Pharma News
10 Mar 2024 to 16 Mar 2024
Mar 16, 2024
StockWatch: Strong Sales Expected for Madrigal MASH Drug
Madrigal Pharmaceuticals has received FDA accelerated approval for its MASH treatment, Rezdiffra, making it the first therapy to be authorized for metabolic dysfunction-associated steatohepatitis (MASH). The approval caused Madrigal shares to rise by 11% and it is estimated that the drug could treat around 525,000 patients in the US with moderate to advanced liver fibrosis. Rezdiffra will be priced at $47,400.
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Mar 15, 2024
Patients recently diagnosed with cervical cancer to receive treatment with Merck's popular drug Keytruda in combination with ...
Merck has announced that its drug Keytruda has met its primary endpoint of overall survival in a Phase 3 trial for newly diagnosed patients with high-risk locally advanced cervical cancer. Keytruda, in combination with chemoradiotherapy, showed a statistically significant improvement in overall survival compared to chemoradiotherapy alone. This is the first immunotherapy-based regimen to demonstrate such improvement in these patients. The safety profile of Keytruda in the trial was consistent with previous studies. Keytruda has two other approved indications for cervical cancer in the U.S.
Mar 15, 2024
First medication in the United States authorized for treatment of a liver disease rapidly spreading globally approved by Nature
The US Food and Drug Administration has approved a drug called resmetirom to treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH), which is on the rise globally and is a leading driver of liver failure and transplants. Resmetirom has been shown to reduce scar tissue and other hallmarks of MASH. It will be marketed as Rezdiffra and will be available to those with moderate to severe liver scarring. However, long-term evidence of the drug's benefits will need to be provided for it to stay on the market.
Mar 15, 2024
Madrigal Pharma experiences a jump in stock price following FDA approval for their first drug targeting fatty liver disease NASH, according to TradingView.
Madrigal Pharmaceuticals shares surged by 23% after its oral drug, Rezdiffra, became the first approved treatment for the fatty liver disease Non-Alcoholic Steatohepatitis (NASH). Rezdiffra was approved by the US health regulator without the need for a liver biopsy, making it easier for patients to access the treatment. The NASH market is expected to reach over $16 billion by 2030, and Madrigal's drug is estimated to generate $5 billion in peak annual sales. The approval also sparked speculation about the company becoming a buyout target.
Mar 14, 2024
The esophageal cancer therapy developed by BeiGene receives approval from the US FDA
The US FDA has approved BeiGene's drug, Tevimbra, for the treatment of advanced esophageal cancer in patients who have previously received chemotherapy. Tevimbra, an anti-PD-1 monoclonal antibody, will be available in the US in the second half of 2024. The therapy will be launched by BeiGene, which regained full rights to it after terminating a deal with Novartis. Tevimbra is expected to help detect and attack tumors, similar to Merck's Keytruda.
Mar 14, 2024
BeiGene's treatment for esophageal cancer receives approval from US FDA - report from Yahoo Finance
The U.S. FDA has granted approval to BeiGene's drug, Tevimbra, for the treatment of advanced esophageal cancer in patients who have previously undergone chemotherapy. Tevimbra, an anti-PD-1 monoclonal antibody, will be available to U.S. patients in the second half of 2024. BeiGene terminated its partnership with Novartis last year and regained global rights to Tevimbra. The drug is expected to launch with pricing details to be announced closer to the launch.
Mar 14, 2024
Madrigal Pharmaceuticals drug approved by FDA as first treatment for prevalent NASH liver disease
The FDA has approved the first-ever treatment for nonalcoholic steatohepatitis (NASH), a common and potentially deadly liver disease. The drug, marketed as Rezdiffra and developed by Madrigal Pharmaceuticals, is specifically approved for those with moderate-to-advanced liver scarring and must be used in conjunction with diet and exercise. NASH affects millions worldwide and is often associated with conditions such as high blood pressure, type 2 diabetes, and obesity. Other companies, such as Novo Nordisk and Eli Lilly, are still testing their weight loss injections as potential NASH treatments.
Mar 14, 2024
The FDA gives green light to the first MASH drug, Rezdiffra by Madrigal, making significant progress in the biopharma industry.
The FDA has approved Rezdiffra, a new drug developed by Madrigal Pharmaceuticals, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a fatty liver disease. Rezdiffra is the first drug approved for this condition and has shown effectiveness in resolving MASH and improving liver scarring in clinical trials. The drug will provide a treatment option for patients with moderate or severe liver scarring who do not respond to diet and exercise alone. Madrigal expects Rezdiffra to generate significant sales, given the large market size for MASH.
Mar 14, 2024
New Report Provides Industry Insights on Biosimilar Market Size, Leading Companies, Growth Trends, and Future Projections
Global biosimilar market reached $21.2 billion in 2023 and is expected to reach $164.5 billion by 2032, growing at a CAGR of 25.1% during 2024-2032, according to a report by IMARC Group. The expiration of patents for original biologic drugs is fueling the growth of the biosimilar market, allowing for the development and marketing of cheaper alternatives. Biosimilars offer cost-effective treatments, addressing the increasing demand for more affordable healthcare solutions. Regulatory support and frameworks are also facilitating the growth of the biosimilar market. Infliximab is currently the largest segment within the market. Europe is the largest market for biosimilars due to early adoption of regulations. Leading companies operating in the global biosimilar industry include Novartis, Pfizer, Teva, and Amgen.
