Pharma News
11 Aug 2024 to 17 Aug 2024
Aug 17, 2024
Australia provides update on Sanofi versus Amgen legal conflict in healthcare sector
Sanofi's appeal against Amgen's patent for the cholesterol-lowering antibody, evolocumab, has been filed with the Federal Court of Australia. The appeal follows a ruling by a delegate of the Commissioner of Patents in 2022 that found five of Amgen's patent applications to be valid. Sanofi argues that the claims lack clarity, fair basis, and sufficiency. The Federal Court hearing began in November 2023, with Sanofi filing two interlocutory applications seeking to limit the evidence and introduce experimental evidence from other jurisdictions. The appeal is ongoing.
Aug 16, 2024
AstraZeneca's stock reaches all-time high following US approval of fast-tracked cancer medication - Business Plus
AstraZeneca's shares reached a new high as US regulators granted its cancer drug Imfinzi priority review for treating small cell lung cancer. The drug works by blocking the tumor's ability to evade the immune system and offers an alternative to chemotherapy. The decision from the Food and Drug Administration is expected in the fourth quarter of 2024. This news comes as AstraZeneca recently became the first UK firm to be valued at over £200 billion. CEO Pascal Soriot has been credited with revitalizing the company and expanding its drug pipeline.
Aug 16, 2024
FDA Gives Green Light to AstraZeneca's Imfinzi for Cancer Treatment Alongside Chemotherapy
The FDA has approved AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC). The approval was based on the AEGEAN trial results, which showed a 32% reduction in the risk of recurrence with the Imfinzi-based regimen. Imfinzi is now the standard of care for unresectable Stage III NSCLC and is also being reviewed for limited-stage small cell lung cancer.
Aug 16, 2024
Roche Falls Short on Weight-Loss Breakthrough Drug, Now Racing to Keep Up in Rapidly Growing Market
Swiss pharmaceutical company Roche turned down the opportunity to acquire a potential blockbuster weight-loss pill, now known as orforglipron, in 2018. The drug, initially developed by Chugai Pharmaceutical, was subsequently acquired by Eli Lilly for $50 million. Despite Roche's caution due to past failures in the obesity market, analysts project orforglipron to generate up to $14 billion annually by 2032. Roche is set to enter the weight-loss market with its own pill in 2028, but Eli Lilly's early advantage may allow it to dominate the market.
Aug 16, 2024
AstraZeneca's non-small cell lung cancer treatment receives approval from US FDA
The US FDA has approved AstraZeneca's non-small cell lung cancer treatment, Imfinzi. The drug is a human monoclonal antibody that targets tumors and boosts the body's anti-cancer immune response. It provides an alternative to chemotherapy for patients with this type of cancer.
Aug 16, 2024
The US reduces prices of 10 patented drugs, raising concerns about generic drug pricing - from CNBC TV18
The US government has mandated price reductions on 10 popular prescription drugs covered by Medicare, including drugs from pharmaceutical companies like Johnson & Johnson, Bristol Myers Squibb, and Eli Lilly. The price cuts, effective from 2026, aim to reduce the burden on Medicare beneficiaries and could impact the landscape for future generic versions of these drugs. Indian pharmaceutical companies, which dominate the global generics market, may be affected as the price cuts could lower the starting point for generic versions, reducing profitability and driving prices down further.
Aug 16, 2024
Genzyme Files Lawsuit Against Sarepta Over Alleged Violation of Gene Therapy Patents
Genzyme Corp. has filed a lawsuit against Sarepta Therapeutics, alleging that Sarepta's gene therapy treatment for Duchenne muscular dystrophy, Elevidys®, infringes on two of its patents. The patents are related to the storage and prevention of aggregation of recombinant adeno-associated virus (AAV) vectors used in gene therapy. Genzyme is seeking compensatory damages, as well as treble damages and attorneys' fees. Stay tuned for updates on this gene therapy litigation.
Aug 16, 2024
Medicare has successfully bargained for drug prices for the first time. Here's the outcome - KUOW
Medicare, for the first time, has negotiated lower prices with pharmaceutical companies for 10 blockbuster drugs, including Januvia and Imbruvica. The discounts range from 79% to 38%. If implemented in 2023, Medicare would save $6 billion and beneficiaries would save $1.5 billion in out-of-pocket costs. These negotiations were made possible by the Inflation Reduction Act, which lifted Medicare's ban on drug price negotiation. The negotiated prices will go into effect in January 2026. The pharmaceutical industry has opposed these negotiations, but the Congressional Budget Office estimates that they will save the government $98.5 billion over a decade.
