Pharma News
21 Jul 2024 to 27 Jul 2024
Jul 26, 2024
Prestige BioPharma receives favorable assessment from EMA for Herceptin biosimilar
Prestige BioPharma's biosimilar candidate, Tuznue, referencing Roche's Herceptin, received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The approval is for the treatment of breast cancer and metastatic gastric cancer. Prestige BioPharma expects to receive authorization from the European Commission and launch the drug in 30 European countries in October. This approval makes Prestige BioPharma the third Korean company to receive approval for a biosimilar in Europe, following Celltrion and Samsung Bioepis.
Jul 26, 2024
A woman from Joburg withdraws lawsuit against pharmaceutical company regarding availability of 'groundbreaking' treatment for cystic fibrosis
A Johannesburg woman has dropped her case against US pharmaceutical company Vertex over its local patents for cystic fibrosis drugs, Trikafta and Kalydeco. Previously, Vertex had patented the drugs in South Africa, preventing the sale of Argentinian-made generics. However, the situation has changed, and Vertex has now arranged to import and distribute Trikafta locally. The high price of the drug remains an issue, but the applicants have not ruled out future action to improve access. They believe their case played a role in pushing Vertex to make the arrangements for drug supply.
Jul 26, 2024
ST Pharm secures a ₩14 billion contract for the supply of oligonucleotide APIs
South Korean pharmaceutical company, ST Pharm, has signed three supply contracts worth a total of $10.14 million with European and American pharmaceutical firms. ST Pharm will supply oligonucleotide active pharmaceutical ingredients (APIs) for three therapeutic drugs targeting cardiovascular disease, hereditary angioedema, and arteriosclerosis. The initial commercial quantities of the drugs are expected to be delivered by the end of 2021. ST Pharm previously supplied API for a hematologic cancer drug that received FDA approval, and industry watchers speculate cooperation with Geron Corporation. Despite this positive development, ST Pharm reported an operating loss in the second quarter of this year.
Jul 26, 2024
Bristol Myers Increases Profit Prediction for 2024 Due to High Demand for New Medication - Report from BNN Bloomberg
Bristol Myers Squibb has raised its 2024 profit forecast after seeing increased demand for its newer drugs. The drugmaker's adjusted earnings for the year are now expected to be between 60 cents and 90 cents a share, an increase of 20 cents at the midpoint of its previous projection. Shares in Bristol rose as much as 9.3% following the news. The company has faced challenges in recent years due to competition and pricing pressures, but its newer drugs, such as Sotyktu, Camzyos, and Reblozyl, have outperformed expectations. Bristol has also made significant acquisitions to bolster its pipeline.
Jul 26, 2024
European Authorities Give Green Light to Novo Nordisk's Weight Management Medication for Heart Conditions
The European Union has granted approval for Novo Nordisk's weight loss drug, Wegovy, to be used in treating heart conditions in adults who are overweight or obese. This label expansion follows positive clinical trial results that showed Wegovy reduced the risk of major cardiovascular events and cardiovascular death. This approval opens up a new market for the blockbuster drug. The United Kingdom also recently approved Wegovy for reducing the risk of heart ailments and strokes. Novo Nordisk plans to update Wegovy's label in Europe within a month.
Jul 26, 2024
Cipla, an Indian pharmaceutical company, exceeds first quarter profit expectations due to high demand, sending its shares to a new all-time high.
Indian drugmaker, Cipla, has reported an 18.3% rise in first-quarter net profit to 11.78 billion rupees ($140.8 million), surpassing analysts' estimates. This increase in profit was driven by higher sales in its North America market, with sales growing 13% in the region. Cipla's respiratory drug, Albuterol, and cancer treatment drug, Lanreotide, were the primary drivers of this growth. The company's shares jumped 6.7% to a record high after the results were announced.
Jul 26, 2024
Sanofi SA (NASDAQ:SNY) fails to meet profit forecasts - as reported by FXDailyReport.Com
French pharmaceutical company Sanofi reported a rise in second-quarter profit on the back of strong demand for its asthma drug Dupixent and better-than-expected new launches sales. Sales of Dupixent, approved to treat asthma and eczema, surpassed analyst expectations, while quarterly sales of Beyfortus and Altuviiio also exceeded estimates. Despite a slight dip in its stock value, Sanofi no longer expects a fall in full-year profit. Expansion in key markets outside the US is also contributing to the company's strong performance. The EU approval for COPD and the anticipation of a US regulatory decision for Dupixent in September are expected to be significant growth drivers going forward.
