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Feb 18, 2024
Eli Lilly and Company has received FDA approval for the drug tirzepatide, which will now be marketed as Zepbound for chronic weight management. This approval positions Eli Lilly as a key player in the obesity drug market, which is predicted to reach $100 billion by 2030. Zepbound's mechanism of action involves activating naturally produced hormones to suppress hunger signals. Despite safety concerns and challenges with insurance coverage, Eli Lilly's CEO is confident in the company's ability to meet the demand for Zepbound.
Feb 18, 2024
A woman from Illinois has filed a lawsuit against Novo Nordisk, claiming that the company's diabetes and weight loss drug Ozempic caused her to experience extreme vomiting, pain, and a blocked bowel. She alleges that the vomiting resulted in a torn esophagus and a week-long hospital stay. The lawsuit is part of a growing legal campaign, with nearly 60 lawsuits filed against the company by patients who suffered severe side effects from the drug. The legal action also includes patients who used Novo Nordisk's other drug, Wegovy. The plaintiffs claim that they were not adequately warned about the drug's side effects. Novo Nordisk has stated that it believes the allegations are without merit and will vigorously defend itself.
Read more about | NOVO NORDISK INC | OZEMPIC| WEGOVY|
Feb 17, 2024
New Delhi: The U.S. Food and Drug Administration (FDA) has approved a combination of AstraZeneca's cancer drug Tagrisso with chemotherapy for the treatment of advanced lung cancer, according to a statement by the company. The approval was based on trials that showed an extension in the median progression-free survival (PFS) by nearly nine months. The addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone. Tagrisso is currently approved as monotherapy in over 100 countries.
Read more about | ASTRAZENECA AB | TAGRISSO|
Feb 17, 2024
Pharmaceutical companies Eli Lilly and Novo Nordisk are experiencing a surge in their stock prices due to investor optimism about the potential demand for their weight-loss drugs. Shares in both companies are trading at high valuations compared to their healthcare peers, similar to those of high-growth tech stocks. Eli Lilly's market value has surpassed that of electric automaker Tesla, making it the ninth-largest U.S.-listed company. Analysts expect both companies' revenues to increase significantly in the coming years. However, the potential risks to this rally include escalating production costs and a potential decrease in product prices.
Read more about | NOVO NORDISK INC | ELI LILLY AND CO |
Feb 16, 2024
BioAge Labs has raised $170m in a Series D financing round led by Sofinnova Investments, with many pharmaceutical companies joining as investors. The funds will support Phase II trials of BioAge’s azelaprag, a drug designed to activate the apelin receptor in order to improve weight loss and body composition. The Phase II trials will combine azelaprag with Eli Lilly’s type 2 diabetes treatment tirzepatide, with the aim of preserving muscle mass during weight loss. The trials are set to begin in mid-2024.
Read more about | LILLY | TIRZEPATIDE|
Feb 16, 2024
Three major pharmaceutical companies have agreed to remove several patents from the Orange Book, a move signaling a shift towards increased transparency and competition in the industry. The decision comes as a response to pressure from the Federal Trade Commission (FTC) to dismantle barriers to competition and lower drug prices. GlaxoSmithKline (GSK) agreeing to delist 12 patents, along with five additional ones, is particularly noteworthy for potentially fostering more competition and improving access to medications for patients. This development highlights the influence of regulatory intervention in promoting a fairer pharmaceutical sector.
Read more about | GLAXOSMITHKLINE LLC |
Feb 16, 2024
Danish pharmaceutical company Novo Nordisk is set to acquire contract development and manufacturing organization Catalent for $16.5bn. As part of the deal, Novo Nordisk will pay $11bn to buy three of Catalent's manufacturing sites to strengthen production of its diabetes drug, Ozempic, and weight-loss medication, Wegovy. Catalent has faced challenges in recent years, including quality control problems and declining demand for COVID-19 vaccines. However, analysts believe that the acquisition will allow Novo Nordisk to increase manufacturing capacity for its drugs. The deal is expected to close at the end of 2024, pending regulatory approvals.
Read more about | NOVO NORDISK INC | OZEMPIC| WEGOVY|
Feb 16, 2024
The FDA has granted an expanded label for Novartis and Roche's drug Xolair (omalizumab) based on a positive Phase III study funded by the NIH. The study found that participants who received omalizumab could consume higher doses of peanut, egg, milk, and cashew without experiencing allergic reactions. Additionally, the FDA has converted the accelerated approval for EMD Serono's drug Tepmetko (tepotinib) to full approval for non-small cell lung cancer.
Read more about | EMD SERONO INC | NOVARTIS | TEPMETKO|
Feb 16, 2024
Democratic lawmakers Sen. Elizabeth Warren and Rep. Pramila Jayapal are calling on the FDA to close loopholes that allow pharmaceutical companies to prevent competition and keep drug prices high. They argue that major drug companies are exploiting the system by making insignificant changes to drug listings, extending their protection from generic alternatives. The Federal Trade Commission has already agreed with the lawmakers, stating that improper listings may be illegal. Prescription drugs in the US are more than twice as expensive as in other countries, and brand name drugs are even pricier.
Feb 16, 2024
Iceland-based biotech company Alvotech has reached a settlement with Johnson & Johnson for the biosimilar of its arthritis drug Stelara, called AVT04, in Canada, the European Economic Area, and Japan. The details of the settlement were not disclosed. AVT04 is expected to enter the Canadian market in Q1 2024, the Japanese market in May 2024, and the European market shortly after the expiration of the drug's Supplementary Protection Certificate in July 2024. Alvotech has faced challenges gaining FDA approval for AVT04 in the US. J&J has been making deals to delay the launch of biosimilars for Stelara.