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☆ Sarepta slides as FDA about-turn on panel clouds gene therapy approval path
▼ + stars: | 2023-03-17 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoMarch 17 (Reuters) - Shares of Sarepta Therapeutics Inc (SRPT.O) slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a panel meeting. The U.S. Food and Drug Administration planned to hold a meeting of its independent experts to review the gene therapy, the company said late on Thursday, less than a month after saying it would not do so. Sarepta is developing SRP-9001 as the first gene therapy for the treatment of Duchenne muscular dystrophy, an inherited disorder of progressive muscular weakness typically seen in boys. Gene therapies such as BioMarin's (BMRN.O) bleeding disorder therapy have faced setbacks and tough scrutiny in the past, but the FDA approved multiple such products in 2022.

☆ Novartis initiates new trading line for share buybacks
▼ + stars: | 2023-03-13 | by ( Ludwig Burger | ) www.reuters.com time to read: +1 min

March 13 (Reuters) - Novartis said on Monday it received regulatory clearance to open a separate trading line for potentially up to 16.5 billion Swiss francs ($18.1 billion) in stock repurchases even as its ongoing $15 billion buyback programme is close to completion. At last week's annual shareholder meeting, the company won investor authorization for up to 10 billion francs in buybacks, which comes on top of 6.5 billion francs in prior authorizations. A company spokesperson told Reuters on Monday that the "majority" of its ongoing $15 billion buyback programme was already completed, adding that any repurchases would be decided by the board of directors. Novartis laid out plans for the $15 billion programme in late 2021, after receiving $20.7 billion for the sale of its nearly one-third voting stake in Roche (ROG.S) back to its cross-town rival. ($1 = 0.9118 Swiss francs)Reporting by Ludwig Burger in Frankfurt and John Revill in Zurich Editing by Paul Carrel and Christina FincherOur Standards: The Thomson Reuters Trust Principles.

☆ Bayer braces for falling profits in challenge for new CEO
▼ + stars: | 2023-02-28 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Bayer said in a statement that earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for special items, would likely be between 12.5 billion euros and 13 billion euros ($13.2 billion - $13.8 billion) this year, excluding the effect of currency swings. Bayer said this month it would replace its CEO early, recruiting former Roche (ROG.S) executive Bill Anderson, amid demands by some investors that Bayer should simplify its diversified structure and split into separate groups. A $6.4 billion provision remained on the balance sheet for glyphosate payouts, the larger of the two legal burdens. So Bayer should really not be on the buy list of many investors at the moment," said Molnar. Bayer saw herbicide sales jump 44% in 2022 after hurricane Ida damaged rival producers and constrained Chinese suppliers failed to plug the gap.

☆ 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.

☆ Small caps are on a tear this year. Here’s how investors are playing the rally.
▼ + stars: | 2023-02-16 | by ( Pia Singh | ) www.cnbc.com time to read: +6 min

"A regime change, if you will, is taking place in the market, where small caps are going to do better," said Francis Gannon, co-chief investment officer at Royce Investment Partners, which focuses on small caps. Now investors are pointing to the recent rally as proof that small caps are on the verge of a prolonged period of outperformance. 'Massively outperform' Michael Sesser, equity portfolio manager of the $558-million DWS Small Cap Core fund, believes small caps will "massively outperform" large caps over the next five to 10 years. Cantaloupe , a retail service digital payments company with a $373 million market cap, and medical imaging provider RadNet ($1.2 billion market cap) are among Sesser's picks. DWS Small Cap also owns metallurgical coal producers serving the steel industry, namely Alpha Metallurgical Resources ($2.7 billion market cap), Arch Resources ($2.6 billion market cap) and Peabody Energy ($4.2 billion market cap).

☆ 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.

☆ 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.

☆ Exclusive: Starboard to challenge engineering materials maker Rogers' board -sources
▼ + stars: | 2023-02-04 | by ( Svea Herbst-Bayliss | ) www.reuters.com time to read: +2 min

The board challenge comes after chemical company DuPont (DD.N) in November walked away from a $5.2 billion deal to acquire Rogers because it failed to secure regulatory approval for the transaction in China. Starboard and Rogers did not respond to requests for comment. Its stock price tumbled after the DuPont deal was scrapped and is down 47% over the last 52 weeks. The company has made changes since the DuPont deal fell apart. Starboard has been active, including recent bets on cloud-based software company Salesforce (CRM.N), software company Splunk (SPLK.O) and website maker Wix.com (WIX.O).

☆ 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.

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.

☆ Roche launches new test to detect fast spreading Omicron sub-variant
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: 1 min

ZURICH, Jan 26 (Reuters) - Roche (ROG.S) has launched a new PCR test to detect a fast-spreading sub-variant of the Omicron variant of Coronavirus, the Swiss drugmaker said on Thursday. The new test specifically targets the XBB.1.5 Omicron variant and will help researchers closely track the virus’s lineage and provide insights into the epidemiology and impact it has on public health, the company added. The XBB.1.5 variant is prevalent in the United States and is quickly spreading to other countries, Roche said. "Being able to differentiate emerging variants and understand their similarities and mutations provides a basis for experts to make predictions about their spread and respond with appropriate treatment strategies," Roche said. Reporting by John Revill; Editing by Noele IllienOur Standards: The Thomson Reuters Trust Principles.