Jul 26, 2024
AstraZeneca's Breast Cancer Medication Expensive, Says UK Agency CEO Pascal according to Benzinga
AstraZeneca CEO Pascal Soriot has urged the UK government to reconsider its approach to funding new medicines following the rejection of the company's cancer drug Enhertu by the National Institute for Care and Excellence (NICE). Soriot emphasized the need for a review of how medicines are assessed, while also expressing concerns about the UK's drug pricing compared to other countries. Enhertu, developed in partnership with Daiichi Sankyo, has shown positive results in treating advanced breast cancer but was deemed too expensive by NICE. AstraZeneca reported strong sales growth in its drug portfolio despite the setback.
Jul 26, 2024
UK Agency Criticizes the High Cost of AstraZeneca's Breast Cancer Drug Enhertu, CEO Pascal ...
AstraZeneca CEO Pascal Soriot has urged the UK government to reconsider its approach to funding new medicines following the National Institute for Health and Care Excellence's (NICE) rejection of the company's cancer drug, Enhertu. Soriot emphasized the need for the government to review how medicines are assessed, as the high cost of innovative treatments like Enhertu puts pressure on healthcare systems to justify expenses. NICE approved Enhertu for advanced HER2-positive breast cancer but did not approve it for HER2-low breast cancer. AstraZeneca reported strong sales growth in the first half of the year.
Jul 26, 2024
Sanofi increases profit forecast after experiencing a 10.2% increase in sales during the second quarter
Pharmaceutical company Sanofi raised its full-year profit guidance after reporting a 10.2% sales growth in Q2. The strong sales were driven by the success of asthma drug Dupixent, which grew 29% to $3.57 billion. However, vaccine revenues declined by 4.8% due to the continued drop in COVID-19 vaccinations. Sanofi also highlighted regulatory approvals for Dupixent and Kevzara, as well as the approval of Altuvioct in the EU. Sanofi's CEO stated that the company is on track to reach $13 billion in sales by the end of 2024.
Jul 25, 2024
EU Regulator Endorses Novo Nordisk's Wegovy for Potential Cardiovascular Benefits
European Union drug regulators are supporting a label expansion for Novo Nordisk's blockbuster drug Wegovy. The label update will reflect the drug's potential to reduce the risk of major cardiovascular events, including heart attacks, in obese or overweight adults. The decision comes after positive data from a clinical trial showed a reduction in the risk of adverse cardiovascular events in adults with cardiovascular disease. Novo Nordisk expects the label update to be implemented within a month. The demand for Wegovy has been booming, making Novo Nordisk the most valuable company in Europe.
Jul 25, 2024
EU Regulator Approves Novo Nordisk's Wegovy for Reducing Heart Risks
European Union drug regulators have given their support for Novo Nordisk's Wegovy drug to be expanded to include a label indicating its potential to reduce the risk of major cardiovascular events in obese or overweight adults. The move highlights the growing recognition of the health benefits of drugs like Wegovy and Eli Lilly's Zepbound beyond just weight loss. Novo Nordisk expects the label update to be implemented within a month following the positive opinion from the European Medicines Agency.
Jul 25, 2024
AbbVie raises its 2024 profit outlook, causing its shares to reach an all-time high - AOL.com
Pharmaceutical company AbbVie has increased its profit forecast for 2024 after reporting strong sales of immunology drugs and surpassing Wall Street expectations in its quarterly results. The company's flagship arthritis drug Humira saw global sales fall by nearly 30% in the second quarter due to competition from biosimilar versions, but still exceeded analyst expectations. AbbVie has been focusing on newer immunology drugs Skyrizi and Rinvoq to offset the decline in Humira sales, with both drugs surpassing sales estimates. Overall, AbbVie's strong results demonstrate its ability to navigate the loss of exclusivity for Humira.
