Pharma News
26 May 2024 to 01 Jun 2024
May 31, 2024
Insmed's Stock Soars 150% Following Analysts' Predictions of Next Big Success
Insmed's stock price more than doubled after announcing plans to seek FDA approval for its drug brensocatib, which showed positive results in Phase III trials for treating bronchiectasis. Analysts predict that the drug could have "blockbuster" sales of over $1 billion annually, with an estimated one million bronchiectasis patients worldwide. Insmed's stock surge also reflects its expansion beyond rare diseases, as it seeks to develop drugs for larger patient populations.
May 31, 2024
FDA prolongs deadline and seeks additional information on Sanofi's Dupixent for treatment of lung disease related to smoking
The FDA has extended the deadline for reviewing Sanofi's Dupixent as a potential treatment for 'smoker's lung', or COPD. The FDA has requested more data on the efficacy of Dupixent as an add-on treatment in certain patients.
May 31, 2024
EU Regulator Backs Sanofi's Treatment for Chronic Lung Disease - NDTV Profit
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of a new treatment as an add-on therapy for chronic obstructive pulmonary disease patients with elevated levels of certain white blood cells. The application will now be considered by the European Commission in the coming months.
May 31, 2024
Pharma news roundup includes updates on Ozempic supply, bird flu vaccines, and Merck's future
Ro and Eli Lilly are launching online supply trackers to assist patients dealing with shortages of GLP-1 drugs. Moderna is in discussions with the U.S. government regarding funding for its bird flu vaccine trial. Merck is acquiring Eyebiotech for $3 billion as part of its diversification efforts beyond Keytruda, its top-selling cancer drug.
May 31, 2024
Pfizer predicts that its lung cancer drug Lorbrena has the potential to become a $1 billion success.
Pharmaceutical company Pfizer has announced that its lung cancer drug, Lorbrena, could become a blockbuster drug by 2030. New data from the phase 3 CROWN trial showed that 61% of patients who took Lorbrena had no disease progression after five years, compared to only 8% of patients taking Pfizer's older drug Xalkori. The data also indicated that Lorbrena reduced the risk of disease progression or death by 81% compared to Xalkori. Pfizer believes that Lorbrena has the potential to reach $1 billion in annual sales.
May 30, 2024
Stock of Summit Therapeutics sees a significant increase as its lung-cancer treatment competes against Merck's popular drug
Summit Therapeutics announced that its experimental cancer drug, ivonescimab, has shown superior results compared to Merck & Co.'s Keytruda in a late-stage clinical trial for non-small cell lung cancer patients. The drug demonstrated a significant improvement in progression-free survival across patient subgroups, including those with high and low expression of the protein PD-L1. Summit sees these results as a potential shift in treatment options for cancer patients. Shares of Summit skyrocketed more than 270% in response to the news.
May 29, 2024
India's Potential Wait for Novo Nordisk's Weight-Loss Drug Wegovy Could Be Extended
Danish drug maker Novo Nordisk has announced that its weight loss drug Wegovy will not be launched in India this year. Wegovy, approved by the US FDA in June 2021, stimulates the body's GLP-1 hormone to promote a feeling of fullness, aiding in weight loss for those with obesity or overweight. The drug has gained popularity in the US and other countries but Novo Nordisk is exercising caution in expanding its market footprint.
May 29, 2024
Merck is close to finalizing a $1.3 billion cash acquisition of EyeBio, according to a report from the Wall Street Journal published by SaltWire.
Merck & Co is reportedly finalizing a $1.3 billion cash deal to acquire Eyebiotech, an ophthalmology biotechnology company. The agreement may include additional milestone payments of up to $1.7 billion. The deal is expected to be announced soon, according to sources. Merck aims to address a potential loss of revenue from its cancer immunotherapy drug Keytruda, which is set to lose patent protection, by exploring deals of up to $15 billion. Eyebiotech focuses on treating sight-threatening diseases and its lead drug, Restoret, targets retinal diseases characterized by leakage.
May 29, 2024
Merck Identifies Chance to Expand Pipeline through $1.3B EyeBio Acquisition - MedCity News
Pharmaceutical giant Merck is acquiring clinical-stage startup Eyebiotech for $1.3 billion in cash, with potential milestone payments of up to $1.7 billion. Eyebiotech develops drugs for retinal conditions, including diabetic macular edema, which causes swelling and blurry vision. Eyebiotech's lead program, called Restoret, aims to activate the Wnt pathway in the eye to restore and maintain the blood-retinal barrier. The acquisition will help Merck expand and diversify its pipeline as it prepares for declining revenue when its top product, Keytruda, loses patent protection.
May 29, 2024
Merck plans to purchase EyeBio for a potential $3 billion, marking its return to the eye drug market.
Merck & Co. has agreed to acquire EyeBiotech for up to $3 billion. EyeBio has developed a pipeline of candidates to prevent and treat vision loss associated with retinal vascular leakage. The acquisition will allow Merck to re-enter the eye drug development segment. Merck aims to recoup revenues it expects to lose starting in 2028 when it loses patent exclusivity for Keytruda. The deal is subject to regulatory approval and is expected to close in the third quarter of this year.
