Pharma News
28 Jan 2024 to 03 Feb 2024
Feb 3, 2024
Cystic fibrosis patients urge DPIIT to permit domestic production of CFTR modulators for accessibility
Patients with cystic fibrosis (CF) in India have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to intervene and make CF drugs more affordable. The patients highlighted the high cost of CF drugs, such as Kalydeco, Orkambi, Symdeko, and Trikafta, which are owned by US-based Vertex Pharmaceuticals and cost anywhere from Rs. 21 lakh to Rs. 2.66 crore. They alleged that the prices are inflated due to patent protection, preventing the production of generic versions. The patients urged the DPIIT to issue government use licenses or compulsory licensing to make the drugs accessible and affordable.
Feb 2, 2024
AbbVie's earnings exceed expectations due to strong sales of Humira and Botox.
AbbVie has reported higher-than-expected fourth-quarter profits, mainly due to stronger demand for Botox and a smaller-than-expected decline in sales of its arthritis drug Humira. The company has been dealing with increased competition from biosimilars for Humira, but it has managed to maintain favourable positions on insurance drug coverage lists. AbbVie raised its sales forecast for newer immunology products Skyrizi and Rinvoq, and its 2024 adjusted profit is expected to be in the range of $11.05 to $11.25 per share.
Feb 2, 2024
Examining the Controversial Journey of Aduhelm: A Comprehensive Analysis of Drug Approval Challenges - Medriva
Biogen's drug Aduhelm, initially lauded as a breakthrough in Alzheimer's treatment, will be discontinued due to its failure to meet sales expectations and controversy surrounding its FDA approval. Biogen plans to focus on other Alzheimer's treatments, including Leqembi, which has shown promise in slowing cognitive decline. The Aduhelm case highlights the complexities of drug approval and the need for transparency and evidence-based decision-making. Patients currently on Aduhelm should continue treatment until November and discuss options with their healthcare providers.
Feb 2, 2024
GSK resolves an additional legal dispute related to Zantac in California - The Times
GSK settles a sixth legal case in California ahead of a trial regarding claims that the heartburn drug, Zantac, caused cancer. The confidential settlement reflects GSK's desire to avoid prolonged litigation. The company denies any liability and will vigorously defend itself in other Zantac cases. Shares in GSK and other global companies that sold Zantac declined 18 months ago due to concerns about potential legal liabilities.
Feb 2, 2024
FTC Takes Action Against Drug Manufacturers' "Patent Thicket" - Worldtimetodays
The Federal Trade Commission (FTC) has challenged the validity of over 100 drug patents, focusing on drug delivery devices like inhalers and auto-injectors, as an effort to increase competition and potentially lower prices. Drug manufacturers often extend a drug's patent protection by making changes to the delivery device or method. The FTC argues that patent law protects active ingredients, not delivery methods, and is trying to eliminate so-called patent thickets to make it easier for generics to enter the market. Some companies have already withdrawn patents in response to the FTC's challenge.
Feb 2, 2024
Potential New Medication Holds Promise for Alleviating Intense Pain Without Risk of Dependence - MediaPost
Boston pharmaceutical company, Vertex Pharmaceuticals, has developed an experimental drug that relieves moderate to severe pain by targeting peripheral nerves, rather than opioids which work on the brain and spinal cord. The drug is expected to avoid the risk of addiction associated with opioids. Although the drug did not meet all the required endpoints in trials, the company plans to file for US approval by mid-2024. Analysts predict that if approved, the drug could achieve annual sales of over $5 billion. Other attempts by drug companies to develop opioid alternatives have failed in trials.
Feb 2, 2024
Biogen decides to cease development of Alzheimer's drug due to lack of Medicare funding following a contentious approval.
US drug company Biogen has announced that it is discontinuing its Alzheimer's drug, aducanumab (Aduhelm). Despite being initially expected to be a blockbuster drug, the drug failed to generate significant income due to insurance coverage refusals and low prescriptions. The rights to the drug will be returned to its original developer, Swiss firm Neurimmune. Biogen will also stop a post-market trial aimed at demonstrating the drug's clinical benefit. This decision is seen as a victory for advocates of strong drug regulation and a warning to companies relying on marketing to compensate for data gaps.
