Pharma News
16 Jun 2024 to 22 Jun 2024
Jun 22, 2024
Pharmaceutical Companies Do Not Remove Patent Listings Despite FTC Letters, Reports Law360 Healthcare Authority
Eight pharmaceutical companies have chosen not to remove any patent listings for their products from a federal database, despite warnings from the Federal Trade Commission (FTC) that they may have improperly listed these patents.
Jun 21, 2024
Johnson & Johnson (JNJ) Requests Approval to Extend Tremfya's Application for Treatment of Crohn's Disease - From Yahoo Finance
Johnson & Johnson has submitted a supplemental biologics license application seeking approval for its immunology drug, Tremfya, to be used in the treatment of moderately to severely active Crohn’s disease. The application comes two months after a similar submission for an active ulcerative colitis indication. Tremfya is already approved for the treatment of certain patients with plaque psoriasis and active psoriatic arthritis. The drug is a key driver of J&J’s top-line growth, with sales reaching $808 million in Q1 2024, up 26.3% YoY.
Jun 21, 2024
Pharmaceutical Manufacturers Face Growing Concerns About the Orange Book
In a recent case, Teva has been ordered by a US District Court to correct or delist five improper patents listed in the FDA's Orange Book. The court found that these patents, which were related to components of an inhaler device and not the drug itself, were improperly listed. This ruling is seen as a significant win for the FTC, which has been evaluating the legality of improper Orange Book listings. Pharmaceutical manufacturers should take note of this decision and ensure their own listings are in compliance with the requirements.
Jun 21, 2024
Warning issued by global health authorities regarding counterfeit Ozempic injection pens
The World Health Organization (WHO) has issued a global warning about falsified batches of the weight-loss drug semaglutide, also known as Ozempic, which were found in Brazil, the UK, and the US. The high demand for these drugs has created a growing market for counterfeits. WHO has urged healthcare professionals, regulatory authorities, and the public to be aware of these falsified batches and to refrain from using suspicious medicines. Using counterfeit drugs may result in ineffective treatment or pose serious health risks. Additionally, pharmaceutical company Eli Lilly has warned against counterfeit weight-loss drugs containing the active ingredient tirzepatide.
Jun 21, 2024
TradingView identifies three pharmaceutical stocks with strong potential for blockbuster success
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Jun 20, 2024
Skyrizi, a product by AbbVie, receives important FDA approval for treating ulcerative colitis - reported by Fierce Pharma.
The FDA has granted approval to AbbVie's drug Skyrizi to treat adult patients with moderately to severely active ulcerative colitis (UC), making it the first IL-23 inhibitor cleared for both UC and Crohn's disease. Skyrizi, with its convenient on-body injector device, has already gained favor among gastroenterologists who see it as a significant advance over existing products. AbbVie's plan to build up Skyrizi and Rinvoq as Humira sales decline seems to be working, with both drugs expected to contribute to 42% of AbbVie's total revenue by the end of the decade.
Jun 20, 2024
Eli Lilly Receives a Significant Upgrade to its Growth Potential, as Reported by The Globe and Mail
Pharmaceutical company Eli Lilly's stock, trading at a high valuation, still appears to be a good buy due to its strong growth prospects. The company has been benefiting from the success of its drugs Zepbound for weight loss and Mounjaro for diabetes, and there is potential for significant revenue with the upcoming approval of its early Alzheimer's treatment, donanemab. Analysts have also increased price targets for Eli Lilly stock, signaling long-term growth potential. With promising products in its portfolio, the company is well-positioned for future success in the healthcare market.
Jun 20, 2024
Anticipated positive development expected from Verona Pharma's upcoming PDUFA date next week (NASDAQ:VRNA)
Verona Pharma's lead drug candidate, ensifentrine, is set for FDA approval for its use in the treatment of Chronic Obstructive Pulmonary Disease (COPD), with a Prescription Drug User Fee Act (PDUFA) date scheduled for June 26th. Ensifentrine has demonstrated significant improvements in lung function and reduced exacerbation rates in clinical trials. Verona Pharma has secured funding for a potential commercial launch of the drug through a financing deal with Oaktree Capital and OMERS Life Sciences. However, the potential approval of Sanofi and Regeneron's Dupixent in the COPD indication poses a competitive threat to Verona's ensifentrine.
Jun 19, 2024
Israeli company specializing in female technology patents candida treatment in South Africa - NoCamels
Israeli femtech startup Zero Candida has patented its innovative treatment for candida yeast infection with the authorities in South Africa. The treatment uses high-energy blue light administered through a tampon-like medical device to quickly and effectively destroy the fungus without side effects. Zero Candida aims to become a leader in non-chemical candida treatment and plans to start commercial sales in South Africa following FDA approval. The treatment is expected to bring significant advancements to women's health globally.
