Search Results for “Sanofi” – Page 16 – media

EMA Concern Stirs over Suicide Risk with Weight Loss GLP-1RA Drugs

The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm. The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes. The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts. Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide. GLP-1RAs are a rapidly growing ...
- Source: drugdu
- 105
- July 14, 2023
UAE, Saudi Arabia Serve as Gateway to International Markets for Biopharma

Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
- Source: drugdu
- 149
- July 13, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 111
- July 9, 2023
Moderna strikes deal to develop mRNA drugs in China

Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
- Source: drugdu
- 96
- July 8, 2023
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
- 134
- 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
- 193
- 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
- 117
- 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
- 114
- 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
- 113
- 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
- 119
- June 10, 2023

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