Feb 2, 2024
Bristol Myers Squibb exceeds expectations with impressive sales growth driven by successful launch of new pharmaceuticals - NBC Connecticut
Bristol Myers Squibb has reported quarterly earnings and revenue that surpassed expectations, driven by strong sales growth from its portfolio of new drugs. The company's revenue for the fourth quarter reached $11.48 billion, up 1% from the same period in the previous year. Sales of new drugs such as Reblozyl and Opdualag contributed significantly to the revenue growth. Bristol Myers also provided a full-year revenue forecast in line with expectations, but expects earnings to be higher than anticipated. The company faced pressure to accelerate the launch of new drugs as its blockbuster drug Revlimid faces competition from cheaper generics.
Feb 2, 2024
Morningstar reports that AbbVie's fourth-quarter revenues exceed expectations despite a significant decline in Humira sales.
Pharmaceutical company AbbVie Inc. reported higher-than-expected sales in the fourth quarter, despite facing competition for its top-selling drug, Humira. While net income for the quarter decreased, sales of arthritis drugs Skyrizi and Rinvoq exceeded expectations. AbbVie also raised its sales outlook for Skyrizi and Rinvoq for 2027. The company expects modest operational revenue growth in 2024, after which it anticipates stronger growth. AbbVie's aesthetics business and antipsychotic drug Vraylar also posted positive sales growth. AbbVie is set to acquire ImmunoGen Inc. and Cerevel Therapeutics Holdings Inc. to support future growth.
Feb 2, 2024
Biogen ends development of Aduhelm, an Alzheimer's drug that was anticipated to stimulate increased utilization of imaging
Biogen has announced its decision to stop selling its Alzheimer's drug Aduhelm, which was expected to boost imaging use. The pharmaceutical company will focus instead on its FDA-approved anti-amyloid beta treatment, Leqembi. Aduhelm has had a controversial history, with doubts about its effectiveness and a high price tag of $56,000.
Feb 2, 2024
PharmaLive reports that AbbVie forecasts an increase in sales for its new immunology drugs until 2027, projecting a staggering $27 billion in revenue.
AbbVie has increased its sales forecast for its immunology drugs Skyrizi and Rinvoq to $27 billion by 2027, $6 billion higher than its previous prediction. The company hopes that the sales from these new drugs will offset the declining sales of its arthritis drug Humira. Analysts believe that this higher forecast will alleviate pricing concerns and allow for high-single-digit growth until the end of the decade.
Feb 2, 2024
Merck Achieves $60B in Revenue in 2023 Fueled by Keytruda and HPV Vaccine | BioSpace
Merck's Keytruda achieved over $25 billion in sales in 2023, a 19% increase from the previous year, according to the company's financial results. Keytruda saw a 21% growth in sales in the fourth quarter, attributed to increased usage in early-stage indications such as renal cell carcinoma and triple-negative breast cancer. Merck's HPV vaccine Gardasil also performed well, generating $1.8 billion in 2023. However, Merck's COVID-19 antiviral, Lageviro, saw a significant drop in sales due to low demand. Despite this, Merck's pharmaceuticals segment delivered over $13 billion in sales in Q4 2023 and $60 billion in total for the year.
Feb 1, 2024
Puducherry medical professionals discover unique method to deliver medication directly to the brain, securing exclusive rights
Doctors from Puducherry have discovered a new method to administer drugs into the brains of Parkinson's disease patients. Dr U R Anoop and Dr Kavita Verma successfully administered levodopa, a drug used to treat Parkinson's disease, to an 80-year-old man during a dental procedure. The new method, known as the maxillofacial route, is more effective than conventional methods of administering tablets. The doctors were granted patents for their drug delivery system in India, the US, and Australia, with pending applications in Europe and Canada. Regulatory approval is still needed before it can be considered standard procedure.
Feb 1, 2024
Takeda Pharmaceutical Faces a Decline in Third-Quarter Net Profit due to Reduced Margins | Morningstar
Takeda Pharmaceutical, a Japanese drugmaker, has reported an 11% decrease in net profit for the third quarter, reaching ¥105.7 billion ($719.3 million), due to lower margins. Despite losing market exclusivity for Vyvanse, a drug for attention deficit hyperactivity disorder, Takeda experienced a 1.3% increase in revenue. Sales of Vyvanse declined by 30%, while sales of ulcerative colitis drug Entyvio climbed by 13% and sales of plasma-derived products rose by 18%. Takeda's operating profit margin decreased to 9.4% from 13.4% a year earlier. The company has maintained its revenue and net-profit forecasts for the fiscal year ending March.
