Pharma News
06 Oct 2024 to 12 Oct 2024
Oct 12, 2024
FDA to review decision to take Eli Lilly weight loss drug off shortage list - STAT News
The FDA has decided to reconsider its decision to remove Eli Lilly's diabetes drug, tirzepatide, from its shortage list. The agency will also not pursue regulatory action against certain compounding pharmacies that are producing copies of the drug. This decision comes after objections from compounders, telehealth companies, and patients who claimed that the drug was still in short supply. The Outsourcing Facilities Association has even filed a lawsuit against the FDA, calling its decision "reckless and arbitrary.
Oct 12, 2024
FDA in the US will review its ruling that currently prohibits the production of customized versions of Lilly's weight loss medication
The US FDA has agreed to reconsider its decision to ban drug compounders from selling their own versions of Eli Lilly's weight loss and diabetes drugs. This comes after the agency initially barred the compounders from producing these drugs.
Oct 11, 2024
Teva agrees to pay $450 million to settle kickback lawsuits related to MS drug Copaxone and generic medications
Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve allegations that the company violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) in the US. The settlement covers claims that Teva used assistance foundations to fund patients' copays for the multiple sclerosis drug Copaxone and raised its price over a period of 11 years. Teva will also pay $25 million to settle separate allegations of price-fixing. Teva maintains that it did not cause false claims to be submitted to government programs and that the settlements include no admission of wrongdoing.
Oct 11, 2024
FDA in the United States Approves Two Biosimilars for Popular Eye Medication Eylea
The FDA has approved two biosimilar versions of Regeneron Pharmaceuticals' blockbuster eye treatment, Eylea. Biocon Biologics' Yesafili and Samsung Bioepis and Biogen's Opuviz have been granted clearance, and interchangeability has been allowed, meaning they can be substituted without a doctor's advice. The launch dates of the therapies are not yet known. Regeneron has filed lawsuits against companies seeking to bring Eylea biosimilars to the US market. Eylea, which generated $5.72 billion in US sales last year, faces competition from rivals including Roche's Vabysmo.
Oct 11, 2024
European healthcare industry experiences significant drop in stock prices due to worries related to Novo Nordisk and AstraZeneca.
European health-care stocks, including Novo Nordisk, AstraZeneca, and Roche, are experiencing a downturn in their longest winning streak since March 2010. Concerns over Novo Nordisk's upcoming third-quarter results, as well as updates on experimental drugs from AstraZeneca and Roche, have contributed to the decline. Novo Nordisk's third-quarter results may reveal slower-than-expected sales for their weight-loss drug Wegovy. However, analysts believe that this is short-term pain, with positive long-term prospects. AstraZeneca shares have also dropped due to mixed results from an experimental drug. On the other hand, AstraZeneca plans to invest in innovative drug production in Kazakhstan.
Oct 11, 2024
Dong-A ST has received approval from the U.S. Food and Drug Administration (FDA) for one of its products...
South Korean pharmaceutical company Dong-A ST has received FDA approval for its biosimilar product IMULOSA, developed by Janssen, for the treatment of inflammatory diseases. IMULOSA is the second FDA-approved product for Dong-A ST, following the antibiotic "Civextro" in 2014. The drug has seen global sales of $10.86 billion as of last year. Dong-A ST signed a global license-out contract with Intas, a multinational pharmaceutical company, for the commercialization of IMULOSA.
Oct 11, 2024
Novo Nordisk's $16.5B Acquisition of Catalent Faces Increased Scrutiny from FTC - BioSpace
Pharmaceutical company Novo Holdings' proposed $16.5 billion acquisition of Catalent has raised concerns from Senator Elizabeth Warren regarding potential effects on competition. Novo, which holds a 55% share of the market for obesity and diabetes drugs with its blockbusters Ozempic and Wegovy, has been accused of restricting competition and maximizing profits. The deal, which would give Novo control over manufacturing sites, may impede rival Eli Lilly's ability to produce supplies of its GLP-1 drugs. The Federal Trade Commission is currently reviewing the acquisition.
Oct 11, 2024
Contamination problems discovered by FDA at Thermo Fisher facility in North Carolina - Fierce Pharma
FDA inspectors have identified multiple issues at Thermo Fisher Scientific's Greenville plant in North Carolina, including problems with production procedures and visual inspection processes, as well as concerns with microbiological contamination of sterile drug products. The plant is responsible for producing drugs such as Novo Nordisk's Wegovy and Sanofi and AstraZeneca's Beyfortus. Thermo Fisher has addressed the findings, and the safety and quality of the products remain a priority for the companies involved.
