Search Results for “Sanofi” – Page 17 – media

Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
- Source: drugdu
- 125
- June 5, 2023
After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit

Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. As part of the settlement, which was recorded (PDF) in a federal district court in New Jersey, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. The deal comes three months after the company said it would slash price of the type 1 diabetes treatment to the same level to “make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system.” Lilly’s initial move had come a month after President Joe Biden, in his State of the Union address, called on Congress to limit insulin costs for all patients to $35 per month. The Inflation Reduction Act already had limited insulin costs for patients on Medicare at $35 per month. The lawsuit was ...
- Source: drugdu
- 119
- June 1, 2023
FDA approves Lexicon’s heart-failure drug after defeat in diabetes

Nicole DeFeudis Editor The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi. The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday. The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end ...
- Source: drugdu
- 109
- May 30, 2023
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
- Source: drugdu
- 125
- May 21, 2023
Roche’s fenebrutinib shows promise in relapsing forms of MS

Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
- Source: drugdu
- 115
- May 19, 2023
FTC sues to block Amgen’s $28B Horizon buy in alarming sign for biopharma M&A

Just as biopharma’s M&A prospects seemed to be improving, the U.S. antitrust watchdog is putting a damper on dealmaking. The U.S. Federal Trade Commission has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, the agency said Tuesday. By a unanimous vote among the three Democrat commissioners, the agency is seeking a temporary restraining order and preliminary injunction to prevent the transaction from closing. In an alarming sign for biopharma M&A scrutiny to come, the FTC argues Amgen could leverage its existing product portfolio to “entrench the monopoly positions” of Horizon meds for thyroid eye disease and chronic gout. The antitrust challenge marks the first time that the FTC has reached beyond specific product overlaps in its reviews and instead focused on companies’ past behaviors around drug pricing. It’s an approach that the agency has threatened to implement since 2021 but has only now reared its ...
- Source: drugdu
- 125
- May 18, 2023
After Hemgenix approvals, uniQure cashes out some of its royalty rights for $375M-plus

Months after the U.S. and European approvals of its CSL-partnered hemophilia A gene therapy Hemgenix, uniQure is selling some royalty rights for up to $400 million. In a deal with HealthCare Royalty (HCRx) and Sagard Healthcare, uniQure agreed to part ways with a portion of its Hemgenix royalty rights. The company previously licensed the drug to Australia’s CSL Behring, and it’s entitled to milestone and royalty payments as the launch progresses. Now, though, it’s trading some of those royalty rights for a quick payday. Under the new deal with HCRx and Sagard Healthcare, uniQure will get $375 million upfront and another $25 million if an undisclosed sales threshold is achieved. The cash lets uniQure “continue to invest” in its adeno-associated virus vector gene therapy pipeline, CEO Matt Kapusta said a statement. The pipeline includes a Huntington’s disease prospect, a refractory temporal lobe epilepsy candidate and an SOD-1 amyotrophic lateral sclerosis ...
- Source: drugdu
- 118
- May 17, 2023
Ahead of high-stakes California trial, GSK notches Zantac win in Canada

As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
- Source: drugdu
- 118
- May 16, 2023
Sobi to acquire CTI BioPharma for approximately $1.7bn

Swedish Orphan Biovitrum (Sobi) has said it will acquire CTI BioPharma for approximately $1.7bn, marking a notable expansion to the Swedish drugmaker’s rare haematology pipeline. The deal will grant Sobi access to the US biopharma’s recently-approved Vonjo (pacritinib), a novel oral kinase inhibitor for patients with myelofibrosis and severe thrombocytopenia. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) in February last year to treat adults with intermediate or high-risk primary or secondary myelofibrosis with low platelet counts. This was based on positive results from a phase 3 trial of Vonjo in patients with myelofibrosis. Results showed that 29% of patients receiving Vonjo had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy. Sobi said Vonjo will be ‘highly complementary’ to Doptelet (avatrombopag), its oral thrombopoietin receptor agonist which also addresses rare haematological platelet disorders. Guido ...
- Source: https://www.pmlive.com/pharma_news/sobi_to_acquire_cti_biopharma_for_approximately_$1.7bn_1491454
- 122
- May 14, 2023
Eli Lilly to sell low blood sugar drug Baqsimi to Amphastar in deal worth over $1bn

The drug is available in 27 markets, with worldwide sales totalling over $139m in 2022. Eli Lilly will sell its low blood sugar drug Baqsimi to Amphastar Pharmaceuticals in a deal worth over $1bn, the two companies announced. Under the terms of the definitive agreement, Amphastar will pay Lilly $500m at closing and an additional $125m after one year, with Lilly also eligible to receive sales-based milestone payments of up to $450m. Baqsimi is the first and only nasally administered glucagon to treat severe hypoglycaemia – very low blood sugar – in diabetes patients aged four years and above. Classed as a diabetic emergency, severe hypoglycaemia is a complication that can occur in diabetes patients who take insulin and certain anti-diabetic tablets. The condition is characterised by altered mental or physical functioning, including confusion and disorientation, convulsions, loss of consciousness and coma. Lilly launched Baqsimi ...
- Source: drugdu
- 166
- April 28, 2023

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