Pharma News
22 Sep 2024 to 28 Sep 2024
Sep 27, 2024
FDA approves Dupixent for COPD, developed by Regeneron and Sanofi - Fierce Pharma
Regeneron and Sanofi have received FDA approval to expand the label of the drug Dupixent to include the treatment of chronic obstructive pulmonary disorder (COPD). Dupixent is now the first biologic treatment available for COPD patients in the US. The drug is approved for use as an add-on maintenance treatment for adults with inadequately controlled COPD who have a raised blood eosinophil count. COPD is an inflammatory respiratory condition that restricts airflow from the lungs and is the fourth leading cause of death worldwide.
Sep 27, 2024
Regeneron and Sanofi's Dupixent approved by FDA for treatment of lung disease in smokers
The FDA has granted approval for Regeneron Pharmaceuticals and Sanofi's drug Dupixent as a treatment for inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US for treating these patients, and the approval was based on positive results from two Phase 3 trials. China's National Medical Products Administration has also approved Dupixent as a treatment for COPD.
Sep 27, 2024
Doubts from Analysts Lead to Fading Gains for Novo Nordisk's Wegovy, According to Yahoo Finance
Shares of Novo Nordisk have fallen to a seven-month low amid concerns about slower-than-expected sales of its weightloss drug Wegovy. The Danish pharmaceutical company's third quarter results, due on 6 November, could disappoint investors, according to JPMorgan Chase analyst Richard Vosser. Novo Nordisk's stock has lost almost $149bn in market value and is trading about 20% below June's record high. The stock's struggles come as its biggest rival in the obesity-drug market, Eli Lilly, saw its closest rivals to Wegovy and Ozempic receive regulatory approval.
Sep 27, 2024
FDA approves Regeneron and Sanofi's Dupixent for treating COPD
Dupixent, a blockbuster therapy developed by Regeneron and Sanofi, has received FDA approval for the treatment of chronic obstructive pulmonary disease (COPD). The approval was based on late-stage trials that showed Dupixent improved lung function and reduced flare-ups in patients with COPD. This expanded approval could provide Dupixent with a competitive advantage over other treatments in development.
Sep 27, 2024
FDA in the US grants approval for Dupixent by Sanofi-Regeneron to treat 'smoker's lung' - TradingView
The U.S. FDA has approved Sanofi and Regeneron's drug, Dupixent, for use in patients with chronic obstructive pulmonary disease (COPD). The drug is already used to treat other conditions and is expected to generate significant revenue in the future. COPD is a leading cause of death and commonly affects smokers. Dupixent has shown promising results in clinical trials, reducing exacerbations and improving lung function. Shares of Regeneron rose 2.5% following the announcement.
Sep 27, 2024
Regulatory Agency in the United States Greenlights Bristol Myers Squibb's Schizophrenia Medication
Shares of Bristol Myers Squibb (BMY) have risen 4% after the FDA approved the company's schizophrenia drug called "Cobenfy." Cobenfy, the first new treatment for schizophrenia in 70 years, is expected to be available in the U.S. by late October. Analysts predict that the drug could be a multi-billion-dollar opportunity for Bristol Myers Squibb and potentially boost sales for the company. The stock of Bristol Myers Squibb has a consensus Hold rating among analysts.
Sep 26, 2024
FDA approves expanded use of Tagrisso by AZN for NSCLC - Yahoo Finance
The FDA has approved AstraZeneca's drug Tagrisso for expanded use in lung cancer. Tagrisso is now indicated for the treatment of unresectable, stage III EGFR-mutated non-small cell lung cancer in adult patients whose disease has not progressed following treatment with chemoradiotherapy. The approval was based on data from the phase III LAURA study, which showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Tagrisso is one of AstraZeneca's key revenue drivers, with sales of $3.2 billion in the first half of 2021.
Sep 26, 2024
Orion, a Finnish company, aims to increase sales in the United States with a highly successful drug for prostate cancer.
Finnish drugmaker Orion plans to increase sales in the United States with its prostate cancer drug Nubeqa, developed in partnership with Bayer. Nubeqa is already a billion-euro product and Bayer is seeking approval from US authorities to expand its use to a new group of patients. Orion established a US research centre last year to drive growth in the country, which accounts for approximately half of the global drug market.
