Pharma News
15 Sep 2024 to 21 Sep 2024
Sep 21, 2024
The European Drug Agency backs Novo Nordisk's popular weight-loss medication Wegovy...
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the label of Novo Nordisk's weight-loss drug Wegovy, showing its effectiveness in reducing heart failure-related symptoms and improving physical limitations in people with obesity-related HFpEF. The positive opinion is based on data from clinical trials that demonstrated greater reductions in heart failure symptoms and weight loss compared to placebo. Novo Nordisk expects the label update to be implemented soon in the EU and plans to resubmit the data to the FDA in 2025.
Sep 21, 2024
What is causing the decline in Novo Nordisk stock on Friday? - Reported by Benzinga
Novo Nordisk has announced positive results from a phase 2a clinical trial with monlunabant, an oral cannabinoid receptor 1 (CB1) inverse agonist. The trial showed that all doses of monlunabant led to significant weight loss compared to placebo in individuals with obesity and metabolic syndrome. The most common side effects were gastrointestinal, but there were also mild to moderate neuropsychiatric side effects like anxiety and sleep disturbances. Novo Nordisk plans to conduct a larger phase 2b trial in obesity in 2025 to further investigate the drug's dosing and safety profile.
Sep 20, 2024
J&J receives another important approval for the potentially successful drug Rybrevant - Pharmaphorum.
Johnson & Johnson's bispecific antibody Rybrevant (amivantamab) has received FDA approval for use in combination with chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. This approval brings Rybrevant closer to achieving its sales target of $5 billion. The drug has previously been approved for first-line treatment of EGFR-mutated NSCLC and for post-chemo treatment in patients with EGFR exon 20 mutations. The latest approval is based on positive results from the MARIPOSA-2 trial, which showed improved overall survival and progression-free survival rates compared to chemotherapy alone.
Sep 20, 2024
EU regulatory authority supports the use of Novo's Wegovy for the treatment of heart conditions linked to obesity
The European Medicines Agency has given its approval for the use of Novo Nordisk's drug, Wegovy, to help treat obesity-related heart failure in patients with preserved ejection fraction (HFpEF). This marks the second use of Wegovy beyond weight loss that has been supported by the regulator. Data from a late-stage study showed that patients experienced weight loss and improvement in heart failure-related criteria after one year of treatment with Wegovy. Novo plans to submit data to the US FDA for approval in the same indication next year.
Sep 20, 2024
China takes action against unauthorized reproductions of Novo's weight loss medication - BNN Bloomberg
China is cracking down on the illegal production and sale of medicines similar to Novo Nordisk's diabetes and obesity treatment drugs, Ozempic and Wegovy. Cases of illegal online sales of semaglutide, the key ingredient in these drugs, have been identified. The global supply crunch has created a growing demand for these therapies, leading to the emergence of unregulated knockoffs. Novo Nordisk and Eli Lilly have warned of safety risks associated with these counterfeit drugs. The crackdown in China aims to curb the gray market and protect consumers from potential harm.
Sep 20, 2024
Fierce Biotech reports on the connection between Novo's obesity medication and possible 'neuropsychiatric complications'
Danish pharmaceutical company Novo Nordisk's weight loss drug, monlunabant, which acts as a cannabinoid CB1 receptor blocker, faces challenges after mid-stage trial results showed the drug's potential for psychiatric side effects. The drug, acquired through the purchase of Canada's Inversago, had already demonstrated weight loss in a phase 1b trial. However, similar to Sanofi's Acomplia, which was withdrawn from the European market in 2009 due to psychiatric risk, monlunabant showed an increased incidence of anxiety, irritability, and sleep disturbances. Novo Nordisk will conduct a larger phase 2b trial to further evaluate the drug's safety profile.