Increasingly, they said conversations in C-suites and with financiers had turned to the risks that climate change presented to businesses. Climate activist Greta Thunberg made the journey up the Swiss Alps to call on the global energy industry and its financiers to end all fossil fuel investments. Suni Harford, the president of UBS's asset management arm who leads the bank's sustainability efforts, said her conversations at Davos suggested no let up in focus on climate, despite the shorter-term pressures. "Clients are becoming ever more informed on the energy transition, demand for sustainable and green products has held up well, and clients are increasingly looking to measure the impact of their portfolios." "Put forward credible and transparent transition plans on how to achieve net zero – and submit those plans before the end of this year," Guterres said in a speech.

☆ 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.

☆ European shares head for best week since November, inflation data in focus
▼ + stars: | 2023-01-06 | by ( Bansari Mayur Kamdar | ) www.reuters.com time to read: +3 min

The pan-European STOXX 600 (.STOXX) was flat by 0915 GMT. For the week so far, it was up 3.4% following a drop in natural gas prices and upbeat economic data. All eyes are on the December euro zone inflation data due at 1000 GMT, with economists expecting prices to have declined year-on-year for a second consecutive month. "Inflation readings in the euro zone were not all good news, and core inflation remains high," analysts at UBS Global Wealth Management said in a note. "Despite the encouraging data (this week), we expect central banks to stick with a hawkish stance at this time."

☆ 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.

☆ Big Pharma will find right formula for M&A binge
▼ + stars: | 2022-12-20 | by ( Aimee Donnellan | ) www.reuters.com time to read: +3 min

The year 2022 was relatively thin for pharma M&A, with deals worth nearly $66 billion being announced by early December – 60% below the 9-year average, according to Refinitiv data; 2023 will be better. It helps that drug companies are relatively healthy, with debt around just 1.6 times forecast EBITDA in 2023, according to Berenberg analysts. Seagen (SGEN.O), for example, worth $22 billion in early December, has fought off Merck & Co (MRK.N). That puts Big Pharma in an ideal negotiating position. CONTEXT NEWSGlobal pharmaceutical companies spent nearly $66 billion on takeovers in 2022, according to data from Refinitiv as of Dec. 7.

Earlier, much smaller U.S. studies conducted in the mid-1980's had suggested roughly 60,000 people are diagnosed with Parkinson's disease each year. The estimated economic cost is $52 billion annually in the United States alone, according to a report of the study published in npj Parkinson's Disease. Fox Foundation for Parkinson's Research obtain increased funding for research and access to care. A separate study by Beck's team recently put the number of U.S. patients living with Parkinson's disease at nearly 1 million, whereas earlier estimates had been closer to 650,000, he said. "Because the U.S. population is aging, a lot of people are going to be entering the health system with Parkinson's disease," Beck said, "and there are only about 700 neurologists in the country who specialize in movement disorders."

☆ Roche's head of pharmaceuticals to leave company
▼ + stars: | 2022-12-12 | by ( ) www.reuters.com time to read: +1 min

ZURICH, Dec 12 (Reuters) - Roche's (ROG.S) head of its pharmaceuticals division will leave the drugmaker at the end of the year, the Swiss company said on Monday, as it confirmed other parts of its succession plan. Former Genentech boss Bill Anderson "has decided to pursue opportunities outside of Roche," Roche said, with a successor due to be named by March 2023. Schinecker will replace Severin Schwan, who is slated to become chairman after 14 years as CEO of Roche. He has been instrumental in shaping Roche’s transformation and I wish him all the best for the future," Schwan said in a statement. He had been CEO of Roche's pharmaceuticals business since 2019.

David Beckham, England — World Cup (1998, 2002 and 2006)Nate: The uncontainable aura of a man who transcended the sport and captured the world’s eyes. Eusebio, Portugal — (World Cup 1966)Nate: Rising high by the crowd that carries him; adored by Benfica, adored by Portugal, adored by the whole world. Zlatan Ibrahimović , Sweden (World Cup, 2002 and 2006)Nate: An ever present mythos … seemingly reversing time whilst being a journeyman through it. Lionel Messi, Argentina — (World Cup, 2006, 2010, 2014 and 2018)Nate: Ladies and gentlemen … It’s Lionel Messi. Socrates, Brazil — (World Cup, 1982 and 1986)Nate: Philosopher by name … glory that belongs in the Colosseum.

☆ Activision acquisition would be good for Microsoft and the overall stock market
▼ + stars: | 2022-12-02 | by ( Zev Fima | ) www.cnbc.com time to read: +12 min

That implies that the other 35% of the market is made up of firms with equal to or less than about a 2% market share. For simplicity's sake, let's say an additional 17 firms have a 2% market share each to bring us to 100% of the market. That means the HHI, calculated by the market share number squared and then added together for all 27 companies, would be under 650. If the Microsoft-Activision Blizzard deal goes through, and you combine the market share concentration of the two companies, the HII would be just over 700. The other issue is how one measures the gaming market.

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☆ Rare success for Alzheimer's research unlocks hope for future therapies
▼ + stars: | 2022-11-29 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago. But several antibody therapies from Lilly, Biogen and AbbVie(ABBV.N) that were designed to slow the rate of tau accumulations failed outright last year.

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