Sep 26, 2024
Study finds that Ozempic may decrease the chance of opioid overdose - Quartz
Novo Nordisk's drug Ozempic, which contains the active ingredient semaglutide, may help reduce the risk of opioid overdose in patients with type 2 diabetes and opioid use disorder, according to a study. The research found that patients prescribed semaglutide had a 58% lower risk of overdose compared to those on insulin. This suggests that semaglutide, in addition to its blood sugar regulation and weight loss benefits, could potentially be used as an alternative treatment for opioid use disorder. Another study also found that Ozempic could help individuals with tobacco addiction.
Sep 26, 2024
Orion, a pharmaceutical company from Finland, looks to increase sales in the United States by promoting its successful prostate cancer medication.
Finnish drugmaker Orion has announced that its prostate cancer drug Nubeqa, developed in partnership with Bayer, has generated more than €1bn ($1.2bn) in sales this year, making it Orion's first blockbuster product. Nubeqa, also known as darolutamide, is Bayer's third best-selling drug globally, with sales growing most rapidly in the US. Orion has therefore established a research centre in the US to develop its own innovations in the market, including its pain treatment molecule ODM-111. Bayer is also seeking approval to expand the use of darolutamide to a new patient group in the US.
Sep 26, 2024
FDA is set to review the approval of the first new drug for schizophrenia in more than three decades
FDA is set to decide on the approval of Bristol Myers Squibb's KarXT, the first new schizophrenia drug in over 30 years, which is said to offer better treatment with fewer side effects. Meanwhile, Pfizer has withdrawn its sickle cell disease treatment Oxbryta from all markets due to concerns about the risk of a painful complication and death. In other news, Merck's colorectal cancer therapy has failed a late-stage trial, while a study finds that MRI can help reduce overdiagnosis in prostate cancer screening. Apple also launched a new feature on the Apple Watch to potentially identify sleep apnea.
Sep 26, 2024
Orion from Finland seeks to increase sales in the US market with a successful prostate cancer drug - according to MarketScreener
Finnish drugmaker Orion plans to increase sales in the United States with the success of its prostate cancer drug Nubeqa. Developed in collaboration with German partner Bayer, Nubeqa has generated over a billion euros in sales this year, making it Orion's first blockbuster product. Bayer is seeking approval to extend the drug's usage to a new patient group in the US. Nubeqa is Bayer's third best-selling drug globally, with growing sales in the US market. Orion aims to develop its own innovations in the US, including a pain treatment and a drug for metastatic castration-resistant prostate cancer.
Sep 26, 2024
Potential Connection Found Between Novo's Ozempic and Reduced Risk of Opioid Overdose in Diabetic Patients - BioSpace
Novo Nordisk's Ozempic (semaglutide), a diabetes drug, may reduce the risk of opioid overdose in patients with type 2 diabetes, according to a study published in JAMA Network Open. The study analyzed the health records of over 33,000 patients and found that those on semaglutide had a significantly lower risk of opioid overdose compared to those on other anti-diabetic treatments. However, the study's authors noted that further research is needed to validate the findings and understand the underlying mechanisms of semaglutide's effects. This adds to the growing list of potential therapeutic benefits of semaglutide and GLP-1 treatments.
Sep 26, 2024
Bayer, in collaboration with Orion, applies to U.S. FDA for third indication of ...
Orion's collaboration partner Bayer has submitted a supplemental new drug application (sNDA) to the U.S. FDA for darolutamide, an oral androgen receptor inhibitor, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The application is based on positive results from a Phase III trial, showing that darolutamide plus androgen deprivation therapy significantly reduced the risk of radiological progression or death compared to placebo. Darolutamide, developed jointly by Orion and Bayer, has already gained blockbuster status with in-market sales exceeding one billion euros year-to-date.
Sep 25, 2024
Amgen's medication for muscle disorder achieves primary objective in advanced trial - Yahoo
Amgen's drug, inebilizumab or Uplizna, has shown positive results in a late-stage study for patients with myasthenia gravis, a rare muscle-weakening disease. The trial demonstrated an improvement in daily activities, including chewing and swallowing, for patients receiving the drug. Amgen is now engaging with regulatory bodies for approval of Uplizna in myasthenia gravis patients. However, shares of the drugmaker fell as it also reported data from another experimental drug, rocatinlimab, which fell short compared to existing treatments for atopic dermatitis.
