Pharma News
09 Jun 2024 to 15 Jun 2024
Jun 15, 2024
Eli Lilly Secures Another Significant Victory and Prepares for its Next Highly Successful Product - Yahoo Finance
Eli Lilly recently received positive regulatory news for its Alzheimer's disease drug, Donanemab. Experts convened by the FDA unanimously agreed that the available data shows Donanemab is effective and its benefits outweigh the risks. This suggests that the drug is likely to be approved for use in treating Alzheimer's disease. Eli Lilly's other drugs, such as Zepbound and Mounjaro for obesity and diabetes, are also seeing impressive sales growth.
Jun 15, 2024
The US FTC raises concerns about more than 100 medical patents registered with the FDA, including those for asthma inhalers.
The U.S. Federal Trade Commission (FTC) has sent letters to medical device companies and drugmakers, including AbbVie, AstraZeneca, and Teva, disputing the accuracy or relevance of 110 patents that could lead to delays in generic competition. The patents in question, many of which are for devices such as asthma inhalers and epinephrine autoinjectors, were improperly listed in the FDA's Orange Book, potentially harming fair competition and raising drug prices. The FTC has warned of possible legal action against drugmakers for improper patent listings.
Jun 14, 2024
Quartz reports on JPMorgan's investment in Ozempic and Johnson & Johnson's settlement regarding talc baby powder.
JPMorgan Chase raises $500 million biotech fund, focusing on weight loss drugs. Johnson & Johnson settles multi-state case over safety of talc-based powder products. Moderna's experimental COVID-flu combo vaccine shows promise in outperforming stand alone vaccines.
Jun 14, 2024
The Colorado board rules that a costly Novartis drug is not within budget - STAT News
The Colorado Prescription Drug Affordability Board has labeled Novartis' arthritis drug, Cosentyx, as "unaffordable" for patients and may impose a payment limit. The drug, used to treat plaque psoriasis and psoriatic arthritis, was found to cost an average of $47,000 per patient in 2022. The board noted that Cosentyx contributed to increased insurance premiums and will decide whether to pursue an upper payment limit in a follow-up meeting.
Jun 14, 2024
Decision Upheld in Patent Case Involving Schizophrenia Drug of Johnson & Johnson - Report by Bloomberg Law
Johnson & Johnson's Janssen unit has won a patent infringement suit against Tolmar Inc. over its schizophrenia drug, Invega Sustenna. Judge William C. Bryson of the US District Court for the District of Delaware denied Tolmar's motion for reconsideration, stating that the patent was valid. Tolmar had already admitted to infringing the patent before the trial.
Jun 14, 2024
AbbVie participates in the most recent race for gastrointestinal medication - Yahoo Finance
AbbVie has secured the rights to an antibody drug targeting TL1A, a molecule linked to inflammatory bowel disease, from China-based FutureGen Biopharmaceutical. AbbVie will pay $150 million upfront and could potentially pay up to $1.56 billion in additional fees based on development, regulatory, and sales milestones. The drug, called FG-M701, has the potential to become a successor to AbbVie's Humira and Skyrizi, which are used to treat inflammatory bowel disorders. Other pharmaceutical companies, including Merck, Roche, Teva, and Sanofi, have also invested heavily in TL1A-targeting drugs.
Jun 14, 2024
AbbVie Acquires Worldwide Rights to Promising IBD Drug Candidate - Report from Yahoo Finance Canada
AbbVie has acquired exclusive global rights to develop and commercialize FG-M701, a next-generation TL1A antibody for the treatment of inflammatory bowel disease (IBD), from Chinese biotech FutureGen Biopharmaceutical. The deal strengthens AbbVie's portfolio in the inflammatory and autoimmune disease space. AbbVie will pay $150 million upfront and near-term milestone payments to FutureGen, with additional potential milestone payments of $1.56 billion plus royalties on net sales if the product is approved. TL1A inhibitors are being developed to provide greater efficacy and less frequent dosing than first-generation TL1A antibodies.
