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Eli Lilly reports promising data for alopecia and eczema drugs, eyes label expansion

Eli Lilly announced on Friday safety and efficacy results from two separate late-stage studies testing its approved drugs for alopecia and eczema. The company was testing baricitinib, sold under the brand name Olumiant, in 257 adolescent patients with severe alopecia areata or patchy hair loss. In the trial, a 4 milligram dose of baricitinib helped improve hair regrowth in more than 50% of adolescents after one year of treatment. Successful regrowth was also observed with a 2 milligram dose, the company said, adding that the safety profile of baricitinib remained consistent with previous reports. In another trial, Lilly was testing Ebglyss, chemically known as lebrikizumab, in 103 patients with moderate-to-severe atopic dermatitis, a chronic skin condition commonly known as eczema. The company said lebrikizumab dosed every eight or four weeks provided long-lasting response. Lilly said it has submitted the data from the studies to the U.S. Food and Drug Administration for a potential label update. Ebglyss is an approved injectable medicine used to treat adults and children 12 years and older with moderate-to-severe eczema who cannot use topical therapies. Olumiant is approved to treat adults with severe alopecia areata and adults with moderately to severely active rheumatoid arthritis, if prior treatment did not work.

Sanofi notes ‘negative buzz’ around vaccines as profit beats forecasts

LONDON (Reuters) -Sanofi reported stronger than expected third-quarter profit on Friday, boosted by demand for blockbuster asthma drug Dupixent, even as the French drugmaker flagged lower vaccination rates partly due to a "negative buzz" around vaccines. Sales of Sanofi's flu and COVID-19 vaccines dropped 16.8%, hit by pricing pressure in Germany and lower vaccination rates in the early U.S. season. Rates declined globally, in part due to a post-COVID fatigue. "There might be a little bit of negative feeling about vaccines overall," Sanofi's chief financial officer François-Xavier Roger said after the results. "A little bit of negative buzz around vaccines." In the U.S., health secretary Robert F. Kennedy Jr has taken aim at vaccines, cutting funding for research and ousting the head of the Centers for Disease Control and Prevention, which makes vaccine recommendations. Roger said vaccines are key to prevent disease and as it was the beginning of flu season in the Northern Hemisphere it was difficult to predict future sales growth. The company's overall sales in the U.S. were up 11.1% at 6.84 billion euros, as other medicines offset vaccine weakness. Total global vaccines sales in the quarter were 3.36 billion euros ($3.92 billion), in line with analyst expectations. Sanofi's shares rose nearly...

Biogen licenses Vanqua Bio’s immune disorder drug for up to $1.06 billion

Biogen said on Friday it has gained global rights to privately held Vanqua Bio's experimental drug for up to $1.06 billion to expand its pipeline of immunology drugs. The oral drug targets a protein involved in various inflammatory disorders and is currently in preclinical testing, the drugmaker said. Biogen has been expanding into immunology and rare disease medicines through acquisitions and partnerships to drive revenue growth as sales continue to dwindle for its older multiple sclerosis drugs due to rising competition. Last year, the drugmaker agreed to buy privately held Human Immunology Biosciences for up to $1.8 billion to gain access to its experimental drug being tested for rare immune-related conditions. "This agreement strengthens Biogen's immunology strategy by advancing a proven immune mechanism with the potential to address a broad range of inflammatory disorders with high unmet need," the company said. Under the agreement, Vanqua will receive an upfront payment of $70 million and is eligible to receive up to $990 million upon completion of certain development, regulatory and commercial milestones. Biogen will lead all future development, manufacturing and commercialization efforts for the candidate. The drugmaker said it expects to file a human trial application with the U.S. Food and Drug Administration in 2027.

Daewoong Pharmaceutical Holds Talks with Saudi Officials on Bioindustry Cooperation

Daewoong Pharmaceutical said on October 17 that it met with Saudi Arabian government officials to discuss a range of cooperation plans for the biopharmaceutical industry. The delegation from Saudi Arabia visited Daewoong’s Seoul Samsung-dong headquarters, including Deputy Minister Khalid Al-Buraikan of the Ministry of Health and Sara Aref, Director of Strategic Cooperation. During the meeting, both sides shared assessments of Saudi Arabia’s pharmaceutical and biotech sectors and explored potential partnerships leveraging Daewoong’s new drug development capabilities and global market experience. Representatives from South Korea’s Ministry of Health and Welfare and the Korea Health Industry Development Institute also attended to discuss bilateral industry collaboration measures. Saudi Arabia, the largest pharmaceutical market in the Middle East with an estimated value of about $13 billion, is projected to grow to roughly $19 billion by 2030. The Saudi government is prioritizing expansion of biomanufacturing infrastructure and pharmaceutical self-sufficiency as part of its national strategy. Daewoong has already launched its high purity botulinum toxin product Nabota in the Saudi market in January and is pursuing entry for other products such as the gastroesophageal reflux disease treatment Pexuclu and the diabetes therapy Envlo. Discussions with Saudi officials covered a broad spectrum of cooperation beyond product launches, including local...

Novo Nordisk chair and independent directors to exit in strategy dispute

The chair of Wegovy maker Novo Nordisk and six other independent board members will step down next month after a dispute over strategy with the drugmaker's controlling shareholder, the Novo Nordisk Foundation. The company said on Tuesday that Helge Lund and the other independent directors would step down at an extraordinary shareholder meeting on November 14. The Foundation said it would propose Lars Rebien Sorensen, a former Novo CEO and current chair of the Foundation, as temporary chairman of the drugmaker for two to three years. Novo ousted CEO Lars Fruergaard Jorgensen in May over concerns that the company is losing its first-mover advantage in the highly competitive obesity drug market. His replacement has launched a restructuring drive, including 9,000 job cuts. "Given the rapidly changing environment in which Novo Nordisk operates, we believe it is in the best interest of the company and its shareholders to carry out a board renewal as soon as possible, rather than waiting until the annual general meeting in March next year," Sorensen said in a statement. In a separate statement, Lund said it had "not been possible to reach a common understanding" with the Foundation. "The Board proposed a renewal focusing on the addition of select, new competencies...