Oct 10, 2024
GSK stock sees significant increase following $2.2 billion Zantac lawsuit settlement
Shares of GlaxoSmithKline (GSK) surged more than 6% following the announcement of a $2.2 billion settlement for Zantac lawsuits in the US. The settlement covers 80,000 cases, accounting for 93% of the pending lawsuits against the company. GSK clarified that it has not admitted any liability in connection with the settlement and that it will not affect its growth agenda or investment plans for research and development. Analysts see this settlement as a positive development, ending the company's legal challenges related to Zantac.
Oct 10, 2024
Eli Lilly Sends Legal Notices to Compounders for Replicating Weight-Loss Medication
Drug manufacturer Eli Lilly is escalating its legal campaign against compounding companies that have been producing copycat versions of its weight loss drugs. The FDA recently resolved a shortage of Eli Lilly's tirzepatide injection and reminded compounding facilities of legal restrictions. The compounding groups Outsourcing Facilities Association and FarmaKeio Custom Compounding have filed a complaint in response to the FDA's decision, arguing that patients are being deprived of essential care. Eli Lilly has issued cease-and-desist letters to companies producing imitation drugs, as compounded versions of its drugs can generate up to $1 billion in annual sales.
Oct 10, 2024
Developer of Zantac agrees to settle lawsuits alleging a connection to cancer, reports The New York Times
GSK has agreed to pay $2.2 billion to settle the majority of lawsuits filed by individuals who claimed they developed cancer after taking the popular heartburn drug Zantac. The drug, which was sold by GSK until 2017, was withdrawn from the market after concerns were raised about its potential cancer risk. The settlement does not imply any admission of liability by GSK. The current version of the drug, sold as Zantac 360 by Sanofi, contains a different active ingredient and has not been linked to cancer.
Oct 9, 2024
CSPC Pharma’s medication for treating urticaria has been given approval in China, as announced by Bamboo Works.
CSPC Pharmaceutical Group's chronic spontaneous urticaria treatment, Omalizumab for Injection, has been approved for sale in China by the National Medical Products Administration. The approval will add to the company's autoimmune diseases product portfolio, although it will also increase costs for promotion and commercialization. CSPC's growth has been slow in recent years, and the appointment of a new president of global R&D is expected to help accelerate the commercialization of its products. CSPC's shares fell 6.1% following the news.
Oct 9, 2024
The market for generic drugs is projected to reach a value of USD 795.68 billion by 2032, with a Compound Annual Growth Rate (CAGR) - openPR.com
The global generic drug market, which offers affordable alternatives to brand-name medications, is expected to reach a size of USD 795.68 billion by 2032, with a compound annual growth rate (CAGR) of 8.4%. Key factors driving this growth include the increasing prevalence of chronic diseases, rising investments in R&D in the pharmaceutical sector, and technological advancements in the generic drug industry. The market has experienced robust growth due to factors such as the rising prevalence of chronic diseases, increasing healthcare expenditures, and a growing aging population.
Oct 9, 2024
India's pharmaceutical and medical technology exports anticipated to continue strong growth despite worldwide economic downturn
Exports of India's pharmaceutical and meditech sectors are expected to continue growing despite a global economic slowdown, according to a senior government official. The Indian pharmaceutical industry has seen double-digit export growth in the past year and is now the fourth largest merchandise export item for the country. The official also highlighted the strong performance of the meditech industry and expressed confidence in impressive export results for the current financial year. Additionally, he mentioned that 16 blockbuster molecules are in the pipeline to be produced in India.
Oct 9, 2024
Information on Ozempic and Wegovy, prescription medications for weight loss: A comprehensive guide - Quartz
Pharmaceutical companies Novo Nordisk and Eli Lilly are capitalizing on the surge in demand for weight loss drugs, with medications such as Ozempic, Wegovy, and Zepbound becoming widely popular. Originally developed as treatments for diabetes, GLP-1 drugs have now been approved for weight loss. The global market for these medications is predicted to reach $105 billion by 2030. Despite shortages of these drugs, both companies are investing billions of dollars to ramp up production. Other pharmaceutical companies, including Viking Therapeutics, Roche, Amgen, and Pfizer, are also developing their own weight loss drugs to disrupt the duopoly held by Novo Nordisk and Eli Lilly.
