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☆ Samsung Biologics unveils $920 mln manufacturing deals for Pfizer
▼ + stars: | 2023-07-04 | by ( ) www.reuters.com time to read: +1 min

SEOUL, July 4 (Reuters) - South Korea's Samsung Biologics (207940.KS) announced on Tuesday two deals with Pfizer (PFE.N) worth around a combined 1.2 trillion won ($921.38 million) to manufacture products for the U.S. pharmaceutical giant. The latest orders bring this year's combined tally of orders from Pfizer to $1.08 billion, Samsung Biologics said in a statement. Tuesday's announcements include a 922.7 billion won contract, as well as an additional 254.3 billion won order that is a follow-up to a deal previously announced in March. Samsung Biologics welcomed the orders as an expansion of a strategic partnership, adding that it had won total contracts worth 1.93 trillion won so far this year, surpassing last year's annual contract volume. Earlier this year, Samsung Biologics signed deals with Eli Lilly Kinsale and GlaxoSmithKline (GLAX.NS).

Persons: Samsung Biologics, Eli Lilly Kinsale, 1,302.4000, Hyunsu Yim, Ed Davies Organizations: Samsung, Pfizer, Samsung Group, GlaxoSmithKline, Thomson Locations: SEOUL, South Korea

☆ Samsung Biologics unveils $897 mln manufacturing deals for Pfizer
▼ + stars: | 2023-07-04 | by ( ) www.reuters.com time to read: +1 min

SEOUL, July 4 (Reuters) - South Korea's Samsung Biologics (207940.KS) announced on Tuesday two deals with Pfizer (PFE.N) worth a combined $897 million to manufacture products for the U.S. pharmaceutical giant. The latest orders bring this year's combined tally of orders from Pfizer to $1.08 billion, Samsung Biologics said in a statement. Samsung Biologics welcomed the orders as an expansion of a strategic partnership, adding that its total contracts so far this year had already surpassed last year's annual contract volume. Earlier this year, Samsung Biologics signed deals with Eli Lilly Kinsale and GlaxoSmithKline (GLAX.NS). In March, Samsung Biologics announced a plan to invest 2 trillion won ($1.54 billion) through September 2025 to build a new factory in South Korea.

Persons: Samsung Biologics, Eli Lilly Kinsale, 1,302.8100, Hyunsu Yim, Ed Davies Organizations: Samsung, Pfizer, Samsung Group, GlaxoSmithKline, Samsung Biologics, Thomson Locations: SEOUL, South Korea

☆ A son died, his parents tried to sue. How U.S. courts protect Big Pharma
▼ + stars: | 2023-06-26 | by ( ) www.reuters.com time to read: +26 min

His parents soon started exploring a lawsuit against Merck, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair. The generic drug manufacturer that made the pills England took, Teva Pharmaceuticals, did not respond to inquiries. Since Merck’s patent on Singulair expired in 2012, major generic drug manufacturers have sold millions of prescriptions under the drug’s scientific name, montelukast.

Persons: Nicholas England, Nicholas, Merck, ”, Jennifer England, Nicholas’s, ” Merck, Organon, “, George W, Bush, Daniel Troy, Troy, Medtronic, Nicholas England’s, Adam Zimmerman, ” Zimmerman, Jay Lefkowitz, Ellis, shouldn’t, Bayer, drugmaker Wyeth, Phenegran, Jan Gilpin’s, mumbling, ” Gilpin, ” “, hadn’t, Singulair, Gilpin, Stephane Bissonnette, suicidality, Dr, Judith Kramer, Duke, Robert England, Robert said, Kim Beck Organizations: Merck, U.S, Teva Pharmaceuticals, Reuters, U.S . Food, Drug Administration, FDA, Big, Corporate America, Corporations, Administration, ”, New, University of Southern California’s Gould School of Law, Norfolk, Union Pacific, Federal Railroad Safety, Pacific, GlaxoSmithKline, Monsanto, Bayer, Parent Locations: Virginia, England, U.S, New York, Kirkland, East Palestine , Ohio, Louisiana, Atlanta, Vermont, Wise , Virginia, Wisconsin

GSK on Friday said the settlement reflected its desire to avoid distraction related to protracted litigation in this case. It did not admit any liability and said it would vigorously defend itself in any other Zantac cases. The trial was due to start on July 24, the first test of how Zantac cancer claims would fare before a jury. Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, said the Goetz settlement could create a precedent to settle other cases. "It also removes the distraction of any protracted litigation as the company must focus on its future pipeline which is where value will be created for shareholders," she said.

