Pharma News
23 Jun 2024 to 29 Jun 2024
Jun 29, 2024
India aims to manufacture drugs similar to Ozempic for diabetes and obesity through the Production Linked Incentive (PLI) scheme by 2026.
Indian pharmaceutical companies will begin manufacturing Glucagon-like peptide receptor agonist (GLP-1RA) drugs for diabetes and obesity under the production linked incentive (PLI) scheme starting in 2026, after the patents expire.
Jun 28, 2024
Lexaria (NASDAQ: LEXX) introduces a new research initiative to assess the effectiveness of DehydraTECH...
Lexaria Bioscience has partnered with the National Research Council of Canada (NRC) for an applied research program to evaluate the molecular characteristics of DehydraTECH processed with the GLP-1 drug, semaglutide. This collaboration aims to provide data to support Lexaria's efforts in partnering with the pharmaceutical industry for the rapid introduction of DehydraTECH with GLP-1 drugs.
Jun 28, 2024
European Union facing backlash over cosmetic use of Ozempic amidst drug supply shortages, reports MedWatch
The European Union's drug regulator is urging countries to crack down on the cosmetic use of powerful weight loss and diabetes drugs due to ongoing shortages. The regulator has called for measures to control the distribution of these medicines and for drugmakers to ensure regulatory approval of marketing messages. The success of Novo Nordisk's Ozempic and Eli Lilly's Wegovy has led to shortages, leaving diabetes patients struggling to continue their treatment. Doctors are being advised to prescribe these drugs only for approved uses and to avoid prescriptions for cosmetic weight loss.
Jun 28, 2024
Pfizer hires former Novartis executive as head of oncology commercial operations - Fierce Pharma
Pfizer has appointed Tina Deignan, Ph.D., as the new leader of its oncology commercialization team. Deignan, who previously held senior roles at Novartis and Bristol Myers Squibb, will take over from Suneet Varma, who is retiring after 15 years with the company. Pfizer aims to market eight blockbuster cancer drugs by 2030 and has recently undergone a reorganization to prioritize its oncology division. This move comes as Pfizer's CDK4/6 inhibitor Ibrance has been losing market share, and Novartis' Kisqali has seen increased sales.
Jun 28, 2024
Opportunity worth USD 10 billion available in off-patent drug market for Indian Pharma exports by 2029.
The Indian pharma industry is expected to have a growth opportunity of USD 10 billion in the form of generics as 15 blockbuster drugs whose revenues are worth USD 112 billion will be off-patented between 2023 and 2029. The industry has recorded 8.85% growth in exports during April and May this year. The Director General of Pharmexcil highlighted the importance of prioritizing quality management in light of global regulatory concerns. Challenges such as geopolitical tensions, supply chain issues, pricing pressures, and increased scrutiny by global regulatory agencies still persist in the sector.
Jun 27, 2024
Pharma department announces plans to produce peptide diabetes drugs locally in India under PLI initiative
India plans to manufacture Glucagon-like peptide receptor agonist (GLP-1RA) drugs for diabetes and obesity under the production linked incentive (PLI) scheme starting from 2026 when the patents expire. This move comes in response to the overwhelming demand for GLP-1 drugs, which have been used off-label for weight loss. Companies like Eli Lilly and Novo Nordisk are also increasing their production capacity for these drugs. The market size for GLP-1RA drugs was evaluated to be around $22.4 billion globally in 2022 and is anticipated to grow at a CAGR of around 9.6% until 2032. Additionally, the Indian government is setting up a project monitoring unit to support pharma research and innovation under the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme.
Jun 27, 2024
Ascentage Pharma experiences significant jump after striking partnership with cancer drug rival Bamboo Works
Chinese drug developer Ascentage Pharma Group International has entered into an equity and drug partnership with Japanese pharmaceutical company Takeda International. Takeda will have an exclusive option to develop and market Ascentage's leukemia drug outside of China and Russia, in exchange for an initial payment of $100 million. Ascentage will receive milestone and other payments up to $1.2 billion, plus a percentage of future sales. Additionally, Takeda has taken a 7.73% equity stake in Ascentage. Ascentage also announced plans for a secondary listing in the United States.