May 29, 2024
Merck plans to acquire EyeBio, a developer of eye-focused drugs, for up to $3 billion, as reported by The Globe and Mail.
Merck has agreed to acquire EyeBio, a biotech company, for up to $3 billion. The deal includes a cash payment of $1.3 billion and future milestone-based payments of $1.7 billion. As part of the agreement, Merck will gain access to EyeBio's retinal disease drug Restoret. This acquisition is part of Merck's strategy to strengthen its future growth, particularly as its cancer immunotherapy Keytruda's exclusivity is set to expire soon. The deal is expected to be finalized in the third quarter of 2024.
May 29, 2024
Studies indicate that popular weight-loss medications do not have a connection to suicidal thoughts, says Psychiatric News.
A review by the FDA finds no evidence linking GLP-1 receptor agonists, a class of weight-loss and diabetes drugs, to suicidality. The question of whether psychiatrists should play a more active role in prescribing these drugs to help manage obesity remains. An independent clinical trial also found that patients taking the GLP-1 drug semaglutide were less likely to experience suicidal ideation. It is important for psychiatrists to monitor potential side effects, such as weight gain, when prescribing medications to manage mental illness and obesity.
May 29, 2024
Shareholders of Catalent vote in favor of agreement with Novo Holdings - AOL.com
Catalent stockholders have approved Novo Nordisk parent's $16.5 billion bid to take over the contract manufacturer. The deal is expected to close by the end of 2024, and after the deal closes, three of Catalent's fill-finish sites will be sold to Novo Nordisk for $11 billion. Novo Holdings, the investment arm of Novo Nordisk's controlling shareholder, the Novo Nordisk Foundation, agreed to buy Catalent in February to meet the increasing demand for the obesity drug, Wegovy.
May 29, 2024
Shareholders of Catalent approve agreement with Novo Holdings - TradingView
Catalent stockholders have approved Novo Nordisk's $16.5 billion bid to acquire the contract manufacturer. Novo Nordisk's parent company seeks to boost production of the obesity drug Wegovy, for which Catalent is a key subcontractor. The deal is expected to close by the end of 2024, and as part of the agreement, three of Catalent's fill-finish sites will be sold to Novo Nordisk for $11 billion.
May 29, 2024
Bayer's appeal is denied by UK court in case involving popular blood thinner medication
Bayer has lost a UK Court of Appeal hearing against the decision to revoke its patent for the blood thinner drug Xarelto. The patent covered the use of rivaroxaban to prevent blood clots. The ruling clears the way for generic versions of the drug to enter the market. Xarelto generated nearly $4.1bn in revenue in 2023 and is the fourth best-selling drug in the world. The patent is subject to multi-jurisdictional proceedings in France and South Africa.
May 29, 2024
Lawsuit Filed by Amgen Against Celltrion Regarding Generic Versions of Popular Bone Drugs - Report by Bloomberg Law
Amgen Inc. has accused Celltrion Inc. of patent infringement for their proposed biosimilar versions of bone-strengthening drugs Prolia and Xgeva. Amgen has filed a complaint in the US District Court, claiming that Celltrion has violated 29 patents related to the active ingredient, denosumab, and its manufacturing methods. Prolia is used to treat osteoporosis, while Xgeva is used to prevent skeletal-related events in cancer patients. This accusation comes after Amgen recently settled another patent dispute.
May 29, 2024
US trade organization reports that India has agreed to refrain from issuing 'compulsory' drug licenses
India has given private assurances that it will not grant licences allowing local firms to override patents and make cheap copies of drugs by big Western drugmakers, according to the US-India Business Council (USIBC). The USIBC submitted this information to the US Trade Representative (USTR), which is reviewing global intellectual property laws for an annual report identifying trade barriers to US companies.
May 29, 2024
Ozempic found to decrease mortality risk in patients with diabetes and kidney disease - Healthline
Novo Nordisk's drug Ozempic, containing the active ingredient semaglutide, has shown promising results in reducing the risk of kidney disease-related events and mortality in people with type 2 diabetes and chronic kidney disease, according to new data from the FLOW trial. The trial demonstrated a 24% reduction in kidney- and cardiovascular-related mortality, an 18% reduced risk of major cardiovascular events, and a 20% reduced risk of all-cause mortality. This adds to the growing evidence that GLP-1 drugs like semaglutide have benefits beyond treating diabetes and obesity. Novo Nordisk plans to seek regulatory approvals for label expansion of Ozempic to treat these health conditions.
May 28, 2024
Semaglutide, a potent drug for diabetes and weight loss, shows promise in reducing the risk of kidney failure.
