Pharma News
30 Jun 2024 to 06 Jul 2024
Jul 5, 2024
Potential Link Between GLP-1 Drugs Such as Wegovy and Ozempic to Vision-Threatening Disease Reported by Healthline
Semaglutide, the active ingredient in diabetes and weight loss drugs Ozempic and Wegovy, may be associated with an increased risk of a rare blinding disease called non-arteritic anterior ischemic optic neuropathy (NAION), according to a new study. However, the study does not establish a causal link between the drug and the disease. Researchers found that patients with type 2 diabetes taking semaglutide were more than four times as likely to have NAION, while overweight or obese patients taking the drug were more than eight times as likely. More research is needed to fully understand this potential risk.
Jul 5, 2024
Roche's latest immunotherapy drug does not demonstrate a benefit that surpasses Merck's popular Keytruda in ...
Roche's Phase 2/3 study of tiragolumab, Tecentriq (atezolizumab), and chemotherapy as first-line treatment for lung cancer did not meet primary endpoints of progression-free survival (PFS) and overall survival (OS) compared to Merck's Keytruda. The combination therapy showed reduced efficacy and Roche intends to halt the study based on the results. Roche will evaluate the ongoing tiragolumab program based on these findings.
Jul 5, 2024
Roche to Stop Research on Lung Cancer Drug in a New Setback - BNN Bloomberg
Swiss drugmaker Roche Holding AG will discontinue a study on its potential blockbuster drug, tiragolumab, after it performed worse than existing therapies in lung cancer. The experimental medicine, when combined with another Roche treatment and chemotherapy, did not extend patients' lives or delay disease progression compared to Merck & Co.'s Keytruda and chemotherapy. The trial failure adds to a series of setbacks for Roche in drug development, including disappointments in Alzheimer's disease and cancer. Roche will now assess whether changes are needed in other studies involving tiragolumab.
Jul 5, 2024
Study suggests Ozempic and other GLP-1 drugs may lower cancer risk in individuals with diabetes
A new study published in JAMA Network Open suggests that Novo Nordisk's Ozempic and other GLP-1 medications may lower the risk of certain types of cancer for people with type 2 diabetes. The retrospective study analyzed the medical records of 1.6 million patients and found a significant reduction in the risk of developing 10 types of obesity-related cancers in patients treated with GLP-1 drugs compared to those treated with insulin. Further research is needed to explore the cancer prevention benefits of these medications.
Jul 4, 2024
Indian regulators hold up approval for Eli Lilly's popular drug Mounjaro - report from Business Standard
Pharmaceutical firm Eli Lilly is still awaiting approval from India's drug regulator to market its weight loss drug, Tirzepatide. Despite a subject matter committee clearing the drug for use in diabetes earlier this week, the review for weight loss indication is still ongoing. Meanwhile, an expert panel has recommended the approval of Eli Lilly's Mounjaro, a popular diabetes medication and obesity treatment, in India. The country has a high obesity rate and the global market for weight-loss drugs is projected to exceed $100 billion by the end of the decade.
Jul 4, 2024
Court in United States invalidates patent for Johnson & Johnson's cancer drug Zytiga, announces Yahoo News
A U.S. administrative court has invalidated a patent for Johnson & Johnson's prostate cancer drug Zytiga, allowing rivals to potentially sell generic versions of the drug. The Patent Trial and Appeal Board ruled that the patent, which describes a method of administering Zytiga, should not have been granted as it was deemed obvious. Johnson & Johnson plans to appeal the decision, while generic drug company Argentum Pharmaceuticals welcomes the ruling. Zytiga generated $2.3 billion in sales for Johnson & Johnson in 2016.
Jul 4, 2024
Research connects rare vision loss to popular Novo Nordisk medication - MedWatch
Novo Nordisk's diabetes and obesity drugs, Ozempic and Wegovy, which contain the active ingredient Semaglutide, have been associated with cases of vision loss, according to a study conducted at Harvard University. The study found that obese patients taking Wegovy were seven times more likely to experience a form of vision loss called NAION, while diabetic patients taking Ozempic had a four times higher risk. However, the study's small sample size means further research is needed to confirm these findings.