Jul 25, 2024
Roche's Vabysmo continues to see an increase in sales, although growth has slowed down.
Swiss pharmaceutical company Roche reported strong sales and market share increases for its eye disease drug Vabysmo in the second quarter. Worldwide sales reached 947 million Swiss francs ($1.1 billion), bringing total sales for the first half of the year to 1.8 billion Swiss francs ($2 billion). However, the drug's sequential performance showed a slowdown in growth compared to previous quarters, possibly due to competition from Regeneron and Bayer's Eylea franchise. Roche remains optimistic about Vabysmo's future success, with plans to expand its market share and introduce a prefilled syringe delivery method.
Jul 25, 2024
Wegovy, manufactured by Novo, receives approval from the EU for treating heart patients - BNN Bloomberg
Novo Nordisk's weight-loss drug, Wegovy, has received approval from the European Union regulator to be used as a treatment to reduce the risk of strokes and heart attacks. The decision was based on data from a study that found Wegovy reduced the risk of major heart afflictions by 20%. The expanded approval is part of Novo's plan to position Wegovy as a medicine with a range of health benefits, rather than as a cosmetic treatment. Wegovy has also received clearance in the UK and the US for reducing the risk of heart disease.
Jul 25, 2024
Sanofi maintains confidence in achieving blockbuster sales target for RSV with capacity upgrades in place.
Sanofi expects its antibody drug Beyfortus, developed in partnership with AstraZeneca, to become a blockbuster drug in 2024, with the anticipated approval of two new filling lines in September contributing to increased sales. The drug, used for the treatment of respiratory syncytial virus (RSV), generated €547 million in revenue in 2023 but faced supply constraints. Sanofi is confident in its plan to expand production capacity, aiming for a strong sales season in the last quarter of 2024. The company reported an overall sales increase of 10% in the second quarter, driven by the success of its immunology drug Dupixent.
Jul 25, 2024
AstraZeneca, Roche, and Sanofi are optimistic about their 2024 forecasts following robust sales in the second quarter, according to BioSpace.
In the second quarter of 2024, AstraZeneca, Roche, and Sanofi reported strong financial results, surpassing analyst expectations. AstraZeneca saw significant growth in its cancer franchise, driven by drugs such as Enhertu and Tagrisso. Roche's top-selling assets were Ocrvus and Hemlibra, while Sanofi's Dupixent performed well. All three companies raised their full-year profit outlooks. AstraZeneca expects mid-teen percentage revenue growth, while Roche predicts mid-single-digit sales growth. Sanofi anticipates stable business EPS. Additionally, Roche revealed the discontinuation of development for an investigational gene therapy for Pompe disease.
Jul 25, 2024
Sanofi boosts 2024 profit forecast due to strong Q2 earnings, with popular drug Dupixent performing well.
Sanofi reported a 3.2% increase in second-quarter business operating income, reaching €2.8 billion ($3.03 billion). Sales for the quarter were $11.57 billion (€10.75 billion), surpassing expectations, with a year-on-year increase of 7.8%. Sales of Dupixent, Sanofi's eczema drug, rose 29.2% to €3.30 billion. However, there are concerns about the company's heavy reliance on this drug. Sanofi expects stable business EPS and aims for blockbuster status for its Beyfortus vaccine. Sanofi's stock rose by 3.73% in premarket trading following the announcement.
Jul 25, 2024
Sanofi increases its 2024 profit projection due to strong performance of Dupixent and new product launches, reports PharmaLive.
Pharmaceutical company Sanofi has increased its profit forecast for 2024 due to the success of its asthma drug Dupixent and strong sales of new products. The company now predicts that its earnings per share will remain stable in 2024 compared to 2023, an improvement on its previous expectation of a slight decline.
Jul 25, 2024
Sanofi increases its 2024 profit outlook due to the success of Dupixent and new products.
French drugmaker Sanofi has raised its full-year profit outlook after strong demand for its asthma drug Dupixent and better-than-expected sales of new launches. The company's second-quarter results beat estimates, prompting an upgrade of its forecast for 2024 earnings per share. Sales of Dupixent, which is approved to treat conditions such as asthma and eczema, rose 29.2% to €3.30bn ($3.57bn), above analysts' expectations. Sanofi's shares rose 2.9% on the news.
