Pharma News
25 Feb 2024 to 02 Mar 2024
Mar 2, 2024
A third American judge supports the Medicare program for negotiating drug prices - XM
A federal judge in Delaware has upheld a law that requires certain drugmakers to negotiate prices with Medicare, a program under President Joe Biden's administration. The ruling, the third in favor of the administration's negotiation program, comes as AstraZeneca faces a bid for the price of its diabetes drug Farxiga. Other drugs included in the program are Bristol-Myers Squibb's Eliquis, Merck & Co's Januvia, and Johnson & Johnson's Xarelto. Failure to participate in the program results in fines or withdrawal from Medicare. AstraZeneca expressed disappointment in the ruling and is considering next steps.
Mar 2, 2024
A third judge has upheld the Medicare drug price negotiation program.
A federal judge in Delaware has upheld a law that requires certain drugmakers, including AstraZeneca, to negotiate prices with Medicare, a key initiative of President Joe Biden. The ruling comes as AstraZeneca prepares to respond to the Biden administration's request for the price of its diabetes drug, Farxiga. This is the third time the negotiation program has been upheld in court.
Mar 1, 2024
Another US judge confirms the Medicare drug price negotiation initiative
In a significant victory for President Joe Biden's Medicare negotiation program, a federal judge in Delaware has upheld a law that requires certain drugmakers to negotiate prices with Medicare. AstraZeneca's challenge to the law was rejected by U.S. District Judge Colm Connolly. This marks the third court challenge that the Biden administration's negotiation program has overcome. The chosen drugs for the initial round of negotiations include Eliquis, Januvia, and Xarelto. AstraZeneca is due to respond to the U.S. government's proposal for the price of its diabetes drug Farxiga.
Mar 1, 2024
Akebia fights to protect patents for anaemia drug at EPO during intense Fibrogen conflict
Biotechnology company Akebia has successfully defended two patents for its anaemia drug, Vafseo, at the European Patent Office. The patents cover the drug's active ingredient, vadadustat, which is used to treat chronic kidney disease in adults. Akebia is currently engaged in a patent dispute with Fibrogen, and the upheld patents are commercially important for the company. The global market for anaemia treatment drugs is predicted to be worth $15 billion by 2028.
Mar 1, 2024
Update on the Patent Term Extension Regulations in China featured in WHD Insights Newsletter number 57
China has introduced a patent term extension (PTE) regime through the fourth amendment to its Patent Law. The newly revised regulations provide details on PTEs, which include compensating for delays in prosecution and obtaining administrative approval for new drugs. The extended term of a PTE will be calculated based on the unreasonable delay in prosecution process, reasonable delay, and delay caused by the applicant. The PTE regime is set to go into effect on January 20, 2024, in China. The regulations also outline eligibility criteria and application timelines for PTEs.
Mar 1, 2024
Multiple pharmaceutical companies including BeiGene, BMS, and AZ-FibroGen featured in Fierce Pharma Asia news.
BeiGene has expanded its global workforce by 1,400 people in the past year, driven by strong revenue growth, particularly from its BTK inhibitor Brukinsa. Bristol Myers Squibb has opened a new innovation hub in India, which it expects to be its largest site outside the U.S. by 2025. AstraZeneca has decided to keep its rights to the anemia drug Evrenzo in China and Korea, while returning rights to FibroGen in the U.S. and other territories. The FDA plans to increase inspections of manufacturing facilities in India. Takeda has partnered with Biological E. to manufacture the dengue fever vaccine Qdenga. Biocon Biologics has reached a settlement with Johnson & Johnson over the biosimilar of the inflammatory disease drug Stelara. Teva has partnered with Jiangsu Nhwa Pharmaceutical to market and distribute its drug Austedo in China.
Feb 29, 2024
Pfizer outlines its plans for oncology, aiming for the development of 8 potentially successful cancer medications by 2030
Pfizer has laid out its new oncology strategy following its $43bn acquisition of antibody-drug conjugate specialist Seagen. The company aims to have at least eight blockbuster cancer drugs by 2030, focusing on breast cancer, genitourinary cancer, blood cancer, and thoracic cancers. Pfizer plans to accelerate breakthroughs in these areas and move approved medicines into earlier lines of treatment. The company also aims to increase the proportion of biologics in its revenue mix from 6% to 65% by 2030. Pfizer's top three cancer drugs are expected to decline due to upcoming patent expirations.
Feb 29, 2024
Orbis Medicines begins operations with €26 million in seed funding to revolutionize macrocycle drug development...
