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☆ US FDA approves Pfizer's blood cancer therapy
▼ + stars: | 2023-08-14 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Johanna Geron/File PhotoAug 14 (Reuters) - The U.S. Food and Drug Administration on Monday granted accelerated approval to Pfizer's (PFE.N) therapy for treating patients with a type of blood cancer that is difficult to treat, the company said. Multiple myeloma is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. The FDA approval is based on data from a mid-stage study that showed that 58% of patients treated with Pfizer's therapy had no signs of cancer or had seen a significant decrease in cancer cells in the body. Pfizer said it will continue testing the therapy in ongoing late-stage trials to expand its use in earlier lines of treatment for patients. The therapy's approval comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.

Persons: Johanna Geron, Epkinly, Johnson, Pfizer's, Bhanvi Satija, Leroy Leo, Pratik, Shounak Dasgupta Organizations: Pfizer, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Puurs, Belgium, U.S, Bengaluru

☆ Insight: What happens when a $2 million gene therapy is not enough
▼ + stars: | 2023-08-12 | by ( Deena Beasley | ) www.reuters.com time to read: +13 min

Their experience raises broader questions around other high-cost gene therapies coming to market, sometimes after accelerated regulatory approvals, drug pricing experts said. Gene therapies work by replacing genes – the body's blueprint for its development. The gene Zolgensma delivers instructs the body to make a protein vital for muscle control. If gene therapies do fall short, it becomes harder to justify prices that researchers have argued are already poor value. More recently, the first hemophilia gene therapy approved by the U.S. Food and Drug Administration was priced by CSL Behring at $3.5 million; 26 more gene therapies are in late-stage development, according to IQVIA.

Persons: Elizabeth Kutschke, Ben, Zolgensma, Ben Kutschke, neurologists, Sitra Tauscher, Wisniewski, Ben's, Roger Hajjar, Brigham Gene, Kutschke, Vasant Narasimhan, Stacie Dusetzina, Roche's, Biogen, Roche, Maha Radhakrishnan, Steven Pearson, It's, Sree Chaguturu, Amanda Cook, Weston, Jackson, Cook, Elizabeth, Jerry Mendell, Russell Butterfield, –, Biogen's, Mendell, UMR, Spinraza, Eric Cox, Caroline Humer, Sara Ledwith Organizations: Reuters, U.S, Novartis, IQVIA Institute, Human Data, Novartis Gene Therapies, Mass, Cell Therapy, U.S . Food, Drug Administration, CSL Behring, CSL, Nashville's Vanderbilt University School of Medicine, Clinical, Economic, CVS Health, Aetna, SMA, Nationwide Children's Hospital, University of Utah Health, Children's, UnitedHealth, Thomson Locations: Oak Park, Berwyn , Illinois, Swiss, U.S, Lebanon , Virginia, United States, Columbus , Ohio, Russia, Kazakhstan, Chicago

☆ Regeneron expects FDA decision on higher-dose Eylea this year
▼ + stars: | 2023-08-03 | by ( Khushi Mandowara | ) www.reuters.com time to read: +2 min

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid/File PhotoAug 3 (Reuters) - Regeneron Pharmaceuticals (REGN.O) expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday. The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent (CTLT.N). Regeneron said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August. Regeneron said the higher-dose Eylea was manufactured on the same line as pozelimab, its experimental drug being reviewed to treat a rare blood disease.

Persons: Brendan McDermid, Regeneron, Wells, Mohit Bansal, Bayer, Sanofi, Khushi, Sriraj Organizations: Regeneron Pharmaceuticals, REUTERS, U.S . Food, Drug Administration, FDA, Thomson Locations: Westchester, Tarrytown , New York, U.S, Eylea, Bengaluru

☆ US FDA approves BioMarin's gene therapy for hemophilia A
▼ + stars: | 2023-06-29 | by ( Nathan Gomes | ) www.reuters.com time to read: +3 min

It priced the one-time therapy, Roctavian, at $2.9 million. BioMarin said most study participants continued to respond to the gene therapy through year three and beyond, and it would continue to monitor them for 15 years. BioMarin's therapy will compete for market share with Roche's (ROG.S) Hemlibra, an antibody drug which mimics the function of the blood clotting protein missing in hemophilia A patients. In April, BioMarin cut its annual sales forecast range for Roctavian to $50 million to $100 million, from $100 million to $200 million. There are about 16,000 patients in the United States with hemophilia A in which they are missing the factor VIII clotting protein.