Jul 4, 2024
Roche to Stop Lung Cancer Drug Trial in Latest Setback - Report from SWI swissinfo.ch
Roche Holding AG is discontinuing a clinical trial for its potential blockbuster lung cancer drug, tiragolumab, after it performed worse than existing therapy in extending patients' lives or delaying disease progression. The experimental medicine, which was combined with another Roche treatment and chemotherapy, failed to outperform Merck & Co.'s Keytruda and chemotherapy in the trial. This setback follows a series of disappointments for Roche in drug development. The company will now assess whether changes need to be made to other studies involving tiragolumab.
Jul 3, 2024
European Union gives the green light to Sanofi drug for the treatment of chronic lung disease - Medical Xpress
The European Union has granted approval for Sanofi and Regeneron's drug Dupixent to be used in the treatment of chronic obstructive pulmonary disease (COPD). Dupixent is the first new treatment for COPD in over a decade. The drug, which has already been approved for six different illnesses in the EU, is also being reviewed in the United States, Japan, and China for COPD patients. COPD, also known as "smoker's lungs," is the third-leading cause of death globally.
Jul 3, 2024
India gives the green light to 2 weight loss medications — Mounjaro and Zepbound: Here's everything you should know
The blockbuster weight loss and diabetes drug Tirzepatide, marketed as Mounjaro and Zepbound, has received approval for import and marketing in India. It is expected to be the first injectable drug of its class available to Indians, providing hope for those struggling with diabetes and obesity. Tirzepatide can reduce body weight by up to 18%, and its approval is pending final approval from the Drug-Controller General of India. The drug's effectiveness, along with pricing concerns, are discussed.
Jul 3, 2024
Sanofi's popular medication receives approval in Europe for treatment of lung disorder - BNN Bloomberg
Sanofi's Dupixent has been approved by European regulators as an add-on treatment for chronic obstructive pulmonary disease (COPD), making it the first new treatment option for the disease in over a decade. Dupixent, developed in partnership with Regeneron Pharmaceuticals, has already generated over €10.7 billion ($11.5 billion) in sales. The drug is currently being reviewed by the US FDA and regulators in China and Japan.
Jul 3, 2024
AbbVie reduces projected profits for 2024 due to increased research and development costs - Yahoo Finance
Pharmaceutical company AbbVie has lowered its adjusted profit forecast for 2024, citing expenses related to acquisitions and milestones. The company has been focusing on expanding its pipeline after its arthritis drug Humira lost patent protection last year. AbbVie now expects annual adjusted profit of $10.61 to $10.81 per share, compared to its previous estimate of $11.13 to $11.33. The company also revised its second-quarter adjusted profit to $2.53 to $2.57 per share. AbbVie's second-quarter results are scheduled for release on July 25.
Jul 3, 2024
Possible Association Found Between Novo Nordisk's Obesity Medication and Eye Condition
Shares of Novo Nordisk (NVO) fell after a study in JAMA suggested a potential link between the company's obesity drug semaglutide and an eye disorder called NAION. The research found that patients taking semaglutide were more likely to develop NAION compared to those on other medications. The study analyzed data from over 16,000 patients but further research is needed to confirm the findings. If confirmed, it could impact Novo Nordisk, as semaglutide is a blockbuster drug for the company. Analysts have a Moderate Buy rating on NVO stock with a price target suggesting slight upside potential.
Jul 3, 2024
New Alzheimer's Drug from Eli Lilly Receives Approval from U.S. Regulatory Body - Baystreet.ca
The FDA has approved Eli Lilly's Alzheimer's drug, Donanemab, for the treatment of early-stage Alzheimer's disease. Donanemab, which targets toxic brain plaques called amyloid, is expected to generate significant sales for the company. It will be sold under the brand name Kisunla. This approval comes after the drug was initially rejected due to insufficient data. The only other approved treatment for early-stage Alzheimer's is Biogen's Leqembi. Eli Lilly is also facing high demand for its weight loss drug, Zepbound.