Jun 14, 2024
Eli Lilly aims to introduce a more potent weight loss medication to replace Zepbound - Quartz
Eli Lilly's tirzepatide, found in Mounjaro and Zepbound, has propelled the company to become the most valuable pharmaceutical company in the world. Now, CEO David Ricks is looking ahead to a successor for the blockbuster drug. The GLP-1 medication, used to treat type 2 diabetes and obesity, has reached $5.3 billion in sales in 2023. Eli Lilly has committed billions of dollars to meet the ongoing demand for GLP-1 drugs and is also developing nine obesity and diabetes drugs, with retatrutide showing promising results.
Jun 14, 2024
Pfizer targets development of 8 major cancer drugs by 2030, unveils focus areas - GVS HEALTH
Pfizer sets a target of having eight blockbuster cancer therapies by 2030 in its expanded oncology division. The specific therapies were not disclosed, but they will be developed in the areas of breast surgery, genitourinary surgery, haematology surgery, and thoracic surgery. The company's commitment to cancer is evident with its recent acquisition of Seagen for $43 billion. Pfizer is also focused on managing costs and addressing the side effects of its therapies, particularly Lorbrena for lung cancer and Padcev for genitourinary cancer.
Jun 14, 2024
Top 3 Competitors Threatening Novo Nordisk's Leading Drug, Wegovy
Novo Nordisk's obesity drug, Wegovy, currently leads the market generating $4.5 billion in sales last year. However, three drugs pose a threat to Wegovy's dominance. Eli Lilly's Zepbound/Mounjaro, with sales of $517 million in Q1 2024, could achieve greater weight loss than Wegovy. Novo Nordisk's CagriSema, which combines cagrilintide with semaglutide, has shown significant weight loss advantages over Wegovy. Eli Lilly's orforglipron, a once-daily pill, and other promising weight loss drugs from various companies also present threats. Eli Lilly and Viking Therapeutics are identified as potential investment opportunities.
Jun 14, 2024
Another Chinese pharmaceutical company applies for approval to produce a generic version of Ozempic - SRN News
Livzon Pharmaceutical Group, a Chinese drugmaker, has applied for approval to sell a generic version of Novo Nordisk's diabetes drug Ozempic in China. Novo's Ozempic sales in China more than doubled last year, accounting for 5% of its total global sales. Novo's patent for the drug's active ingredient, semaglutide, is set to expire in 2026, but the company is currently fighting a legal battle over the patent in China. Livzon is the second Chinese firm to seek approval for a semaglutide-based drug.
Jun 13, 2024
Novo Nordisk faces backlash over expensive pricing of popular obesity medication Wegovy - Irish Examiner
The Danish health authority's Institute for Rational Pharmacotherapy has advised doctors to limit prescriptions of Novo Nordisk's obesity drug, Wegovy, due to its high cost. The institute stated that it would cost over €800,000 to prevent a single heart attack, stroke, or severe cardiac problem with Wegovy. They recommend that doctors only start a few patients on the treatment. This comes as experts in Denmark and the US question the drug's cost despite its impact on weight loss and related ailments. Novo Nordisk disputes the conclusions and plans to engage in a dialogue with the Danish health authority.
Jun 13, 2024
Denmark's authorities scrutinize Novo's popular weight loss medication Wegovy - reported by The Business Times
Denmark's drug oversight panel has advised doctors to limit prescriptions of Novo Nordisk's obesity drug, Wegovy, due to its high cost. The Danish Health Authority's Institute for Rational Pharmacotherapy stated that it would cost approximately $870,000 to prevent a single heart attack, stroke, or severe cardiac problem with the medication. The Institute recommends that Wegovy be used for only a "few" patients and not as a first choice treatment. Denmark is one of several locations where concerns about the drug's cost have been raised despite its efficacy in weight loss.
Jun 13, 2024
Formycon initiates clinical development efforts for FYB206, a biosimilar, according to EQS-News.