Persons: BioMarin, Joel Beatty, Robert W Baird, Roctavian, Beatty, Khushi Mandowara, Bhanvi Satija, Nathan Gomes, Akash Sriram, Deena Beasley, Krishna Chandra Eluri, Maju Samuel, David Gregorio Our Organizations: U.S . Food, Drug Administration, European Union, Los, Thomson Locations: U.S, California, Novato , California, hemophilia, United States, Bengaluru, Los Angeles

☆ Regeneron shares fall after FDA rejects high-dose eye disease treatment
▼ + stars: | 2023-06-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York. Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment. Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler." That suggests the drug could potentially win approval down the road. But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings ' eye drug, Vabysmo.

Persons: Regeneron Organizations: Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Roche Holdings Locations: Tarrytown , New York, U.S

☆ US FDA declines to approve Regeneron's higher-dose Eylea, shares tumble
▼ + stars: | 2023-06-27 | by ( ) www.reuters.com time to read: +2 min

The Food and Drug Administration cited an ongoing review of inspection findings at a third-party filler of the higher dose for the decision. Eylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's (ROG.S) rival treatment Vabysmo was approved last year for wet AMD. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 milligrams at longer intervals without any additional safety issues. The two trials included treatment of patients with wet AMD and diabetic macular edema (DME). An estimated 1.1 million people in the U.S. have wet AMD, while 1.2 million are estimated to have DME, according to Regeneron.

Persons: Vabysmo, Regeneron, Eylea, Raghav Mahobe, Krishna Chandra Eluri, Maju Samuel, Sriraj Organizations: Regeneron Pharmaceuticals, Drug Administration, FDA, AMD, biosimilars, Thomson Locations: U.S, Bengaluru

☆ These 9 global stocks have raised dividends for the last 30 years
▼ + stars: | 2023-06-07 | by ( Ganesh Rao | ) www.cnbc.com time to read: +3 min

Nine global stocks have raised dividends every year for the past three decades, according to CNBC Pro analysis. Of about 92,000 global stocks screened by CNBC Pro, the following nine consistently rewarded their shareholders. Novartis' stock has been on an upward trend recently – rising 8.9% year to date – after moving sideways for more than six months. Novartis' dividend yield is currently 3.5%. NOVNEE-CH 1Y line Roche Like its peer Novartis, Roche , the pharmaceuticals and diagnostics company headquartered in Basel, Switzerland, offers a 3.3% dividend yield.

Persons: Maurice Choy, . Choy, Eric Le Berrigaud, Roche, Luisa Hector, James Halstead Organizations: CNBC, CNBC Pro, Fortis Canadian, Fortis, RBC Capital, Novartis, Roche, Pharma, Sage Group, Kerry Locations: Novartis Swiss, Basel, Switzerland, ROG, Spirax, Saco

☆ Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data
▼ + stars: | 2023-06-05 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.

Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature

☆ BioNTech, Roche's experimental pancreatic cancer treatment wins Nature plaudit
▼ + stars: | 2023-05-10 | by ( ) www.reuters.com time to read: +2 min

FRANKFURT, May 10 (Reuters) - Scientific journal Nature on Wednesday said a personalised treatment based on messenger RNA by BioNTech (22UAy.DE) potentially bodes well for the future of fighting an extremely aggressive form of cancer after the regimen was shown to trigger a promising immune reaction in some pancreatic cancer patients. Pancreatic cancer is among the most deadly forms of cancer because it typically grows undetected until an effective treatment is too late. The trial focused on pancreatic ductal adenocarcinoma (PDAC), which accounts for more than 90% of pancreatic cancer cases. Nature covers a wide range of topics in science and technology beyond medicine. Among the eight trial participants with a detectable immune response, there was no evidence of cancer recurrence 18 months after surgery, while the median time to recurrence was 13.4 months among the non-responders.

