Pharma News
27 Oct 2024 to 02 Nov 2024
Nov 1, 2024
Essa discontinues development of primary cancer drug following unsuccessful trial compared to Xtandi - Fierce Biotech
Canadian biotech Essa Pharma has terminated a phase 2 trial of its androgen receptor inhibitor, masofaniten, combined with Pfizer and Astellas' prostate cancer drug Xtandi. The trial was abandoned after patients given Xtandi alone achieved a significantly higher rate of prostate-specific antigen response than expected. As a result, Essa has terminated all further trials of masofaniten and will "initiate a strategic process to explore and review a range of strategic options focused on maximizing shareholder value".
Nov 1, 2024
EU imposes a €460 million fine on Teva Pharmaceuticals for patent infringement and antitrust violations
The European Commission has fined Teva, a pharmaceutical giant, €60.5 million for engaging in practices to extend patent protection for its multiple sclerosis (MS) drug, Copaxone. The Commission accused Teva of running a campaign against Syntheon, a competitor authorized to market a similar drug in Europe, in order to slow down or block its entry into the market. Teva plans to appeal the decision. This fine follows a recent settlement in the US where Teva was ordered to pay $225 million for pricing charges related to another drug.
Nov 1, 2024
MMA recommends educating patients on IJN's mandatory transition to generic medications - CodeBlue
The Malaysian Medical Association (MMA) has urged caution in the government's directive for the National Heart Institute (IJN) to switch its public patients to generic drugs. The MMA calls for patient education and obtaining high-quality generic medications. They also note that in cases where generic versions are not available, originator drugs must still be given. The MMA emphasizes the need for clear communication and confidence in the safety and efficacy of generic drugs.
Nov 1, 2024
Novo Nordisk's GLP-1 Medication Achieves Objectives in MASH Study, Paving the Way for Submissions to FDA and EMA
Novo Nordisk's obesity drug Wegovy has shown positive results in a Phase 3 clinical trial for treating metabolic dysfunction steatohepatitis (MASH), a prevalent fatty liver disease. The trial demonstrated that 37% of patients who received Wegovy injections alongside standard care showed improvement in liver fibrosis without worsening the disease compared to 22.5% of those receiving a placebo. The drug is expected to expand its label to include the treatment of MASH. Novo Nordisk anticipates filing applications for US and EU approval in the first half of 2022.
Oct 31, 2024
The European Commission imposes a fine on Teva, a pharmaceutical company, for misuse of patents.
Israeli drug maker Teva has been fined over €460m by the European Commission for misusing the patent system and disparaging a rival company's development of a competing multiple sclerosis drug. Teva extended the patent protection of its drug Copaxone by conducting a "disparagement campaign" against Synthon. The commission said that Teva's actions may have prevented significant savings for countries across Europe, as other versions of the drug could have been up to 80% cheaper than Copaxone. Teva intends to appeal the decision.
Oct 31, 2024
Teva, a pharmaceutical company, fined by European Commission for misuse of patents related to multiple sclerosis drug
Pharmaceutical firm Teva has been fined €462.6m ($520m) by the European Commission for abusing the patent system to extend the protection for its multiple sclerosis drug Copaxone. It was found to have conducted a "disparagement campaign" against Synthon, the only other company with an authorised drug containing the same active ingredient, glatiramer acetate. Teva has said that it disagrees with the decision and intends to appeal. The EU Commission stated that Teva's actions may have prevented significant savings by European countries, with other versions of the drug potentially being 80% cheaper.
Oct 31, 2024
Teva to be fined $500 million for violating antitrust laws related to multiple sclerosis drug, in Europe
The European Commission accuses pharma company Teva of blocking generic versions of Copaxone, a blockbuster multiple sclerosis (MS) drug. The company is alleged to have engaged in abusive conduct to artificially extend the exclusivity of Copaxone. This action could result in Teva being found in violation of Article 102 of TFEU.
Oct 31, 2024
Regeneron stock declines after sales for stronger Eylea drug fall short of expectations
Regeneron Pharmaceuticals reported weaker-than-expected sales for the higher dose version of its eye disease drug Eylea, causing its shares to fall by 9%. The company has been trying to upgrade patients to the higher dose version due to increasing competition from biosimilar products and rivals. While sales of Eylea HD missed expectations, total US net sales of Eylea rose by 3% to $1.54 billion. Fourth-quarter Eylea HD net sales are expected to be negatively impacted due to an increase in wholesaler inventory.
Oct 31, 2024
Teva hit with $500 million fine by EU Commission for obstructing competitor's multiple sclerosis drug
Pharmaceutical company Teva plans to appeal the decision made by the EU Commission regarding its disagreement over a legal theory that it considers extreme and unsupported. Teva, a longtime supporter of the multiple sclerosis (MS) community, expressed its intention to challenge the decision.