Persons: drugmaker, James Goetz, Emily Field, Lucy Coutts, JM Finn, Goetz, Dado Ruvic, Boehringer Ingelheim, Zantac, Natalie Grover, Eva Mathews, Dhanya Ann Thoppil, Barbara Lewis Organizations: GSK, Barclays, GlaxoSmithKline, REUTERS, Pfizer, Sanofi, Companies, Bank of America, FDA, Thomson Locations: U.S, British, California, Delaware, London, Bengaluru

☆ Pfizer RSV vaccine for older adults is only slightly less effective after 18 months
▼ + stars: | 2023-06-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Pfizer 's vaccine that protects adults ages 60 and older from respiratory syncytial virus was slightly less effective after 18 months, according to clinical trial results the company announced Wednesday. The data is from New York-based Pfizer's clinical trial on more than 34,000 older adults over two RSV seasons, or 24 months. The vaccine was roughly 49% effective against the same condition with two or more symptoms after 18 months, according to Pfizer. Anderson said studies are ongoing, and so is research evaluating the shot's efficacy in older adults with weak immune systems. RSV kills 6,000 to 10,000 older adults and hospitalizes 60,000 to 160,000 of them every year, according to the CDC.

Persons: Pfizer's, It's, Annaliesa Anderson, Anderson, Pfizer hasn't Organizations: Pfizer, Northern, That's, Centers for Disease Control, and Drug Administration, GlaxoSmithKline, CNBC, CDC Locations: New York, U.S

☆ Stocks making the biggest moves midday: Dollar Tree, Amazon, FedEx and more
▼ + stars: | 2023-06-21 | by ( Alex Harring | ) www.cnbc.com time to read: +4 min

People walk by a Dollar Tree store on December 11, 2018 in the Brooklyn borough of New York City. FedEx — The delivery company fell 1.7% after quarterly revenue missed expectations and announced CFO Mike Lenz would retire on July 31. Adjusted earnings were better than expected at $4.94 per share against the anticipated $4.89, while forward guidance was around flat. Advanced Micro Devices — Shares of the chipmaker pulled back nearly 5%, on track for their biggest intraday loss in two weeks. Dollar Tree — Shares of Dollar Tree popped more than 3% after the discount retailer reiterated its fiscal second-quarter 2023 earnings guidance.

Persons: Mike Lenz, MicroStrategy, Tesla, Rivian, Goldman, OneSpaWorld, Walt Disney, Needham, Laura Martin, Bob Iger, Raymond James, Uniqure, hemophilia, Yun Li, Michelle Fox, Jesse Pound, Sarah Min, Brian Evans Organizations: Federal Trade Commission, Amazon, FedEx, Securities and Exchange Commission, Barclays, GlaxoSmithKline —, Petrobras —, Walt Disney —, AMD Locations: Brooklyn, New York City, bitcoin, Netherlands

☆ GSK says RSV vaccine for older adults provides protection over two seasons
▼ + stars: | 2023-06-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

GlaxoSmithKline on Wednesday said its vaccine to protect adults ages 60 and older from respiratory syncytial virus, or RSV, remained effective across two seasons of the disease. The shot was also 78.8% effective against severe RSV disease after two seasons, compared with 94% after one season. The London-based company said high efficacy was similarly maintained in older adults with underlying conditions, who are most at risk of severe RSV. The committee will form a recommendation on when and how often the company's RSV shot — and a vaccine from rival Pfizer — should be administered in the U.S. Pfizer's RSV shot became the second to win approval shortly after.