☆ 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.

☆ Bristol Myers CEO Caforio steps down
▼ + stars: | 2023-04-26 | by ( ) www.reuters.com time to read: +1 min

[1/2] A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File PhotoCompanies Bristol-Myers Squibb Co FollowApril 26 (Reuters) - Bristol Myers Squibb Co (BMY.N) said on Wednesday CEO Giovanni Caforio, who has been in the role since 2015, has decided to step down from his position. Outgoing CEO Giovanni will continue as executive chairman of the company's board. Bristol Myers is due to report first-quarter financial results on Thursday. Bristol Myers shares rose 0.39% to $68.29 in after-hours trading.

☆ Roche Q1 sales decline tempered by swift uptake of new eye drug
▼ + stars: | 2023-04-26 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

[1/2] The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. Quarterly group revenue fell to 15.3 billion Swiss francs ($17.2 billion), the company reported on Wednesday, beating market expectations of 14.8 billion francs. The company, which does not report earnings for its first and third quarter, reiterated that pandemic-related sales - mainly lab testing, antibody treatment Ronapreve and repurposed arthritis drug Actemra - would drop by 5 billion francs this year. "We are very happy with the very rapid and significant uptake in the different markets around the world," he said on a media call. Sales and core earnings per share were still expected to decrease at a "low single-digit" percentage in 2023, the pharmaceuticals and diagnostics company added.

March 1 (Reuters) - Roche's Genentech Inc (ROGING.UL) sued Biogen MA Inc on Tuesday in San Francisco federal court, claiming Biogen owes additional patent royalties from worldwide sales of its blockbuster multiple-sclerosis and Crohn's disease drug Tysabri. Genentech's lawsuit said Biogen owes royalties for all the Tysabri that was produced using Genentech's patents before the patents expired, even if it was sold later. According to Genentech, Biogen has refused to pay royalties on any Tysabri sales since the patents expired more than four years ago. It said Biogen owes royalties for "most or all" of the Tysabri sold in "2019 and beyond," which it said was made with the patented technology before the patents expired. The case is Genentech Inc v. Biogen MA Inc, U.S. District Court for the Northern District of California, No.

☆ Bayer sees lower 2023 operating profit on cost inflation
▼ + stars: | 2023-02-28 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

FRANKFURT, Feb 28 (Reuters) - Agriculture and healthcare company Bayer (BAYGn.DE) said operating earnings would likely decline in 2023, hurt by higher costs and the reversal of last year's price boost for its glyphosate-based weedkillers. In a statement on Tuesday, Bayer said earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for special items, would likely be between 12.5 billion euros ($13.23 billion) and 13 billion euros this year, excluding the effect of currency swings. In his last presentation of the company's quarterly results, Chief Executive Werner Baumann said the company is active in the right areas of business. For 2023, "the company anticipates lower prices for agricultural herbicides as well as for some of its established pharmaceutical products," Bayer said, also citing high inflation-driven cost increases. ($1 = 0.9447 euros)Additional reporting by Patricia Weiss Editing by Friederike Heine, Kirsten DonovanOur Standards: The Thomson Reuters Trust Principles.

☆ G1 Therapeutics to scrap cancer drug trial, shares plunge
▼ + stars: | 2023-02-13 | by ( ) www.reuters.com time to read: +1 min

The drug, trilaciclib or Cosela, was unlikely to meet the main goals of extending overall survival or the time that a patient lives without the disease worsening, G1 Therapeutics said. Cosela is the company's lead therapy and the only drug being tested in clinical trials. However, the drug achieved its goal in the trial of the drug to reduce the occurrence of Neutropenia - an abnormally low count of a type of white blood cell - during induction and reduce its duration. The company is studying the drug in other indications such as breast and bladder cancer. The study was testing a combination of the drug administered along with chemotherapy and Roche's (ROG.S) therapy Avastin in patients with a type of colorectal cancer.