German biotechnology company Formycon has initiated its clinical development program for FYB206, a biosimilar candidate for the immuno-oncology drug Keytruda. The program includes a Phase I clinical trial, called Dahlia, to evaluate the pharmacokinetics, safety, and tolerability of FYB206 in patients with malignant melanoma who have undergone complete surgical removal of the tumor. Additionally, a Phase III trial, named Lotus, will assess the safety and efficacy of FYB206 in non-small cell lung cancer patients. Keytruda is currently the world's top-selling drug, with sales of $25 billion in 2023.
Jun 13, 2024
Approval granted in Korea for Celltrion's Stelara biosimilar
South Korean biosimilar company Celltrion has received approval from the Ministry of Food and Drug Safety for its biosimilar referencing Johnson & Johnson's drug Stelara. Celltrion's biosimilar, named Steqeyma, is now approved for use in all indications of Stelara, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion is now able to sell Steqeyma in the Korean market and is also seeking approval in the US and Europe. The company has already reached a settlement agreement with Johnson & Johnson for launching Steqeyma in the US in 2023.
Jun 13, 2024
Formycon has initiated a clinical development program for FYB206, a potential biosimilar candidate for...
German biopharmaceutical company Formycon has commenced a clinical development programme for FYB206, a biosimilar candidate for the immuno-oncology blockbuster drug Keytruda. The Phase I clinical trial, called "Dahlia," will compare the pharmacokinetics, safety, and tolerability of FYB206 with Keytruda in patients who have had malignant melanoma completely removed. Another trial, "Lotus," will assess FYB206's safety and efficacy against Keytruda in patients with non-small cell lung cancer.
Jun 13, 2024
Takeda, a Japanese company, is close to making a significant advancement in the treatment of narcolepsy according to Nikkei Asia.
Takeda Pharmaceuticals moves closer to offering a breakthrough treatment for narcolepsy with the launch of the final phase of clinical studies for their drug candidate, TAK-861. The findings from a Phase 2 trial were presented at a recent sleep medicine meeting.
Jun 13, 2024
Pfizer anticipates the development of 8 highly successful cancer drugs in various target areas.
Pfizer has announced its goal to have eight blockbuster cancer drugs by 2030, although it has not specified which drugs will achieve this status. The company's Oncology division plans to contribute to this goal through its focus on breast, genitourinary, hematology, and thoracic cancers. Pfizer's recent acquisition of Seagen and its antibody-drug conjugate portfolio will help expand commercial capabilities in biologics. Lung cancer, specifically, is an area where Pfizer aims to achieve critical mass and further improve its portfolio through drugs like Lorbrena.
Jun 12, 2024
Legal battle in the Netherlands between PAF and AbbVie over alleged price gouging discussed by Knowledge Ecology International
The Pharmaceutical Accountability Foundation (PAF) has begun legal action against AbbVie, a pharmaceutical company, over its pricing practices for the drug Humira. PAF is suing AbbVie under the Dutch Collective Settlement of Mass Damage Act (WAMCA) for excessive pricing between 2004 and 2018. PAF claims that AbbVie's pricing led to unnecessary displacement of care and cost the Dutch healthcare system €1.2 billion. AbbVie argues that PAF's collective action is inadmissible, highlighting jurisdictional issues and the lack of evidence provided. The court will rule on the admissibility of the case on June 26th.
Jun 12, 2024
Teva Unsuccessful in Inhaler Patent Lawsuit Against Amneal, Required to Modify Orange Book Entry
Teva Pharmaceuticals has lost a ruling in a New Jersey federal court, finding that five patents for its inhaler product ProAir HFA have been "improperly listed" on the FDA's Orange Book. The judge agreed with the plaintiffs, Amneal Pharmaceuticals, that Teva's patents only apply to the inhaler device and not to its albuterol sulfate drug formulation. This ruling allows Amneal to develop a generic version of the drug. The FTC has recently increased scrutiny of "junk" patents listed on the Orange Book.