Persons: —, drugmaker Organizations: GlaxoSmithKline, Northern Hemisphere, GSK, Pfizer, Centers for Disease Control, CDC, U.S, The, Drug Administration Locations: London

☆ GSK's cancer drug Jemperli gets file acceptance from US FDA
▼ + stars: | 2023-06-06 | by ( ) www.reuters.com time to read: 1 min

[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/IllustrationCompanies GSK plc FollowJune 6 (Reuters) - GSK (GSK.L) said on Tuesday that the U.S. Food and Drug Administration had granted file acceptance for its cancer drug, Jemperli, when combined with chemotherapy to treat adult patients with certain types of endometrial cancer. (The story has been refiled to change the image)Reporting by Radhika Anilkumar in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

Persons: Dado Ruvic, Radhika Anilkumar, Savio D'Souza Organizations: GSK, GlaxoSmithKline, REUTERS, U.S . Food, Drug Administration, Thomson Locations: U.S, Bengaluru

☆ Fact Check-SKYCovion vaccine is not sprayed from aircraft
▼ + stars: | 2023-06-01 | by ( Reuters Fact Check | ) www.reuters.com time to read: +2 min

A South Korean COVID-19 vaccine recently authorised in Britain is administered by injection, not sprayed into the sky from aircraft, as social media posts falsely claim. Some social media users have since been saying that SKYCovion will be sprayed on people from aircraft in a possible misinterpretation of the vaccine’s name (here). However, the vaccine is not based on mRNA and is administered through intramuscular injection, according to the MHRA and SK bioscience. SKYCovion is not an mRNA vaccine but has a traditional protein-antigen design. The SKYCovion vaccine authorised in Britain is injected intramuscularly, not sprayed from the sky.

Persons: chemtrails, Read Organizations: South, SK bioscience, GlaxoSmithKline, GSK, SK Chemicals, Britain’s Medicines, Healthcare, Agency, Twitter, ” SK bioscience, Reuters Locations: Britain, South Korean

☆ Fact Check-Tdap vaccine use in pregnancy proven safe in studies, not ‘an experiment’
▼ + stars: | 2023-05-18 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

TDAP TRIALSThe Tdap vaccine can help prevent three diseases: tetanus, diphtheria, and pertussis, which is also known as whooping cough (here). Whooping cough can be “extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death,” according to the CDC (here). FDA-approved vaccine package-insert documentation for Adacel (here) and Boostrix (here) shows that neither manufacturer states the vaccine has not been tested in clinical trials. In 2017, about 49% of all pregnant women in the U.S. received a Tdap vaccine during their pregnancy (here). Clinical trials and population data have shown the Tdap vaccine to be safe and effective in pregnancy.

☆ FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns
▼ + stars: | 2023-05-18 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Thursday recommended full approval of Pfizer's vaccine that protects infants from RSV, but raised safety concerns over premature births that may be tied to the shot. Ten of the advisors said the safety data on Pfizer's shot was adequate, while four said it was not. The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy.

☆ Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say
▼ + stars: | 2023-05-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's RSV vaccine that protects infants is administered to expectant mothers in the late second or third trimester of their pregnancy. Some of the participants' children also had low birth weights, the staff review said. But the FDA staff said it is unlikely that those deaths are related to Pfizer's shot.

☆ FDA approves GSK's RSV vaccine for older adults, world's first shot against virus
▼ + stars: | 2023-05-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. London-based GSK during an earnings presentation last week said it has "millions" of doses of the RSV vaccine ready to ship. In March, an independent panel of advisors to the FDA recommended GSK's RSV vaccine based on data from a phase three trial on older adults. A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDA briefing document. The FDA flagged the disorder as a potential safety issue with Pfizer's RSV vaccine for older adults.

