Pharma News
12 May 2024 to 18 May 2024
May 18, 2024
Biocon's CEO Shreehas Tambe forecasts significant growth ahead - reported by NDTV Profit
Biocon Ltd., a pharmaceutical company, has exceeded its target of becoming a billion-dollar company by March 2024. Despite a 46% drop in net profit, the company's revenue increased by 3.8% and surpassed analysts' expectations. The CEO of Biocon Biologics Ltd., Shreehas Tambe, credited the company's achievements to its strong presence in the US, Europe, and emerging markets.
May 18, 2024
Enveric Biosciences shifts focus from Cannabinoid IP to emerging Psychedelic sector by selling related intellectual property.
Enveric Biosciences has sold a portfolio of patents and patent applications for a cancer treatment combining cannabidiol (CBD) with additional therapeutic agents. The undisclosed purchaser acquired the portfolio, which includes patents issued in various countries, as well as pending applications. The sale aligns with Enveric's focus on developing psychedelic-inspired drug technologies for treating severe mental health disorders. The company also plans to license a collection of preclinical compounds, including psilocybin prodrugs and derivatives and MDMA derivatives.
May 17, 2024
Pfizer awarded $107.5 million in US cancer drug patent trial against AstraZeneca, reports Yahoo
A Delaware federal jury has ordered AstraZeneca to pay Pfizer $107.5 million in damages after finding that AstraZeneca's lung cancer drug Tagrisso violated Wyeth's patent rights. The jury agreed that Tagrisso infringed two patents covering cancer treatment methods with Pfizer's drug Nerlynx. AstraZeneca expressed disappointment with the verdict but maintains confidence in its intellectual property position. AstraZeneca will vigorously defend its rights. Pfizer did not immediately comment on the verdict. AstraZeneca's Tagrisso generated approximately $5.8 billion in revenue last year. A separate bench trial on AstraZeneca's defenses will be held in June, potentially impacting the outcome.
May 17, 2024
AstraZeneca to Pay Pfizer $108 Million for Tagrisso after Patent Lawsuit - Bloomberg Law Report
AstraZeneca has been ordered to pay Pfizer's Wyeth unit $107.5 million as a federal jury found that the cancer drug Tagrisso infringes on two patents for Pfizer's Vizimpro. AstraZeneca argued for the patents to be voided but the jury rejected this. Although the infringement was not deemed intentional, AstraZeneca still had to pay the awarded amount.
May 17, 2024
FDA Grants Accelerated Approval for Amgen Drug Targeting Aggressive Lung Cancer Formulation
Amgen has received FDA approval for its drug tarlatamab, now named Imdelltra, to treat adults with extensive-stage small cell lung cancer whose cancer has progressed after platinum-based chemotherapy. The approval, which came ahead of schedule, is based on the results of a Phase 2 clinical trial in which the overall response rate was 40% and the median duration of response was 9.7 months. The drug is a bispecific T cell engager, activating T cells to kill cancer cells. Imdelltra is Amgen's second approved drug of this type, with its first being Blincyto for certain types of leukemia.
May 17, 2024
The FDA greenlights Amgen's promising lung cancer drug Imdelltra as a potential breakthrough - Fierce Pharma
The FDA has given accelerated approval to Amgen's immunotherapy drug Imdelltra (tarlatamab) for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) whose disease has worsened after or throughout platinum-based chemotherapy treatments.The approval is based on results from a phase 2 trial in which the drug was shown to reduce tumors in 40% of patients who had failed on two previous lines of treatment. Amgen's R&D chief called the approval a "pivotal moment for patients battling ES-SCLC". The drug had a median length of overall survival of 14.3 months, much longer than the expected 5 months for ES-SCLC patients.