Jul 3, 2024
Semaglutide: A Potential Miracle Drug for Diabetes, Obesity, and Heart Failure
Novo Nordisk's blockbuster drug, semaglutide, which is marketed under the commercial name Wegovy, has received a new approval from the FDA. The drug is now approved for reducing the risks of cardiovascular death, stroke, and heart attack in adults with heart disease who are obese or overweight. Furthermore, a new study has shown that women are losing more weight from using semaglutide compared to men. The study also suggests that semaglutide may have a direct effect on the cardiovascular system beyond just weight loss.
Jul 3, 2024
European Union gives green light to Sanofi medication for long-term lung condition
The European Union has granted approval for Sanofi's drug Dupixent to be used in the treatment of chronic obstructive pulmonary disease (COPD). Dupixent is the first new treatment option for COPD in over 10 years and offers hope to approximately 220,000 adults in the EU. The EU's European Medicines Agency was the first regulatory authority to approve Dupixent for COPD patients. Dupixent has also been approved for other illnesses and is being reviewed by other countries for COPD treatment.
Jul 3, 2024
Bloomberg Law News reports that the Lipitor ruling sets a higher bar for class status in pay-for-delay cases
Sun Pharmaceutical Industries won a case accusing the company of conspiring to impede the release of a generic cholesterol drug. The ruling sets a higher standard for plaintiffs to achieve class status in pay-for-delay cases. Judge Peter G. Sheridan of the US District Court for the District of New Jersey denied class certification to two groups of purchasers of the drug Lipitor, reinforcing the difficulty for plaintiffs in challenging patent litigation settlements. The ruling is expected to be cited in other pay-for-delay cases.
Jul 3, 2024
FDA Approves Second Medication for Slowing Alzheimer's Disease Progression
FDA Approves Lilly's Kisunla as Second Drug to Slow Alzheimer's Disease Progression
The US Food and Drug Administration has granted approval for Kisunla, a drug developed by pharmaceutical company Lilly, as a treatment for mild Alzheimer's disease. Following in the footsteps of Eisai's Leqembi, Kisunla works by targeting amyloid plaques in the brain and has been shown to moderately delay cognitive decline in clinical studies. While safety concerns exist, with potential brain swelling or bleeding, Kisunla offers the advantage of requiring fewer infusions compared to Leqembi. This approval provides hope for patients and their families seeking effective treatments for Alzheimer's.
Jul 3, 2024
Biotechnology company aims to challenge major pharmaceutical companies through innovative patent strategy for drug modifications - Report by Bloomberg Law
Terran Biosciences, a biotech platform company, is utilizing drug-approval shortcuts in the pharmaceutical industry to develop advancements in psychiatric treatments. The company aims to patent secondary drug advances before major pharmaceutical companies, bypassing the prolonged process of pharmaceutical drugs' availability. Terran Biosciences uses a ferromagnetic surgical instrument in its surgical practices to treat Parkinson's and other neurological disorders. By utilizing tactics that pharmaceutical firms apply to extend a branded drug's exclusivity, Terran aims to expedite advancements in neurological and psychiatric treatment options for patients.
Jul 2, 2024
Shares of Novo Nordisk and Eli Lilly drop after President Biden calls for stricter regulations on obesity medications - Quartz
Pharmaceutical giants Novo Nordisk and Eli Lilly saw their stocks drop after President Joe Biden called for price cuts on their diabetes and weight loss drugs. In an op-ed, Biden and Sen. Bernie Sanders criticized the high prices charged for Novo Nordisk's Ozempic and Wegovy brands, as well as Eli Lilly's Mounjaro and Zepbound drugs. Sanders said an investigation found that the net cost of Ozempic in the US is around $600 per month, compared with $59 in Germany. Novo Nordisk CEO Lars Fruergaard Jørgensen has agreed to testify before the Senate Health Committee in September.