Sep 25, 2024
Algorae Pharmaceuticals unveils new platform using AI technology to create innovative drug possibilities
Algorae Pharmaceuticals has launched AlgoraeOS, a biopharmaceutical platform that utilises artificial intelligence to predict fixed-dose combination (FDC) drugs. The platform aggregates medical and scientific data on over 5,000 drugs and molecules across 150 human cell types to identify potential FDCs that could enhance efficacy and reduce side effects. Algorae aims to develop new therapies without the high costs and time associated with discovering new molecular entities, potentially collaborating with big pharma. The company plans to conduct lab tests, intellectual property assessments, and partner evaluations for the predicted FDCs.
Sep 25, 2024
Novo Nordisk Under Political Pressure for High Prices of Weight-Loss Drug Prior To ...
Drug manufacturer Novo Nordisk is facing political pressure over the high prices of its weight-loss drugs, Ozempic and Wegovy, in the US market. The pricing disparity between the US and other international markets has drawn criticism, leading Novo Nordisk's CEO, Lars Fruergaard Jorgensen, to testify before US lawmakers. The company attributes the pricing issue to pharmacy benefit managers (PBMs), but there are concerns that reducing list prices may not result in lower costs for patients due to the influence of PBMs on insurance coverage. However, these pricing cuts are unlikely to significantly impact Novo Nordisk's bottom line or demand for its drugs in the US market in the short term. With the 2024 US presidential election approaching, drug pricing has become an important issue for both major political parties, potentially leading to more affordable drugs in the future. Post-election, there may also be an increase in merger and acquisition activity in the pharmaceutical sector, particularly in the weight-loss and obesity treatment space.
Sep 25, 2024
Muscular disorder drug from Amgen achieves primary objective in final-phase trial
Amgen's drug, Uplizna, has met the main goal of a late-stage study by improving daily activities in patients with myasthenia gravis, a rare muscle-weakening disease. The trial showed a significant improvement in patients after two doses of the drug. Amgen is now engaging with regulatory bodies for approval. However, the company's shares fell over 2% in extended trading as data from another experimental drug, rocatinlimab, fell short of already approved treatments for eczema.
Sep 25, 2024
US lawmakers urge Novo Nordisk to decrease drug prices, reports France 24
The CEO of Danish pharmaceutical company Novo Nordisk, Lars Fruergaard Jorgensen, has committed to exploring options to lower the prices of their diabetes and weight-loss drugs, Ozempic and Wegovy, in the United States. The drugs are currently sold at significantly higher prices in the US compared to other countries, with Senator Bernie Sanders citing the vast difference in cost. Jorgensen acknowledged the issue and expressed willingness to make the drugs more affordable for American patients, while also highlighting the role of Pharmacy Benefit Managers (PBMs) in driving up prices.
Sep 25, 2024
A Chinese biotech company with limited recognition aims for global success with its cancer drug surpassing Keytruda.
Chinese biotech company Akeso is gaining attention after its drug, ivonescimab, outperformed Merck's Keytruda in a late-stage lung cancer trial. Akeso's leaders aim to position the company as a global biotech and emphasize their deep pipeline of drugs beyond ivonescimab.
Sep 25, 2024
Novo's Ozempic Expected to Advance in Medicare Price Negotiations
Novo Nordisk's blockbuster type 2 diabetes drug Ozempic is expected to be included on the list for Medicare drug price negotiations in 2027, according to industry analysts. The inclusion of Ozempic, which was approved by the FDA in 2017, is seen as a foregone conclusion due to its popularity and the expiration of its US patent in 2032. Novo Nordisk has expressed concerns about government price-setting and the implementation of the negotiation process.
Sep 25, 2024
Politicians question Novo Nordisk's CEO about the cost of weight-loss medications
Pharmacy company Novo Nordisk faced questioning from lawmakers regarding the high prices of weight-loss drugs Ozempic and Wegovy. Novo Nordisk CEO Lars Jorgensen blamed pharmacy benefits managers for the prices, stating that 74 cents of every dollar earned goes to them. Senator Bernie Sanders called it a moral issue, pointing out the stark contrast between prices in the US, Canada, and Germany. Jorgensen emphasized that the company does not determine the prices set for patients, as these are determined by insurance companies. The hearing aimed to address why Americans pay significantly more for these drugs.
Sep 24, 2024
Sanofi's Chief Executive Officer is optimistic about the company's potential for expansion due to the introduction of new medications.