Jun 27, 2024
Federal Circuit revives lawsuit alleging infringement of narrow label - BioWorld
The U.S. Court of Appeals for the Federal Circuit has revived a case involving drug label carveouts, stating that their previous decision will not eliminate "skinny labels". The decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will allow generics to enter the market while some of the brand's indications still have patent protection.
Jun 27, 2024
Nxera Pharma receives $10 million milestone payment from AbbVie, reported by Business Weekly
AbbVie has reached a milestone in its partnership with Nxera Pharma, resulting in a $10 million payment to Nxera. The collaboration, launched in 2022, aims to discover and develop new medicines targeting novel G protein-coupled receptor (GPCR) targets for neurological diseases. Nxera could potentially receive up to $40 million in near-term research milestones, along with further payments of up to $1.2 billion and royalties on global sales. The achievement of this milestone demonstrates the productive working relationship between the two companies. Nxera is focused on addressing unmet needs in medicine and has a pipeline of over 30 active programs.
Jun 27, 2024
AbbVie to acquire biotech company Celsius in Cambridge for $250 million, reports The Boston Globe.
Pharmaceutical company AbbVie has agreed to acquire Celsius Therapeutics for $250 million in cash. Celsius Therapeutics, a biotech company based in Cambridge, has developed an experimental drug for inflammatory bowel disease. AbbVie is known for its popular drug Humira, used to treat rheumatoid arthritis and other inflammatory conditions. The acquisition will allow AbbVie to further advance the development of Celsius's novel antibody for the treatment of inflammatory bowel disease.
Jun 27, 2024
Pharma Exports Increase by 8.8% to $4.73 Billion in Two Months, Reports Pharmexcil Director General
Indian pharmaceutical companies are expected to have a growth opportunity of $10 billion as 15 blockbuster drugs, worth $112 billion, go off patent by 2029. The Pharmaceutical Export Promotion Council of India (Pharmexcil) anticipates that this, along with various other factors such as the PLI scheme for pharma and trade agreements, will boost Indian pharma exports. The Indian pharmaceutical market is estimated to reach $130 billion by 2030, with the US, UK, and South Africa being the top three destinations for exports. Challenges include localisation efforts by destination countries and increasing competition from countries like Bangladesh and Vietnam.
Jun 27, 2024
Opportunity of $10 billion available in the off-patent drug market by 2029
The Indian pharma industry has a potential growth opportunity of $10 billion through generics as 15 blockbuster drugs worth $112 billion will be off-patent between 2023 and 2029, according to Udaya Bhaskar, Director General of Pharmexcil. Indian pharma exports also saw an 8.85% growth in April and May 2024, reaching $4.73 billion. Bhaskar emphasized the need for quality management to overcome challenges such as geopolitical tensions, pricing pressures, and increased scrutiny by regulatory agencies. Latin America and Africa are the targeted regions for Indian pharma exports.
Jun 27, 2024
Novo Nordisk intends to limit the initial distribution of Wegovy in China - Quartz
Danish pharmaceutical giant Novo Nordisk plans to launch its weight loss drug Wegovy in China, following approval from the Chinese National Medical Products Administration. However, the company will initially restrict sales of the medication in order to manage supply shortages. Wegovy, the first GLP-1 treatment approved in China for long-term weight management, targets overweight and obese patients with a BMI greater than 27kg/m2 and weight-related comorbidities. Novo Nordisk's exclusivity in China will be limited, as the Chinese patent on the active ingredient in Wegovy is set to expire in 2026.
Jun 27, 2024
Nature explores how popular weight loss medications induce a sense of fullness before eating - a breakthrough in combating obesity.