☆ US subsidies make UK financial reform urgent, business warns
▼ + stars: | 2023-04-26 | by ( Huw Jones | ) www.reuters.com time to read: +2 min

LONDON, April 26 (Reuters) - U.S. clean technology subsidies are sucking capital from Europe, making it more urgent to improve London as a global financial centre, business bosses told UK lawmakers on Wednesday. It's the biggest shift in competitive dynamic in my career," GlaxoSmithKline chair Jonathan Symonds told a Treasury Select Committee hearing on why UK companies are listing in New York instead. "The effect of what's happening through the Inflation Reduction Act across the whole of Europe is like a dirty great hoover on full suction mode," said Jonathan Hill, who authored a government-backed report on reforming UK listing rules. Britain has already eased listing rules in line with Hill's recommendations, and plans further changes. UK listed companies disclose whether they follow governance best practice or explain why they do not, but critics say flexibility has been lost.

Such "skinny labels" typically allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers' patents. GSK sued Teva for patent infringement in Delaware federal court in 2014 over its generic version of Coreg. In its petition to the Supreme Court last year, Teva said the ruling would cause "havoc" for skinny labels, which it said are "extraordinarily common" and "save patients and the federal government billions." GSK countered that the case does not threaten generic drugmakers that "operate properly under the law." The Biden Administration backed Teva on Wednesday, arguing generic drugmakers should be entitled to rely on the FDA's carve-out instructions, which are based on brand-name drugmakers' own statements to the agency.

☆ Johnnie Walker maker Diageo appoints Debra Crew CEO
▼ + stars: | 2023-03-28 | by ( Hanna Ziady | ) edition.cnn.com time to read: +2 min

London CNN —One of the world’s largest alcoholic drinks companies has appointed its first female CEO. Diageo, which makes Guinness beer and Johnnie Walker whisky, said Tuesday that chief operating officer Debra Crew would succeed Ivan Menezes, who will retire from the company after 10 years at the helm. Diageo is the seventh-largest member of the FTSE 100 (UKX) index and will now become the largest UK-listed company led by a woman. There are just nine other FTSE 100 (UKX) companies led by women, including pharmaceutical company GlaxoSmithKline (GLAXF) and bank NatWest. Diageo is the world’s fourth biggest alcoholic drinks company by market value, after AB InBev (BUD) and China’s Wuliangye Yibin and Kweichow Moutai.

☆ FDA advisors recommend GSK's RSV vaccine for older adults, but flag potential safety risks
▼ + stars: | 2023-03-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

Ten of the FDA advisors said the safety data on GSK's vaccine was adequate, while two said it was not. The panel reached a similar conclusion in a narrow 7 to 4 vote Tuesday on Pfizer's application to clear its RSV vaccine. While the advisors erred toward recommending approval, they also raised concern over a possible link to Guillain-Barre syndrome. Both companies have asked the FDA to approve their RSV shot for adults ages 60 and older. The FDA said the cases are possibly related to either GSK's RSV vaccine or the flu shot that was administered with it.

☆ Pfizer/BioNTech, Moderna gear up for 2024 London trial over COVID vaccine patents
▼ + stars: | 2023-02-16 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Ivan AlvaradoLONDON, Feb 16 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) are gearing up for a 2024 trial with Moderna Inc (MRNA.O) at London's High Court in competing patent lawsuits over their rival COVID-19 vaccines. The case reached London's High Court for the first time for a preliminary hearing on Thursday, ahead of a trial which is due to take place in April 2024. Pfizer and BioNTech sued Moderna in London in September, seeking to revoke two of Moderna's patents in relation to its messenger RNA (mRNA) vaccines. Moderna brought its own lawsuit that month over Pfizer and BioNTech’s Comirnaty vaccine, seeking damages for alleged infringement of its patents. Pfizer, BioNTech and Moderna are also engaged in litigation in Germany, the Netherlands and the United States.

☆ Investor Sarat Sethi said he is buying into this 'unloved' pharma stock
▼ + stars: | 2023-02-06 | by ( Sarah Min | ) www.cnbc.com time to read: +2 min

It's time for investors to get back into British pharmaceutical company GSK , according to investor Sarat Sethi. He has been adding to the stock that was known as GlaxoSmithKline since buying it a couple months ago, Sethi told the panel on CNBC's " Halftime Report " on Monday. GSK shares have notably underperformed this year. While the S & P 500 has rallied more than 7% since the start of 2023, GSK shares are just slightly higher for the year, up 0.6%. Hightower's Stephanie Link approved of the buy, saying that GSK has a "great story."