Orbis Medicines, a leader in oral macrocycle drug discovery, has secured €26 million in financing led by Novo Holdings and Forbion. The funding will be used to support the expansion and advancement of Orbis' portfolio of next-generation macrocycle drugs called 'nCycles'. Orbis' pipeline focuses on developing high-value oral alternatives to blockbuster biologic drugs and targets challenging for established modalities. The company's nGen platform combines chemical synthesis, large-scale assaying, and machine learning to explore the macrocycle chemical space and design orally bioavailable and membrane permeable drugs.
Feb 29, 2024
Orbis Medicines has launched with $26 million in funding to transform the field of oral drug discovery.
Orbis Medicines, a biotechnology company, has emerged with $26 million in seed funding from investors Novo Holdings and Forbion. They aim to revolutionize macrocycle drug development with their nGen1 platform, creating oral alternatives to blockbuster biologic drugs. The platform utilizes high-throughput chemical synthesis, large-scale assaying, and machine learning to rapidly generate diverse macrocycle compounds. Orbis Medicines' goal is to address unmet medical needs and expand patient populations. With strong scientific foundations and support, the company is poised to lead in oral macrocycle drug discovery.
Feb 29, 2024
Actress Amy Schumer discontinues use of Ozempic— Are new popular weight loss medications linked to cancer risk?
Comedian Amy Schumer, known for her openness about her body and health, shared on “Watch What Happens Live with Andy Cohen” that she tried the weight loss drug Ozempic and experienced severe side effects, prompting her to stop taking it. Schumer also divulged that she had undergone liposuction. Ozempic, the brand name for Novo Nordisk’s semaglutide, has been associated with an increased risk of cancer, according to healthcare company Lexicomp. semaglutide" style="color: #F36C42; font-weight:600";>Semaglutide is an injectable prescription medicine for adults with type 2 diabetes, and is also approved for weight loss.
Feb 29, 2024
PharmAust progresses monepantel for ALS treatment towards FDA approval - Yahoo Finance
PharmAust Limited is advancing the development of monepantel, an approved veterinary drug, for the treatment of motor neurone disease. The company recently had a positive Pre-Investigational New Drug Application meeting with the US FDA, highlighting the drug's potential in breaking down toxic protein build-ups in neurons. PharmAust has completed a Phase 1 oncology clinical study in humans and is preparing for a pivotal field trial in dogs. Monepantel's mechanism also positions it as a potential treatment for neurodegenerative diseases like Alzheimer's and Parkinson's. The FDA's positive feedback indicates the potential for full approval after a 48-week study.
Feb 28, 2024
Eli Lilly, a prominent pharmaceutical company, announces intentions to launch its popular diabetes medication Mounjaro in the United States.
Eli Lilly plans to bring its diabetes medication, Mounjaro, to the Indian market next year pending regulatory approval. The drug has already been approved in the US, UK, and Europe for weight loss. Alongside Mounjaro, Lilly's weight loss drug Zepbound is also scheduled for launch pending regulatory clearance. The company is focusing on launching these drugs in new markets as part of its expansion efforts. India presents a promising market for anti-obesity drugs due to its high diabetes and obesity rates. Several other pharmaceutical companies also offer weight loss medications in the country.
Feb 28, 2024
Major American Pharmaceutical Companies Focus on Indian Market for Launching Their Popular Drugs, Including ...
Pharmaceutical giant Eli Lilly plans to introduce its obesity drug tirzepatide in India next year. The drug, marketed as Mounjaro for diabetes and Zepbound for weight loss in the US, holds potential for the Indian market. Eli Lilly's CEO, David Ricks, emphasized the need for India to enhance patent protection and eliminate redundant policies to attract more investment. Competitor Novo Nordisk plans to bring its weight-loss drug Wegovy to India by 2026. Bristol Myers Squibb also announced plans to expand its research and development footprint in India.
Feb 28, 2024
PharmAust makes progress with monepantel for motor neurone disease towards approval by the FDA
PharmAust Limited CEO, Dr. Michael Thurn, announces the "pivotal" Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA regarding the development of monepantel for motor neurone disease. Positive feedback from the FDA indicates the potential for full approval after a 48-week study. Monepantel's mechanism also positions it as a promising treatment for neurodegenerative diseases like Alzheimer's and Parkinson's. The company has completed Phase 1 oncology clinical studies for monepantel in humans and is preparing for a pivotal field trial in dogs for B cell lymphoma. Data for the motor neurone disease program is expected by the end of February.