Jun 19, 2024
Skyrizi, a popular blockbuster drug, receives new approval in the US - Report from The Pharma Letter
AbbVie's drug Skyrizi (risankizumab-rzaa) has received approval for treating adults with moderately to severely active ulcerative colitis, making it the first drug to be approved for both moderate to severe ulcerative colitis and Crohn's disease. Skyrizi is now approved for four immune-mediated inflammatory diseases.
Jun 18, 2024
Munich Regional Court remains firm in preliminary injunction conflict involving Bayer's Xarelto - JUVE Patent
Bayer has successfully defended its market share for the drug Xarelto in Germany. The Munich Regional Court upheld preliminary injunctions against seven generics manufacturers, prohibiting them from selling their products in Germany. The court rejected the challenges to the patent in suit EP 1 845 961, which is important in protecting Xarelto throughout Europe. The defendants may now appeal to the Higher Regional Court, with further hearings scheduled in the coming months. The patent has also been revoked in the UK and France, but Bayer can still ask for a review of the decisions.
Jun 18, 2024
Celltrion expands its presence in the United States, the largest pharmaceutical market globally, by introducing new products.
South Korean biopharmaceutical company Celltrion is expanding its presence in the US market with new drugs such as Gimpentra, Beggzelma, and U-Flyma. The company aims to increase sales and raise expectations for future blockbuster drugs. Celltrion's drug, Gympentra, has already made a successful entry into the US market, with prescription book listing contracts signed with large prescription drug benefit management companies. The company is also working on securing approval for additional products in various therapeutic areas. Celltrion aims to achieve annual sales of over KRW 1 trillion by 2025 and become a global big pharma company.
Jun 18, 2024
GSK rekindles hopes for Blenrep blockbuster success based on Phase III study results, according to BioSpace.
GSK is reconsidering its multiple myeloma treatment, Blenrep, after promising Phase III data from studies DREAMM-7 and DREAMM-8. Blenrep showed a significant increase in progression-free survival compared to Johnson & Johnson's Darzalex in DREAMM-7 and a decrease in disease progression in comparison to Takeda's Velcade in DREAMM-8. GSK estimates Blenrep could reach peak sales of over $3 billion and potentially dislodge Darzalex as the standard of care for multiple myeloma. Blenrep was initially withdrawn from the US market in November 2022 after failing to meet its primary efficacy endpoint.
Jun 18, 2024
Pharmaceutical Leaders in the Fight Against Covid-19 Push Boundaries in Cancer Therapy
AstraZeneca has received FDA approval for its cancer drug Imfinzi in combination with chemotherapy for the treatment of certain endometrial cancer patients. The late-stage trial showed a 58% reduction in the risk of disease progression or death compared to chemotherapy alone. On the other hand, BioNTech faced a setback as the FDA put its experimental cancer drug study on partial clinical hold due to concerns regarding patient safety.
Jun 18, 2024
Exploring the Success and Challenges of Humira, the Top-Selling Drug globally - Yahoo Finance
AbbVie’s blockbuster drug Humira is expected to generate $15.2bn through to 2024, maintaining its dominance in the marketplace. AbbVie’s lifecycle management and investment in clinical trials for multiple indications has been critical to the success of the drug. The European patents for Humira will expire in October this year, allowing for the entry of biosimilars on the European market. However, AbbVie has used its patent portfolio and newer patents for manufacturing methods and formulations to gain extra years of exclusivity. The company is also developing a stronger pipeline to manage the expected biosimilar erosion Humira will face in the future.
Jun 18, 2024
Analyst anticipates robust expansion for respiratory medications co-developed by GSK and Innoviva
Pharmaceutical company Innoviva, Inc. has been given an Overweight rating by Cantor Fitzgerald due to their unique business model centered around royalties and healthcare assets. The company receives royalties from GSK for popular asthma and COPD products, and Cantor projects significant royalty revenues for the next five years. Innoviva's lead pipeline product, zoliflodacin, is a potential oral drug for uncomplicated gonorrhea that is expected to achieve high sales. The company also plans to expand its product portfolio through organic and inorganic growth opportunities.
Jun 18, 2024
Russian pharmaceutical companies plan to concentrate on developing unique drugs - The Pharma Letter
Russian pharmaceutical market experiencing transformation with decline in share of foreign drugs due to import substitution, leading to increase in number of pharmaceutical patent applications filed by Russian companies, surpassing foreign applications for the first time in seven years.
Jun 17, 2024
Novo Nordisk executive VP emphasizes the significant responsibility that comes with the success of Wegovy and Ozempic
Pharmaceutical company Novo Nordisk faces supply issues for its obesity drug Wegovy, approved for use in Singapore since March 2023. A launch timeline has not been provided, but Novo Nordisk is working to meet the high demand. The company's other drug, Ozempic, has gained global attention for its weight-loss effects and experienced shortages. Both drugs contain the active ingredient semaglutide, which mimics the actions of a hormone that regulates appetite and blood sugar levels. Novo Nordisk acknowledges the responsibility to educate users on the appropriate use of their drugs.
