than 4% on Monday, sliding to their lowest since July 19. An AstraZeneca spokesperson declined to comment on the report. Two of the analysts and the shareholder also mentioned that an article published on Monday in Britain's Times newspaper could have affected the shares, though it appeared to contradict the Mail on Sunday report. The Times' article focused on the retirement of Mene Pangalos, the long-time biopharmaceuticals head of research at AstraZeneca, which was announced in July.

Persons: Brendan McDermid, Pascal Soriot, Mene Pangalos, Pangalos, Pascal, Maggie Fick, Samuel Indyk, Amanda Cooper, Tomasz Janowski Organizations: AstraZeneca, New York Stock Exchange, REUTERS, drugmaker's, Reuters, Britain's Times, Times, Thomson Locations: London

FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. The drug price negotiation program is part of President Joe Biden's signature Inflation Reduction Act (IRA). The program faces several other court challenges, including from leading industry groups and other drug companies. ‍AstraZeneca said it was filing a legal challenge in a bid to "protect timely access to medicines for orphan indications" in the United States. Reporting by Bhanvi Satija in Bengaluru; Editing by Dhanya Ann Thoppil and Shilpi MajumdarOur Standards: The Thomson Reuters Trust Principles.

Persons: Brendan McDermid, Joe Biden's, AstraZeneca, Bhanvi, Dhanya Ann Thoppil, Shilpi Majumdar Organizations: AstraZeneca, New York Stock Exchange, REUTERS, drugmaker AstraZeneca, Thomson Locations: United States, Bengaluru

☆ Novavax posts quarterly profit on COVID vaccine sales
▼ + stars: | 2023-08-08 | by ( ) www.reuters.com time to read: +2 min

Companies Novavax Inc FollowAstraZeneca PLC FollowBioNTech SE Follow Show more companiesAug 8 (Reuters) - Novavax (NVAX.O) reported a second-quarter profit on Tuesday, helped by strong revenue from its COVID-19 vaccines, but still trimmed its annual forecast for sales of the shot. As part of the agreement, Novavax will issue 6.5 million shares to SK Bioscience at $13 per share. Following the agreements, Novavax now owes SK Bioscience $65 million in cash. The company reported revenue of $424 million, compared with analysts' estimates of $240 million, according to Refinitiv IBES data. Novavax lowered the sales forecast for its COVID-19 vaccines to between $1.3 billion and $1.5 billion this year, compared with a previous outlook of $1.4 billion to $1.6 billion.

Persons: Novavax, Leroy Leo, Michael Erman, Varun H, Maju Samuel, Shounak Organizations: AstraZeneca, SK Bioscience, South Korean, South, Thomson Locations: KS, South Korean, United States, Bengaluru, New York

☆ US CDC panel recommends Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +1 min

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier/File PhotoCompanies AstraZeneca PLC FollowSanofi SA FollowAug 3 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said its advisory panel on Thursday recommended use of Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The Advisory Committee on Immunization Practices unanimously recommended nirsevimab for preventing lower respiratory tract disease in newborns and infants below eight months of age born during or entering their first RSV season. It also recommended its use in children aged 8-19 months who remain vulnerable to severe RSV disease through their second such season. The therapy, branded as Beyfortus, will be available in the U.S. ahead of the upcoming 2023-24 RSV season, Sanofi said.

Persons: Benoit Tessier, AstraZeneca's, Sanofi, Mrinmay Dey, Mariam Sunny Organizations: Sanofi, REUTERS, Companies AstraZeneca, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Thomson Locations: Paris, France, U.S, Bengaluru

☆ AstraZeneca planning China business spin off, Financial Times reports
▼ + stars: | 2023-06-18 | by ( ) www.reuters.com time to read: +1 min

Companies AstraZeneca PLC FollowJune 18 (Reuters) - Drugmaker AstraZeneca (AZN.L) is drafting a plan to spin off its China business, and listing a separate unit in Hong Kong is being viewed as an option, the Financial Times reported on Sunday. The company would seek to be a patriotic company in China that "loves the Communist Party", its China president said in May. Last year, the country accounted for 13% of AstraZeneca's total sales, and the company is China's biggest drugmaker. The spin off could protect AstraZeneca from tensions between China and other global powers, while the company retained control of the business, the FT's report said. AstraZeneca said it did not comment on "rumours or speculations around future strategy or M&A."

Persons: Bharat Govind Gautam, Rishabh Jaiswal, Chris Reese, Diane Craft Organizations: AstraZeneca, Financial Times, Communist Party, Thomson Locations: China, Hong Kong, Shanghai, Bengaluru

☆ European shares edge lower as banking jitters resurface
▼ + stars: | 2023-04-27 | by ( ) www.reuters.com time to read: +1 min

April 27 (Reuters) - European shares edged lower on Thursday, despite a raft of positive corporate earnings, as troubles at U.S. lender First Republic Bank continued to rattle investors over the global banking sector. The pan-European STOXX 600 index (.STOXX) was down 0.1% by 0720 GMT. The index was dragged lower by media shares (.SXMP), which dropped 1.6%, while Universal Music Group (UMG.AS) fell 4% after it posted a slump in its first-quarter core profit. Worries over the banking sector unnerved investors as shares of First Republic Bank (FRC.N) sank almost 30% on Wednesday, hitting a record low for the second consecutive day. Still, banking shares (.SX7P) rose 0.4%, led by Barclays Plc (BARC.L) that climbed 2.4% on an estimate-beating quarterly profit, as a resilient performance from its consumer bank offset pressure on key other business lines.