Scientists have identified a brain region responsible for the feeling of fullness before and after a meal. The study found two distinct groups of neurons associated with feeling full, one for pre-meal fullness and one for post-meal fullness. The research also showed that weight-loss drugs, such as liraglutide, act on these neurons to trigger a feeling of fullness. Further research is needed to determine the exact mechanism of these drugs. The findings contribute to the understanding of the brain's role in regulating appetite and could inform the development of new obesity treatments.
Jun 26, 2024
China approves AstraZeneca's Tagrisso in combination with chemotherapy for initial cancer treatment
China has approved the use of AstraZeneca's cancer drug Tagrisso in combination with chemotherapy as a first-line treatment for adults with advanced lung cancer. The approval by China's National Medical Products Administration was based on trials showing that patients given the combination treatment lived without the disease getting worse longer than those given just Tagrisso. The approval provides another effective treatment option for EGFR-mutated lung cancer in China.
Jun 26, 2024
Approaches of Pfizer, Bristol Myers Squibb, and Johnson & Johnson in Tackling Patent Expirations
Pharmaceutical companies Pfizer, Bristol Myers Squibb, and Johnson & Johnson are preparing for patent cliffs by employing various strategies. Pfizer has made a $43 billion acquisition of Seagen and entered into licensing agreements, while Bristol Myers Squibb is exploring alternative formulations and multiple IP strategies. Meanwhile, Johnson & Johnson is developing alternative treatments and cutting back on expenditures. The expiration of patents for drugs such as Eliquis, Ibrance, Opdivo, and Stelara could result in significant revenue loss for the companies.
Jun 26, 2024
Verona's Ohtuvayre receives approval from FDA, poised to make waves in the COPD market - Fierce Pharma
The FDA has approved Verona Pharma's Ohtuvayre (ensifentrine) to treat chronic obstructive pulmonary disorder (COPD). Ohtuvayre is the first novel treatment for COPD in over a decade and is approved as an add-on medicine with current therapies. Ohtuvayre combines two properties in one medicine, opening the airways of patients and reducing inflammation. Verona plans to launch Ohtuvayre in the third quarter of this year, and analysts estimate potential sales of $1.05 billion by 2029.
Jun 26, 2024
Novo Nordisk Sees Record Sales for Wegovy and Ozempic, Prompting Significant Investment in Factory
Pharmaceutical company Novo Nordisk plans to invest over $4 billion in a new factory in North Carolina to meet the high demand for its weight loss drugs, Wegovy and Ozempic. Sales of Wegovy have more than doubled, with 130,000 prescriptions being filled each week, while Ozempic's popularity has helped push Novo Nordisk's value close to $500 billion. The new factory will add 1,000 jobs and is expected to be operational by 2027. The investment aims to address supply shortages and meet the growing market demand for weight loss drugs.
Jun 26, 2024
Drug shortages persist at US cancer centers, affecting various types of medications, warn health institutions
A new report reveals that despite an improved shortage of chemotherapy drugs cisplatin and carboplatin, some of the largest cancer centers in the US report additional concerns related to drug shortages. The survey shows that 89% of the 28 centers surveyed had at least one drug in short supply, including 57% of Vinblastine, 46% of Etoposide, and 43% of Topotecan. These drugs are used in combination to treat Hodgkin's lymphoma, non-Hodgkin's lymphoma, and cancer of the testicles.
Jun 26, 2024
Intra-Cellular Therapies' Caplyta Receives Buy Rating Confirmation, Expected to Achieve Blockbuster Success
Jefferies analyst Andrew Tsai has assigned a Buy rating to Intra-Cellular Therapies (ITCI), with a price target of $105. Tsai believes that the company's drug, Caplyta, has the potential to be a blockbuster treatment for schizophrenia and depression, with anticipated peak sales of $2 billion. He sees an attractive entry point for investors, as the company's valuation is below pre-major depressive disorder (MDD) data price levels. Tsai also highlights that recent deals in the CNS/neuro space indicate Big Pharma's interest in these areas, supporting the positive outlook for ITCI.