May 14, 2024
AbbVie broadens potential in psychiatric drugs by entering research and development partnership with a neuroscience startup
AbbVie has formed a research alliance with Gilgamesh Pharmaceuticals to develop psychiatric therapies with advantages over psychedelic medicines. AbbVie will pay Gilgamesh $65 million upfront, with the potential for additional option fees and milestones totaling up to $1.95 billion, as well as royalties from sales of any approved products. Gilgamesh is using machine learning algorithms to design new drugs that optimize safety, efficacy, and patient access. AbbVie's current psychiatric drug pipeline is limited to Vraylar and ABBV-932.
May 14, 2024
Novo amplifies the success of obesity treatment Wegovy with 4-year data, boosting its popularity | Fierce Pharma
Novo Nordisk presented four-year data at the European Congress on Obesity that supports the long-term use of its obesity medication, Wegovy. In a study of over 17,000 overweight and obese patients with preexisting heart disease, patients lost an average of nearly 10% of their total body weight over 65 weeks and sustained a weight loss of 10.2% after four years. The data could potentially allow Novo Nordisk to counter arguments against the medication's long-term effectiveness and unlock a $2 billion opportunity. Additionally, a separate analysis showed the cardiovascular benefits of Wegovy over a five-year span.
May 14, 2024
Study shows that individuals who use the weight loss medication Wegovy are able to maintain their weight loss for an extended period of time
Two new analyses of the long-term clinical trial of semaglutide, the active ingredient in Wegovy, have revealed that people maintained weight loss for up to four years and experienced heart health benefits regardless of the amount of weight lost. The findings support the argument for the coverage of the expensive weight loss medication by insurers and governments. Wegovy, manufactured by Novo Nordisk, costs $1,349 for a month's supply in the US.
May 14, 2024
Study reveals that Wegovy can help individuals maintain weight loss achievements for as long as 4 years
Novo Nordisk's obesity drug, Wegovy, has shown to help people sustain weight loss for several years and may provide cardiovascular benefits, according to new analyses of data from a long-term trial. The research found that people maintained an average 10% weight loss over four years while taking Wegovy. Additionally, the drug was found to have cardiovascular benefits regardless of the individuals' weight before starting the medication. The findings may prompt insurers to cover the costly medication, which could benefit over 3 million Medicare recipients.
May 13, 2024
Merck halts late-stage study of combination therapy for skin cancer - WKZO
Merck has halted testing of its experimental antibody-based drug, vibostolimab, in combination with its immunotherapy drug, Keytruda, for patients with advanced skin cancer. The decision was made after an analysis showed that the trial would not meet its main goal of improving recurrence-free survival. Merck will now recommend Keytruda monotherapy for these patients. This comes after the failure of the same drug combination in a late-stage study for lung cancer patients last year.
May 13, 2024
Merck halts late-stage study testing of combination therapy for skin cancer - TradingView
Merck has discontinued an experimental combination treatment for severe skin cancer due to high discontinuation rates caused by side effects. The treatment consisted of vibostolimab, which selectively binds to TIGIT, a receptor on immune cells, and Merck's top-selling cancer drug, Keytruda. The trial showed that the combination did not achieve the desired improvement in recurrence-free survival compared to Keytruda alone. Merck will now recommend Keytruda monotherapy for patients. This setback adds to the challenges faced by the anti-TIGIT class of immunotherapies, with other drugmakers also experiencing setbacks in this area.
May 13, 2024
New studies show that Lilly's obesity drug results in approximately a 26% reduction in weight.
Pharmaceutical company Eli Lilly has announced that its experimental obesity drug, known as Mounjaro or tirzepatide, has helped patients reduce an average of 26.6% of weight across two late-stage studies. The drug is being tested in patients who are obese or overweight but do not have type 2 diabetes. If approved, the drug is expected to become a blockbuster treatment and a key growth driver for Lilly. The data gives Lilly a competitive advantage in the obesity treatment market, which includes rivals such as Novo Nordisk, Pfizer, and Amgen.