Feb 1, 2024
Daiichi Sankyo Increases Predictions for Enhertu Sales Again Due to International Expansion | BioSpace
Daiichi Sankyo has increased its revenue forecast once again for its antibody-drug conjugate Enhertu. The company now expects Enhertu to bring in approximately $2.61 billion for the fiscal year 2023, driven by growth outside the U.S. This is the second time this year that Daiichi Sankyo has raised Enhertu's sales forecast. However, the company lowered its sales expectations for Enhertu in the U.S. to $1.54 billion. Overall, Daiichi Sankyo reported strong growth in its oncology business, driven primarily by Enhertu.
Feb 1, 2024
Merck's Keytruda sales surge leads to higher-than-anticipated financial results | SaltWire
Pharmaceutical company Merck & Co is on the lookout for deals worth up to $15bn as it prepares for a decline in revenue from its top-selling drug Keytruda. The company, which saw better-than-expected Q4 results, plans to focus on business development and collaborations similar to its co-development agreement with Japan's Daiichi Sankyo. Merck's shares rose 2.5% in early trading. Keytruda generated $25bn in sales in 2023, and is anticipated to exceed $30bn in sales by 2026. However, as its patent protection is set to expire, Merck is seeking to boost its pipeline and revenues through deals and collaborations.
Feb 1, 2024
Merck's financial results surpass predictions due to the impressive sales of its leading medications, Keytruda and Gardasil.
Merck has announced strong fourth-quarter revenue and earnings, driven by high demand for its cancer drug Keytruda and HPV vaccine Gardasil. The pharmaceutical giant posted a net loss due to charges relating to a deal with Daiichi Sankyo. Despite the loss, Merck's results were above Wall Street's expectations. The company also issued its full-year 2024 guidance, which was generally in line with expectations. Merck CEO Robert Davis stated the company is interested in signing acquisitions or collaboration deals to continue growing its drug portfolio.
Feb 1, 2024
Pfizer Delivers Unexpectedly Positive Earnings, With Focus on Innovative Cancer Treatment
Pfizer reported mixed results for Q4 2023, with revenue down over 41% to $14.25bn, falling below Wall Street estimates. The decline in revenue was attributed to a drop in COVID-19 vaccine sales, which fell by 53% YoY. However, Pfizer is hopeful for the future, forecasting revenue growth in 2024 and focusing on cancer treatment as a potential area for growth. The company expects its new drugs to generate $20bn in revenue by the end of the decade.
Feb 1, 2024
Sanofi anticipates the RSV antibody will achieve blockbuster status by 2024, despite ongoing supply issues.
Sanofi expects to see dividends in 2024 as it strives to become a global immunology leader. The company reported that its partner AstraZeneca's respiratory syncytial virus (RSV) antibody, Beyfortus, pulled in 547 million euros in its first year on the market, a figure that is expected to double this year. However, supply challenges still need to be addressed before the antibody is fully available. Sanofi's influenza vaccine business was down due to dropping immunization rates and increased competition in the US. On a positive note, Sanofi's immunology drug, Dupixent, generated around 10.7 billion euros in 2023 and is expected to bring in approximately 13 billion euros in sales in 2024.
Feb 1, 2024
Merck surpasses market expectations with strong financial performance driven by increased sales of Keytruda - SaltWire
Pharmaceutical company Merck & Co is seeking deals worth up to $15bn as it prepares for a decline in revenue from its bestselling cancer drug Keytruda. Merck has already signed several deals in the past year, including a $5.5bn collaboration with Japan's Daiichi Sankyo. CEO Rob Davis said the company would also look for partnerships similar to those with Daiichi Sankyo. Keytruda generated $25bn in sales in 2023, surpassing peak sales of AbbVie's drug Humira. However, the drug is set to lose its patent protection by the end of the decade.
Feb 1, 2024
Daiichi Sankyo boosts Enhertu sales outlook once more, fueled by international expansion - PharmaLive
Japanese pharma company Daiichi Sankyo has once again raised its revenue forecast for its antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki). It now expects Enhertu to bring in approximately $2.61 billion for fiscal year 2023, driven by growth outside the U.S. The company also reported strong performance in international markets but lowered its sales expectations for Enhertu in the U.S. The overall revenue outlook for the full fiscal year has been raised to around $10.75 billion. Daiichi Sankyo is awaiting the FDA's decision on using Enhertu as a treatment option for HER2-expressing solid tumors.