Aug 16, 2024
AstraZeneca's non-small cell lung cancer treatment receives approval from US FDA - ZAWYA
The U.S. FDA has granted approval to AstraZeneca's drug, Imfinzi, for the treatment of non-small cell lung cancer. The drug can now be used as an additional treatment after surgery in adult patients with this type of cancer. Imfinzi, a human monoclonal antibody, works by blocking a tumor's ability to evade the immune system, providing an alternative to chemotherapy. AstraZeneca's shares hit a record high following the news.
Aug 15, 2024
Late-stage trial shows effectiveness of Incyte's drug for blood cancer
Incyte announced that its drug Monjuvi, in combination with Bristol Myers Squibb's Revlimid and Biogen's Rituxan, achieved progression-free survival in patients with follicular lymphoma (FL) in a late-stage trial. FL is a slow-growing type of non-Hodgkin lymphoma. Incyte plans to file a supplemental marketing application to the FDA by the end of the year based on these results. Other treatment options for FL include Novartis' Kymriah, Gilead Sciences' Yescarta, and Bristol Myers Squibb's Breyanzi.
Aug 15, 2024
FDA grants priority review to AstraZeneca's Imfinzi drug for specific lung cancer indication
AstraZeneca's cancer drug, Imfinzi, has been granted priority review by the US FDA for the treatment of limited-stage small cell lung cancer. The drug showed positive results in improving overall and progression-free survival in patients. AstraZeneca also successfully overturned a jury's decision to pay $107.5 million for patent infringement of cancer drug patents owned by Pfizer subsidiary Wyeth. Imfinzi has received Breakthrough Therapy Designation from the FDA as well, further expediting the regulatory review process.
Aug 15, 2024
Report reveals that Big Pharma deployed a large number of lawyers to prevent the reduction of Medicare drug prices
Manufacturers of certain medications under the Medicare price-negotiation program have exploited patent laws to keep costs high for patients, according to a report from watchdog group Accountable.US. The report found that companies used tactics such as "patent thicketing" and "pay-to-delay agreements" to maintain exclusivity on drugs and prevent competition. The negotiated prices for these drugs are set to be released in September, with prices going into effect in 2026. A study by the Commonwealth Fund found that the average price of the listed drugs is three to eight times higher in the US compared to other countries.
Aug 15, 2024
AstraZeneca's Imfinzi Receives Priority Review from FDA - The NRI Nation
AstraZeneca's drug, Imfinzi, has been granted Priority Review by the FDA for the treatment of small cell lung cancer patients. Imfinzi has shown positive results in improving overall survival and progression-free survival in patients whose disease has not progressed following chemoradiotherapy. This designation will speed up the regulatory review process for the drug. Imfinzi is a human monoclonal antibody that enhances the body's anti-cancer immune response and offers an alternative to chemotherapy.
Aug 15, 2024
Negotiations with IRA lead to significant price reductions of up to 79% for top-selling medications from Big Pharma on Medicare
The White House has announced significant price reductions for 10 prescription drugs as part of the Medicare negotiations mandated by the Inflation Reduction Act. List prices for the drugs have been cut by at least 50%, with diabetes treatments such as Merck's Januvia and Novo Nordisk's Fiasp seeing price drops of 79% and 76% respectively. Johnson & Johnson's cancer treatment, Imbruvica, saw a 38% price reduction. The reductions are set to go into effect in 2026.
Aug 15, 2024
HHS Administration collaborated with pharmaceutical companies to reduce Medicare drug costs - NPR
The Biden administration has announced savings of $6 billion on 10 common medications through negotiations with drug companies. The medications involved are the most expensive drugs covered by the Medicare program. The savings would have been passed on to both taxpayers and Medicare beneficiaries, with beneficiaries estimated to save about $1.5 billion. The negotiations are part of the Inflation Reduction Act passed a couple of years ago, which allows the US to negotiate drug prices for Medicare.