Sep 20, 2024
New lung cancer treatment shows superior results compared to popular drug Keytruda, but with a caveat
Akeso has announced that its experimental monoclonal antibody, ivonescimab, has outperformed Merck's pembrolizumab in a third-phase clinical trial. The study, known as HARMONi-2, enrolled 400 patients with advanced non-small cell lung cancer, and showed that ivonescimab significantly extended median progression-free survival compared to pembrolizumab. Ivonescimab is a bispecific antibody that targets two different cancer receptors, PD-1 and vascular endothelial growth factor.
Sep 20, 2024
Eli Lilly seeks information on individuals who obtained its weight-loss drug copies - Business Standard
Eli Lilly is asking individuals who took copies of its weight-loss drug, Zepbound, from compounding pharmacies to provide access to their medical records for safety purposes. The move comes as Lilly builds a case against businesses selling compounded copies of its drugs. The compounding pharmacies argue they are following the law and helping patients access medicines during times of shortage. Lilly and other drug manufacturers have been taking legal action against medical spas, doctors, and compounding pharmacies selling or promoting knockoff versions of their products.
Sep 20, 2024
Researchers who identified the Glucagon Yusa peptide (GLP-1) have been named as the recipients of ...
Scientists who discovered the GLP-1 peptide, the basis of obesity treatments, have won the Lasker Prize, known as the U.S. version of the Nobel Prize in Physiology or Medicine. The winners include Professor Joel Habener of Massachusetts General Hospital, the chief scientific adviser to Roche-owned Novo Nordisk. GLP-1 is a hormone that regulates blood sugar and controls appetite. Its synthetic analogs are used in obesity drugs such as Novo Nordisk's "Wigobi." The Lasker Prize is considered a precursor to the Nobel Prize, and there is speculation that GLP-1 developers may win the upcoming Nobel Prize in Physiology or Medicine.
Sep 20, 2024
Researchers honored for creating new weight-loss medications | Semafor
Three scientists, including Svetlana Mojsov, have won Laskar Awards for their work in developing anti-obesity drugs based on the GLP-1 hormone. The awards are often seen as a predictor of potential Nobel Prizes. In other news, Novo Nordisk's shares declined after a mid-stage trial of their new weight loss drug, which contains the compound monlunabant, showed mild to moderate side effects like anxiety and sleep disturbances.
Sep 19, 2024
Innovators of obesity treatments honored with esteemed Lasker Award in medical research - article in Nature
Three scientists, Joel Habener, Svetlana Mojsov, and Lotte Bjerre Knudsen, who were involved in the development of blockbuster anti-obesity drugs that mimic the hormone glucagon-like peptide 1 (GLP-1), have been recognized with a Lasker Award. GLP-1-based drugs have proven effective in treating obesity, diabetes, cardiovascular disease, sleep apnea, and kidney disease. The recognition of their work has led to speculation that they may also be in line for a Nobel Prize.
Sep 19, 2024
Corbus views Novo's bold obesity strategy as a potential pathway to significant success - STAT News
Danish pharma company Novo Nordisk and biotech firm Corbus Pharmaceuticals are among the companies developing drugs that inhibit type 1 cannabinoid receptors, with hopes of tapping into the potential $150 billion obesity market. Novo Nordisk's drug, currently in a Phase 2 study, is expected to read out this quarter. Corbus Pharmaceuticals is looking to benefit from Novo's success.
Sep 19, 2024
Creators of Obesity Medication honored with esteemed Lasker Award in Medical Science
Three scientists, Joel Habener, Svetlana Mojsov, and Lotte Bjerre Knudsen, have been honored with a 2024 Lasker Award for their contributions to the development of anti-obesity drugs that mimic the hormone glucagon-like peptide 1 (GLP-1). The drugs have had a significant impact on healthcare, and there is speculation that the scientists may also be considered for a Nobel Prize. GLP-1 research has expanded beyond diabetes treatment to include obesity, cardiovascular disease, sleep apnea, and kidney disease.