Jun 17, 2024
FDA Approves AstraZeneca's Imfinzi for the Treatment of Endometrial Cancer
The FDA has approved AstraZeneca's cancer drug Imfinzi, in combination with chemotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. The approval was based on the results of the DUO-E Phase III trial, which showed that the Imfinzi combo reduced the risk of disease progression or death by 58% compared to chemotherapy alone. AstraZeneca is also investigating Imfinzi in combination with its PARP inhibitor Lynparza. Imfinzi has been a significant earner for AstraZeneca, with over $1.1 billion in sales in Q1 2024.
Jun 17, 2024
Pharmaceutical Industry's Approach to Innovation in Anticipation of Patent Expirations | Opto - CMC Markets
Several major pharmaceutical companies are preparing for the patent cliff, as several blockbuster drugs face patent expiration in the coming years. Merck is focusing on mergers and acquisitions to boost its product pipeline ahead of the expiration of its cancer drug Keytruda's patent. Bristol-Myers Squibb is investing in research and development in India to mitigate the revenue loss from the expiration of patents for its drugs Eliquis and Opdivo. Moderna is leveraging artificial intelligence to expand its portfolio beyond its mRNA Covid-19 vaccine.
Jun 17, 2024
US approves AstraZeneca's chemotherapy treatment for specific endometrial cancer type
AstraZeneca's cancer drug Imfinzi has received US FDA approval as a treatment for adult patients with primary, advanced, or recurrent endometrial cancer that is mismatch repair deficient (dMMR). In a late-stage trial, Imfinzi combined with chemotherapy reduced the risk of disease progression or death by 58% compared to chemotherapy alone. This approval provides an important new option for patients with dMMR endometrial cancer, according to AstraZeneca.
Jun 17, 2024
AstraZeneca's Imfinzi, in combination with chemotherapy, receives approval in the United States for specific endometrial cancer subtype
AstraZeneca's cancer drug Imfinzi has been approved by the FDA for the treatment of adult patients with primary, advanced, or recurrent endometrial cancer that is mismatch repair deficient. The drug, when combined with chemotherapy, showed a 58% reduction in the risk of disease progression or death compared to chemotherapy alone in late-stage trials. This provides an important new option for patients with this type of cancer.
Jun 17, 2024
Merck vaccine receives FDA approval for safeguarding adults against bacterial infections, reports NBC Los Angeles
The Food and Drug Administration has approved Merck's new vaccine, Capvaxive, designed to protect adults from the bacteria pneumococcus, which can cause serious illnesses including pneumonia. Capvaxive specifically covers 21 strains of the bacteria, providing broader protection than existing shots on the market. Merck's new vaccine could be a key growth driver for the company as it looks to offset losses from its cancer drug Keytruda. An advisory panel is set to discuss eligibility for the vaccine on June 27.
Jun 17, 2024
Hikma Pharmaceuticals to acquire portions of a Danish competitor in a transaction valued at up to £146 million, as reported by This is Money.
Hikma Pharmaceuticals is set to acquire parts of Xellia Pharmaceuticals, a Danish company specialising in injectable antibiotics. The London-listed firm will pay $135m upfront for Xellia's US finished dosage form business and assets, with an additional $50m dependent on the achievement of specific milestones. The acquisition will expand Hikma's US portfolio by adding eight approved and marketed injectable products, as well as 11 pipeline products.
Jun 16, 2024
Considering Investing in Madrigal Pharmaceuticals? Eli Lilly Wants to Discuss.
Eli Lilly poses a competitive threat to Madrigal Pharmaceuticals in the diabetes and obesity market with the approval of tirzepatide, marketed as Mounjaro and Zepbound. Mounjaro has already generated over $1.8 billion in sales during Q1 and Zepbound is expected to become a blockbuster drug in the coming quarters.
Jun 16, 2024
A competitor emerges for AbbVie's Humira in the United States, potentially maintaining high costs
Amgen has launched Amjevita, the first biosimilar version of AbbVie's arthritis drug Humira, in the U.S. The biosimilar is priced at a 5% discount to Humira's monthly price, but another cheaper version may not be widely used due to lack of appeal to pharmacy benefit managers (PBMs). The introduction of biosimilars in the U.S. has not resulted in the expected price reductions due to the private insurance system's negotiation and rebates. The U.S. government's inflation reduction act will allow Medicare to negotiate drug prices, but drugs with direct competition, like Humira, are excluded.
Jun 16, 2024
Orchid Pharma experiences success with new top-selling medication - The Hindu BusinessLine
Orchid Pharma has received approval from the Drugs Controller General of India to produce and sell Enmetozobactum, the first India-discovered drug to receive US FDA approval. Enmetazobactum is an antibiotic used to combat anti-microbial resistance and will be used in combination with Cefepime. Orchid Pharma, which recently stabilized after facing financial difficulties, is also engaged in backward integration and expansion into new drugs. The company is planning to manufacture 7ACA, a drug intermediate, and is preparing for the production of Cefiderocol under a low-cost deal.