Mar 14, 2024
Argenx prepares for a major opportunity with its new antibody drug, reports STAT News.
Argenx, a Belgian drugmaker, plans to expand the use of its antibody Vyvgart to treat patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is an autoimmune nerve disorder that leads to muscle weakness and loss of feeling in the limbs. The commercial launch is scheduled for this summer.
Mar 14, 2024
Moody's upgrades pharmaceutical industry outlook due to increased focus on GLP-1 drugs - as reported on TradingView
Moody's Ratings has upgraded the outlook for U.S. pharmaceutical credit from "stable" to "positive" due to the increasing use of blockbuster drugs such as GLP-1 treatments for diabetes and weight loss from Novo Nordisk and Eli Lilly. The agency expects 4%-6% annual core earnings growth over the next 12-18 months, driven by growth in oncology, immunology, and other blockbuster areas. However, the industry may face constraints in the future due to drug pricing provisions and patent cliffs. Additionally, the growth outlook for generic drugs is improving, and several deals are bolstering companies' pipelines.
Mar 13, 2024
Lilly introduces Zepbound weight-loss drug on Amazon Pharmacy according to BioSpace
Eli Lilly has partnered with Amazon Pharmacy to deliver prescriptions of its weight-loss treatment Zepbound, as well as migraine and diabetes medicines, to patients who order them through the pharma's digital health portal LillyDirect. Amazon can deliver orders within two days for certain patients. This collaboration is seen as a good distribution partnership due to Amazon's experience in developing tech-enabled solutions and commitment to patient safety and customer service. Lilly is also considering a partnership with a retail pharmacy to provide pick-up options for orders placed on LillyDirect.
Mar 13, 2024
Mirum receives second FDA approval for Livmarli, a drug for treating PFIC, a rare liver disease
Mirum Pharmaceuticals has secured FDA approval for its rare liver disease treatment, Livmarli, to treat cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). This approval, combined with the drug's previous FDA approval for Alagille syndrome, allows Livmarli to be available to patients with two of the three rare pediatric liver diseases that cause pruritus. Livmarli's higher dose provides superior itch relief and bile acid clearance from the liver compared to its rival drug, Bylvay. Mirum is now seeking a label expansion to treat younger PFIC patients with Livmarli.
Mar 13, 2024
Merck submits four IPRs contesting Pembrolizumab patents held by The Johns Hopkins University
Pharmaceutical company Merck has filed four IPRs challenging patents held by The Johns Hopkins University for the use of pembrolizumab, sold by Merck under the trade name Keytruda®. The patents were allegedly obtained by JHU after a joint research collaboration with Merck, and Merck is now accusing JHU of breaching the collaboration agreement and improperly licensing the patents. Keytruda® was the top-selling drug worldwide in 2023. The litigation is ongoing, and updates will be provided as they arise.
Mar 12, 2024
The parent company of Novo Nordisk plans to increase operations in India in the upcoming year, according to ThePrint.
Novo Holdings, the controlling shareholder of Novo Nordisk, plans to open an office in India this year to tap the growing healthcare market and innovation. Novo Holdings already has offices in Singapore and Shanghai and intends to invest between $300 million and $500 million in Asia each year for the next five years. The company has invested in Indian private hospital chain Manipal Hospitals and medical imaging specialist Qure.ai, as well as several companies in China and Southeast Asia. Novo Holdings recently announced its acquisition of manufacturing subcontractor Catalent for $16.5 billion.
Mar 12, 2024
Amycretin, Novo Nordisk's latest weight loss drug, outperforms Ozempic in terms of potency - Quartz
Danish pharma company Novo Nordisk has revealed promising early-stage results for its experimental weight loss pill, amycretin. The company announced that a small trial found the pill to be twice as effective as its current weight loss drug. Novo Nordisk's CEO stated that amycretin "could develop into a best-in-class medicine." The company's stock surged following the announcement, and it has now become the 12th-most valuable company in the world. While larger trials are still needed, Novo Nordisk plans to begin a phase II trial of the drug in the second half of the year.
Mar 12, 2024
Novo Nordisk introduces a promising weight loss medication that may outperform Ozempic and Wegovy. Find out more here.
Danish pharma company Novo Nordisk has revealed promising early-stage trial results for its experimental weight loss pill, amycretin. The drug is reported to be twice as effective as the company's current weight loss drug, Wegovy, and has the potential to be a "best-in-class medicine". Novo Nordisk plans to conduct a phase II trial of amycretin later this year, with results expected in early 2026. The news comes as other drug makers aim to challenge Novo Nordisk's dominance in the weight loss market.