Sep 19, 2024
Promising drug candidates showing blockbuster potential for Central Nervous System disorders - Drug Target Review
Swedish pharmaceutical company IRLAB Therapeutics has a pipeline of five drug candidates for the treatment of Parkinson's disease (PD), with potential to revolutionize PD treatment. The lead candidate, mesdopetam, is a dopamine D3-receptor antagonist being developed for levodopa-induced dyskinesias. Another candidate, pirepemat, aims to improve balance and reduce falls in PD patients. IRL757 is being developed for the treatment of apathy in PD and Alzheimer's disease patients. IRLAB also has two promising preclinical projects targeting cognitive function and basic symptoms of PD. The company's proprietary drug discovery and development platform, the Integrative Screening Process (ISP), has contributed to the identification and development of these novel drug candidates.
Sep 18, 2024
Analysis of Market for Antipyretic and Analgesic Drugs from 2024 to 2031
The global market for antipyretic and analgesic drugs is expected to see significant growth due to the increasing demand for pain and fever relief medications. The market is valued at approximately USD 30 billion and is driven by factors such as the rising prevalence of chronic conditions and an aging population. Pharmaceutical companies are investing in research and development to introduce new and more effective drugs, and innovations in drug formulations and delivery methods are creating further opportunities for growth. The market is projected to experience continued growth and dynamic changes in value.
Sep 18, 2024
Organon expands its presence in the dermatology sector through the acquisition of Roivant's dermatology subsidiary
Organon has announced plans to acquire Dermavant, a subsidiary of Roivant Sciences, in a deal worth up to $1.2 billion. Dermavant's key asset is Vtama, a topical cream used to treat plaque psoriasis. The drug is currently under FDA review for atopic dermatitis, with a decision expected later this year. This acquisition will expand Organon's presence in dermatology and provide them with a product that has the potential for global growth.
Sep 18, 2024
Organon to acquire Dermavant and its steroid-free skin cream Vtama for a sum up to $1.2B
Organon has announced its acquisition of dermatology company Dermavant for up to $1.2 billion. The deal includes an upfront payment of $175 million, as well as potential milestone and commercial payments. The key asset in the deal is Vtama, Dermavant's steroid-free cream for plaque psoriasis, which received FDA approval in May 2022. The drug is expected to have significant expansion opportunities in atopic dermatitis. Organon's CEO, Kevin Ali, stated that this acquisition is part of the company's strategy for revenue and earnings growth.
Sep 18, 2024
Opposition from Indian patient groups to patent applications for lenacapavir, a popular HIV drug
US pharmaceutical giant Gilead Sciences is facing opposition from civil society organizations in India over its patent applications for lenacapavir, an antiretroviral drug used to prevent HIV infection. Lenacapavir has shown high efficacy in preventing HIV infection, and Gilead is seeking patents across low- and middle-income countries. Concerns have been raised that granting these patents could hinder access to affordable generic versions of the drug, which have been crucial in treating HIV/AIDS globally. The Indian Patent Office is currently examining the patent applications for lenacapavir.
Sep 18, 2024
Biosimilar drugs gaining traction in the Eurasian pharmaceutical industry according to Uza.uz.
The Fifth Eurasian Pharmaceutical Summit in Tashkent focused on discussions regarding the accessibility of biosimilars in the Eurasian Economic Union (EAEU) countries. The CEO of Uzbekistan's STADA, Bakhtiyar Khadjimuhamedov, emphasized the potential economic benefits of biosimilars, especially in countries with limited healthcare budgets, citing successful examples in European countries. Khadjimuhamedov called for increased collaboration between manufacturers, regulators, and industry specialists to ensure patient access to necessary drugs. STADA plans to develop educational programs to enhance healthcare workers' qualifications in using bioproducts.
Sep 18, 2024
The Indian Patent Office will consider challenges to Gilead's claims for a patent on an HIV drug
Indian Patent Office will address objections raised against Gilead Sciences' patent claims for its HIV drug, Lenacapavir. Sankalp Rehabilitation Trust, a civil society group supporting vulnerable communities, has challenged the claims.
Sep 17, 2024
Novo anticipates Ozempic could be subject to the next price reduction in the United States, according to Bloomberg.