Jun 26, 2024
China gives the green light to AstraZeneca's combination of Tagrisso and chemotherapy as initial treatment option
China's National Medical Products Administration (NMPA) has approved the use of AstraZeneca's cancer drug, Tagrisso, in combination with chemotherapy as a first-line treatment for adults with advanced lung cancer. Trials have shown that patients given the combination treatment lived longer without the disease progressing compared to those given just Tagrisso. Median progression-free survival for patients treated with Tagrisso and chemotherapy was 25.5 months, 8.8 months longer than those treated with just Tagrisso.
Jun 26, 2024
Europe faces criticism over the use of Ozempic in cosmetics amidst drug supply issues - report by The Business Times
The European Union's drug regulator has called on member states to control the cosmetic use of weight loss and diabetes drugs due to ongoing shortages. The regulator emphasised that priority should be given to patients who require these medicines for legitimate medical reasons. It also urged doctors to prescribe these treatments strictly according to their approved uses and discouraged prescribing for cosmetic weight loss. The regulator also warned against purchasing weight-loss drugs online without a prescription, highlighting the dangers of obtaining counterfeit products.
Jun 26, 2024
China greenlights AstraZeneca's Tagrisso-chemotherapy combination for initial therapy
China has approved the use of AstraZeneca's cancer drug Tagrisso in combination with chemotherapy as a first-line treatment for advanced lung cancer patients. The approval was based on trials that showed patients receiving the combination treatment had a longer progression-free survival compared to those receiving Tagrisso alone. The median progression-free survival for patients on the combination treatment was 25.5 months, 8.8 months more than those on solo Tagrisso.
Jun 26, 2024
Innovent and Eli Lilly reveal weight loss candidate information, aim to rival Novo in Chinese market
Innovent Biologics and Eli Lilly have provided new details about their weight loss drug candidate, mazdutide, following the approval of Novo Nordisk's Wegovy in China. Mazdutide has shown a 15% weight loss in a study involving 610 obese Chinese individuals, similar to results seen with Eli Lilly's Zepbound. Innovent intends to seek approval for Mazdutide in China, and it is projected to reach sales of $1.3 billion by 2030.
Jun 26, 2024
China Approves Wegovy Weight-Loss Medication - Global News on Chinadaily.com.cn
Danish drugmaker Novo Nordisk has received approval for its injectable weight-loss drug Wegovy in China, where over 50% of adults are overweight or obese. The launch date and volume details have not been announced yet. Novo Nordisk's Ozempic, approved for diabetes treatment in China in 2021, saw sales in the region double in 2023. Novo Nordisk plans to guarantee supplies before launching Wegovy in China due to ongoing shortages in the US market. The drug will initially be available to patients with a body mass index indicating obesity and at least one weight-related comorbidity.
Jun 26, 2024
Indian and Chinese pharmaceutical companies working on developing more affordable obesity medications - Juta MedicalBrief
Indian and Chinese pharmaceutical companies are developing biosimilar versions of weight-loss drugs as patents for the original drugs near expiry. These biosimilars are cheaper versions of the expensive brand-name drugs and are expected to widen access to these effective treatments for obesity. With over 1 billion people globally being obese or overweight, the demand for anti-obesity drugs is strong. By developing biosimilars, companies hope to reduce the cost of these drugs, making them more accessible to patients who need them.
Jun 25, 2024
Imfinzi, a Cancer Drug from AstraZeneca, Fails to Meet Expectations in Follow-Up Trial for Early-Stage ...
AstraZeneca's cancer drug Imfinzi did not achieve statistical significance in a Phase 3 trial for early-stage non-small cell lung cancer, according to topline data released by the company. However, Imfinzi did meet its primary goal in a separate Phase 3 study for bladder cancer. The drug is already approved for certain lung cancer patients and is being investigated for use in other settings.