Mar 12, 2024
FDA Recommends New Drug to Help Prevent Heart Attacks
The US FDA has approved Novo Nordisk's weight loss drug, Wegovy, for the additional purpose of preventing cardiovascular events in adults with cardiovascular disease and obesity or overweight. Wegovy has already been approved for treating obesity and has shown significant weight loss results. The recent approval for reducing the risk of serious heart problems will allow more patients to use the drug and potentially expand insurance coverage. Novo Nordisk conducted a clinical trial showing Wegovy's effectiveness in reducing the risk of stroke, heart attack, and heart-related death.
Mar 11, 2024
Pfizer changes direction, shifting focus from COVID treatments to cancer drugs in an effort to regain market value
Pharmaceutical giant Pfizer is shifting its focus from COVID to cancer drugs as it aims to bounce back from a challenging year. Pfizer plans to increase the proportion of biologic drugs in its oncology pipeline and recently acquired cancer drugmaker Seagen to bolster its portfolio. The company expects to have at least eight blockbuster medicines by 2030. Additionally, Pfizer is expanding its respiratory syncytial virus vaccine application, developing combination vaccines for respiratory viruses, and working on an obesity treatment. Pfizer shares are up 3.1% following the announcement.
Mar 11, 2024
In a midstage study, Incyte's JAK cream Opzelura demonstrates effectiveness in treating hidradenitis suppurativa
Incyte's topical JAK inhibitor, Opzelura, has shown promising results in a phase 2 study for patients with mild to moderate hidradenitis suppurativa (HS). The study demonstrated a significant reduction in abscesses and inflammatory nodules after 16 weeks of treatment with Opzelura cream. This marks an important step in progressing research for HS, as there are currently no approved therapies for milder cases. Opzelura is already approved for atopic dermatitis and vitiligo and has been a successful dermatology launch for Incyte.
Mar 11, 2024
Amlitelimab from Sanofi shows promise for blockbuster success - Reported by The Pharma Letter
French pharma company Sanofi is optimistic about the potential of amlitelimab, a drug in its immunology pipeline, as it shows promise in maintaining response in atopic dermatitis. The company is also exploring its potential in five other chronic inflammatory diseases. Positive results from the drug's investigation have been reported.
Mar 11, 2024
Breakthrough obesity medication improves the health of individuals with HIV - Nature
The anti-obesity drug semaglutide could help people with HIV lose weight and reduce certain conditions associated with fat accumulation, according to studies presented at a conference in Denver. Semaglutide, which is marketed as Wegovy and Ozempic, has been associated with an average weight loss of 6.5kg in HIV patients and was found to reduce liver fat in those with metabolic dysfunction-associated steatotic liver disease. The medication is a glucagon-like peptide 1 analogue that controls appetite and blood sugar levels.
Mar 11, 2024
Incyte achieves success in Phase II trial and aims to compete with Dupixent for treating skin disease, targeting blockbuster status - BioSpace
Incyte presented positive Phase II results for its oral JAK1 inhibitor, povorcitinib, at the American Academy of Dermatology annual meeting. The drug showed significant improvement in itch reduction for patients with prurigo nodularis compared to a placebo. Povorcitinib could potentially challenge Sanofi and Regeneron's blockbuster injectable, Dupixent, for the treatment of prurigo nodularis, which is characterized by intense itching and thickened bumps on the skin. Incyte is planning a Phase III trial for prurigo nodularis as well as studying the drug for other indications.
Mar 10, 2024
Novo Nordisk introduces weight-loss drug Wegovy in Germany, entering the largest EU market.
Danish drugmaker Novo Nordisk has launched its weight-loss drug, Wegovy, in Germany. The drug, which helps reduce body weight by around 15% when used alongside exercise and lifestyle changes, is already available in the US but has only been on sale in small markets in Norway and Denmark in Europe. Public health insurance plans in Germany do not cover weight-loss drugs, so patients are expected to pay out of pocket. Novo is monitoring prescriptions to ensure access for people with obesity, but there may be supply delays.
Mar 10, 2024
Pfizer is pinning high hopes on cancer medications to revitalize its business following a drop due to the pandemic.
Pfizer is placing its hopes on cancer drugs to recover from a difficult year. It has been trying to rebuild investor confidence after a sharp decline in its Covid business, which caused its shares to fall by over 40% in 2023. Pfizer is betting on its combined drug pipeline with cancer drugmaker Seagen, aiming to produce at least eight blockbuster medicines by 2030. The company believes that by focusing on oncology, it can offset upcoming patent losses and drive growth in the future.
Mar 10, 2024
Pfizer is relying on cancer medications to revive business following Covid-related setbacks, reports CNBC.
Pfizer is shifting its focus from COVID-19 to cancer drugs as it aims to recover from a challenging year. The pharmaceutical giant highlighted its deeper push into oncology during an investor event, following its acquisition of targeted cancer drugmaker Seagen. Pfizer expects its oncology drug pipeline to produce at least eight blockbuster medicines by 2030. The company also plans to increase the proportion of biologic drugs in its pipeline from 6% to 65% by 2030, as biologics offer more durable revenue potential. The shift comes as Pfizer looks to offset upcoming patent losses and drive future growth in its oncology business.