Aug 15, 2024
Negotiations on Drug Prices in the US Lead to $7.5 Billion in Savings in First Year - Report from BNN Bloomberg
The Biden administration announced that the US government’s drug price negotiations will save Americans $7.5 billion in its first year. The savings will be split between senior citizens and the government. Some of the world’s biggest medicines made by leading drug companies will see prices slashed by 38% to 79%. Diabetes drugs saw the biggest reductions, including significant discounts for Merck & Co.’s Januvia and AstraZeneca Plc’s Farxiga. This landmark policy is a victory for the administration and aims to cut medication costs and reduce the federal deficit.
Aug 15, 2024
FDA prioritizes review of AstraZeneca's Imfinzi for specific type of lung cancer - TradingView
AstraZeneca's cancer drug Imfinzi has been granted priority review by the FDA for the treatment of patients with limited-stage small cell lung cancer. The regulatory decision is expected in Q4 2024. Imfinzi has shown improved overall survival and progression-free survival in patients with the disease. AstraZeneca's shares have hit a record high, making it London's most valuable listed company. The drugmaker also successfully convinced a federal judge to dismiss a jury's decision that it owes $107.5 million for infringing on cancer-drug patents owned by Pfizer's subsidiary Wyeth.
Aug 15, 2024
Imfinzi from AstraZeneca granted priority review by FDA for specific lung cancer type, as reported by Yahoo
AstraZeneca's cancer drug Imfinzi has received a priority review from the FDA for patients with limited-stage small cell lung cancer. The regulatory decision is expected in the fourth quarter of 2024. Imfinzi has shown positive results in improving overall survival and progression-free survival in patients with this type of lung cancer. The drug has also been granted Breakthrough Therapy Designation by the FDA. AstraZeneca's shares have hit record highs, solidifying its position as London's most valuable listed company.
Aug 15, 2024
AstraZeneca's stock reaches an all-time high as the US expedites approval for their successful cancer treatment Imfinzi
AstraZeneca's shares reached a record high after its cancer drug, Imfinzi, received fast-track status from US regulators. The drug is undergoing a priority review by the Food and Drug Administration (FDA) for the treatment of certain patients with small cell lung cancer. Imfinzi works by blocking a cancer tumor's ability to evade the immune system, providing an alternative to chemotherapy. AstraZeneca's market valuation exceeded £200 billion this week, making it the first UK company to achieve this milestone. The FDA's decision on Imfinzi is expected in Q4 2024. AstraZeneca's CEO, Pascal Soriot, has received praise for the company's success and drug pipeline.
Aug 14, 2024
Novartis' initial attempt to prevent a generic version of their successful heart drug Entresto has been unsuccessful.
Swiss pharmaceutical company Novartis is considering its options to defend its intellectual property after a judge denied its request for an injunction to block the launch of a generic version of its best-selling drug, Entresto, by MSN. Novartis maintains its financial guidance for 2024 but expressed disappointment in the ruling. The judge ruled that Novartis was unlikely to win on its infringement claims and rejected its argument of potential harm from other generic versions entering the market.
Aug 14, 2024
Novartis fails in first attempt to prevent generic version of popular heart medication from entering the market
Novartis has failed to stop MSN Pharmaceuticals from launching a generic version of its heart-failure drug, Entresto, with a federal court ruling that Novartis' chances of winning its patent-infringement lawsuit were too low. Although the court has temporarily prevented MSN from selling the drug while Novartis appeals the decision, the ruling is a blow to the Swiss pharmaceutical company, as Entresto generated more than $6bn in revenue last year. Novartis said it is considering its options to defend its intellectual property and maintain its financial guidance for 2024.None
Aug 14, 2024
Incyte and Syndax receive FDA approval for promising Niktimvo drug in treating graft-versus-host disease, potential blockbuster.
Incyte has received FDA approval for its drug Niktimvo as a third-line treatment for chronic graft-versus-host disease (GVHD), a condition in which the transplanted immune cells attack the recipient's body. Niktimvo showed positive results in a phase 2 trial, with a 75% overall response rate. Incyte plans to initiate further trials for Niktimvo in combination with other drugs for first-line GVHD patients. The drug is expected to generate peak sales of $1 billion.
