Pharma News
11 Feb 2024 to 17 Feb 2024
Feb 17, 2024
Eli Lilly and Novo Nordisk are recognized as growth stocks due to increased sales of weight-loss drug - KFGO
Pharmaceutical companies Eli Lilly and Novo Nordisk are experiencing a surge in their stock prices due to investor optimism about the potential demand for their weight-loss drugs. Shares in both companies are trading at high valuations compared to their healthcare peers, similar to those of high-growth tech stocks. Eli Lilly's market value has surpassed that of electric automaker Tesla, making it the ninth-largest U.S.-listed company. Analysts expect both companies' revenues to increase significantly in the coming years. However, the potential risks to this rally include escalating production costs and a potential decrease in product prices.
Feb 17, 2024
AstraZeneca's Tagrisso-chemo combination approved by the U.S. FDA - ET HealthWorld
New Delhi: The U.S. Food and Drug Administration (FDA) has approved a combination of AstraZeneca's cancer drug Tagrisso with chemotherapy for the treatment of advanced lung cancer, according to a statement by the company. The approval was based on trials that showed an extension in the median progression-free survival (PFS) by nearly nine months. The addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone. Tagrisso is currently approved as monotherapy in over 100 countries.
Feb 16, 2024
Novo steps in to aid Catalent in $16.5 billion agreement. What comes next? - BioSpace
Danish pharmaceutical company Novo Nordisk is set to acquire contract development and manufacturing organization Catalent for $16.5bn. As part of the deal, Novo Nordisk will pay $11bn to buy three of Catalent's manufacturing sites to strengthen production of its diabetes drug, Ozempic, and weight-loss medication, Wegovy. Catalent has faced challenges in recent years, including quality control problems and declining demand for COVID-19 vaccines. However, analysts believe that the acquisition will allow Novo Nordisk to increase manufacturing capacity for its drugs. The deal is expected to close at the end of 2024, pending regulatory approvals.
Feb 16, 2024
Alvotech plans to launch Stelara biosimilars in international markets in the near future, according to Fierce Pharma.
Alvotech announced settlements with Johnson & Johnson that will enable the launch of its biosimilar to J&J's Stelara, called AVT04, in Japan, Canada, and the European Economic Area this year. The biosimilar has been approved by regulatory authorities in these areas. Alvotech aims to introduce AVT04 in Canada during the first quarter of this year, followed by Japan in May and the European markets after Stelara's European supplementary protection certificate expires in late July. In the US, Alvotech and Teva are cleared to launch the biosimilar no later than Feb. 21, 2025, pending FDA approval.
Feb 16, 2024
Lawmakers urge for stricter regulations on drug companies in response to high costs of EpiPen and inhalers
Democratic lawmakers Sen. Elizabeth Warren and Rep. Pramila Jayapal are calling on the FDA to close loopholes that allow pharmaceutical companies to prevent competition and keep drug prices high. They argue that major drug companies are exploiting the system by making insignificant changes to drug listings, extending their protection from generic alternatives. The Federal Trade Commission has already agreed with the lawmakers, stating that improper listings may be illegal. Prescription drugs in the US are more than twice as expensive as in other countries, and brand name drugs are even pricier.
Feb 16, 2024
FDA broadens labeling for Novartis and Roche's popular drug, transforms EMD Serono's treatment for non-small cell lung cancer ...
The FDA has granted an expanded label for Novartis and Roche's drug Xolair (omalizumab) based on a positive Phase III study funded by the NIH. The study found that participants who received omalizumab could consume higher doses of peanut, egg, milk, and cashew without experiencing allergic reactions. Additionally, the FDA has converted the accelerated approval for EMD Serono's drug Tepmetko (tepotinib) to full approval for non-small cell lung cancer.
Feb 16, 2024
Alvotech and J&J have reached an agreement on the Stelara biosimilar - according to BioSpace.
Iceland-based biotech company Alvotech has reached a settlement with Johnson & Johnson for the biosimilar of its arthritis drug Stelara, called AVT04, in Canada, the European Economic Area, and Japan. The details of the settlement were not disclosed. AVT04 is expected to enter the Canadian market in Q1 2024, the Japanese market in May 2024, and the European market shortly after the expiration of the drug's Supplementary Protection Certificate in July 2024. Alvotech has faced challenges gaining FDA approval for AVT04 in the US. J&J has been making deals to delay the launch of biosimilars for Stelara.
Feb 16, 2024
BioAge, backed by $170M, partners with Lilly to develop innovative obesity treatment for preserving oral and muscle health
BioAge Labs has raised $170m in a Series D financing round led by Sofinnova Investments, with many pharmaceutical companies joining as investors. The funds will support Phase II trials of BioAge’s azelaprag, a drug designed to activate the apelin receptor in order to improve weight loss and body composition. The Phase II trials will combine azelaprag with Eli Lilly’s type 2 diabetes treatment tirzepatide, with the aim of preserving muscle mass during weight loss. The trials are set to begin in mid-2024.