Jun 25, 2024
China Approves Novo Nordisk's Weight Loss Drug Wegovy - Reported by Caixin Global
Danish pharmaceutical company Novo Nordisk has received approval from the National Medical Products Administration in China to market its weight management drug Wegovy for the treatment of overweight or obese individuals. Wegovy, the weekly jab version of the drug Ozempic, is set to compete with next-generation obesity drugs in the Chinese market.
Jun 25, 2024
Shares of Novo Nordisk rise following reports of approval for Wegovy weight-loss drug in China
Shares of Novo Nordisk reached record highs after the company's weight-loss treatment, Wegovy, received approval from regulators in China. The drug has been approved for long-term weight management, although the company did not provide details on pricing or availability. Novo Nordisk faces competition in the Chinese market, where the number of overweight adults is expected to increase. The global weight-loss market is projected to be worth at least $100 billion by 2030. Novo Nordisk has seen high demand for Wegovy, leading to supply shortages and the need to increase manufacturing capabilities.
Jun 25, 2024
Victoza generic version now on sale in the United States, according to DiaTribe.
Pharmaceutical company Teva Pharmaceuticals has launched the first generic GLP-1 receptor agonist, Generic Victoza, in the U.S. The drug is indicated for the treatment of type 2 diabetes and reducing the risk of cardiovascular events in adults. Generic Victoza will be available at a reduced price compared to the brand-name version. Sandoz and Viatris are also working on their generic versions of Victoza, which may launch in December 2024, further increasing competition and reducing prices.
Jun 25, 2024
Novo Nordisk to Build $4.1 Billion Fill-Finish Plant at Clayton, North Carolina Facility
Novo Nordisk will invest $4.1bn to build a new fill-finish plant on its campus in Clayton, North Carolina, to meet rising demand for its obesity drugs and strengthen its manufacturing capacity for injectable treatments. The new plant will create 1,000 jobs and add 1.4 million square feet of space for manufacturing and production processes. It will be one of the largest manufacturing investments in Novo Nordisk's history. Construction is expected to be completed between 2027 and 2029. Novo Nordisk is expanding its global manufacturing capacity and has invested $6.8bn in production initiatives this year.
Jun 25, 2024
Novo Nordisk receives approval to market weight-loss medication Wegovy in China - Morningstar
Danish pharmaceutical company Novo Nordisk has received approval to market its weight-loss drug Wegovy in China. This approval will allow Novo Nordisk to expand sales of its blockbuster drug in the world's second-largest economy. Wegovy is a long-term weight-management treatment for individuals who are overweight or obese. The injection-based drug has already seen success in other countries, and Novo Nordisk aims to tap into China's significant demand for weight-loss medications. The approval from China's National Medical Products Administration marks another milestone for Novo Nordisk as it continues to generate substantial sales from its weight-related drugs.
Jun 25, 2024
Lilly partners with OpenAI to explore innovative treatments for antibiotic-resistant bacteria
Pharmaceutical company Eli Lilly and Company has announced a collaboration with OpenAI to develop new antimicrobials to treat drug-resistant pathogens. The partnership will leverage OpenAI's generative AI technology to accelerate the discovery of novel antimicrobials. Antimicrobial resistance is a significant global health challenge, and this collaboration aims to address the problem by finding innovative breakthroughs in the field of pharma.
Jun 25, 2024
Pharmaceutical companies resist FTC's recent patent enforcement push. What are the implications?
Eight pharmaceutical companies, including Novo Nordisk and GlaxoSmithKline (GSK), have decided not to remove patents listed in the US Food and Drug Administration's (FDA) Orange Book, despite challenges from the Federal Trade Commission (FTC). The agency argues that some companies are using sham patents to prevent timely generic competition, delaying the entry of lower-priced generic drugs. The FTC is "considering all options" in response to the drugmakers' refusal to remove the listings, but Novo Nordisk and GSK have argued that the listings are "appropriate and in compliance with applicable law".