Feb 28, 2024
Major American pharmaceutical companies focus on the Indian market for selling their popular drugs, such as ...
Eli Lilly plans to introduce its obesity drug, tirzepatide, in India next year. The drug, marketed as Mounjaro and Zepbound in the US, shows promise for the Indian market. Lilly's CEO, David Ricks, stressed the need for India to enhance patent protection and establish a robust social safety net to attract increased investment from global pharmaceutical companies. Danish rival Novo Nordisk also plans to introduce its weight-loss drug in India by 2026. Additionally, Bristol Myers Squibb aims to expand its research and development presence in India through a $100 million facility.
Feb 28, 2024
Executive Changes in Leadership Roles at ReNAgade, Adaptimmune, Vittoria, and Others
AbbVie CEO Richard Gonzalez will retire in July after 11 years at the helm of the biopharmaceutical company, during which he helped navigate the U.S. patent cliff for the blockbuster drug Humira. ReNAgade Therapeutics, ranked 6th in BioSpace's 2024 NextGen class, appointed Joe Bolen, former R&D boss at Moderna Therapeutics, as its first chief science innovation officer. Other executive moves include Cintia Piccina returning as chief commercial officer at Adaptimmune, and Rosemary Mazanet joining Vittoria Biotherapeutics as chief medical officer.
Feb 28, 2024
PharmaBiz reports Roche introduces Ocrevus for the treatment of multiple sclerosis in India
Roche Pharma India has launched Ocrevus (ocrelizumab), its breakthrough drug for the treatment of multiple sclerosis (MS) in India. Ocrevus is the only monoclonal antibody drug approved for both relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). It has shown significant impact in slowing disability progression and has a high persistence and adherence rate due to its twice-yearly dosing. Ocrevus has been approved for both forms of MS and has been used to treat over 300,000 patients globally.
Feb 28, 2024
CEO of Eli Lilly suggests possibility of launching obesity drug in India in the coming year
Eli Lilly plans to launch its diabetes and obesity drug, Mounjaro, in India next year, pending regulatory approval. India, with its high obesity rates and a large population with type-2 diabetes, presents a significant market opportunity. Lilly is open to partnering with other companies to bring the drug to the market. Mounjaro, also known as tirzepatide, is a GLP-1 receptor agonist that controls blood sugar and aids weight loss. Market analysts estimate that the global market for these treatments will reach $100 billion by the end of the decade.
Feb 28, 2024
CEO of Eli Lilly Reveals Plans to Potentially Introduce Obesity Drug in India in 2023
Eli Lilly plans to launch its blockbuster diabetes and obesity drug, Mounjaro, in India next year after completing the regulatory review process. With high obesity rates and a large population of people with type-2 diabetes, India presents a significant market opportunity. Indian drug manufacturers are also developing their own weight-loss drugs, while illegal versions are sold online. Lilly is open to partnering with others to expand access to the drug. Mounjaro is currently sold under different brand names in the UK, Europe, and the US. The global market for GLP-1 receptor agonists is expected to reach $100 billion by the end of the decade.
Feb 28, 2024
Eli Lilly's CEO has disclosed plans to potentially introduce an obesity medication in India by next year, as reported by The Economic Times.
American drugmaker Eli Lilly plans to launch its diabetes drug Mounjaro, which contains the active ingredient tirzepatide, in India as early as next year. This move comes in response to the significant market opportunity driven by high obesity rates and a large number of people with type-2 diabetes in the country. Indian drugmakers are also developing their own versions of similar drugs, and Lilly is open to authorized generic versions of its drugs if it is feasible and helps expand access to patients.
Feb 28, 2024
Eli Lilly's CEO reveals plans to potentially introduce obesity drug in India in the coming year, in an exclusive interview with SaltWire.
U.S. drugmaker Eli Lilly plans to launch its blockbuster diabetes and obesity drug, Mounjaro, in India next year following regulatory approval. India's high obesity rates and large number of people with type-2 diabetes make it an attractive market. Eli Lilly is open to partnerships to expand its reach in the country. Mounjaro, also known as tirzepatide, is currently sold in the UK and Europe for both conditions under the same brand name but is sold as Zepbound for weight loss in the U.S. Indian drugmakers are also developing their own versions of weight-loss drugs.