The diabetes shot Ozempic, manufactured by Novo Nordisk, is expected to be targeted for a price cut by the US government's Medicare program. This comes after the implementation of the Inflation Reduction Act, which allows direct negotiation of drug prices. The list of drugs to be targeted in the next round is expected to be announced early next year.
Sep 17, 2024
Federal government taking steps to lower drug prices
The U.S. faces challenges in making medical advancements accessible to its people as the prices of patented drugs are significantly higher than in other countries. Companies use strategies like patent thickets and evergreening to extend patent exclusivity and maintain high profit margins. The Federal Trade Commission (FTC) has challenged numerous patents, leading to some withdrawals, but the overall impact depends on whether the FTC initiates antitrust investigations. Additionally, the Biden administration has enacted a new march-in policy to retract patents that lead to excessive prices. However, concerns about stifling innovation and the limited reach of march-in rights remain.
Sep 17, 2024
The Indian Patent Office will consider challenges to Gilead's patent claims for its HIV drug
Sankalp Rehabilitation Trust, a civil society organization in India, is objecting to patent claims filed by Gilead Sciences on its HIV prevention drug, Lenacapavir. The organization argues that the patents could hinder access to affordable treatment and generic versions of the drug. Gilead is seeking patents in India for Lenacapavir and if approved, it would extend its monopoly over the drug until 2038. Public health advocates are concerned that this would limit access to the drug for millions of people in need. Similar patent challenges have been filed globally as part of the "Make Medicines Affordable" campaign.
Sep 17, 2024
Sanofi and AZ increase production to prevent Beyfortus shortages this year
Pharmaceutical companies Sanofi and AstraZeneca are preparing for this year's respiratory syncytial virus (RSV) season by ensuring an adequate supply of their drug Beyfortus. The partners have shipped doses of the long-acting monoclonal antibody to healthcare providers and the CDC's Vaccines for Children program. They expect to provide enough supply for every eligible baby born during the virus season. Sanofi and AstraZeneca continue to work together to build inventory for this and future seasons. The drug is approved to prevent RSV lower respiratory tract disease in newborns and infants.
Sep 17, 2024
US Doctors Anticipate Changes in Lupus Treatments
The landscape of treatments for systemic lupus erythematosus (SLE) may be evolving with the introduction of new medicines and indications. Biogen's experimental drug, litifilimab, is seen as a strong competitor to GSK's Benlysta and AstraZeneca's Saphnelo, with promising midstage data showing superior treatment profile. Additionally, AbbVie's Rinvoq and Bristol Myers Squibb's Sotyktu are being tested for SLE and may offer convenience for patients. However, challenges in patient adherence and black box warnings on certain drugs need to be considered. Despite this, Benlysta remains the preferred choice in SLE and lupus nephritis.
Sep 17, 2024
Novo expects Ozempic to undergo discussions regarding drug pricing - BNN Bloomberg
Novo Nordisk's blockbuster diabetes drug, Ozempic, is expected to be included in the next round of drug price negotiations with Medicare, according to an executive from the company. The US government's Medicare program now has the ability to directly negotiate drug prices with manufacturers for the first time. Novo Nordisk's CEO will testify before a Senate committee on drug prices, and it is speculated that the price cuts could impact innovation in the industry. The official announcement of the drugs to be included in the negotiations will be made by February 2025.
Sep 17, 2024
Bernie Sanders claims that Ozempic can be manufactured for under $100 per month, according to NBC News.
Senator Bernie Sanders has criticized drugmaker Novo Nordisk, claiming that the CEOs of major generic pharmaceutical companies have informed him that they can produce and sell Novo Nordisk's diabetes drug Ozempic for less than $100 a month. Novo Nordisk charges around $1,300 a month for Ozempic in the U.S., while it is significantly cheaper in other countries. Although generic drugmakers are barred from producing Ozempic due to Novo Nordisk's exclusive patent, Sanders' remark sheds light on the pricing practices that Novo Nordisk CEO Lars Fruergaard Jørgensen may face during his testimony before the Senate committee.