Jun 12, 2024
Promising anti-inflammatory results observed in phase 1b/2a obesity trial for NodThera's NLRP3 inhibitor
NodThera's NLRP3 inhibitor, NT-0796, has shown promise in reducing inflammation in patients with obesity, according to early results from a phase 1b/2a trial. The drug demonstrated a significant reduction in C-reactive protein (CRP), a biomarker of chronic inflammatory diseases. Over 75% of patients on NT-0796 achieved a CRP reduction of 2mg/L or more, compared to less than 25% on placebo. The results also showed reductions in other pro-inflammatory and cardiometabolic biomarkers. The biotech is now preparing for a phase 2 study in obesity.
Jun 12, 2024
During FTC crackdown, judge finds Teva inhaler patents not listed correctly in FDA Orange Book
A federal judge in New Jersey has ruled that five of Teva's patents on the metered dose inhaler for its asthma medication, ProAir HFA, are "improperly listed" in the FDA's Orange Book. The ruling is part of the Federal Trade Commission's ongoing campaign against questionable drug patents, which can delay the entry of more affordable generic drugs. The ruling opens the door for Amneal Pharmaceuticals to launch its generic version of ProAir HFA. Teva intends to appeal the ruling.
Jun 12, 2024
Influence of pharmacy benefit managers on drug pricing discussed in STAT News
In the second part of the "Behind the Counter" video series, the complex factors influencing the price of prescription drugs are explored. The video explains how pharmacy benefit managers (PBMs) mediate between drugmakers, health insurers, and pharmacies to influence drug costs. It also discusses the role of formularies and rebates in determining drug coverage and pricing. The series is supported by a grant from the Commonwealth Fund.
Jun 11, 2024
The USPTO Releases Guidance for Examiners on Conducting Searches for Drug-related Applications - JD Supra
The US Patent and Trademark Office (USPTO) has issued guidance to examiners on complying with Executive Order 14036 from the Biden Administration regarding drug patents and inflated drug prices. The guidance focuses on enhancing collaboration with other agencies, improving patent procedures, and considering new proposals for incentivizing innovation while minimizing unnecessary delays in getting more affordable drugs to the market. The USPTO also announced a new duty of reasonable inquiry to review documents and disclose information material to patentability.
Jun 11, 2024
FDA Approval Expected for Eli Lilly's Alzheimer's Drug, According to Baystreet.ca
A panel of FDA advisors has recommended regulatory approval for Eli Lilly's new Alzheimer's drug, Donanemab. If approved, it would be the second drug of its kind available in the U.S. after Biogen's Leqembi. The panel unanimously agreed that Donanemab is effective in treating early-stage patients, and that its benefits outweigh the risks. This approval would provide more treatment options for the over six million Americans with Alzheimer's. Eli Lilly is pleased with the recommendation and anticipates bringing the drug to patients nationwide.
Jun 10, 2024
AbbVie strengthens its cancer drug portfolio through $21 billion acquisition of Pharmacyclics - Yahoo News UK
AbbVie Inc. has announced plans to acquire Pharmacyclics Inc. in a deal worth $21 billion. This move will give AbbVie access to Pharmacyclics' cancer drug, Imbruvica, which is expected to become one of the world's top-selling cancer drugs. The deal allows AbbVie to expand its presence in the oncology market and decrease its dependence on its current top-selling drug, Humira. The acquisition is expected to be highly beneficial to AbbVie's revenue and earnings by 2017. The deal is set to close in the middle of this year.
Jun 10, 2024
Three biotechnology companies in the Valley achieve FDA progress, as reported by the Los Angeles Business Journal
Amgen Inc. has received FDA approval to market a "biosimilar" drug called Bekemv, which is a biosimilar to the blockbuster Soliris drug used for treating certain rare diseases. Atara Biotherapeutics Inc. has submitted an application to the FDA for a drug called tabelecleucel, or tab-cel, to treat patients with Epstein-Barr virus-infected cells. Avita Medical Inc. has received FDA approval for an upgraded version of its cell-harvesting device, Recell-Go, which is used to treat burn patients with their own skin cells.