Feb 1, 2024
Merck surpasses expectations with strong financial performance fueled by impressive sales growth of Keytruda
Merck & Co plans to pursue deals worth up to $15 billion as it anticipates a decline in revenue from its cancer immunotherapy Keytruda. The pharmaceutical company is looking for collaborations similar to its $5.5 billion deal with Daiichi Sankyo for three antibody drug conjugate cancer drugs. Merck reported better-than-expected fourth-quarter results, with Keytruda sales exceeding analyst expectations at $6.6 billion. The company expects Keytruda sales to surpass $30 billion by 2026 but is preparing for its patent protection to expire by the end of the decade.
Feb 1, 2024
Devdiscourse reports that Merck surpasses expectations with improved financial results fueled by a significant boost in Keytruda sales.
Merck & Co reported better-than-expected fourth-quarter results, driven by strong sales of its cancer immunotherapy drug Keytruda. Keytruda generated $6.6 billion in sales, surpassing AbbVie's Humira as the world's biggest selling prescription medicine. Despite a $5.5 billion payout to Japan's Daiichi Sankyo for cancer drug co-development, Merck recorded adjusted earnings of 3 cents a share in Q4. The company also announced a restructuring program to optimize manufacturing operations and expects annual sales growth of up to 6.8% through 2024.
Feb 1, 2024
Merck's quarterly results exceed expectations as Keytruda sales surge
Merck & Co has reported better-than-expected fourth-quarter results, buoyed by strong sales of its cancer immunotherapy Keytruda. The drug generated $6.6bn in sales, beating analyst forecasts of $6.5bn. Keytruda also surpassed the sales of AbbVie's arthritis drug Humira at its peak, racking up $25bn in sales for the full year. Merck forecast 2024 sales of between $62.7bn and $64.2bn, with estimated growth of up to 6.8% year on year.
Jan 31, 2024
GSK affirms that Arexvy is highly successful, however, they acknowledge that the fight against RSV is far from over - Fierce Pharma.
GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, generated sales of £1.2 billion in its first year on the market, outperforming Pfizer's RSV vaccine Abrysvo. However, GSK acknowledges the evolving market and competition from Moderna, whose mRNA vaccine for RSV has shown comparable efficacy. GSK's vaccine division achieved a 25% increase in sales driven by the success of Arexvy and its shingles vaccine, Shingrix, rebounding to reach £3.45 billion for the year. GSK expects revenue of £38 billion by 2031 and plans to launch a dozen products with $2 billion peak sales potential over the next four years.
Jan 31, 2024
SEC suggests granting approval to Johnson & Johnson's Tremfya while waiving the requirement for Phase III clinical trial
The Subject Expert Committee has recommended granting permission to Johnson & Johnson to import and market its psoriatic arthritis drug Guselkumab, branded as Tremfya in the US, in India. The committee advised a Phase III clinical trial waiver with certain conditions. Johnson & Johnson had approached the committee with data and justification for the waiver, as it was previously recommended to conduct Phase III trials. The drug is currently approved in the US, Japan, European Union, Canada, Switzerland, and Australia.
Jan 31, 2024
News-Medical.Net reports that the FTC is targeting drug manufacturers' extensive patent portfolios.
The Federal Trade Commission (FTC) is challenging the validity of over 100 drug product patents, specifically targeting devices used for drug delivery in an effort to increase competition and lower prices. This move, supported by President Joe Biden, aims to cut away at patent thickets created by pharmaceutical companies that make it difficult for cheaper generics to enter the market. The FTC argues that patent law protects active ingredients, not delivery methods. Several companies have already withdrawn patents in response to the FTC's challenge. The agency plans to continue examining other types of patents as well.
Jan 31, 2024
NPR reports that the highly anticipated Alzheimer's medication is withdrawn due to underwhelming sales
Drugmaker Biogen is pulling the plug on its Alzheimer's drug Aduhelm after disappointing sales. The drug, which was expected to be a blockbuster, aimed to clear sticky clumps of protein called amyloid from the brains of Alzheimer's patients. Despite receiving FDA approval in 2021, the drug failed to gain traction due to limited coverage by Medicare and weak demand. Biogen will now focus on its other FDA-approved Alzheimer's drug, Leqembi.
Jan 31, 2024
Biogen intends to terminate the production of its Alzheimer's drug Aduhelm, which has faced significant controversy - The Week
Biogen has announced that it will discontinue the development of its Alzheimer's treatment Aduhelm and stop its sales. The drug had initially been granted accelerated approval by the FDA in 2021 but faced challenges due to weak evidence of its effectiveness. Biogen will now focus on other Alzheimer's treatments and assist Japanese drugmaker Eisai in selling the FDA-approved treatment Leqembi. Aduhelm's discontinuation will result in a charge of approximately $60 million for Biogen.