Feb 28, 2024
Eli Lilly plans to introduce obesity drug Tirzepatide in India by the following year - Republic World
US-based drug company Eli Lilly plans to introduce its breakthrough obesity drug, Tirzepatide, to the Indian market next year. The CEO, David Ricks, stated that the company is committed to expanding patient access to the drug to address the rising obesity epidemic in India. Tirzepatide has shown efficacy in managing diabetes and promoting weight loss. This move by Eli Lilly follows a trend in the pharmaceutical industry of focusing on innovative therapies for chronic conditions like obesity and diabetes. The global market for these treatments is projected to exceed $100 billion by the end of the decade.
Feb 28, 2024
CEO of Lilly indicates possibility of introducing obesity medication in India in the coming year, report The Economic Times
Drug company Lilly is considering launching an obesity drug in India next year, according to its CEO. The move would address the growing problem of obesity in the country and provide a new treatment option for patients.
Feb 28, 2024
Innovative Approach Facilitates Development of Cancer Treatments - Report from Faharas News
The University at Buffalo has proposed a streamlined approach to cancer drug development that focuses on linker placement in molecule fragments. By optimizing the connection points, researchers have found significant increases in drug potency against cancer. This innovative method has the potential to revolutionize fragment-based drug discovery and could lead to more efficient and cost-effective cancer treatments. The research team has already filed patents for their EGFR inhibitors, demonstrating the practical applications of their findings. The support and validation from the National Institutes of Health further enhance the credibility and potential of this new approach.
Feb 28, 2024
UCB aims to expand use of psoriasis medication Bimzelx with four new indications in 2024 to achieve success similar to a blockbuster.
Pharmaceutical company UCB is focused on growing its blockbuster drug Bimzelx and expanding its indications for the treatment of psoriasis to include psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. The company expects these additional approvals to happen before the end of 2024. UCB's recent approvals include drugs for generalized myasthenia gravis and epileptic seizures. The company is projecting revenue between 5.5 billion euros and 5.7 billion euros in 2024, driven by the global launches of several drugs.
Feb 27, 2024
India potentially shifting stance on pharmaceutical patents in Swiss trade agreement
Switzerland and India have made progress in their negotiations on a free trade agreement, with a focus on intellectual property protection. The Swiss pharmaceutical industry has argued for stronger patent protection to prevent Indian drug-makers from producing copycat generics, while India has resisted attempts by multinational drug-makers to strengthen patent protection. The outcome of the negotiations could have significant implications for affordable medicine access, as India is the largest producer of generics in the world and supplies around two-thirds of the world's antiretroviral drugs.
Feb 27, 2024
Hikma Pharmaceuticals poses early generic competition for Merck's popular drug Bridion
Hikma Pharmaceuticals' US unit has filed for pre-patent expiry approval from the US Food and Drug Administration (FDA) to launch a generic version of Merck's Bridion injection. Bridion, a key muscle relaxant reversal agent used in surgery, is currently under patent protection. If approved, the entry of a generic version could potentially reduce costs for healthcare providers and patients. However, Merck has hinted at potential legal challenges to protect their intellectual property. This clash could set important precedents for future pharmaceutical patent disputes, highlighting the ongoing tension between innovation and accessibility in healthcare.
Feb 27, 2024
Boosting Israeli Pharmaceutical Companies - News From The Jewish Community
Teva Pharmaceuticals, the world's largest manufacturer of generic drugs, is aiming to generate more revenue from branded drugs such as Copaxone, an injectable treatment for multiple sclerosis. Sales of Copaxone rose by 25% in 2009 and Teva's overall sales since 2002 have totalled $11bn. Teva is also developing other branded drugs, including Laquinimod, a new drug for the treatment of multiple sclerosis, which has fast-track designation from the US Food and Drug Administration and is expected to be on the market by 2012.
Feb 27, 2024
Roche introduces Ocrevus in India for managing multiple sclerosis - ET HealthWorld
Roche Pharma India has launched its breakthrough drug, Ocrevus (ocrelizumab), for the treatment of multiple sclerosis (MS) in India. Ocrevus is the only monoclonal antibody drug approved for the treatment of both RRMS and PPMS, showing significant impact on slowing disability progression. The drug has a streamlined administration and a commendable long-term safety record. It is the first and only approved therapy for both PPMS and RMS. Ocrevus is administered every six months, leading to high persistence and superior adherence to treatment. It is estimated that 300,000+ patients have been treated globally with Ocrevus.