Oct 31, 2024
Eli Lilly reports lower-than-anticipated quarterly revenue and earnings - The Times
Pharmaceutical giant Eli Lilly reported weaker sales and profits in the third quarter due to higher manufacturing costs and fluctuation in wholesaler levels for its anti-obesity drug, Zepbound. The company trimmed the top end of its full-year revenue estimates and shares fell by 11.8%. Eli Lilly's revenues came in at $11.4 billion, lower than analyst forecasts, with Zepbound sales of $1.2 billion below expectations. The company attributed the decline to higher inventory levels at wholesalers impacting demand and manufacturing costs.
Oct 31, 2024
Amgen sees benefits from Horizon acquisition in third quarter and prepares to launch biosimilars
Amgen reports a 23% increase in sales for the third quarter, boosted by the acquisition of Horizon Therapeutics and the success of their rare disease drug Tepezza. Tepezza, a treatment for thyroid eye disease, brought in $488 million in quarterly sales and has shown potential for further growth. Amgen plans to continue expanding its rare disease portfolio and expects to reach a revenue of $33 billion to $33.8 billion by 2024. Additionally, Amgen's biosimilar franchise is set to launch Wezlana, a biosimilar to Johnson & Johnson's Stelara, next year.
Oct 30, 2024
Reasons for the Decline in Eli Lilly's Stock Price Today - Reported by The Globe and Mail
Shares of Eli Lilly (LLY) plunged 6.3% after the company reported disappointing Q3 results. While revenue was up 20% year over year, it fell short of analyst expectations. Net income and earnings per share also missed estimates. The company's type 2 diabetes drug, Mounjaro, and weight-loss drug, Zepbound, performed well, but sales were negatively impacted by inventory decreases. Additionally, Lilly revised its full-year earnings guidance downward, citing charges related to the acquisition of Morphic Holdings. Despite the setback, the company's opportunities in diabetes, obesity, and its promising pipeline make it a potential buy on the dip.
Oct 30, 2024
Lilly lowers forecast due to underwhelming sales of weight-loss drug
Eli Lilly & Co. has lowered its sales guidance for the year after disappointing sales of its weight-loss drug. Inventory issues caused sales to be almost $900 million below estimates in the third quarter. Despite the setback, the company does not expect the inventory swings to continue. Eli Lilly has invested heavily in boosting manufacturing capacity for its weight-loss drugs, as demand in the sector is booming. The weight-loss drug market is estimated to be worth $130 billion by 2030.
Oct 30, 2024
Cipla's growth path may face obstacles in the near future, says report from Moneycontrol
Pharmaceutical company Cipla has reported better-than-expected Q2 numbers, but is facing multiple near-term challenges. Supply challenges for its tumor drug Lanreotide and regulatory delays for key launches have raised concerns among investors. Brokers have reduced price targets due to the high product concentration risk and challenges faced by key drugs. Lanreotide, Revlimid, and Albuterol account for approximately 20% of Cipla's projected FY26 EBITDA. Cipla's stock fell close to 5% following the release of its quarterly numbers.
Oct 30, 2024
New treatment for arthritis shown to have significant benefits in reducing obesity - study published in Nature
A clinical trial conducted in 11 countries has found that the weight-loss drug semaglutide reduces pain from obesity-related knee arthritis and improves a person's ability to engage in activities such as walking. The trial, sponsored by Novo Nordisk, proved that semaglutide can treat arthritis on par with opioids. However, concerns remain about the long-term outlook for those using the drug as it is expensive and weight regain is common after discontinuation. The findings were published in the New England Journal of Medicine.
Oct 30, 2024
Study finds that Semaglutide may reduce arthritis knee pain in individuals with obesity
In a phase 3 clinical trial, patients with osteoarthritis who took semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy, saw significant weight loss and reported a greater reduction in knee pain compared to those who lost weight through diet and exercise alone. The study, which included about 400 patients, found that semaglutide led to an average weight loss of 14% and a 42-point decrease on the pain scale. Experts believe the pain reduction is due to the reduced pressure on the joints caused by weight loss. However, the drug is currently in shortage and is inaccessible for many patients.
Oct 30, 2024
Lilly lowers forecast following disappointing sales of obesity drug (4) - Bloomberg Law report
Pharmaceutical company Eli Lilly & Co. has lowered its guidance due to weak sales of its weight-loss drug Zepbound and diabetes drug Mounjaro. The company's stock has experienced a significant drop, and the sales miss has raised concerns about the demand for these drugs.
Oct 30, 2024
Eli Lilly lowers forecasts due to underwhelming sales of weight-loss medication | Business News
Eli Lilly, a pharmaceutical company based in Indianapolis, has revised its sales guidance due to disappointing sales of a weight-loss drug. The company now expects full-year sales to range between $45.4 and $46 billion, down from the previous guidance of $46.6 billion.
Oct 30, 2024
Eli Lilly's shares drop by 10% as the pharmaceutical company falls short of expectations and reduces its profit forecast.