Semaglutide, a diabetes and weight-loss drug, has been found to significantly reduce the risk of kidney failure, heart attacks, and death in patients with type 2 diabetes and kidney disease, according to a study published in the New England Journal of Medicine (NEJM). The study showed that patients who received semaglutide once a week had a 24% lower risk of their kidney disease worsening or of dying prematurely from cardiovascular or kidney-related causes compared to those who received a placebo. This development provides a promising treatment option for patients with type 2 diabetes and chronic kidney disease.
May 28, 2024
Examining Pharmaceutical Patents in Effort to Reduce Costs | Reviewing Regulations
The Federal Trade Commission (FTC) has challenged over 100 drug patent listings and sent warning letters to 10 drug manufacturers in order to crack down on improperly listed drug patents. The move by the FTC is aimed at deterring improper patenting activity and weakening pharmaceutical monopolies. However, current law and oversight mechanisms may still fail to encourage competition and control drug prices. The Patents and Trademarks Office grants various types of patents and drug manufacturers often apply for multiple patents on the same product. These practices create barriers for generic drugs to enter the market, resulting in higher drug prices. The recent actions by the FTC aim to address these issues, but more systemic changes are needed.
May 28, 2024
Kiwoom Asset Management introduces ETF that follows Solactive Blockbuster Biotech Drugs Index
Solactive has partnered with Kiwoom Asset Management to launch the KIWOOM KOSEF US Blockbuster Biotech Drugs Plus ETF. The ETF tracks the performance of the Solactive Blockbuster Biotech Drugs Index, which focuses on companies operating in the biotech industry that have achieved annual biotechnology product revenues of over $1 billion. The biopharma sector is expected to experience annual sales growth of 5.2% until 2028, presenting a compelling investment opportunity. The ETF provides a way for global investors to invest in blue-chip biotech companies with proven innovation and profitability.
May 28, 2024
Amgen's biosimilar for rare blood disorder treatment gets approval from US FDA
The U.S. FDA has granted approval to Amgen for its drug Bkemv, the first biosimilar for AstraZeneca's Soliris, a treatment for rare blood disorders. Marketed as Bkemv, the drug carries a black-box warning for the risk of serious infections caused by neisseria meningitidis bacteria. The approval confirms that Bkemv is an interchangeable biosimilar with no clinically meaningful differences to Soliris. Bkemv is indicated for the treatment of two rare blood disorders, paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. AstraZeneca acquired Soliris through its acquisition of Alexion Pharmaceuticals in 2020.
May 28, 2024
Insmed's latest study outcomes enable progress towards seeking FDA approval for a previously untreated lung disease.
Insmed's drug, brensocatib, has outperformed placebo in a clinical trial for non-cystic fibrosis bronchiectasis (NCFB), a chronic lung condition with no approved therapies. Preliminary results have set the stage for a regulatory submission later this year. Brensocatib, which blocks dipeptidyl peptidase 1 (DPP1), yielded a reduction in the rate of pulmonary exacerbations compared to placebo. Leerink Partners estimates NCFB represents a US market of around 450,000 patients.
May 28, 2024
Kiwoom Asset Management introduces new ETF following Solactive's Blockbuster Biotech Drugs Index
Solactive has partnered with Kiwoom Asset Management to launch the KIWOOM KOSEF US Blockbuster Biotech Drugs Plus ETF. The ETF tracks the Solactive Blockbuster Biotech Drugs Index, which focuses on companies in the biotech industry that have achieved annual revenues of more than $1 billion with at least one product. The biopharmaceuticals industry is expected to experience growth, driven by advancements in medical technology and research on diseases. The ETF provides a way for investors to access blue-chip biotech companies with proven innovation and profitability.
May 28, 2024
Leaders at AstraZeneca and Daiichi Sankyo eye another major success in pharmaceuticals
AstraZeneca and Daiichi Sankyo have reported positive results from their Phase III TROPION-Lung01 study, testing the investigational drug datopotamab deruxtecan in non-small cell lung cancer. The trial met its primary endpoint of progression-free survival.
May 27, 2024
India could face a delay in receiving Novo Nordisk's weight loss medication Wegovy - reported by Business Today
Danish drug maker Novo Nordisk's weight loss drug Wegovy is not expected to be available in India this year, according to the company's CFO and EVP. Wegovy, which mimics the body's GLP-1 hormone to promote fullness and aid weight loss, has been approved by the US FDA and has seen widespread adoption in countries like Denmark, Norway, Germany, and the UK. However, the demand for the drug continues to outstrip supply in established markets, and Novo Nordisk is cautious about expanding into new markets while ensuring patient continuity.
May 27, 2024
French regulators investigate pharmaceutical company Sanofi for irregularities in financial reporting
French pharma company Sanofi is under investigation by judicial authorities for allegedly issuing false financial reporting statements, potentially for market manipulation. The investigation is focused on the dissemination of misleading information related to Sanofi's financial communications. The probe may be connected to the launch of Sanofi's eczema drug, Dupixent, in 2017. Sanofi denies knowledge of the investigation and maintains that its financial information is accurate. Shares of Sanofi dropped following the news of the investigation.
