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☆ Novartis says operating profit to grow again ahead of Sandoz spin-off
▼ + stars: | 2023-02-01 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

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.

☆ 4 major trends in health startups in 2022, after an unexpected post-pandemic dropoff in funding
▼ + stars: | 2022-12-24 | by ( Riddhi Kanetkar | ) www.businessinsider.com time to read: +6 min

VCs poured $13.5 billion into healthtech startups in 2022 — down nearly 50% from 2021. But a global slump and the tech downturn changed all of that, and funding into health startups fell by nearly 50% to $13.5 billion this year. AI-driven drug development and mental health startups also boomed during COVID-19 but have seen a funding dropoff in 2022. Tech that served underrepresented groups was spotlightedFrom menopause to mental health, health conditions that were billed as 'taboo' pre-pandemic have come to the forefront this year. Startups offering personalized treatments for niche issues or demographics, such as menopause app Vira Health, mental health platform MyMynd, and men's health platform Numan, all raised capital this year.

☆ Biden blacklists China's YMTC, crackdowns on AI chip sector
▼ + stars: | 2022-12-15 | by ( Alexandra Alper | ) www.reuters.com time to read: +5 min

WASHINGTON, Dec 15 (Reuters) - The Biden administration on Thursday added Chinese memory chipmaker YMTC and 21 "major" Chinese players in the artificial intelligence chip industry to a trade blacklist, broadening its crackdown on China's chip industry. It also comes as Congress prepares to finalize legislation to bar the U.S. government from buying products that contain semiconductors made by YMTC, Chinese memory chipmaker CXMT or China's top chip manufacturer SMIC. The Commerce Department on Thursday also targeted nine Chinese entities for allegedly seeking to support China's military modernization, including Shanghai Micro Electronics Equipment Group Co Ltd (SMEE), China's only lithography company. Two of the Chinese companies removed from the unverified list - YMTC and SMEE- were added to the entity list. Being added to the unverified list forces U.S. suppliers to perform greater due diligence before shipping to the targeted companies.

"This falls into the category of a game changing view of Chinese companies because the threat of their delisting seems to have been eliminated," said Art Hogan, chief market strategist at B. Riley Financial. However, the relief was not seen in Thursday's trading for U.S.-listed shares of Chinese companies, which were higher amid the news, but gave up gains and some ended sharply lower. Washington and Beijing reached a landmark deal in August to settle a long-running dispute over auditing compliance of U.S.-listed Chinese firms. Authorities in China have long been reluctant to let overseas regulators inspect local accounting firms, citing national security concerns. U.S. lawmakers in 2020 agreed to legislation that would oust Chinese companies from U.S. stock exchanges unless they adhere to American auditing standards.

☆ AstraZeneca boosts cancer portfolio with $320 mln Neogene deal
▼ + stars: | 2022-11-29 | by ( ) www.reuters.com time to read: +2 min

Nov 29 (Reuters) - AstraZeneca (AZN.L) will acquire biotechnology company Neogene Therapeutics for up to $320 million, the London-listed drugmaker said on Tuesday, seeking to build its pipeline of cell-based cancer treatments. Though AstraZeneca's oncology portfolio accounted for more than a third of the company's revenue last year, it does not have an approved cell-based cancer therapy and is behind rivals such as Novartis (NOVN.S) and Gilead (GILD.O). Neogene's approach goes one step further in that its experimental T-cell receptor therapies seek to target DNA mutations specific to tumours, not only certain proteins on the surface of cancer cells. Linnemann founded Neogene in the Netherlands in 2018 along with the Netherlands Cancer Institute's Ton Schumacher. AstraZeneca will make an initial payment of $200 million to Neogene, with a further $120 million dependent on the company meeting certain targets.

☆ U.S. FDA declines to approve Spectrum's lung cancer drug
▼ + stars: | 2022-11-25 | by ( ) www.reuters.com time to read: +1 min

Nov 25 (Reuters) - Spectrum Pharmaceuticals Inc (SPPI.O) said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs. The company said it will no longer focus on developing the drug, poziotinib, for treating non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2%-4% of the cancer patients. They have fallen 42.5% since an expert panel to the FDA recommended against the drug's approval in September. Nevada-based Spectrum said it will cut 75% of its research and development workforce and focus on its other cancer drug, Rolvedon. Reporting by Khushi Mandowara; Editing by Krishna Chandra Eluri, Shounak Dasgupta and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ AstraZeneca lifts 2022 earnings outlook as cancer drugs boost results
▼ + stars: | 2022-11-10 | by ( Natalie Grover | ) www.reuters.com time to read: +4 min