Jun 10, 2024
Plaintiff in Illinois drops case against GSK related to Zantac - Fierce Pharma报道
GlaxoSmithKline (GSK) has seen another personal injury lawsuit related to its heartburn medication Zantac voluntarily dismissed. The plaintiff, Eugenia Kasza, alleged that her use of Zantac caused her to develop breast cancer. GSK stated that it did not settle or pay Kasza anything for the dismissal and will continue to defend itself against ongoing litigation. This comes as GSK faces thousands of lawsuits regarding Zantac's alleged link to cancer. The US FDA ordered the removal of the original Zantac formulation from the market in 2020 due to potential carcinogen concerns.
Jun 10, 2024
Demcon successfully uses focused ultrasound (FUS) and microbubbles to transport drugs through the blood-brain barrier, reports BioWorld.
Demcon's subsidiary, Demon Curonix BV, has filed its first patent for a system combining microvesicles and focused ultrasound to deliver drugs across the blood-brain barrier. This innovative method could potentially revolutionize drug delivery to the brain.
Jun 10, 2024
The United States is working to address high drug costs, while the pharmaceutical industry remains calm - according to Quartz.
The Biden administration's efforts to lower healthcare costs and drug prices have produced mixed responses from the pharmaceutical industry, according to experts and regulators. The Federal Trade Commission (FTC) crackdown on improper drug patent listings and the upcoming announcement of the first ten Medicare negotiation drug prices by the Centers for Medicare and Medicaid Services (CMS) have been seen as key challenges. The FTC's challenges to junk drug patent listings, which can delay the entry of affordable generics, have resulted in companies like Kaleo, Impax Labs, and GlaxoSmithKline delisting patents or committing to lower costs. Meanwhile, analysts see the CMS's Medicare price negotiations as an even bigger threat to the industry, as the negotiation of prices for brand name drugs could have a more significant impact on prices than generic competition. The Inflation Reduction Act allows CMS to negotiate drug prices and the first set of prices are expected to be set by August 2023. Despite concerns from the industry, some experts believe the impact of the act on drug sales remains to be seen.
Jun 10, 2024
AstraZeneca announces decision to depart prominent U.S. pharmaceutical industry association - Yahoo Lifestyle Canada
AstraZeneca has announced its decision to leave the Pharmaceutical Research and Manufacturers of America (PhRMA), the main U.S. drug lobby group. The move comes after evaluating the utility of their membership, with AstraZeneca stating that it will redirect the funds previously used for the membership to other advocacy efforts in the U.S. The departure follows similar moves by AbbVie and Teva, and highlights the challenges faced by drugmakers in the U.S. market, particularly regarding drug price negotiations.
Jun 10, 2024
Reasons for the Surge in Madrigal Pharmaceuticals' Stock Today
Shares of Madrigal Pharmaceuticals have surged 75% after the company announced positive mid-stage results for its experimental non-alcoholic steatohepatitis (NASH) drug, MGL-3196. The drug demonstrated a significant decline in liver fat compared to a placebo, suggesting a potential blockbuster drug in an untapped market. However, the company faces competition in the NASH drug race and is lacking the resources of its rivals. A secondary offering is expected in the near future to bolster Madrigal's balance sheet.
Jun 9, 2024
Geron's medication receives FDA approval for a type of blood cancer - report from MedCity News
The FDA has approved Geron Corporation's drug, imetelstat, to treat anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), giving the company its first commercialized product and competition against Bristol Myers Squibb's Reblozyl. Imetelstat, administered under the brand name Rytelo, functions differently from Reblozyl, as it blocks the telomere-protecting enzyme in malignant cells. In a Phase 3 study, 39.8% of Rytelo-treated patients achieved the goal of not requiring red blood cell transfusions for eight weeks, while adverse effects included lower blood cell levels. The drug is already under review by the European Medicines Agency.