Jul 2, 2024
Approval given for the launch of diabetes and obesity drug tirzepatide in India
India's Central Drugs Standard Control Organisation (CDSCO) has recommended regulatory approval for the import and marketing of tirzepatide, a drug for type 2 diabetes and obesity, in the country. The drug is sold by Indianapolis-based pharmaceutical firm Eli Lilly and Company under the brand names Mounjaro and Zepbound. The regulatory approval is expected to take effect next year. tirzepatide" style="color: #F36C42; font-weight:600";>Tirzepatide is currently available in the US and has been approved as a drug for weight management.
Jul 2, 2024
Teva under investigation by FTC for disputed product patents in the pharmaceutical industry
The Federal Trade Commission (FTC) has launched an investigation into Teva Pharmaceuticals over certain patents that may have hindered competition for asthma and chronic obstructive pulmonary disease (COPD) medications. The patents in question relate to Teva's AirDuo Respiclick, AirDuo Digihaler, ArmonAir Respiclick, and ArmonAir Digihaler products. The FTC has ordered Teva to provide internal communications, analysis, and financial data related to the contested patents. Teva has until 24 July to comply with the order.
Jul 2, 2024
US Federal Trade Commission intensifies efforts to combat improper patents with inquiry into Teva's inhaler intellectual property, according to sources.
The US Federal Trade Commission (FTC) has launched an investigation into drugmaker Teva's refusal to remove around 24 patent listings for its asthma and chronic obstructive pulmonary disease inhalers. The FTC has said that these "improper patents" can delay regulatory approval of rival generics, hindering competition in the pharmaceutical industry. Teva has until 24 July to comply with the FTC's demands.
Jul 2, 2024
FTC Looking Into Teva Regarding Disputed Patents For Inhalers, Reports KFF Health News
The Federal Trade Commission (FTC) is investigating Teva Pharmaceuticals over its patents on asthma and COPD inhalers. The FTC has ordered Teva to provide internal documents related to the contested patents, as part of an ongoing dispute regarding minor tweaks made by pharmaceutical companies to prolong patent protection and hinder competition from generics. The investigation comes amidst concerns of high prices for inhalers in the US compared to overseas markets.
Jul 2, 2024
The Senate and FTC are targeting pharmaceutical companies for deceptive patent practices, reports STAT News.
The Senate Judiciary Committee is addressing the issue of high drug prices in the United States, attributing it to the tactics used by dominant pharmaceutical companies to protect their power and maximize profits. These tactics include blocking competition through the improper listing of patents, which delays the approval of generic alternatives. The committee has advanced five bipartisan bills to combat this issue, while the FTC has challenged improper patent listings and secured agreements from asthma inhaler manufacturers to cap out-of-pocket costs at $35. The aim is to promote fair competition and lower drug prices for Americans.
Jul 1, 2024
Government panel recommends regulatory approval for importing American medication for diabetes and obesity
An Indian government expert panel has recommended that the country's drug regulator approves the import and sale of Eli Lilly's diabetes and obesity treatment drug, Mounjaro. This drug, also known as tirzepatide, is part of a class of therapies called GLP-1 receptor agonists. India has a high prevalence of type 2 diabetes and obesity, making it a potentially lucrative market for such treatments. Lilly is expected to launch Mounjaro in India next year.
Jul 1, 2024
The market for generic drugs is expected to experience significant growth, with a projected value of $615.72 billion by 2030.
The global generic drugs market is projected to reach nearly USD 615.72 billion by 2030, with a CAGR of 5.22% from 2024 to 2030. The market is driven by increased demand for more affordable treatment options due to the rising prevalence of chronic diseases. The market is segmented by product (simple generics, super generics, and biosimilars), application (cardiovascular products, anti-infective drugs, etc.), and distribution channel (hospitals, pharmacies, etc.). North America dominates the market, while Asia Pacific is expected to have the highest growth rate. Key players in the market are engaged in strategic initiatives to drive growth.
Jul 1, 2024
Teva Pharmaceutical under Investigation by FTC for Patent Issues - BNN Bloomberg
The US Federal Trade Commission is investigating Teva Pharmaceutical Industries over patents for drugs, including asthma inhalers. The agency is looking into contested patents that may have been used improperly to block competition for asthma and COPD treatments. Teva confirmed that it received a civil investigative demand from the agency. The company's US depositary receipts fell by 3.9% following the news. This investigation comes after the FTC sent letters to 10 drug companies, including Teva, accusing them of improperly using patents to prevent generic competition.