Feb 16, 2024
Major pharmaceutical companies remove patents to enhance competition and reduce drug prices, reports BNN Breaking News
Three major pharmaceutical companies have agreed to remove several patents from the Orange Book, a move signaling a shift towards increased transparency and competition in the industry. The decision comes as a response to pressure from the Federal Trade Commission (FTC) to dismantle barriers to competition and lower drug prices. GlaxoSmithKline (GSK) agreeing to delist 12 patents, along with five additional ones, is particularly noteworthy for potentially fostering more competition and improving access to medications for patients. This development highlights the influence of regulatory intervention in promoting a fairer pharmaceutical sector.
Feb 15, 2024
Alvotech reaches an agreement with J&J to release Stelara biosimilar in Europe and Canada - AOL.com
Alvotech has reached settlement agreements with Johnson & Johnson to launch a biosimilar of the blockbuster psoriasis drug Stelara in Japan, Canada, and Europe this year. The biosimilar, Ustekinumab BS (F), will enter the Canadian market in Q1 and Japan in May, with entry into European markets expected after July. The patent for Stelara began to expire last year. Alvotech previously reached a settlement and licensing agreement with J&J for the launch of another biosimilar, AVT04, in the US by February 2025. Amgen is set to launch its own biosimilar, Wezlana, next year.
Feb 15, 2024
Pfizer to Resolve Lipitor Antitrust Lawsuit with Settlement of $93 Million
Cancer test firm Freenome has raised $254 million in funding from Roche to develop tests that can detect multiple early-stage cancers. Eli Lilly's weight-loss drug Mounjaro has been launched in Britain, making it the fourth European country to introduce the drug. A study from the United States found that telemedicine abortion, where abortion pills are sent to pregnant women after video call or text message consultations, is as safe and effective as in-person care. GSK has completed the acquisition of Aiolos Bio for up to $1.4 billion. Ukraine has legalized the medical use of cannabis. Pfizer has agreed to pay $93 million to settle antitrust claims related to its cholesterol drug Lipitor. Alvotech has reached settlement agreements with Johnson & Johnson to launch a biosimilar of the psoriasis drug Stelara in Japan, Canada, and Europe. The FDA has classified Philips' recall of medical imaging machines as most serious due to the risk of a faulty component falling on patients during scans. The use of Novo Nordisk's weight-loss drug Wegovy has sharply risen among U.S. youth to address pediatric obesity.
Feb 15, 2024
Alkermes witnesses a 10% rise in share price due to positive updates on Lybalvi - Fierce Pharma
Alkermes, a "pure-play neuroscience company," is heavily relying on the success of its new schizophrenia and bipolar disorder drug, Lybalvi. The drug's sales have been increasing steadily, with a 61% year-over-year growth. Alkermes projects sales of Lybalvi to reach between $275 million to $295 million in 2024. However, the approval of Karuna Therapeutics' drug KarXT poses a threat. Despite this, Alkermes' stock price rose by 10% due to positive investor sentiment. The company also reported a net income of $113 million in the fourth quarter, largely driven by Lybalvi sales.
Feb 15, 2024
Here's the outcome after we put my 15-year-old son, weighing 385lbs, on Wegovy
A 16-year-old boy in California experienced significant weight loss and health improvements after taking the weight loss drug Wegovy, manufactured by Novo Nordisk. Despite initial concerns about side effects, the boy's pediatrician deemed the risks of obesity-related health issues to be more significant. Wegovy is increasingly being prescribed to adolescents in the US to address pediatric obesity, but some medical experts are urging caution due to a lack of long-term evidence on the drug's effects on younger patients.
Feb 15, 2024
Pfizer Resolves Antitrust Lawsuit Over Lipitor Through $93 Million Settlement - Report from Bloomberg Law
Pfizer has agreed to pay $93 million to settle an antitrust lawsuit accusing the company of conspiring to delay sales of generic versions of the cholesterol drug Lipitor. The settlement comes after over a decade of litigation brought by drug distributors. Despite the settlement, Pfizer denies any wrongdoing. The settlement awaits a judge's approval. The case against pharmaceutical company Ranbaxy Laboratories is still ongoing. Lipitor, patented in 1997, generated over $130 billion in sales for Pfizer. The Supreme Court had previously rejected Pfizer's appeals to block lawsuits over its Lipitor patent settlements.
Feb 15, 2024
Ayvakit by Blueprint Medicines: A Promising Solution for Rare-Disease Therapy - BNN Breaking
Blueprint Medicines has reported strong financial results for 2023, driven by the success of its rare-disease treatment Ayvakit. The drug generated $71 million in sales in the fourth quarter and showcased a 31% sequential growth. The company anticipates continued growth in 2024, with global net product revenue expected to reach between $360 million and $390 million. Blueprint Medicines is also focusing on expanding Ayvakit's commercial reach and investing in its pipeline opportunities. The company's scientific endeavors, including presentations on Ayvakit's safety and efficacy, further bolster its position in the market.