May 13, 2024
Patent Portfolios Safeguarding the Intellectual Property of Popular Prescription Medications | Legal and Medical News from JAMA Network
A study found that the patent thickets surrounding the top-selling prescription drugs in the US consist of many patents filed after FDA approval and covering aspects other than the active ingredient. The study highlights the need for careful scrutiny of patent applications and those filed after FDA approval to promote timely competition from generics and biosimilars.
May 13, 2024
Biocon plans to market a long-term weight management medication in Mexico, reports NDTV Profit.
Biocon has signed a distribution and supply agreement with Mexico-based Medix for the commercialization of its drug Liraglutide (gSaxenda) in Mexico. Biocon will be responsible for manufacturing and supply, while Medix will handle commercialization in the Mexican market. The partnership aims to provide affordable access to Liraglutide for patients dealing with obesity in Mexico, where the prevalence of overweight and obesity is high. The total addressable market opportunity for Liraglutide in Mexico is estimated to be around $37 million.
May 13, 2024
JAMA Network report highlights patent portfolios safeguarding popular prescription medications
A study analyzing the patent thickets of the top-selling prescription drugs in the US found that almost three-quarters of the patents were filed after FDA approval. These patents, which protect parts of the drugs other than the active ingredient, contribute to dense patent thickets that can delay generic competition. The study highlights the need for careful scrutiny of patent applications and patents filed after FDA approval to promote timely generic and biosimilar competition.
May 13, 2024
Merck halts late-stage trial for skin cancer combination therapy
Merck has halted an experimental combination treatment using a new type of immunotherapy, vibostolimab, in patients with severe form of skin cancer due to high side effects. The trial was being conducted with Merck's top-selling cancer drug, Keytruda. The company will now recommend Keytruda monotherapy to patients. Vibostolimab works by activating the immune system against cancer cells. This is the latest setback for anti-TIGIT drugs, with other companies also facing challenges in developing similar treatments.
May 13, 2024
AbbVie and Gilgamesh Pharmaceuticals reach agreement for collaboration on psychiatric medication - Report from Green Market
Pharmaceutical company AbbVie has agreed to pay around $2bn to New York-based biotech firm Gilgamesh Pharmaceuticals for the development of new psychiatric medications. Under the deal, AbbVie will lead the research and commercialisation activities for multiple drugs being developed by Gilgamesh to treat a range of psychiatric disorders. The move is part of AbbVie's strategy to expand its psychiatry portfolio as it searches for new blockbuster drugs.
May 13, 2024
Complex Patent Situations in Pharmaceutical Industry Indicate 'Strategic Actions' - MedPage Today
Nearly 72% of patent applications for the top 10 best-selling prescription drugs were filed after FDA approval, according to a study published in JAMA Internal Medicine. For the four biologics among the top 10 drugs, the share of patents filed post-approval was 80%, compared to 58% for the six small molecule drugs. The authors of the study noted that the high numbers of patents filed after approval could be seen as an attempt by drug companies to delay competition and maintain their revenue stream.
May 13, 2024
AbbVie and Gilgamesh Pharmaceuticals strike agreement for collaboration on psychiatric medication, as reported by Crain's Chicago Business
AbbVie has announced a partnership with Gilgamesh Pharmaceuticals, in which AbbVie will pay Gilgamesh $65 million upfront and potentially up to $1.95 billion in option fees and milestones. Under the agreement, AbbVie will lead the development and commercialization activities. Gilgamesh is known for its focus on developing next-generation drug compounds called neuroplastogens, which have shown potential in providing clinical benefits for psychiatric disorders. This deal is part of AbbVie's efforts to expand its drug pipeline and address the decline in sales of its best-selling drug Humira.
May 13, 2024
Merck stops skin cancer drug trial due to significant number of participants discontinuing - Yahoo Finance
Pharmaceutical company Merck has announced the discontinuation of a phase 3 trial for its vibostolimab and pembrolizumab coformulation as an adjuvant treatment for resected high-risk melanoma. The decision was made due to a high discontinuation rate and immune-mediated adverse experiences. Merck will unblind the study and offer patients the option of continuing treatment with Keytruda monotherapy. Ongoing phase 3 studies of the coformulation in lung cancer are not affected by this decision.