☆ AstraZeneca confident new COVID antibody protects against known variants
▼ + stars: | 2023-04-18 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

REUTERS/ Albert GeaCompanies AstraZeneca PLC FollowBARCELONA, April 18 (Reuters) - AstraZeneca is confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants, its vaccines head said. AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. In January, the U.S. health regulator withdrew its emergency use authorization for AstraZeneca's original COVID-19 antibody cocktail Evusheld, as new dominant variants made it obsolete. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. However, demand for COVID-19 vaccines have dramatically declined with competition from mRNA vaccines and given many countries already have an oversupply of COVID-19 shots.

☆ UK's FTSE 100 kicks off week on grim note; miners fall
▼ + stars: | 2023-03-06 | by ( Johann M Cherian | ) www.reuters.com time to read: +2 min

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.

☆ U.S. FDA panel to review expanded use of Merck-AstraZeneca's cancer drug
▼ + stars: | 2023-03-02 | by ( ) www.reuters.com time to read: +2 min

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.

☆ Shionogi sees COVID pill reaping $2 billion in annual sales upon U.S. approval
▼ + stars: | 2023-02-27 | by ( Rocky Swift | ) www.reuters.com time to read: +3 min

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.

[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.

☆ 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.

"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.

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.

☆ U.S. Appeals Court Sides With Drugmakers on Discount Program
▼ + stars: | 2023-01-30 | by ( Anna Wilde Mathews | Joseph Walker | ) www.wsj.com time to read: 1 min

The ruling by a three-judge panel of the Philadelphia-based Third Circuit Court of Appeals can be appealed. A U.S. appeals court ruled that pharmaceutical companies can limit their shipments of federally-discounted drugs to pharmacies, in a major win for the drugmakers and a blow to hospitals and clinics that receive the low-priced medicines. The ruling on Monday, by a three-judge panel of the Philadelphia-based Third Circuit Court of Appeals, was in favor of drugmakers Sanofi SA, AstraZeneca PLC and Novo Nordisk A/S, and against the Health Resources and Services Administration, or HRSA, which oversees the federal drug-discount program known as 340B.

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.

☆ AstraZeneca to Buy U.S. Cardiorenal-Drug Maker
▼ + stars: | 2023-01-09 | by ( Joseph Hoppe | ) www.wsj.com time to read: +1 min

Anglo-Swedish pharma giant AstraZeneca PLC has agreed to buy CinCor Pharma Inc., including global rights to its baxdrostat cardiorenal drug, for an upfront transaction value of around $1.3 billion. It has also committed to a further $10 a share in cash, payable upon a specified regulatory submission of a baxdrostat product. AstraZeneca said the acquisition will bolster its cardiorenal pipeline by adding baxdrostat, an inhibitor that has shown promise in clinical trials lowering blood pressure in treatment-resistant hypertension. The upfront cash portion of the acquisition represents a 121% premium to CinCor’s closing market price of $11.78 on Friday. Combined, the upfront and so-called maximum potential contingent value payments represent a transaction value of around $1.8 billion.

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.

☆ FDA pulls U.S. authorization for Eli Lilly's COVID drug bebtelovimab
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: +1 min

Nov 30 (Reuters) - Eli Lilly and Co's COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron. Wednesday's announcement takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer Inc's (PFE.N) antiviral drug Paxlovid, Merck's (MRK.N) Lagevrio and Gilead Sciences' (GILD.O) Veklury as treatments for the disease, besides convalescent plasma for some patients. AstraZeneca Plc's monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people. The drug, which was discovered by Abcellera (ABCL.O) and commercialized by Eli Lilly, received an authorization from the FDA in February. BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last two months, surpassing Omicron's BA.5 sub-variant, which had driven cases earlier in the year.

☆ U.S. FDA staff flags unclear benefits of Ardelyx's kidney disease drug
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +2 min

Nov 14 (Reuters) - U.S. Food and Drug Administration staff reviewers on Monday raised concerns over unclear benefits of Ardelyx Inc's (ARDX.O) drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval. The FDA's staff reviewers said, "the magnitude of treatment effect appears less than that observed with approved drugs," in briefing documents released on Monday. Ardelyx's oral drug, tenapanor, is aimed at reducing elevated blood phosphate levels in patients with chronic kidney disease (CKD). The advisers' meeting, set for Nov.16, was called by the FDA following Ardelyx's appeal against the regulator's initial rejection of the drug in July last year, after it identified deficiencies. Around 37 million people, or one in seven people, in the United States have chronic kidney disease, as per a government report last year.

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