Feb 27, 2024
Roche introduces Ocrevus to transform the treatment of Multiple Sclerosis in India
Roche Pharma India has launched Ocrevus (Ocrelizumab), a breakthrough drug for the treatment of multiple sclerosis (MS). Ocrevus is the first and only approved high efficacy therapy, with over 300,000 patients treated worldwide. It is the only monoclonal antibody drug approved for both relapsing-remitting and primary progressive forms of MS. Clinical data has shown that Ocrevus can significantly delay disability progression, with over 80% of people with RRMS and over 33% with PPMS showing no signs of disability. The drug is already available in over 100 countries.
Feb 27, 2024
Roche, a leading pharmaceutical company, introduces innovative treatment for Multiple Sclerosis in the Indian market.
Roche Pharma India has launched Ocrevus (ocrelizumab) in India for the treatment of multiple sclerosis (MS). Ocrevus is the only monoclonal antibody drug approved for both relapsing forms of MS and primary progressive MS, and has demonstrated significant efficacy and safety. The drug is administered twice a year, making it convenient for patients. Roche Pharma India's neurology portfolio aims to address the unmet needs of MS patients in India.
Feb 26, 2024
Krystal reveals ambitious plans for topical gene therapy as part of its global expansion strategy
Krystal Biotech's Vyjuvek, a topical gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB), has generated $50.7 million in product revenues in its first six months on the market. Vyjuvek, the first topical gene therapy to be approved by the FDA, is a genetically modified herpes simplex virus that delivers copies of the COL7A1 gene when applied to DEB wounds. The company is also working on an eye-drop formulation of Vyjuvek to treat ocular DEB complications, and plans to launch in Europe and Japan by 2025.
Feb 26, 2024
GSK sees positive results in gonorrhoea drug trial: Gepotidacin shown to be equally effective as...
GSK's drug Gepotidacin has shown success in treating gonorrhoea, according to trial data. The clinical trial found that the antibiotic was just as effective as the current combination of drugs used to treat the infection. Gepotidacin, discovered by scientists at GSK, offers an alternative for patients who may have allergies or intolerances to the current antibiotics. The drug is also expected to have blockbuster potential, potentially earning over £1 billion in annual sales.
Feb 26, 2024
Inhibitors of TL1A may herald a new era in the treatment of IBD, suggests BioSpace报道.
TL1A inhibitors may revolutionize the treatment of immune-mediated diseases such as inflammatory bowel disease, psoriasis, and rheumatoid arthritis. Two monoclonal antibodies targeting TL1A have recently attracted significant attention, resulting in major acquisitions and collaborations in the biopharma industry. These inhibitors show promise in breaking the efficacy ceiling seen with current treatment options and offer the potential for higher remission rates and durability of response. Diagnostic tools that use genetic testing may also help identify patients who are more likely to benefit from TL1A inhibitors. Additionally, TL1A inhibitors may have applications in reversing fibrosis and scarring, offering novel benefits in other autoimmune diseases.
Feb 26, 2024
Scammers send odd red liquid to patients receiving Ozempic - Medical Republic
A compounding pharmacy scam in Australia has been targeting general practices and patients, with fake products being shilled to those seeking semaglutide, a drug in shortage worldwide. Pharmacist Adam Reinhard says his business's name and reputation have been co-opted by the scammers.
Feb 26, 2024
New weight loss drug competitor for Ozempic and Wegovy introduced by Zealand Pharma - Quartz
Zealand Pharma's stock surged by over 34% after announcing positive results from a clinical trial for its liver disease and weight loss drug, survodutide. The drug, being developed in partnership with Boehringer Ingelheim, demonstrated significant improvements in treating a liver condition called MASH in 83% of patients. Survodutide is currently undergoing phase three trials for obesity treatment and previous trials showed promising weight loss results. With the demand for weight loss drugs on the rise, Zealand Pharma is competing with companies like Novo Nordisk and Eli Lilly in this lucrative market.
Feb 26, 2024
Eli Lilly and Novo Nordisk's Approaches to Counter New Competition in Weight-Loss Drug Market
Danish pharmaceutical company, Zealand Pharma, saw a 30% increase in its shares after positive results from Phase 2 trials of its obesity drug, survodutide, were published. The drug demonstrated efficacy in 83% of patients being tested for the liver disease MASH caused by excess fat cells. The success of rival drugs from Novo Nordisk and Eli Lilly has driven other companies to develop weight-loss treatments, with around 70 drugs currently in development. Novo Nordisk and Eli Lilly are expected to face increased competition in the weight loss market as new treatments receive fast-track designations.