Oct 9, 2024
GSK agrees to pay $2.2 billion to settle lawsuits regarding cancer linked to Zantac - as reported by The Times
GSK agrees to settle 80,000 US state court cases related to its old blockbuster drug Zantac for up to $2.2 billion. The settlements, reached with ten firms representing 93% of the Zantac product liability cases, were announced by GSK after the stock market closed in London. The heartburn drug has been at the center of litigation over allegations of causing cancer. GSK's shares rose 8% in New York trading following the settlement announcement.
Oct 9, 2024
Exploring the Use of Generative AI in Drug Development and Materials Exploration: Intellectual Property Considerations
GenAI, or generative artificial intelligence, is revolutionizing drug and materials discovery. AI has accelerated the drug discovery process by analyzing large datasets to predict effective compounds for specific diseases. Companies like Exscientia and XtalPi have made significant strides in using AI to discover and develop drug candidates. In materials science, AI algorithms predict the properties of new materials, leading to breakthroughs in developing more efficient batteries and stronger materials. However, the rapid integration of AI technologies brings complex intellectual property (IP) challenges, including ownership and protection strategies. Companies must navigate these challenges while staying informed about changes in IP laws.
Oct 8, 2024
FDA gives green light to new oral medication offering comprehensive parasite protection for dogs - DVM360
Elanco Animal Health has received FDA approval for its chewable tablets, Credelio Quattro, which protect canines against fleas, ticks, heartworms, roundworms, hookworms, and tapeworms. The tablets contain lotilaner, moxidectin, praziquantel, and pyrantel, and are suitable for dogs aged 8 weeks and older. The treatment is expected to be launched in the first quarter of 2025. The broad-spectrum parasite protection offered by Credelio Quattro helps prevent the spread of zoonotic diseases and provides a monthly solution for parasite control.
Oct 7, 2024
Amgen files lawsuit against Fresenius to prevent the production of generic versions of Prolia and Xgeva medications
German company Fresenius SE & Co. is facing a federal lawsuit for its proposed biosimilar versions of Amgen Inc.'s Prolia and Xgeva drugs. The lawsuit claims that Fresenius' biosimilars infringe on 33 patents for the bone-strengthening drugs, which generated over 15% of Amgen's 2023 revenue.
Oct 7, 2024
Novo Nordisk resolves legal dispute with Viatris in the US regarding Ozempic and Wegovy
Novo Nordisk and Viatris have reached a settlement to resolve a patent dispute over Novo's weight-loss drugs Ozempic and Wegovy. The companies informed a US Patent and Trademark Office tribunal about the settlement, which includes a Novo patent covering the use of specific dosages of the drugs to treat type 2 diabetes and obesity. Novo had separately sued Viatris in federal court to block proposed generics of the drugs. The terms of the settlement are confidential.
Oct 7, 2024
Novo Nordisk and Viatris reach agreement in patent dispute over weight-loss medications
Novo Nordisk and Viatris have reached a confidential settlement over a patent dispute related to Novo's weight-loss drugs, Ozempic and Wegovy. The settlement resolves both a case before the U.S. Patent and Trademark Office and a federal lawsuit filed by Novo to block generic versions of Ozempic. The news resulted in a 2% increase in Novo Nordisk's shares and a more than 2% decrease in Viatris' shares. The global weight-loss market is expected to experience significant growth, with the obesity drugs market alone potentially reaching over $100 billion by 2030.
Oct 7, 2024
Repurposed older drug shows potential for treating Schizophrenia and may also have benefits for Alzheimer's, reports Mint
Drug company Bristol-Myers Squibb has gained approval from the US Food and Drug Administration for its new antipsychotic drug, Cobenfy, to treat schizophrenia. The drug was first studied in Alzheimer's patients in the 1990s and later repurposed for schizophrenia. Bristol-Myers is now conducting clinical trials to study the drug's effects on Alzheimer's patients, with results expected in 2026. The company expects Cobenfy to generate over $4 billion in annual sales and analysts believe it could be effective in treating psychotic symptoms in Alzheimer's patients as well.
Oct 7, 2024
The Compounding Group takes legal action against FDA for delisting Lilly's weight loss medication from shortage catalog
The Outsourcing Facilities Association, a drug compounding industry group, has sued the U.S. Food and Drug Administration (FDA) over the removal of Eli Lilly's weight loss and diabetes drugs, Mounjaro and Zepbound, from its list of medicines in short supply. The association claims that the FDA's decision was arbitrary and accuses Lilly of self-interest in monopolizing the market. Compounding facilities have been producing their own versions of these drugs due to shortages, and the active ingredient in Novo Nordisk's drugs, semaglutide, remains on the shortage list.