China’s Innovent signs $11.4 billion cancer therapy deal with Japan’s Takeda

-China’s Innovent Biologics said on Wednesday it had signed an $11.4 billion deal with Japan’s Takeda Pharmaceutical Co to accelerate the development of its immuno-oncology and antibody-drug conjugate cancer therapies. Under the agreement, Innovent is set to receive a $1.2 billion upfront payment from a unit of Takeda. It is also eligible for potential milestone payments totalling up to $10.2 billion, bringing the total deal value to $11.4 billion. The Takeda unit has also agreed to invest $100 million in the Chinese innovative medicines developer and producer through a subscription, wherein Innovent will issue shares at a price of HK$112.56 apiece. The collaboration also aims to explore and maximise the potential of Innovent’s late-stage investigational medicine for non-small cell lung cancer and colorectal cancer.

Merck begins construction of $3 billion manufacturing facility in Virginia

Merck said on Monday it has begun construction of a $3 billion pharmaceutical manufacturing facility in Elkton, Virginia as part of its more than $70 billion investment to expand domestic manufacturing and research and development in the U.S. The U.S. drugmaker said it plans to invest an additional $3 billion in biologics and small molecule manufacturing sites and capabilities in the U.S., while also investing more than $3.5 billion at its headquarters in Rahway, N.J. Global drugmakers have been scrambling to shore up their U.S. manufacturing capacities and domestic inventories after the Trump administration imposed tariffs on imports of branded and patented drugs. Merck had previously said it will invest $1 billion in a new Delaware plant to make biologics and cancer drug Keytruda, to boost U.S. production and potentially create over 4,500 jobs. It also opened a $1-billion facility at its North Carolina site in March.

AbbVie’s Rinvoq shows superiority over Humira in head-to-head arthritis study

AbbVie (ABBV.N), opens new tab said on Monday its newer arthritis drug Rinvoq showed superiority over the company's previous bestseller Humira in a head-to-head . AbbVie has been banking on its newer immunology drugs Skyrizi and Rinvoq to counter the drop in Humira sales due to a loss of exclusivity and competition from cheaper biosimilars. Humira generated peak global sales of more than $21 billion in 2022 before it lost patent exclusivity in the U.S. The study tested the two drugs in 492 patients with rheumatoid arthritis. About 43.3% of patients receiving Rinvoq saw an improvement in their condition compared with 22.4% of patients on Humira, meeting the main goal of the trial. The drug also met the trial's secondary goal, with 28.4% of patients on Rinvoq showing no visible signs or symptoms of rheumatoid arthritis compared with 14.5% of patients on Humira. Rheumatoid arthritis occurs when the immune system mistakenly attacks joints, creating inflammation that causes the tissue inside the joints to thicken, damaging the bones. The condition affects more than 17 million people worldwide, according to AbbVie. The patients in the trial had been receiving methotrexate, which is commonly used to treat autoimmune diseases such as rheumatoid arthritis. "These positive results strengthen the...

Pelage Pharma raises $120 million to advance development of hair loss treatment

Pelage Pharmaceuticals said on Wednesday it had closed a $120 million funding round to help advance the development of its novel hair loss treatment. The Series B financing round was co-led by ARCH Venture Partners and Google Ventures, with participation from existing investors including Main Street Advisors, Visionary Ventures and YK Bioventures. Pelage declined to share its valuation. The financing will help the company begin multiple late-stage trials and grow its headcount necessary to conduct larger-scale studies, Chief Medical Officer Christina Weng said. The company plans to begin late-stage trials next year to test its lead experimental program, PP405, which is a non-invasive topical therapy designed to reactivate dormant hair follicle stem cells and restart hair growth in men and women. "The science is a strong differentiator in terms of the mechanism of PP405. It's a regenerative medicine approach that targets the hair follicle stem cells and really addresses the root cause of hair loss, rather than currently available treatments which target secondary drivers like hormones," Weng said. There are currently two FDA-approved drugs for androgenetic alopecia or pattern hair loss - minoxidil and finasteride. Only minoxidil is approved for use in women. In a mid-stage trial, which enrolled 78 men and women with androgenetic alopecia,...

Gilead Stock Ignites Retail-Trader Frenzy As Trodelvy Cuts Breast Cancer Progression Risk By 38% In Phase 3 Trial

Gilead Sciences' Trodelvy lowered the risk of disease progression in an aggressive type of breast cancer by 38% when used as an initial treatment, according to trial results presented on Sunday. The trial compared Trodelvy to a standard treatment of chemotherapy in 558 previously untreated patients with advanced triple-negative breast cancer, or TNBC, whose tumors don't express the PD-L1 protein — targeted by immune system checkpoint inhibitors such as Keytruda. The drug received its first U.S. approval in 2020 for the treatment of advanced TNBC in patients who had received at least two prior therapies. TNBC is an aggressive type of invasive breast cancer that tends to grow and spread faster, has fewer treatment options and tends to have a worse prognosis. It accounts for about 10% to 15% of all breast cancers. Antibody-drug conjugates such as Trodelvy are designed to deliver an anti-cancer drug more precisely to malignant cells, causing less damage to healthy cells than chemotherapy. During the trial, patients on Gilead's drug went for a median period of 9.7 months without their cancer progressing, a measure known as progression-free survival, compared to 6.9 months for those on chemotherapy. The trial's initial results were shared in May. The latest findings were shared at...