Jun 25, 2024
Imfinzi from AstraZeneca does not show effectiveness in late-stage trial for treating specific lung cancer type
AstraZeneca's cancer drug Imfinzi has failed to improve disease-free survival in a late-stage trial for early-stage lung cancer. The ADJUVANT BR.31 trial did not meet its primary endpoint of disease-free survival compared to a placebo in patients whose tumors expressed PD-L1 on 25% or more tumor cells. Imfinzi, a human monoclonal antibody, blocks a tumor's ability to evade the immune system while boosting the body's anti-cancer response. AstraZeneca expressed disappointment in the results.
Jun 25, 2024
Novo Nordisk receives authorization in China for GLP-1 obesity treatment Wegovy - Fierce Pharma
Novo Nordisk's obesity treatment, Wegovy, has received marketing approval from China's National Medical Products Administration. The drug, which is the same compound as Novo Nordisk's diabetes drug Ozempic, will be marketed as NovoCare in China. With obesity on the rise in China, Wegovy's approval will address the high medical need for effective treatments. However, Novo Nordisk will face challenges as its patent for semaglutide, the compound in the drug, is set to expire in two years, potentially leading to increased competition in the market.
Jun 25, 2024
Johnson & Johnson's Tremfya fails to meet expectations in Phase II study for giant cell arteritis - BioSpace
Johnson & Johnson (J&J) has halted a mid-stage trial investigating its monoclonal antibody, Tremfya (guselkumab), in giant cell arteritis after it failed to reach the primary endpoint. The Phase II study did not meet the percentage of participants achieving glucocorticoid-free remission, but no specific details were disclosed. The decision does not impact other guselkumab development programs, and J&J remains committed to developing therapies for rheumatologic diseases. Tremfya has been successful in other indications and generated significant sales for J&J. Other companies have made progress in the treatment of giant cell arteritis.
Jun 25, 2024
Novo Nordisk, the creator of Ozempic, has now entered one of the biggest weight loss markets globally
Danish pharma company Novo Nordisk has obtained approval from the Chinese National Medical Products Administration for its weight loss treatment, Wegovy. This approval allows Novo Nordisk to enter one of the world's largest weight loss markets. Wegovy is the first and only GLP-1 treatment approved in China for long-term weight management. However, the company's exclusivity will not last long, as its Chinese patent on the active ingredient in Wegovy is set to expire in 2026.
Jun 24, 2024
Novo Nordisk plans to construct a new $4.1 billion facility in North Carolina to increase production of Wegovy and Ozempic.
Danish drugmaker Novo Nordisk plans to invest $4.1bn in a new manufacturing plant in Clayton, North Carolina, to increase supply of its weight loss drug Wegovy and diabetes treatment Ozempic. The facility will be responsible for filling and packaging syringes and injection pens for the drugs. Novo Nordisk's investment in production this year will be $6.8bn, up from $4bn in 2020.
Jun 24, 2024
FDA Gives Green Light to Argenx Drug for Rare Nerve Disease CIDP, First New Treatment in Decades
Amsterdam-based biotech company Argenx has received additional FDA approval for its drug Vyvgart Hytrulo as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare autoimmune disorder that affects the nerves. The approval marks the first new treatment for CIDP in decades and provides a new blockbuster opportunity for Argenx. Vyvgart Hytrulo is designed to reduce levels of immunoglobulin G autoantibodies, which damage the nerves in CIDP patients. The drug is already approved for the treatment of generalized myasthenia gravis.
Jun 24, 2024
Which other medical conditions are weight loss medications being undergoing testing for? - ET HealthWorld
Eli Lilly's diabetes drug Mounjaro and weight-loss therapy Zepbound, as well as Novo Nordisk's rival medicines Ozempic and Wegovy, are being studied to determine their effectiveness in treating other health conditions. Zepbound has shown promise in resolving obstructive sleep apnea, while semaglutide is being investigated for alcohol addiction, Alzheimer's disease, heart failure and obesity, strokes caused by blocked blood vessels in the brain, chronic kidney disease, fatty liver disease, and neurological disorders.