Feb 15, 2024
Ayvakit peak sales estimate skyrockets to $2B with the help of new blueprint - Fierce Pharma
Blueprint Medicines has increased its peak sales estimate for rare disease drug Ayvakit to $2 billion, following better-than-expected Q4 results. The company reported sales of $71 million in the quarter, beating forecasts by 8%. The revenue increase was driven by the expansion of Ayvakit into indolent systemic mastocytosis, for which it gained FDA approval in May 2023. Blueprint expects Ayvakit revenue to be in the range of $360 million to $390 million in 2024.Blueprint also revealed it is looking for a US partner for Roche-returned Gavreto.
Feb 15, 2024
Alvotech reaches agreement with J&J, plans to introduce Stelara biosimilar in Europe and Canada
Alvotech has reached settlement agreements with Johnson & Johnson to launch a biosimilar of the psoriasis drug Stelara in Japan, Canada, and Europe this year. The biosimilar will be marketed as Ustekinumab BS (F) in Japan, sold by Alvotech's partner JAMP Pharma in Canada, and sold by STADA Arzneimittel under the name Uzpruvo in select European countries. Stelara's key patents began to expire last year, allowing competitors to enter the market. Alvotech and Teva Pharmaceutical also reached a settlement and licensing agreement with J&J for the biosimilar launch in the U.S. pending FDA approval.
Feb 14, 2024
Medriva Reports Biogen's Future Prospects in 2024: Encountering Obstacles and Optimism in Novel Alzheimer's Medication
Biogen is projecting flat product revenue for 2024 due to competition and sluggish sales. However, the company is hopeful about its new Alzheimer's drug, Leqembi, which could boost revenue. Biogen's adjusted profit forecast for 2024 falls short of expectations, and its Q4 revenue and profit decreased compared to the previous year. The company plans to bolster Leqembi's sales by increasing its U.S. sales force. While Biogen is optimistic about returning to profit growth in 2024, its shares fell after missing Wall Street's estimates for Q4 results.
Feb 13, 2024
GSK's breakthrough hepatitis drug receives accelerated approval from American regulators - The Times
British pharmaceutical company GSK has been granted a fast-track review by the US Food and Drug Administration for its potential blockbuster treatment, bepirovirsen, for chronic hepatitis B. The drug has the potential to address an unmet medical need for the life-threatening condition, which affects almost 300 million people globally. GSK forecasts annual peak sales of at least £2 billion for bepirovirsen.
Feb 13, 2024
Current biotech news stories worth knowing today
Merck's Ebola vaccine, Ervebo, has been found to reduce the risk of death even after a person has been infected with the virus, according to a study published in Lancet Infectious Diseases. The research, based on data from the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo, showed that the vaccine halved the risk of dying among those who had received it before developing symptoms. This finding suggests that the vaccine can be effective even if administered just a day or two before a person falls ill.
Feb 12, 2024
FDA reverses decision and readmits Xspray's application for potential competitor to BMS' Sprycel, following initial rejection
Swedish pharmaceutical company, Xspray Pharma, expects to launch its leukemia candidate, Dasynoc, in late summer after the FDA accepted the resubmission of its approval application. Dasynoc is an improved version of Bristol Myers Squibb's cancer drug, Sprycel, offering advantages such as being unaffected by stomach pH and allowing for more consistent uptake in the body at a lower dose. Xspray plans to launch Dasynoc on September 1, pending FDA approval, and has partnered with Eversana for commercialization.
Feb 12, 2024
In a surprising turn of events, Takeda successfully obtains FDA endorsement for previously overlooked Eohilia drug following noteworthy findings
Takeda has received FDA approval for Eohilia, an oral suspension formulation of the corticosteroid budesonide, for the treatment of eosinophilic esophagitis (EoE). Eohilia becomes the first FDA-approved oral medication for EoE, with estimated peak sales of $300 million to $500 million. The drug's approval comes after previous setbacks and a refile by Takeda, incorporating additional data. While Eohilia has shown efficacy for 12 weeks of treatment, the FDA highlights that it hasn't been proven effective beyond this duration.
Feb 12, 2024
AFR reports that CSL shares experience a $7 billion decline after setback in drug for 'second heart attack' treatment.
Australian biotechnology company CSL has announced that its trial for its cardiovascular drug, CSL112, has not met its primary endpoint. The AEGIS-II study, which involved over 17,000 heart attack patients, aimed to evaluate whether CSL112 reduced the risk of major cardiovascular events. While CSL has acknowledged the disappointing results, it still believes the study can provide valuable insights for future cardiovascular and metabolic drug development programs. CSL's earnings guidance, so the failure of the trial is not expected to have a significant financial impact.