Jul 25, 2024
Sanofi's stock rises due to Dupixent driving strong performance in Q2 and prompting an increase in 2024 outlook - according to TradingView
Shares of French pharmaceutical company Sanofi rose 2.5% as the company raised its full-year profit guidance. The boost was attributed to strong sales of its blockbuster asthma drug, Dupixent. Sanofi now expects stable business EPS for 2024, up from its previous forecast of a drop in the low single-digit percentage. The company's Q2 earnings per share exceeded expectations, leading J.P.Morgan to describe the results as strong. Analysts also believe that Sanofi's pipeline in Immunology is undervalued.
Jul 25, 2024
Eisai in Japan considers using blood test to determine eligibility for Alzheimer's drug - Nikkei Asia
Pharmaceutical company Eisai is working on a blood test to assess the suitability of Alzheimer's patients for their drug, lecanemab. Developed in partnership with Biogen, lecanemab targets the removal of amyloid beta in the brain, a protein associated with Alzheimer's. Clinical trials have shown the drug to slow disease progression by 27%. Eisai aims to expand its dementia treatment and care business with this development.
Jul 25, 2024
AbbVie Welcomes Their Second CEO with a Strong Start - BNN Bloomberg
AbbVie Inc. expects to earn more than originally forecast during CEO Robert Michael's first year at the helm, thanks to the success of its newer medicines such as Skyrizi and Rinvoq. These medicines have helped the company reduce its dependence on Humira, its blockbuster autoimmune drug that has faced competition from lower-cost biosimilar drugs. AbbVie's adjusted earnings for Q2 beat expectations, and the company raised its full-year forecast for Skyrizi and Rinvoq. AbbVie also anticipates closing its $8.7 billion acquisition of Cerevel Therapeutics soon. Shares of AbbVie rose to a record high on the news.
Jul 24, 2024
Are Weight Loss Medications from Custom Pharmacies: Beneficial or Dangerous? - Digital Chew
Compound pharmacies in the U.S. are producing copycat versions of popular weight loss drugs like Wegovy, Ozempic, Rybelsus, and Zepbound, despite opposition from major pharmaceutical companies Novo Nordisk and Lilly. While these compounded drugs offer a cheaper alternative, concerns persist about their safety. The compounding pharmacies argue that if the big companies want to eliminate competition, they should increase production. However, if the FDA removes these weight loss drugs from the shortage list, it could have devastating consequences for both the businesses and the patients relying on these affordable alternatives.
Jul 24, 2024
Is Merck Considering Acquiring Moderna for Keytruda's Cancer Vaccine Collaboration? - BioSpace
An anonymous biopharma executive has urged Merck and Moderna to accelerate a deal for their shared investigational personalized cancer vaccine, mRNA-4157 (V940), arguing that Moderna's stake is "grossly undervalued" and that the sale of its half of the combination treatment could double the biotech's market cap. Merck, which is facing a looming patent cliff for its blockbuster cancer drug Keytruda, could benefit from the future sales of mRNA-4157 (V940) to offset the potential losses from Keytruda.
Jul 24, 2024
Sichuan Biokin intends to pursue a listing in Hong Kong following a successful deal with BSM Pharmaceuticals regarding Bamboo Works.
Sichuan Biokin Pharmaceutical is seeking a secondary listing in Hong Kong to secure funding for its work on next-generation cancer therapies. The biopharma company, which specializes in antibody-drug conjugates (ADCs), has put six ADCs into around 60 clinical trials, with nine at the Phase Three stage. In December 2023, it entered into a collaboration with Bristol Myers Squibb to jointly develop the bispecific drug BL-B01D1, which could be worth up to $8.4 billion for the overall deal. However, Sichuan Biokin's revenue has been affected by slowing generic drug sales and rising R&D spending.
Jul 23, 2024
CR Double-Crane secures exclusive license for Oneness Fespixon® from BioSpace
Oneness Biotech has out-licensed its blockbuster new drug, Fespixon®, for the treatment of diabetic foot ulcers (DFUs), to CR Double-Crane in China. DFUs have been a burden due to the lack of effective solutions, with over 8.3 million DFU patients and 1.6 million amputations occurring annually in China. The agreement includes an upfront fee and milestone payments based on net sales, with the potential for the total payments to exceed $100 million. Fespixon® has been submitted for inclusion in China's National Reimbursement Drug List.