Jul 1, 2024
Federal Trade Commission Takes Action Against Teva Pharmaceuticals for Misuse of Inhaler Patents - TradingView
The Federal Trade Commission (FTC) has opened an investigation into Teva Pharmaceutical Industries Ltd over allegations that it has maintained market exclusivity and blocked generic competition by refusing to remove patents for its asthma and COPD inhalers. The FTC has issued a subpoena to Teva, demanding internal communications and financial data related to these patents. The FTC argues that pharmaceutical companies have made minor product adjustments to keep patents listed, preventing cheaper generics from entering the market and leading to higher prices in the US compared to other countries.
Jul 1, 2024
Trodelvy, a cancer asset of Gilead, faces setbacks in advanced trials yet retains high value
Gilead Sciences' antibody-drug conjugate, Trodelvy, has failed to meet its primary endpoint in a Phase III trial for metastatic urothelial cancer. The drug also showed a higher number of deaths compared to chemotherapy. Despite this setback, analysts are still optimistic about Trodelvy's potential as a cornerstone of Gilead's oncology franchise. Trodelvy has also failed a Phase III trial for non-small cell lung cancer but showed promise when compared to chemotherapy in a subgroup of patients. The drug is currently approved for the treatment of breast cancer.
Jul 1, 2024
Panel in India recommends drug regulator to grant approval for Lilly's obesity drug Mounjaro
An Indian government expert panel has recommended that the country's drug regulator approves the import and sale of Eli Lilly's diabetes and obesity drug, Mounjaro. The drug is a GLP-1 receptor agonist designed to control blood sugar and promote weight loss. The panel's recommendation is a significant step towards approval, and if granted, Mounjaro could be launched in India as early as next year. India has a high prevalence of type 2 diabetes and obesity, making it an attractive market for diabetes and weight-loss drugs.
Jul 1, 2024
Pharmaceutical Companies Push Back Against FTC and Legislators' Attempts to Invalidate Drug Patents - Report from Bloomberg Law
Major pharmaceutical companies, including Boehringer Ingelheim, Novo Nordisk, and GlaxoSmithKline, are resisting requests from the Biden administration and Democratic lawmakers to curb patenting practices on high-cost drugs. The Federal Trade Commission (FTC) has sent letters to companies warning them about improperly listed patents, but drugmakers appear ready to fight requests from the government. The FTC's latest action includes an investigation against Teva Pharmaceutical Industries seeking information about contested patents that may have been improperly listed. Attorneys suggest that the Biden administration and lawmakers may need to take more aggressive steps to address the issue.
Jul 1, 2024
FTC Faces Resistance as Drug Manufacturers Decline to Cooperate and Remove Orange Book Listings - Mondaq
The Federal Trade Commission (FTC) has sent warning letters to multiple drug and medical device manufacturers regarding patents listed in the FDA's Orange Book that may violate antitrust laws. In response to the first round of letters, some manufacturers withdrew patents or agreed to cap drug costs. However, in the second round of letters, all manufacturers recertified their patents. The FTC now has the opportunity to take further action. Additionally, a federal court recently ordered Teva Pharmaceuticals to delist five patents from the Orange Book, setting a precedent for patent delisting in antitrust cases.
Jun 30, 2024
AbbVie Boosts IBD Drug Development Efforts Through $250M Purchase of Celsius Therapeutics
AbbVie has acquired clinical-stage startup Celsius Therapeutics for $250 million in cash. Celsius's lead program, CEL383, is an antibody designed to block TREM1, a protein that amplifies inflammation. The Phase 1 clinical trial for CEL383 has been completed, and AbbVie aims to advance its development as a potential treatment for inflammatory bowel disease (IBD). This acquisition is part of AbbVie's strategy to diversify its IBD prospects, adding to its existing portfolio of blockbuster drugs for the condition.