Jan 31, 2024
Fox Business reports that in response to the increasing demand, Novo Nordisk plans to boost the availability of Wegovy.
Novo Nordisk is increasing the supply of its weight loss drug Wegovy after facing supply issues due to high demand. The company is doubling the amount of the lower dose strengths of the drug in the US market and gradually increasing overall supply throughout the year. However, Novo Nordisk warns that demand will still exceed supply, meaning some patients may struggle to fill prescriptions. The company is closely monitoring market dynamics and prescribing trends to support continuity of care for patients.
Jan 31, 2024
Biogen announces discontinuation of sales for its Alzheimer's drug Aduhelm - WAVY.com
Biogen has announced that it will stop selling its Alzheimer's treatment drug, Aduhelm. The drug, which was initially seen as a potential blockbuster, faced challenges after its launch. Biogen will also be ending a study of the drug needed for full approval from the FDA. The company will now focus on other treatments for Alzheimer's disease, including helping Japanese drugmaker Eisai sell its approved Alzheimer's treatment, Leqembi. The FDA is currently reviewing another potential drug from Eli Lilly and Co.
Jan 31, 2024
With increasing rivalry in the Lilly market, Novo CEO reveals plan for upcoming releases of Wegovy
Danish drugmaker Novo Nordisk is planning to target markets where it already has strong sales of its weight-loss drug Saxenda for the launch of its obesity shot Wegovy. This move comes as Novo Nordisk faces increased competition from US rival Eli Lilly, which received approval for its obesity drug Zepbound in multiple markets. Novo Nordisk CEO Lars Fruergaard Jorgensen stated that the company is closely monitoring Lilly's launches and will be looking at tactics market by market in response to the competition. The obesity drug market is projected to be worth over $100 billion by 2030.
Jan 31, 2024
Biogen to Cease the Sale of Aduhelm, Its Controversial Alzheimer's Medication - USNews.com
Biogen will stop selling its Alzheimer's treatment Aduhelm and end a study needed for full FDA approval. The drugmaker will focus on other treatments for Alzheimer's and continue to support the sales of Eisai's Leqembi. Aduhelm, the first new Alzheimer's drug in nearly two decades, faced challenges in insurance coverage and prescribing due to weak evidence of its effectiveness. Biogen will book a charge of about $60 million for shutting down the Aduhelm program.
Jan 31, 2024
Wegovy supply boost enables Novo Nordisk to expand patient access
Novo Nordisk has increased the supply of the lowest dose of its weight loss drug, Wegovy, in response to overwhelming demand. The supply restrictions had prevented many new patients from starting treatment and led to some being prescribed the off-label use of Ozempic for weight loss instead. Novo Nordisk also noted that insurance coverage for Wegovy continues to improve, making the drug more accessible to the estimated 50 million people in the US with obesity.
Jan 31, 2024
Novo's stock market value skyrockets above $500bn fueled by the frenzy over Wegovy obesity drug - Irish Examiner
Danish pharmaceutical company Novo Nordisk has reached a stock market valuation of over $500bn, driven by the success of its obesity drug Wegovy. The company's positive outlook and potential for growth have contributed to its recent gains. Novo has struggled to meet demand for Wegovy and its sister medicine Ozempic, prompting the company to increase its manufacturing capacity. However, analysts remain cautious and anticipate a decline in Novo's shares over the next year.
Jan 31, 2024
Novartis CEO highlights promising prospects despite disappointment with Pluvicto's radiotherapy
Novartis reports Q4 sales growth of 10%, but disappoints investors; radiotherapy drug Pluvicto falls below analysts' expectations with $273 million in Q4 sales; CEO Vas Narasimhan expects robust growth for Pluvicto in 2024; heart drug Entresto sees 26% sales growth; breast cancer drug Kisqali enjoys 76% year-over-year growth; Novartis CFO assures investors of continued margin improvement in 2024.
Jan 31, 2024
Biogen's Decision to Cease Production of its Alzheimer's Drug Aduhelm Draws Attention - Time
Biogen is discontinuing its development of the Alzheimer's treatment Aduhelm and ending sales of the drug. Although initially anticipated to be a blockbuster drug, Aduhelm faced challenges with weak evidence of its effectiveness, limited insurance coverage, and restrictions by Medicare. Biogen will shift its focus towards other Alzheimer's treatments and will assist in selling Eisai's Leqembi, which has already received full FDA approval. Aduhelm was the first new Alzheimer's drug in nearly 20 years but failed to meet expectations, generating only millions in sales rather than the predicted billions.