☆ German union opposes Bayer split after CEO departure - taz newspaper
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +1 min

BERLIN, Feb 9 (Reuters) - Germany's IGBCE union opposes any splitting-up of Bayer after the departure of its chief executive and warned that the company should not bow to pressure from hedge fund activism, taz newspaper reported on Thursday. "From the point of view of the employees, Bayer with its three pillars is perfectly positioned for the challenges of the future," said IGBCE executive board member Francesco Grioli, who is also a member of the supervisory board at Bayer. The company currently has three divisions - pharmaceuticals, consumer health and crop science. "You can only manage the transformation of the industry with a corporate policy based on risk diversification and sustainability - not on hedge fund activism," Grioli told taz. Bayer announced on Wednesday that it was replacing its CEO early, recruiting the former head of Roche's pharmaceuticals business, as investor criticism over the company’s lacklustre share price grew.

☆ Factbox: Bayer's new CEO: long-time Roche, Genentech executive, Bill Anderson
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: +1 min

LONDON, Feb 8 (Reuters) - Bayer (BAYGn.DE) bowed to investor pressure on Wednesday and named Bill Anderson, most recently head of Roche's (ROG.S) pharmaceuticals business, to take over from Werner Baumann as its CEO in June. Here are some key facts about the career about the 56-year-old American who will run the nearly 160-year-old German drugmaker:He is a chemical engineer by education and has worked for Genentech and its parent Roche since 2006CAREER:1989: started his career at Ethyl Corp, a U.S.-based fuel additives company, with postings in Belgium and the Netherlands1995: joined Raychem Corp., a U.S. technology and electronics firm1997-2006: worked at Biogen (BIIB.O) in the United States, UK and Ireland; roles included running its neurology unit, its largest business2006: joined Genentech as senior vice president, immunology and ophthalmology2010: became svp BioOncology2013: left Genentech to become global product strategy head/chief marketing officer at Genentech's parent company, Roche (ROG.S)2016: returned to Genentech as head of North American operations2017: appointed chief executive officer at Genentech2019-2023: CEO of Roche PharmaceuticalSources: Roche and BayerCompiled by Josephine Mason. Editing by Jane MerrimanOur Standards: The Thomson Reuters Trust Principles.

☆ Bayer picks outsider Anderson as CEO after investor pressure
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: +2 min

News of the CEO change sent the German drugs-to-pesticides giant's shares to their highest level in nearly eight months. Shares in Bayer closed up 6% on the news of the new CEO, reaching the top of Frankfurt's blue-chip index and hitting their highest level since June last year. "Bill Anderson's mission is clear: enable Bayer to realize its full potential and create sustainable value for our shareholders, farmers, patients, consumers, employees, and all stakeholders of the company," Winkeljohann added. Sources told Reuters earlier this week that activist investor Jeff Ubben had contacted fellow investors to drum up support for big changes at Bayer, including the swift replacement of Baumann. Reporting by Patricia Weiss, Kirsti Knolle and Christoph Steitz; Editing by Tom Sims and Alexander SmithOur Standards: The Thomson Reuters Trust Principles.

☆ Roche flags 2023 earnings decline on slump in COVID products
▼ + stars: | 2023-02-02 | by ( Ludwig Burger | ) www.reuters.com time to read: +1 min

Last year, group revenue edged 1% higher to 63.3 billion Swiss francs ($69.78 billion), the company reported, beating market expectations of 63.2 billion francs, while core operating profit gained 1% to 22.2 billion Swiss francs, just shy of the average analyst estimate of 22.4 billion francs. The onus to reinvigorate the pipeline will be on chief executive officer-designate Thomas Schinecker, who is Roche's head of diagnostics, and due to be promoted to group CEO in March. In the wake of Schinecker's appointment, the head of Roche's pharmaceuticals division, Bill Anderson, decided in December to leave after 16 years with the Swiss drugmaker. Roche said on Thursday that Teresa Graham, currently Head of Global Product Strategy for Roche Pharmaceuticals, would succeed Anderson. ($1 = 0.9071 Swiss francs)Reporting by Ludwig Burger; Editing by Paul Carrel and Rashmi AichOur Standards: The Thomson Reuters Trust Principles.