Sanofi's CEO, Paul Hudson, stated in an interview that the company is expecting strong growth from new drugs and does not face imminent patent expirations like some rivals. He mentioned the potential of drugs such as tolebrutinib for multiple sclerosis, Beyfortus for respiratory syncytial virus, and Dupixent for chronic obstructive pulmonary disease. Sanofi has a pipeline of 12 potential blockbuster assets and aims to participate in the obesity drug market. The company is also considering different options for the separation of its Opella consumer healthcare unit, including a spinoff or sale.
Sep 24, 2024
Novo's Chief Executive Holds Drug Intermediaries Responsible for Ozempic's Expensive Price - BNN Bloomberg
Novo Nordisk CEO Lars Fruergaard Jorgensen will argue before a congressional committee that pharmacy benefit managers (PBMs) are responsible for high US drug prices. Jorgensen is defending the prices of Novo's blockbuster drugs Ozempic and Wegovy, stating that the net price the company receives is far below the list price and lowering it can have unintended consequences. Novo is under pressure to make its medicines more affordable, as demand for the treatments rises. Lawmakers are increasingly scrutinizing PBMs' role in high drug prices.
Sep 24, 2024
Senator Marshall criticizes PBM's pricing strategies during hearing on Ozempic and Wegovy drug costs
Senator Marshall criticized Pharmacy Benefit Managers (PBMs) for inflating the prices of drugs, specifically Novo Nordisk's Ozempic and Wegovy. During a hearing on drug pricing, Senator Marshall highlighted how PBMs take 74% of the revenue from these drugs, while Novo Nordisk only receives 26%. He called for urgent PBM reform to lower prescription drug prices for patients and emphasized the need to bring competition and promote biosimilars and generics. Senator Marshall stated that Novo Nordisk is not to blame but rather the PBMs.
Sep 24, 2024
Court rejects Regeneron's request to stop production of generic version of popular eye medication
Regeneron has filed a lawsuit against Sandoz, accusing the Swiss pharma company of patent infringement and violation of the BPCIA. The lawsuit claims that Sandoz failed to provide necessary information during the approval process for its biosimilar drug, putting Regeneron in a position of having to guess which patents were being infringed.
Sep 24, 2024
Regeneron experiences a decline in stock after failing to prevent Amgen's Eylea biosimilar - Fierce Pharma
Regeneron's request to block Amgen's biosimilar drug, Pavblu, which replicates the 2 mg version of Eylea, has been denied by a federal judge in West Virginia. Regeneron, which claimed that Amgen's drug infringed on 32 patents, immediately filed an appeal following the decision. The ruling allows Amgen to pursue an "at-risk" biosimilar launch. Regeneron's shares dropped by 9% following the decision, highlighting the company's reliance on Eylea, which accounted for 44% of its revenue in 2023. Eylea's market share has been affected by Roche's Vabysmo, which offers a longer-acting treatment option.
Sep 24, 2024
Senators question Novo Nordisk CEO about the high price of Ozempic.
Novo Nordisk CEO Lars Fruergaard Jørgensen faced questioning from senators about the high prices of the company's weight-loss drug Wegovy and diabetes drug Ozempic in the United States compared to other countries. Sen. Bernie Sanders criticized the price disparity, with U.S. residents paying significantly more for the drugs. Jørgensen defended the pricing, highlighting that many Americans can access the drugs for $25 or less per month. The hearing also addressed the role of health insurance companies and pharmacy benefit managers in influencing drug prices.
Sep 24, 2024
Regeneron faces increased competition for Eylea biosimilar following legal decision - STAT News
Shares of Regeneron dropped 5% as the company's attempt to block Amgen from launching a biosimilar version of its eye drug Eylea was denied by a judge. The ruling came as a surprise since the same judge had previously granted injunctions against other companies seeking to launch Eylea biosimilars. Although Amgen could bring its drug, Pavblu, to the market at risk, Regeneron has filed an appeal.
Sep 24, 2024
Novo announces that Ozempic will be eligible for US pricing discussions within the next twelve months
The CEO of Novo Nordisk, Lars Fruergaard Jorgensen, has stated that the diabetes drug Ozempic will be eligible for U.S. government's price negotiations within a year. The announcement confirms speculation from analysts that Ozempic will be included on the 2027 list for negotiations. The high prices of Ozempic and weight-loss drug Wegovy, both manufactured by Novo Nordisk, have faced criticism. Jorgensen also mentioned that the net prices for both drugs have declined and are expected to continue to do so.