Aug 14, 2024
Eli Lilly makes progress in weight loss drug market, gaining ground on Novo Nordisk
Novo Nordisk and Eli Lilly have been vying for dominance in the weight loss and diabetes drug market, but Eli Lilly may be pulling ahead, according to BMO Capital Markets analyst Evan Seigerman. Novo Nordisk lowered its profit outlook after sales of its weight loss injection Wegovy fell short of expectations, while Eli Lilly reported strong performance for its weight loss injection Zepbound and diabetes treatment Mounjaro. Eli Lilly raised its revenue outlook by $3 billion and increased its full-year profit guidance, contributing to a more positive manufacturing outlook for both drugs.
Aug 14, 2024
Eli Lilly Exceeds Expectations due to High Demand for Diabetes and Weight...
Pharmaceutical company Eli Lilly reported impressive second-quarter results, driven by the success of its diabetes drug Mounjaro and weight loss injection Zepbound. Revenue rose by almost 36%, with Mounjaro sales alone reaching $3.09 billion. Eli Lilly's leading position in the weight loss field sets it apart from competitor Novo Nordisk, whose weight loss drug Wegovy faced challenges due to price concessions. Eli Lilly also raised its full-year guidance, expecting increased revenue and adjusted earnings. The company's strong performance reflects its investment in manufacturing and focus on expanding its innovative medicine portfolio.
Aug 14, 2024
Specialists scrutinize the impact of IRA as the healthcare sector anticipates negotiated CMS drug prices - BioSpace
The first 10 drugs subject to CMS negotiation under the Inflation Reduction Act (IRA) are reaching the end of their exclusivity and have already been discounted, making them not particularly representative of the overall impact of the law, according to experts. The final outcomes of the IRA negotiations, which aim to generate around $25bn in drug cost savings for the US government, are expected to be announced no later than 1 September. Analysts have identified some possible unintended consequences of the IRA, including the likelihood of higher drug launch prices.
Aug 14, 2024
Natco Pharma reports a 59 percent surge in net profit to Rs 668 crore in the first quarter - Medical Dialogues
Hyderabad-based Natco Pharma has reported a 21.6% growth in consolidated total revenue for the first quarter of 2024, compared to the same period last year. The company's net profit also increased by 59%, driven by its exports formulation business. Natco Pharma has declared an interim dividend of ₹3.0 per equity share.
Aug 14, 2024
AstraZeneca successfully overturns a $107 million verdict against Pfizer in U.S. patent battle over cancer drug
A federal judge in Delaware has thrown out a jury's decision that AstraZeneca owes $107.5 million for infringing cancer-drug patents owned by Pfizer's subsidiary Wyeth. Judge Matthew Kennelly determined that the two patents, which Pfizer accused AstraZeneca's Tagrisso of infringing, were invalid. Pfizer and AstraZeneca have yet to comment on the decision. Tagrisso, which earned AstraZeneca nearly $5.8 billion in revenue last year, was the focus of the patent infringement lawsuit.
Aug 13, 2024
Filament Health reveals extensive growth in intellectual property rights
Filament Health Corp. has expanded its intellectual property portfolio with the acceptance of twelve patents by IP Australia and has been issued five patents by the Canadian Intellectual Property Office and three patents by the United States Patent and Trademark Office for methods of extraction, purification, standardization, and delivery of naturally-derived psychedelic drug candidates. The company now holds a total of 46 accepted patents from Canada, the United States, Australia, and Mexico.
Aug 13, 2024
Legal Disputes Arising from Antibody-Drug Conjugate Treatment in Cancer Patients Handled by Foley & Lardner LLP
The increasing development and use of antibody-drug conjugates (ADCs) in cancer treatment has resulted in a rise in patent litigation surrounding these technologies. Companies may engage in litigation over patents for ADCs, particularly if claims are infringed by competitors working on similar products. Partnerships in research and development may also lead to disputes over the ownership of intellectual property. Additionally, as ADCs become more prominent in the market, lawsuits related to product liability and Medicare pricing negotiations may also arise.