☆ Here's where to look for the next developments in the fight against Alzheimer's disease
▼ + stars: | 2023-01-17 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +10 min

The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.

☆ EMA seeks to issue guidance on liver damage from Novartis' gene therapy
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +1 min

Jan 13 (Reuters) - The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's (NOVN.S) Zolgensma, calling on them to monitor patients for any liver injury after treatment. The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August. Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness. The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks. In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

☆ U.S. FDA grants priority review to Roche's bispecific antibody Glofitamab
▼ + stars: | 2023-01-06 | by ( ) www.reuters.com time to read: 1 min

ZURICH, Jan 6 (Reuters) - Roche (ROG.S) announced on Friday the U.S. Food and Drug Administration has granted priority review to the Swiss pharmaceutical company's bispecific antibody Glofitamab. Glofitamab is intended for patients with relapsed or refractory large b-cell lymphoma. The FDA is expected to make a decision on approval of the cancer immunotherapy by July 1, 2023. Reporting by Noele Illien; Editing by Tom HogueOur Standards: The Thomson Reuters Trust Principles.

☆ Biotech investor Brad Loncar shares 10 predictions for 2023, including a hot new cancer target, Nobel Prize winners, and a biotech founder running for president
▼ + stars: | 2023-01-04 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +14 min

Loncar shared his 2023 forecast, including new drugs, Nobel Prize winners, and more globalization. Brad Loncar isn't expecting a miraculous rebound for the biotech industry in 2023. In an interview with Insider, Loncar shared 10 predictions for biotech in 2023, ranging from Nobel Prize winners and presidential runs to hot cancer targets and bankruptcy worries. 2022 was a rough year for the biotech industry, which once again underperformed the stock market. The industry runs to the next super-hot cancer target: Claudin 18.2In cancer research, drug companies are always on the hunt for the next promising target.

☆ Brazilian soccer legend Pelé died of colon cancer. Here are the cutting-edge clinical trials trying to find new treatments for the disease.
▼ + stars: | 2022-12-30 | by ( Sarah Braner | ) www.businessinsider.com time to read: +4 min

The Brazilian soccer legend Pelé died of colon cancer Thursday at 82. Colon cancer is the third most common cancer, affecting almost 2 million people each year. Colorectal cancer is the third most common cancer, according to the World Cancer Research Fund International. Pelé isn't the only celebrity to have died of colon cancer in recent years — the Black Panther star Chadwick Boseman died of the disease in 2020 at the age of 43. Here are the cutting-edge phase-three clinical trials for colon cancer, in order of how recently they began.

☆ Pfizer's hemophilia B gene therapy succeeds in late-stage study
▼ + stars: | 2022-12-29 | by ( ) www.reuters.com time to read: +1 min

Dec 29 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) said on Thursday its experimental gene therapy for the treatment of hemophilia B, a rare inherited blood disorder, met its main goal in a late-stage study. The drugmaker licensed its hemophilia B gene therapy from Roche's (ROG.S) Spark Therapeutics unit in 2014 for a $20-million upfront payment. Pfizer plans to discuss the late-stage data with regulatory authorities in Europe and the United States and share additional data for the experimental therapy at a scientific conference in early 2023. According to government data, the estimated prevalence of hemophilia in the United States is 12 cases per 100,000 males for hemophilia A and 3.7 cases per 100,000 males for hemophilia B. In November, the U.S. health regulator approved the first gene therapy, CSL Ltd and uniQure's Hemgenix, to treat hemophilia B.Pfizer is also testing other experimental gene therapies in late-stage trials as potential treatments for the bleeding disorder hemophilia A and muscular disorder Duchenne muscular dystrophy.

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