AstraZeneca is seen as a bellwether for the pharmaceutical sector in China, which accounted for about 16% of the company's total revenue last year. Sales in China have been hurt by lower drug prices while COVID lockdown measures have kept some patients from being diagnosed and seeking care. Better-than-expected sales of AstraZeneca's cancer medicines, including Tagrisso, Imfinzi and Enhertu, helped the company's quarterly revenue beat, with sales of its broader oncology portfolio rising 24%. But global sales of the company's COVID therapy, Evusheld, have steadily grown, partially offsetting the rapid decline in COVID vaccine sales. Evusheld continues to demonstrate strong efficacy but there are a couple of variants that are resistant to it, Soriot said.

☆ AstraZeneca tops quarterly estimates buoyed by cancer drug sales
▼ + stars: | 2022-11-10 | by ( Natalie Grover | ) www.reuters.com time to read: +1 min

Sales of AstraZeneca's key cancer medicines — Tagrisso and Imfinzi — helped the company's revenue beat, with sales of its broader oncology portfolio rising 24%. Previously, it had forecast a 2022 gain in the "mid-to-high twenties percentage". Novartis in late October said strong U.S. currency was a drag on the value of its quarterly sales generated outside the United States. AstraZeneca on Thursday said its anticipated 2022 revenue growth would be impacted by a currency headwind of a "mid single-digit percentage". Core earnings per share for the year will also be negatively affected by "mid-to-high single-digit percentage," it added.

☆ Stocks making the biggest moves premarket: Tapestry, WeWork, Rivian and others
▼ + stars: | 2022-11-10 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Tapestry slid 2% in premarket trading. Nio shares jumped 5.5% in premarket trading. AstraZeneca (AZN) – AstraZeneca gained 4.8% in premarket trading after the drug maker reported upbeat quarterly results and raised its full-year profit forecast. Bumble (BMBL) – Bumble slumped 14% in premarket action after issuing a weak current-quarter revenue forecast. ZipRecruiter (ZIP) – ZipRecruiter surged 12.6% in premarket trading after the online jobs site operator posted better-than-expected quarterly results and raised its full-year forecast.

☆ AstraZeneca's COVID vaccine suffers a setback in nasal spray trial
▼ + stars: | 2022-10-10 | by ( ) www.reuters.com time to read: +2 min

Also, the immune response measured in the blood was weaker than that from a shot-in-the-arm vaccination. India's health minister last month approved Bharat Biotech's COVID-19 nasal spray vaccine while China's CanSino Biologics Inc (6185.HK) last month won emergency approval by the country's drug regulator for an inhaled version of its COVID-19 vaccine. The British trial enrolled 30 previously unvaccinated participants as well as 12 volunteers, who had previously received a standard two-dose vaccine course by injection. "The nasal spray did not perform as well in this study as we had hoped," said Sandy Douglas, chief investigator of the trial at Oxford University's Jenner Institute. No serious adverse events or safety concerns were reported during the trial, which was funded by AstraZeneca, according to the statement.

Companies are added to the unverified list because the United States could not complete on-site visits to determine whether they can be trusted to receive sensitive technology exports from the United States. U.S. inspections of Chinese companies require the approval of China's commerce ministry. Under the Biden administration's new policy, if a government prevents U.S. officials from conducting site checks at companies placed the unverified list, Washington will start the process for adding them to the entity list after 60 days. The United States removed a unit of Wuxi Biologics, maker of ingredients for AstraZeneca's COVID-19 vaccine, from the unverified list. The company looks forward to scheduling an inspection of its Shanghai subsidiary, which also was placed on the unverified list in February, she added.

☆ U.S. FDA panel votes against Spectrum's lung cancer drug
▼ + stars: | 2022-09-22 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoSept 22 (Reuters) - Advisers to the U.S Food and Drug Administration on Thursday voted against recommending Spectrum Pharmaceuticals' (SPPI.O) experimental drug for the treatment of patients with a form of non-small cell lung cancer. The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing marginal efficacy, high level of toxicities, and lack of dose optimization. Poziotinib is intended to treat non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2-4% of total patients with NSCLC. There is no prior FDA-approved treatment for the rare lung cancer, and the patients suffering from the disease are given treatments similar to those with non-small cell lung cancer without the mutation.

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