Jul 23, 2024
A recent investigation by the House reveals that pharmacy benefit managers are directing patients towards more expensive medications - KFF Health News
PBMs are being accused of steering patients towards higher-priced medicines and affiliated pharmacies, leading to increased spending and reduced patient choice, according to a House investigation. The investigation found that PBMs are creating formularies of preferred medicines that encourage the use of higher-priced drugs over cheaper alternatives. In other news, a study has revealed that sinking prices for generic medications are contributing to the drug shortage crisis in the US, as drugmakers struggle to keep up with the low prices. Additionally, a draft report from the Institute for Clinical and Economic Review (ICER) has found that Pfizer's blockbuster heart drug, tafamidis, needs a 96% discount off its list price to be considered cost-effective.
Jul 23, 2024
Study finds that errors in U.S. Patent Office software lead to extended patent protection for pharmaceuticals, according to STAT News.
Researchers have highlighted issues with automated software used by the U.S. Patent Office, which is mistakenly extending the life of drug patents. The software is intended to handle delays in the patent review process, compensating companies by extending the patent term. However, the incorrect calculations are enabling pharmaceutical companies to prolong exclusivity and subsequently increase drug costs. The researchers suggest amending the software to rectify the problem and prevent abuse of the patent system.
Jul 23, 2024
Wegovy, Novo's obesity drug, receives UK approval for therapeutic use in heart conditions - BNN Bloomberg
Novo Nordisk's weight-loss shot, Wegovy, has gained expanded clearance as a heart drug in the UK. The Medicines and Healthcare products Regulatory Agency has allowed UK doctors to prescribe Wegovy to prevent heart attacks or strokes in overweight or obese individuals with heart disease. This expanded use is part of Novo's strategy to increase access and sales. Wegovy has been shown to reduce the risk of major heart afflictions by one-fifth. The UK approval comes ahead of its European Union counterpart.
Jul 22, 2024
Doctors show interest in Takeda's Eohilia, posing a challenge to Sanofi and Regeneron's successful drug Dupixent.
Takeda's revived drug, Eohilia, is gaining traction in the market for eosinophilic esophagitis treatment. A survey of physicians found that Eohilia's launch is on par with the previous success of Dupixent, delaying the use of Regeneron and Sanofi's blockbuster drug. The survey also suggested that Eohilia's user base could be comparable to Dupixent in the long run, potentially increasing Takeda's market share fourfold. However, there are concerns about Eohilia's limitations, as it performed no better than a placebo in a 36-week extension study, which raises questions about its long-term effectiveness.
Jul 22, 2024
Enhertu poised for success as it surpasses Kadcyla in performance, predicts Yahoo Finance.
Enhertu, a promising new drug developed by Daichi Sankyo and AstraZeneca, has shown to be superior to Roche's Kadcyla in treating HER2-positive cancers. Enhertu has a higher drug antibody ratio (DAR) and elicits a bystander effect, making it more cytotoxic and suitable for cancers with heterogenous HER2 expression. The FDA has granted approval for Enhertu's use as a second-line therapy for HER2-positive breast cancer, and additional label expansions are being explored. Multiple clinical trials are also investigating its potential for HER2-low breast cancers. Enhertu is set to become a blockbuster drug in the market.
Jul 22, 2024
Predictions for the breast cancer immunotherapy market and clinical trials on a global scale by 2028
The global breast cancer immunotherapy market is projected to reach over USD 60 billion by 2028. The introduction of immunotherapy, particularly immune checkpoint inhibitors like Keytruda developed by Merck, has transformed the treatment for breast cancer. Other novel treatment approaches such as bispecific antibodies, oncolytic viruses, cancer vaccines, tumor infiltrating lymphocyte therapy, and cell and gene therapies are also being explored. Collaborations between pharmaceutical companies and academic institutions are driving innovations in the field. The report provides an in-depth analysis of commercially available breast cancer immunotherapy drugs and market trends.