Pharmaceutical company Eli Lilly reported lower-than-expected profits and revenues for the third quarter, primarily due to disappointing sales of its weight loss drug Zepbound and diabetes treatment Mounjaro. The company also revised its full-year profit guidance downward. Eli Lilly attributed the poor performance to a $2.8 billion charge related to its acquisition of Morphic Holding and a decrease in inventory among wholesalers. Despite the setback, Eli Lilly CEO David Ricks stated that the underlying demand for Zepbound and Mounjaro remains strong, and the company expects expansions in manufacturing capacity in the future.
Oct 30, 2024
Lilly revises forecast due to lower-than-expected sales of weight-loss drug - Yahoo Finance
Pharmaceutical company Eli Lilly & Co. has revised its guidance downwards due to lower-than-expected sales of its weight-loss and diabetes drugs, Zepbound and Mounjaro, respectively. The company attributed the sales slump to inventory issues, stating that wholesalers had excess stock at the end of Q2. Eli Lilly's shares fell by nearly 8%, wiping out around $110 billion in market value. The company now expects full-year sales to reach $46 billion, a reduction of $600 million from its previous outlook.
Oct 29, 2024
BioNxt progresses with patent applications for innovative drug delivery technology - from WebDisclosure
BioNxt Solutions Inc. has successfully nationalized patents for sublingual anticancer drugs aimed at treating autoimmune neurodegenerative diseases. The European Patent Office has given positive reviews on these fully-owned patents, prompting BioNxt to proceed with filings in multiple countries including the USA and Japan. The patent family is expected to provide protection until 2045. BioNxt's main project is a sublingual Cladribine product for Multiple Sclerosis, addressing the needs of Dysphagia patients, as well as a Cladribine product for Myasthenia Gravis. The company's focus on innovative CNS drug delivery systems aligns with market demands.
Oct 29, 2024
BioNxt reveals submission of patents at the national level for sublingual cancer-fighting medication...
BioNxt Solutions has initiated the process of filing national level patents for a family of sublingual anticancer drugs for the treatment of autoimmune neurodegenerative diseases. The patents, which are 100% owned by BioNxt, have been accepted by the European Patent Office for patentability. The company plans to file in various international jurisdictions including the US, Japan, Australia, Canada, and several European countries. The drug delivery market is expected to grow to $3.18 trillion by 2034, and the market for drugs to treat CNS diseases is forecasted to reach $238.8 billion by 2032.
Oct 29, 2024
Harris and Trump's Influence on the Biopharma Industry: What Can We Expect from the Presidential Election?
With one week remaining until the 2024 presidential election, the contest between Vice President Kamala Harris and former President Donald Trump has raised speculation about what a victory for either candidate would mean for the biopharma industry. Analysts and stakeholders have weighed in on high-profile biopharma issues, including drug pricing reforms, that could play a significant role in the new administration. While it is too close to call, some analysts believe a Trump win would be more positive for biopharma sentiment, while Harris focuses on cracking down on pharmaceutical companies and pharmacy benefit managers to lower prescription drug prices.
Oct 29, 2024
Analysts predict that Novo Nordisk's stocks are expected to perform better than Lilly's following a decline in the summer, as reported by BNN Bloomberg.
Danish pharmaceutical company Novo Nordisk is expected to catch up to rival Eli Lilly in the obesity drug market. Novo Nordisk's obesity drug, Wegovy, currently lags behind Eli Lilly's Zepbound in terms of sales, causing Novo Nordisk shares to fall. However, analysts predict that Novo Nordisk will see bigger gains in the future due to anticipated trial results on its next-generation weight-loss drug. Novo Nordisk shares are expected to jump 25% in the next year compared to Eli Lilly's predicted 13% increase.
Oct 28, 2024
Carol Satler, MD appointed to position at Insilico Medicine - EurekAlert!
Insilico Medicine has appointed Carol Satler as Vice President for Non-oncology programs Clinical Development. Satler will be responsible for the clinical validation of Insilico's leading program, ISM001-055, a first-in-class treatment for idiopathic pulmonary fibrosis. She will also oversee the clinical validation of the company's non-oncology assets and contribute to strategic planning and clinical study protocol design. Satler has over 20 years of experience in clinical development across various companies and has contributed to the development and commercialization of blockbuster drugs such as Plavix and Lipitor. Insilico aims to leverage AI to bring transformative therapies to market.
Oct 28, 2024
Eli Lilly receives approval to introduce new weight-loss medication in Hong Kong - Report by The Business Times
Eli Lilly plans to start selling its weight-loss drug, tirzepatide (branded as Mounjaro), in Hong Kong by the end of this year, making it the first of its kind to be available in the region. The drug has already been approved in mainland China, but its launch date there is uncertain. The global shortage of highly effective weight-loss drugs is driving demand, potentially leading customers from mainland China, where counterfeit versions are common, to seek the authentic drug in Hong Kong. Novo Nordisk is also limiting sales of its weight-loss drug, Wegovy, in China to avoid supply disruptions.