Jan 31, 2024
Pharmaceutical company announces discontinuation of controversial Alzheimer's drug Aduhelm
Biogen has announced that it will discontinue the development of its drug Aduhelm for the treatment of Alzheimer's disease. The decision comes after the drug faced challenges, including limited prescribing by doctors and restricted insurance coverage. Biogen will now shift its focus to other treatments for Alzheimer's. The company also plans to help Japanese drugmaker Eisai sell another Alzheimer's treatment, Leqembi. Aduhelm was initially expected to be a blockbuster drug that would generate billions in sales for Biogen.
Jan 31, 2024
The Washington Post reports a significant increase in profit for Novo Nordisk due to the successful expansion of Wegovy supply.
Novo Nordisk reported its highest annual profit in decades, driven by the strong sales of its diabetes and obesity drugs, including Ozempic and Wegovy. The company announced it is increasing supplies of Wegovy in the US to alleviate shortages. Novo plans to gradually increase supply throughout 2024 and is doubling the amount of lower-dose strengths available to new patients. Ozempic accounted for 41% of Novo's total sales in 2023, generating nearly $14 billion, while Wegovy brought in sales of approximately $4.5 billion.
Jan 31, 2024
Biogen intends to cease production of their contested Alzheimer's medication, Aduhelm - WBAL.
Drugmaker Biogen has announced that it will stop selling its Alzheimer's treatment, Aduhelm, and end a study of the drug required for full FDA approval. Aduhelm was the first new Alzheimer's drug in nearly two decades but faced challenges in insurance coverage and limited evidence of meaningful improvement in patients' lives. Biogen will now focus on other treatments for the disease, including helping Japanese drugmaker Eisai sell their Alzheimer's treatment, Leqembi. Another potential treatment option from Eli Lilly and Co is currently under FDA review.
Jan 31, 2024
Biogen intends to cease the production and distribution of Aduhelm, its Alzheimer's drug that has sparked controversy - CityNews Halifax.
Biogen has announced that it will stop selling its Alzheimer's treatment Aduhelm and will end a study for full FDA approval. The company will shift its focus to other treatments for the disease. Aduhelm, the first new Alzheimer's drug in nearly two decades, failed to gain wide adoption due to weak evidence of its effectiveness and restricted insurance coverage. Biogen is now helping Eisai sell another Alzheimer's treatment called Leqembi, which received full FDA approval last summer and has shown modestly positive effects in slowing cognitive decline.
Jan 31, 2024
STAT News reports that Pfizer's financial year commences with a modest level of profitability.
Summary: Biogen is terminating its partnership with Neurimmune, allowing the Swiss company to regain full rights to the intravenous medicine Aduhelm, which was Biogen's first approved drug for Alzheimer's disease. The decision marks the end of a nearly two-decade saga for the drug. Meanwhile, Vertex Pharmaceuticals' novel pain drug, VX-548, missed its secondary endpoint of outperforming acetaminophen and the opioid hydrocodone. Analysts and pain experts are now questioning the potential success of the drug. Additionally, 23andMe received FDA approval for the first clinical trial of its drug 23ME-01473, which targets ULBP6, a ligand found on the surface of cancer cells.
Jan 31, 2024
Biogen intends to cease production of its highly contested Alzheimer's medication Aduhelm - Quartz
Biogen has announced that it will stop selling its Alzheimer's treatment, Aduhelm, following its underwhelming performance in the market. The drugmaker will also end a study of the drug necessary for full approval from the FDA. Biogen will now focus on other treatments for Alzheimer's disease, including Leqembi, which received full FDA approval last summer. Aduhelm, initially priced at $56,000 a year, was expected to generate billions in revenue but faced skepticism from doctors and restricted coverage from insurers. Biogen will incur a charge of approximately $60 million in its fourth quarter for shutting down the Aduhelm program.
Jan 31, 2024
Novo Nordisk Initiates Steady Increments in Availability of Popular Weight-Loss Medication Wegovy
Novo Nordisk, the Danish pharmaceutical company, is gradually increasing the supply of lower-dose strengths of its weight-loss drug, Wegovy, after experiencing limited supply in the U.S. due to high demand. The company plans to invest over $6 billion to boost capacity. The popularity of Wegovy has led to shortages of Novo Nordisk's diabetes drug, Ozempic, as both medications share the same active ingredient. The company expects periodic supply constraints and drug shortages across various products and geographies. Sales of Novo Nordisk's GLP-1 medications, including Wegovy, grew 55% in Q4 2023.