Sep 23, 2024
Three new FDA approvals quickly enhance Bimzelx's potential for success at UCB
UCB's drug Bimzelx has received three additional indications from the FDA for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The drug is the first of its kind to be approved for these indications. This approval is expected to boost the drug's potential peak sales, which are projected to be at least 4 billion euros. UCB is also awaiting FDA approval for another use of Bimzelx in hidradenitis suppurativa. The drug has already achieved significant sales in the psoriasis market and is known for its rapid treatment effect and sustained benefits.
Sep 23, 2024
Novo Pharmaceuticals announces that Ozempic will be eligible for price negotiations in the US within a year.
Novo Nordisk CEO Lars Fruergaard Jorgensen stated in written testimony that the company's diabetes drug Ozempic could be eligible for U.S. government price negotiations in less than a year. Novo Nordisk's Ozempic and weight-loss drug Wegovy have faced criticism over high prices in the United States. Jorgensen also mentioned that the net prices for both drugs continue to decline.
Sep 23, 2024
Study finds AstraZeneca breast cancer medication does not increase patient survival - This is Money
AstraZeneca announced that its experimental breast cancer drug, Datopotamab deruxtecan (Dato-DXd), did not succeed in prolonging the survival of patients with the disease. The trial focused on patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer. The drug did not achieve statistical significance in terms of survival rates compared to chemotherapy. AstraZeneca, which had set a target of $80 billion in annual revenues by 2030, will continue discussions with regulatory authorities regarding the drug's clinical development.
Sep 23, 2024
Lilly requests information on individuals who have used unauthorized weight-loss products - MedWatch
Pharmaceutical company Eli Lilly is requesting individuals who have taken its popular weight loss drug to share their medical records to ensure safety. This request is being made as the company takes legal action against companies selling compounded versions of the drug.
Sep 23, 2024
Novo Nordisk Faces Congressional Investigation for Drug Pricing Practices | Science and Environment
Novo Nordisk's CEO is set to meet with U.S. Senator Bernie Sanders to discuss the high costs of their diabetes and weight loss medications, particularly Ozempic. This meeting comes as the U.S. government examines drug prices. Novo Nordisk will defend the costs by highlighting research, development, and production expenses. This confrontation reflects the growing concern over healthcare costs and the need for affordable medications.
Sep 23, 2024
CEO of Novo Nordisk to undergo Senate investigation regarding high prices of Ozempic and Wegovy
Novo Nordisk's CEO, Lars Fruergaard Jørgensen, will face tough questions from U.S. lawmakers regarding the high prices of the company's diabetes and weight-loss drugs, including Ozempic and Wegovy. The Senate committee hearing, led by Senator Bernie Sanders, aims to address the exorbitant costs imposed on American patients compared to other countries. Novo Nordisk is expected to defend the prices by emphasizing insurance coverage and blaming pharmacy benefit managers, while Sanders argues that the company is ripping off the American people. Jørgensen will likely highlight the extensive development costs of the drugs, totaling over $10 billion.
Sep 23, 2024
Senator Warren and a group of colleagues call for the government to permit the production of generic versions of Novo's popular GLP-1 medications ...
Lawmakers are urging the US government to use its "march-in" rights to allow the entry of generic versions of Novo Nordisk's semaglutide drugs, Wegovy and Ozempic, in order to promote competition and reduce prices. Senators Elizabeth Warren and Lloyd Doggett penned a letter to the Department of Health and Human Services, stating that the move would stabilise supplies and increase access to these medications. Advocacy groups have also highlighted potential annual savings of over $10bn from generic versions. Novo's CEO, Lars Fruergaard Jørgensen, is due to testify at a Senate hearing on the company's pricing.
Sep 23, 2024
Novo announces that Ozempic will qualify for US price discussions within a year.
Novo Nordisk's CEO, Lars Fruergaard Jorgensen, has confirmed that the company's diabetes drug, Ozempic, will be eligible for price negotiations by the US government in less than a year. The drug's inclusion on the 2027 list of price negotiations, set to be announced in February 2025, is in line with expectations. Novo Nordisk has faced criticism for the high prices of Ozempic and its weight-loss drug, Wegovy, both of which have seen declining net prices since their respective launches.
Sep 23, 2024
AstraZeneca Pharmaceuticals receives approval to introduce cancer medication durvalumab in the Indian market - CNBC TV18报道
AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation to import and distribute durvalumab (Imfinzi) for an additional indication in India. Durvalumab is now approved for use in combination with chemotherapy as a neoadjuvant treatment for patients with resectable NSCLC and no EGFR mutations or ALK rearrangements.