Sep 16, 2024
AstraZeneca's top-selling medication achieves significant success in treating bladder cancer - CNBC TV18
AstraZeneca's Imfinzi has shown promising results in extending the lives of patients with bladder cancer. In a late-stage trial, Imfinzi reduced the risk of disease recurrence by 32% when used alongside the standard of care for muscle-invasive bladder cancer. The drug also reduced the risk of death by a quarter when combined with chemotherapy and surgery. This marks the first time an immunotherapy drug has significantly improved overall survival in patients with this type of bladder cancer, potentially opening up a new market for Imfinzi.
Sep 16, 2024
Third Eye News reports on the projected size, share and forecast of the market for anti-HIV drugs in the United States for the year 2030.
The United States Anti-HIV Drugs market is projected to reach a valuation of USD xx.x billion by 2031, with a compound annual growth rate of xx.x percent from 2024 to 2031. The market is segmented by type, including Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), Protease Inhibitors (PIs), Integrase Strand Transfer Inhibitors (INSTIs), entry inhibitors, and fusion inhibitors. Prominent manufacturers in this market include Gilead Sciences, ViiV Healthcare, Merck & Co., AbbVie, and more. The market analysis provides insights into market size, competitive landscape, current conditions, and emerging trends. The report also analyzes market segments based on type and application.
Sep 16, 2024
Lexaria (NASDAQ: LEXX) is exploring market opportunities with its innovative delivery platform and GLP-1 program.
Lexaria Bioscience Corp. has released its fiscal report for the third quarter of the 2024 financial year, highlighting significant growth in cash and marketable securities. The company also discussed its glucagon-like peptide-1 (GLP-1) agonist research program, which aims to improve the oral bioavailability of GLP-1 drugs for the treatment of diabetes and obesity. Lexaria's drug delivery platform offers the potential for simple oral application, which could have a significant impact on the market.
Sep 16, 2024
Astra's leading medication achieves significant success in battling bladder cancer, reports The Japan Times.
Pharmaceutical company AstraZeneca has announced that its drug Imfinzi has shown promising results in extending the lives of patients with bladder cancer. In a late-stage trial, Imfinzi reduced the risk of disease recurrence by 32% when used in combination with standard care treatments. The drug also decreased the risk of death by 25%. This could potentially open up a new market for Imfinzi in the treatment of bladder cancer.
Sep 15, 2024
AstraZeneca's Highly Effective Medication Secures Significant Victory in Treatment of Bladder Cancer, Reports BNN Bloomberg
AstraZeneca's drug, Imfinzi, has shown promising results in extending the lives of patients with bladder cancer. In a late-stage trial involving over 1,000 patients, Imfinzi reduced the risk of disease recurring by 32% and the risk of death by a quarter when added to current treatments. This is the first time that an immunotherapy drug has significantly improved overall survival in patients with this type of bladder cancer. If approved, the drug could generate an additional $500 million in revenue for AstraZeneca.
Sep 15, 2024
AstraZeneca's Successful Drug Achieves Significant Victory in Treating Bladder Cancer - Bloomberg
AstraZeneca's Imfinzi shows promising results in extending the lives of bladder cancer patients, reducing the risk of disease recurrence by 32%. The study involved over 1,000 patients and found that Imfinzi, when added to current standard treatments, also decreased the risk of death by 25%.
Sep 15, 2024
Costs for generic drugs will increase in October, impacting out-of-pocket expenses - The Japan Times
Revised system in Japan will increase out-of-pocket expenses for patients opting for original drugs over generics. Aimed at reducing overall medical costs, the change will affect 1,095 items such as moisturizing ointments. Under the new system, patients will be responsible for a portion of the price difference between original and generic drugs, in addition to existing out-of-pocket expenses. Usage of generics in Japan stands at 80% in volume terms but only 56.7% in value terms. The government hopes the revision will save ¥11 billion annually and plans to support drug development with the savings.