Aug 13, 2024
Novartis' attempt to prevent the production of a generic version of its popular heart medication is unsuccessful at first - ET HealthWorld
Novartis has failed to block generic drugmaker MSN Pharmaceuticals from launching its own version of Novartis' heart-failure drug Entresto. U.S. District Judge Richard Andrews ruled that Novartis' chance of winning its patent-infringement lawsuit was too low to justify stopping MSN's launch. While Novartis plans to appeal the decision, Andrews has temporarily ordered MSN not to sell the drug. Entresto is Novartis' best-selling drug, generating over $6 billion in revenue last year. MSN's generic version of the drug was approved by the FDA last month.
Aug 13, 2024
Novartis unable to prevent Indian competitor from introducing first generic for heart-failure medication
A Delaware judge has denied pharma giant Novartis' request for an injunction on a generic version of their drug Entresto. The judge deemed Novartis "unlikely to succeed" in proving infringement. This lawsuit is part of Novartis' efforts to protect the exclusivity of Entresto as its patent approaches expiry and amid increasing US price regulations.
Aug 13, 2024
Amgen files lawsuit against Samsung's biotech division for producing unauthorized replicas of bone medication
Amgen files lawsuit against Samsung Bioepis over proposed biosimilar versions of Prolia and Xgeva in New Jersey federal court.
Aug 13, 2024
Novartis fails in first attempt to prevent generic version of popular heart medication
Pharmaceutical company Novartis has been unsuccessful in its bid to block generic drugmaker MSN Pharmaceuticals from launching its own version of the heart-failure drug Entresto. However, U.S. District Judge Richard Andrews temporarily ordered MSN not to sell the drug while Novartis appeals the decision. Entresto is Novartis' top-selling drug, earning over $6 billion in revenue last year. MSN's version of the drug was approved by the U.S. Food and Drug Administration and would be the first U.S. generic of Entresto. Novartis is considering its options to defend its intellectual property.
Aug 12, 2024
Ascendis Pharma Receives Buy Rating Due to Yorvipath Approval and High Sales Potential
Goldman Sachs analyst Paul Choi has maintained a bullish stance on Ascendis Pharma (ASND) stock, giving a Buy rating. This is due to the recent FDA approval of Ascendis Pharma's TransCon PTH, now known as Yorvipath, which is viewed as a key milestone. Choi remains positive about the drug's market potential, despite concerns about the company's readiness for launch and the delay in commercial availability. The projected financial success of Yorvipath, with an estimate of EUR1.6 billion in peak sales, further strengthens the Buy rating. Jefferies also assigned a Buy rating to the stock.
Aug 12, 2024
Legislation aimed at eliminating the issue of double patenting affecting biosimilars progresses to the House
The US Senate has passed the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," which aims to curb anti-competitive practices in the pharmaceutical industry. The bill authorizes the Federal Trade Commission to enforce limits on patent litigation for biological products and includes measures to combat "product hopping." The legislation is part of broader efforts to control rising drug costs and foster market conditions for the entry of lower-cost biosimilars and generics. Despite opposition from the pharmaceutical industry, the bill's strong bipartisan support suggests it may continue to progress through the legislative process.
Aug 12, 2024
Huisheng Pharm Introduces Self-Developed IDegAsp from China, Aiming to Become a Leader in Diabetes Medication
Sihuan Pharmaceutical Holdings Group subsidiary Huisheng Biopharmaceutical has gained approval to market the first domestically-produced biosimilar drug for the treatment of adult type 2 diabetes. The drug, Insulin Degludec/Insulin Aspart Injection (IDegAsp) is a combination of 70% insulin degludec and 30% insulin aspart, and offers superior efficacy and more economical advantages compared to traditional insulin preparations. Huisheng Pharm has a range of products in the diabetes and complications treatment field and is positioning itself for international expansion, particularly in Southeast Asia and the Middle East where there is high demand for diabetes drugs.
Aug 12, 2024
Novartis fails in first attempt to prevent generic version of popular heart medication - Mint
Novartis has failed to block generic drugmaker MSN Pharmaceuticals from launching a generic version of its heart-failure drug, Entresto. U.S. District Judge Richard Andrews ruled that Novartis' chances of winning its patent-infringement lawsuit were too low to justify stopping MSN's launch. However, MSN has been temporarily ordered not to sell the drug while Novartis appeals the decision. Entresto is Novartis' best-selling drug, earning over $6 billion in revenue last year. MSN's version of the drug is the first U.S. generic of Entresto.