☆ Unilever's new CEO will inherit a company in flux
▼ + stars: | 2023-02-05 | by ( Alex Bitter | Ellen Thomas | ) www.businessinsider.com time to read: +9 min

Two of the five divisions remain focused on food products, an area that CEO Jope said Unilever considered spinning off. Food brands like Ben & Jerry's and Hellmann's would have become a separate company. Unilever's decision last year to spin off its tea business into a new company, Ekaterra, left many workers inside Unilever's food division nervous, the former employee said. One former Unilever executive pointed to Fernando Fernandez, who will assume the top job at the company's new beauty and wellbeing division. Fernandez has been Unilever's executive vice president for Latin America since 2019 and held other jobs with the company in the region before that.

☆ GSK CEO Emma Walmsley on beating Q4 earnings
▼ + stars: | 2023-02-01 | by ( ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailGSK CEO Emma Walmsley on beating Q4 earningsGlaxoSmithKline CEO Emma Walmsley joins 'Squawk Box' to discuss company's growth drivers this quarter, the company's Shingles vaccine and the medical giant's RSV vaccine.

☆ Here comes the biggest week of earnings. Plus an AI ode to the Dow
▼ + stars: | 2023-01-28 | by ( Zev Fima | ) www.cnbc.com time to read: +7 min

While only six companies in the Dow Jones Industrial Average are reporting next week, about 20% of the S & P 500 reports, making it the biggest week of earnings this season. The Dow and the S & P 500 gained 2.2% and 2.9% this week, respectively, while the Nasdaq Composite rose 4.7%. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.

☆ Stocks may face an inflection point in the week ahead as the Fed meets and Apple posts earnings
▼ + stars: | 2023-01-27 | by ( Patti Domm | In | ) www.cnbc.com time to read: +9 min

The Fed's meeting Tuesday and Wednesday comes amid a flood of corporate earnings reports, with about 20% of the S & P 500 reporting that week. The most important day for earnings is Thursday, when Apple , Alphabet and Amazon report after the bell. The Nasdaq Composite was up 11% for the month as of Friday afternoon, well ahead of the 6.2% gain in the S & P 500. Traders have been watching the S & P 500 edge closer to the key threshold of 4,100 , its high from December. AAPL 1Y line apple Apple is also important because of the signals it can send about the strength of the consumer, supply chains and China's reopening.

☆ Biogen's new CEO says Alzheimer's will become a major franchise for the company but that a different drug has the 'biggest undervalued potential'
▼ + stars: | 2023-01-09 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +4 min

But new CEO Christopher Viehbacher said that he sees Alzheimer's becoming a new franchise. He added that zuranolone, an antidepressant, is the "biggest undervalued potential" of the company. On the heels of the approval of a new Alzheimer's drug, Cambridge-based biotech company Biogen seems focused on expanding its focus to a wider range of illnesses. New Alzheimer's drug lecanemab could signal a new franchiseThe first is lecanemab, a drug for Alzheimer's disease that was granted an accelerated approval by the US Food and Drug Administration last week. "I think zuranolone is the biggest undervalued potential of Biogen," Viehbacher said.

☆ U.S. experts recommend weight-loss drugs for obese children
▼ + stars: | 2023-01-09 | by ( Bhanvi Satija | ) www.reuters.com time to read: +4 min

Metformin has been used off label to achieve weight loss in children. Of the 27 randomized trials of metformin for weight loss in children reviewed by the guidelines panel, 74% showed some positive effect of the medication. Wegovy last month won U.S. approval for chronic weight management in children ages 12 and older. For children ages 2 to 12 years, AAP said there was not currently enough evidence to recommend use of these medications. They also include recommendations for diagnosing obesity annually in children ages 6 years and older, through checks on BMI, and practices such as motivational interviewing.

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