May 13, 2024
Wegovy shows promise in potentially reducing diuretic dependence for heart failure patients, according to UPI.com.
The weight loss drug Wegovy (semaglutide) may help heart failure patients reduce their dependence on diuretic medications, according to a study presented at the Heart Failure 2024 conference. After a year of treatment with Wegovy, patients experienced a significant reduction in the average dose of diuretics, a lower likelihood of treatment escalation, and a greater likelihood of treatment de-escalation compared to those on a placebo. In addition to weight loss, patients taking Wegovy also showed improvements in heart failure measurements and reported fewer adverse events.
May 13, 2024
Merck Stops Clinical Trial for Skin Cancer Drug Due to High Rate of Participant Withdrawals - TradingView
Merck & Co Inc has announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial evaluated the coformulation of vibostolimab and Keytruda (pembrolizumab) as adjuvant treatment for patients with resected high-risk melanoma. Data analysis showed that the coformulation arm had a higher discontinuation rate due to adverse experiences, making it unlikely to achieve a statistically significant improvement in recurrence-free survival. Patients in the coformulation arm will be offered Keytruda monotherapy. Ongoing Phase 3 studies of the coformulation in lung cancer are unaffected.
May 13, 2024
Dupixent to undergo FDA evaluation for chronic inflammatory sinus disease in adolescents
The US FDA has accepted a supplemental biologics license application for Regeneron and Sanofi's immunology drug, Dupixent, for use as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The FDA has designated the application for priority review, with a target decision date set for 15 September 2024. If approved, it would be the first treatment approved for adolescents with CRSwNP in the US. Dupixent is already approved for adults with this condition, as well as other type 2 inflammatory diseases.
May 13, 2024
Merck discontinues testing of combination therapy for skin cancer in advanced study - SRN News
Drug company Merck has halted testing of its experimental combination treatment, vibostolimab, for a severe form of skin cancer due to high discontinuation rates caused by side effects. The treatment, which was being tested alongside Merck's top-selling drug Keytruda, failed to achieve its main goal of improving recurrence-free survival in a late-stage study. Merck will now recommend Keytruda monotherapy for patients receiving the combination treatment. Despite this setback, Merck still plans to evaluate the vibostolimab-Keytruda combination as part of its extensive clinical development program. Other companies, including Gilead Sciences, Roche, and GSK, are also vying for a share of the lucrative anti-TIGIT cancer drug market.
May 13, 2024
Merck terminates combination branch of Keytruda clinical trial for high-risk melanoma, reports Morningstar.
Pharmaceutical company Merck & Co. has discontinued part of a late-stage study of a co-formulation of its cancer drug Keytruda in skin-cancer patients due to the study's likely failure. The study compared the co-formulation of Keytruda with Merck's investigational antibody vibostolimab to Keytruda alone as treatment for high-risk melanoma patients. Data showed that the primary endpoint of recurrence-free survival did not meet pre-specified criteria, and a higher rate of discontinuation in the co-formulation arm made it unlikely to achieve significant improvements in survival. Merck recommends offering Keytruda monotherapy as an alternative treatment.
May 12, 2024
FDA in United States Delays Approval Process for Widened Use of Abbvie's Medication for Arthritis - Yahoo News UK
The U.S. FDA has extended the review period for Abbvie's rheumatoid arthritis drug, Rinvoq, by three months, citing the need for more time to assess its benefit-risk profile. The drugmaker is banking on Rinvoq as its flagship drug, Humira, is set to lose patent protection in the U.S. by 2023. Abbvie is also seeking approval for expanded use of Rinvoq in atopic dermatitis and patients with active psoriatic arthritis. Shares of Abbvie fell by 7.04% in response to the news.
