Search Results for “Sanofi” – Page 16 – media

Biogen Shareholders Elect Susan Langer to Board of Directors Despite Controversy

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
- Source: drugdu
- 126
- June 28, 2023
Generics to Novartis’ leukemia drug Tasigna to reach poor countries under 4 MPP licenses

More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
- Source: drugdu
- 190
- June 28, 2023
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Pictured: FTC sign on a wall/iStock Six U.S. states are joining the Federal Trade Commission’s lawsuit seeking to block Amgen’s $27.8 billion buyout of rare disease biotech Horizon Therapeutics, Reuters reported on Thursday. The acquisition “would allow Amgen to monopolize the market for certain crucial medications,” which would make these treatments less affordable and accessible to patients, Illinois Attorney General Kwame Raoul said in a statement. Illinois is one of the states joining the FTC’s lawsuit, along with California, Minnesota, New York, Washington and Wisconsin. In the amended lawsuit, the six states and the FTC are asking the District Court of the Northern District of Illinois to issue a preliminary injunction against the Amgen-Horizon deal while the Commission prepares an administrative complaint, and until decisions have been made about the complaint. The plaintiffs are also seeking a temporary restraining order against the acquisition and any other related transactions. “When drug ...
- Source: drugdu
- 113
- June 25, 2023
Biogen Makes Changes to Board of Directors Ahead of Annual Shareholder Meeting

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock Biogen announced Monday that three of its directors—Alexander Denner, William Jones and Richard Mulligan—will not stand for re-election at the company’s annual stockholder meeting Wednesday. Instead, Susan Langer will be up for election to Biogen’s board of directors. This latest shake-up comes after board chair Stelios Papadopoulos announced he was stepping down from his post after the annual meeting. Papadopoulos will be succeeded by Caroline Dorsa, a long-standing member of Biogen’s board who had previously served for more than two decades at Merck. Meanwhile, Langer is currently serving as president of Souffle Therapeutics, a privately held start-up that has most recently scored $50 million in investments, according to PitchBook. Before that, Langer was also the founding president of Kojin Therapeutics and the founding chief business officer of Paratus Sciences. She also previously worked at Biogen in posts of increasing responsibility. Endpoints ...
- Source: drugdu
- 110
- June 15, 2023
After Albireo buyout, Ipsen’s Bylvay picks up new FDA-approved use

After Ipsen made a splash at this year’s J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo Pharma, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.First approved by the FDA to treat cholestatic pruritus from progressive familial intrahepatic cholestasis, Bylvay has now won an FDA approval in another liver disease. Specifically, the drug can now treat cholestatic pruritus due to Alagille syndrome in patients 12 months of age and older. Cholestatic pruritus is the intense itching that afflicts patients with the diseases. A once-daily ileal bile acid transport inhibitor (IBATi), Bylvay will challenge Mirum Pharmaceuticals’ Livmarli in this disease. Livmarli won an FDA approval in Allagile syndrome back in 2021 and generated $29 million during the first quarter of 2023. Analysts with Evercore ISI have previously put a $1 billion peak sales target on Mirum’s rival drug. Bylvay’s new approval is based on results ...
- Source: drugdu
- 109
- June 15, 2023
FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

By Jamie Gumbrecht, CNN CNN — Advisers to the US Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV. Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus. Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment. The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable. If approved, it will be the first single-dose preventative treatment for all ...
- Source: drugdu
- 116
- June 10, 2023
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
- 122
- 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
- 117
- 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
- 106
- 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
- 122
- May 21, 2023

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