Jan 31, 2024
Lina Khan's FTC utilizes available resources to target Big Pharma's 'patent ...
The Federal Trade Commission (FTC) has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, such as inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices. The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. The move by the FTC is part of President Joe Biden's directive to be more aggressive in reining in the pharmaceutical industry.
Jan 31, 2024
FTC Takes Action Against Drugmakers' 'Patent Thickets', according to KFF Health News.
The Federal Trade Commission (FTC) has initiated the challenge of over 100 drug product patents, particularly those related to inhalers and autoinjectors, in an effort to enhance competition and potentially lower prices. Drugmakers have allegedly utilized these patents to hinder the production of cheaper generic alternatives. This marks the FTC’s first attempt at this tactic, highlighting its commitment to reducing drug prices and encouraging generic competition, as directed by President Joe Biden. The targeted patents concern devices that dispense medications for asthma, epinephrine injections for severe allergic reactions, and other related treatments.
Jan 30, 2024
Guest perspective: A resolution for the New Year - Reducing pharmaceutical costs - Standard-Examiner
Utah residents are calling on Congress to reform the prescription drug pricing system to make medication more affordable. The article highlights the high costs of medications for conditions such as strokes, macular degeneration, and diabetes, and how pharmaceutical companies use tactics like creating patent thickets to maintain long-term profits. The article also mentions that the US Patent and Trademark Office (USPTO) often approves secondary patents that delay generic competition, and calls for stronger proof of non-obvious innovation. The Centers for Medicare and Medicaid Services (CMS) recently regained the ability to negotiate lower prices for certain medications, but further reforms are needed. Various bills offering solutions have already passed committees with bipartisan support.
Jan 30, 2024
The focus is on Eli Lilly's upcoming Q4 results as the highly successful weight-loss medication Zepbound gains attention.
Eli Lilly's weight-loss drug Zepbound has surpassed expectations, with strong market adoption and claims of 25,000 new prescriptions per week. Zepbound, a dual agonist targeting gut hormones involved in appetite control and metabolism, is seen as a potential game changer in the anti-obesity market, challenging Novo Nordisk's Wegovy as the first-line treatment. However, concerns about supply constraints and potential side effects exist. With the obesity market projected to reach $27.6 billion in the US by 2031, pharmaceutical companies are investing in expanding production capacity.
Jan 30, 2024
Pfizer's RSV vaccine gains momentum in Q4 following CEO's comment about a challenging start. What is the outlook for its performance?
Pfizer reported fourth-quarter sales of its respiratory syncytial virus (RSV) vaccine Abrysvo at $515 million, falling behind rival GSK's Arexvy. However, Pfizer remains focused on increasing Abrysvo's market share by expanding vaccination discussions year-round and targeting adults with underlying medical conditions. The company is also encouraged by the initial sales of Abrysvo as a maternal vaccine. Additionally, Pfizer prioritizes achieving world-class oncology leadership and plans to maximize the performance of its new products, including its pneumococcal vaccine and the development of COVID/flu and RSV vaccine combinations.
Jan 30, 2024
'Drug with significant impact' successfully eliminates pain directly without addictive properties - Daily Mail
Vertex Pharmaceuticals has revealed that an experimental drug called VX-548 has shown promise in treating moderate-to-severe pain without causing addiction. The drug works by cutting off pain signals at their source, rather than acting on the brain's perception of pain like opioids. In Phase 3 trials involving 3,000 surgery patients, VX-548 was found to be as effective as acetaminophen in easing acute pain. Vertex Pharmaceuticals is planning to seek approval from the FDA for the drug. If approved, it could provide an alternative to opioids and help combat the opioid crisis.
Jan 29, 2024
BioWorld reports that Doma Biopharmaceutical has developed novel antibody-drug conjugates (ADCs) that target EGFR and MET, offering potential treatments for cancer.
Doma Biopharmaceutical, a pharmaceutical company, has patented new antibody-drug conjugates, E-6C4-M-2F11, targeting EGFR and MET for cancer treatment.
Jan 29, 2024
Major pharmaceutical corporations face a critical juncture, with J&J, Merck, and other industry leaders bracing for substantial losses...
