EMA Approves Factor VIII Deficiency Clotting Drug EMA Approves Factor VIII Deficiency Clotting Drug
European Union marketing authorization recommended for Altuvoct for hemophilia A caused by factor VIII deficiency.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 26, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
FDA OKs Second Gene Therapy for Hemophilia B
(MedPage Today) -- The FDA has approved a second gene therapy for adults with hemophilia B, drugmaker Pfizer announced on Friday.
The approval of fidanacogene elaparvovec (Beqvez) stipulates use in adult men with moderate to severe hemophilia... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 26, 2024 Category: American Health Source Type: news
FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B
NEW YORK--(BUSINESS WIRE) April 26, 2024 -- Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Second Gene Therapy for Hemophilia B FDA Approves Second Gene Therapy for Hemophilia B
Pfizer reported a list price of $3.5 million for its new gene therapy, Beqvez, for adults with this rare bleeding disorder.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 26, 2024 Category: Consumer Health News Tags: Internal Medicine News Alert Source Type: news
FDA approves Pfizer ’s first gene therapy for rare inherited bleeding disorder
The Food and Drug Administration on Friday approved Pfizer 's treatment for a rare genetic bleeding disorder, making it the company's first-ever gene therapy to win clearance in the U.S. The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B…#pfizer #beqvez #hemophilia #adamcuker #comprehensiveand #sparktherapeutics #cslbehring #fda #hemgenix #hemophiliaa (Source: Reuters: Health)
Source: Reuters: Health - April 26, 2024 Category: Consumer Health News Source Type: news
U.S. FDA approves Pfizer & #039;s BEQVEZ ™ (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with Hemophilia B
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. (Source: World Pharma News)
Source: World Pharma News - April 26, 2024 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 2% (CER) in first quarter with both divisions growing in high single digit ex COVID-19
Group sales grew by 2%1 at constant exchange rates (CER) (-6% in CHF), driven by the strong growth of newer medicines and diagnostics. Excluding COVID-19-related products, sales increased by 7%. Going forward, there will be no further material impact of COVID-19 sales declineDue to the appreciation of the Swiss franc against most currencies,saleswere 6% lower when reported in CHFPharmaceuticals Divisionbase business2 grew by 7%, driven by strong sales of medicines to treat severe diseases, such as Vabysmo (eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A...
Source: Roche Investor Update - April 24, 2024 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 2% (CER) in first quarter with both divisions growing in high single digit ex COVID-19
Group sales grew by 2%1 at constant exchange rates (CER) (-6% in CHF), driven by the strong growth of newer medicines and diagnostics. Excluding COVID-19-related products, sales increased by 7%. Going forward, there will be no further material impact of COVID-19 sales declineDue to the appreciation of the Swiss franc against most currencies,saleswere 6% lower when reported in CHFPharmaceuticals Divisionbase business2 grew by 7%, driven by strong sales of medicines to treat severe diseases, such as Vabysmo (eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A...
Source: Roche Media News - April 24, 2024 Category: Pharmaceuticals Source Type: news
South Africa: This Week - Discussions On Basic Income in SA, Joburg Crisis Summit, and Dullah Omar Memorial Lecture
[Daily Maverick] World Haemophilia Day, a special screening of 'Tomorrow's Freedom', and Ndifuna Ukwazi's 12-week political and legal education programme kick off this week. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - April 16, 2024 Category: African Health Tags: Health and Medicine South Africa Southern Africa Source Type: news
FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus ' s supplemental Biologics License Application (sBLA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2024 Category: Drugs & Pharmacology Source Type: news
The World ’s Most Expensive Drug Is Now a $4.25 Million Gene Therapy
A new gene therapy for an ultra-rare disease will have a wholesale cost of $4.25 million, making it the world’s most expensive drug.
The one-time treatment, Lenmeldy, won U.S. regulatory approval on Monday to correct the underlying cause of a hereditary condition called early-onset metachromatic leukodystrophy, or MLD.
MLD is a fatal disease in which infants sometimes start to lose the ability to walk and talk. Orchard Therapeutics said the drug’s price “reflects its clinical, economic and societal value” in a statement Wednesday.
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Source: TIME: Health - March 21, 2024 Category: Consumer Health News Authors: Gerry Smith/Bloomberg Tags: Uncategorized healthscienceclimate wire Source Type: news
7 Biotech Stocks Ready to Ride the Sector ’s Resurgence
A rotation may be on the way Why do you want to consider biotech stocks? Simply, the narrative comes down to numbers and a possible rotation. First, the hard data supports bullishness in biotech stocks. According to Grand View Research, the underlying global industry reached a valuation of $1.55…#grandviewresearch #minneapolis #minnesota #biotechne #q4 #eps #hemophilia #cnta #q3 #westconshohocken (Source: Reuters: Health)
Source: Reuters: Health - March 19, 2024 Category: Consumer Health News Source Type: news
Why Novo Nordisk Stock Was a Winner Today
One of the healthcare stocks of the moment, Novo Nordisk (NYSE: NVO), had a good Tuesday on the market. Investors pushed its price 3% higher, more than double the percentage rate increase of the S&P 500 index, on the back of a positive move by an analyst. That action occurred late Monday…#novonordisk #nvo #argusresearch #jimkelleher #capitalonefinancial #denmark #hemophilia #ozempicwegovy #elililly #ericvolkman (Source: Reuters: Health)
Source: Reuters: Health - March 13, 2024 Category: Consumer Health News Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
Group salesgrow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidanceExcluding COVID-19 products,Group sales increase by 8%Pharmaceuticals Divisionsalesincrease by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)Diagnostics Division salesare 13% lower due to high demand for COVID-19 tests in 2022; strong ...
Source: Roche Media News - February 1, 2024 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
Group salesgrow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidanceExcluding COVID-19 products,Group sales increase by 8%Pharmaceuticals Divisionsalesincrease by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)Diagnostics Division salesare 13% lower due to high demand for COVID-19 tests in 2022; strong ...
Source: Roche Investor Update - February 1, 2024 Category: Pharmaceuticals Source Type: news