Pharmaceutical companies like Johnson & Johnson, Merck, and Bristol Myers Squibb will face significant revenue losses as patents on their blockbuster drugs expire, allowing competitors to sell cheaper versions. The expiration of patents for drugs such as Merck's Keytruda and J&J's Stelara poses a challenge for these companies, but some are preparing by building their drug pipelines and exploring acquisitions and partnerships. Biosimilars, which are not identical copies of branded biologic drugs, may struggle to gain market share compared to generics, which are exact copies of small-molecule drugs. Medicare drug price negotiations will also impact revenues.
Jan 29, 2024
SK Biopharmaceuticals experiences a profitable turnaround aided by successful sales of epilepsy medication
SK Biopharmaceuticals reported a return to profit in the fourth quarter, driven by strong sales of its epilepsy drug, Xcopri. The company's operating profit for the quarter was 15.2 billion won ($11.4 million), exceeding analyst expectations. SK Biopharmaceuticals plans to use the additional funds to expand its pipelines, including targeted protein degradation and cell and gene therapies. The CEO projects that Xcopri will generate $1 billion in the US market alone by 2029.
Jan 29, 2024
US Regulators Greenlight Dupixent for Treating Esophageal Condition in Children
Regeneron and Sanofi's Dupixent have received approval from the US FDA to treat eosinophilic esophagitis (EoE) in children aged one to 11 years old who weigh at least 15 kg. EoE is a condition where white blood cells build up in the esophagus, causing inflammation that affects the ability to eat food. Dupixent, which is currently used for various inflammatory conditions, generated $8.68 billion in global sales in 2022. The companies are also hoping to gain FDA approval for Dupixent to treat chronic obstructive pulmonary disease (COPD).
Jan 29, 2024
Anticipated Q3 Performance of Dr Reddy's Labs: Modest Rise in Revenue and Net Profit Due to Sluggish Domestic Sales
Indian pharmaceutical company Dr Reddy's Laboratories is expected to report marginal year-on-year revenue growth and a low double-digit increase in net profit for the October-December quarter. Despite weak sales in the domestic market and price erosion in other key products in the US, the contribution from the blockbuster cancer drug Revlimid is expected to remain stable and offset the loss of revenue from other segments. The generic version of Revlimid is estimated to contribute around $100 million to the company's US revenue for the quarter.
Jan 29, 2024
Pfizer and Astellas aim to obtain revised authorization from EMA for Padcev in combination with Keytruda.
Pfizer and Astellas Pharma have applied to the European Medicines Agency to expand the use of their antibody-drug conjugate, Padcev (enfortumab vedotin), in combination with Keytruda (pembrolizumab), for the first-line treatment of advanced bladder cancer. The marketing authorisation update follows positive trial results, which indicated that the combination boosted survival rates. A decision on the application is expected this year. Padcev was originally approved in April 2022 for advanced and metastatic urothelial cancer patients.
Jan 29, 2024
Synthekine joins forces with Sanofi for the development of cytokine therapies, resembling the return of Dupixent.
Sanofi is partnering with Synthekine to develop and commercialize therapies for inflammatory diseases based on IL-10 receptor agonists. The collaboration will pay Synthekine at least $40 million upfront and includes additional payments tied to achieving milestones as well as tiered royalties on net sales. Sanofi already has success co-developing the blockbuster drug Dupixent, which generated €7.725 billion ($8.35 billion) in sales for the company in the first nine months of 2023. Sanofi will assume sole responsibility for subsequent preclinical, clinical, and commercial activities for the IL-10 therapeutics.
Jan 29, 2024
GSK receives a significant boost from the highly successful RSV vaccine, with sales projected to reach $1bn.
GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, is expected to reach $1 billion in sales, making it a blockbuster drug. The success of Arexvy has allowed GSK to outperform its main US rival, Pfizer. European regulators are reviewing the potential use of Arexvy for treating adults in their 50s, potentially expanding its patient base. This achievement may help alleviate concerns about GSK's pipeline of new drugs, as the company focuses on developing new treatments after spinning out its consumer division in 2022.
Jan 28, 2024
The pharmaceutical industry faces a crucial juncture, with J&J, Merck, and other major players bracing for substantial revenue declines...
Big pharmaceutical companies like Bristol Myers Squibb, Merck and Johnson & Johnson are facing a looming threat known as the patent cliff, which are expected to put tens of billions of dollars in sales at risk by 2030. Patent cliffs occur when a company's patents for leading branded products expire, allowing competitors to sell copycat drugs at lower prices. Some companies are well-prepared to offset losses caused by patent expirations by building their drug pipelines and forming partnerships with other firms.
