// Biotech and Pharma Therapeutics
Novo’s Once-Weekly Insulin Treatment Part of a Transforming T2D Space
September 22, 2022 / Novo / Insulin / Type 2 Diabetes – Insulin icodec differs from other basal insulin products currently on the market, as they require once-daily injections. The trial reached its primary endpoint, with 37% of adults with type 2 diabetes who received the drug achieving an HbA1C less than 7% without having any indications of low blood sugar (hypoglycemia). This compared to 27% of patients receiving insulin degludec at 26 weeks. Read Full Article on BioSpace >>
September 22, 2022 / Novo / Insulin / Type 2 Diabetes – Insulin icodec differs from other basal insulin products currently on the market, as they require once-daily injections. The trial reached its primary endpoint, with 37% of adults with type 2 diabetes who received the drug achieving an HbA1C less than 7% without having any indications of low blood sugar (hypoglycemia). This compared to 27% of patients receiving insulin degludec at 26 weeks. Read Full Article on BioSpace >>
GenScript and Gladstone-UCSF Institute of Genomic Immunology Collaborate on Groundbreaking Non-Viral Cell Therapy Study
September 22, 2022 / Cell Therapy / GenScript / Gladstone – A new study, published in Nature Biotechnology, details methods for achieving highly efficient non-viral knock-in using GenScript’s GenExact™ single-strand DNA (ssDNA) modified with Cas9-target sequences (CTS). This method achieved up to ˜90% knock-in efficiency in primary immune cell types. Read Full Article on BioSpace >>
September 22, 2022 / Cell Therapy / GenScript / Gladstone – A new study, published in Nature Biotechnology, details methods for achieving highly efficient non-viral knock-in using GenScript’s GenExact™ single-strand DNA (ssDNA) modified with Cas9-target sequences (CTS). This method achieved up to ˜90% knock-in efficiency in primary immune cell types. Read Full Article on BioSpace >>
Stryker receives FDA clearance for OptaBlate™ Bone Tumor Ablation System
September 20, 2022 / Stryker / FDA / OptaBlate – Stryker’s first bone tumor ablation system with patented microinfusion technology offers a reliable solution for people living with painful metastatic tumors Read Full Article on BioSpace >>
September 20, 2022 / Stryker / FDA / OptaBlate – Stryker’s first bone tumor ablation system with patented microinfusion technology offers a reliable solution for people living with painful metastatic tumors Read Full Article on BioSpace >>
AVROBIO’s Cystinosis Gene Therapy Snags Rare Pediatric Designation
September 20, 2022 / AVROBIO’s / Gene Therapy / Pediatric Designation –The designation provides AVROBIO with a pathway to initiate its own clinical study in cystinosis next year, Essra Ridha M.D., chief medical officer, told BioSpace in an interview. Ridha said the company aims to build on the success seen in a Phase I/II collaborator-initiated study that showed the gene therapy was not only safe and well-tolerated but also generated meaningful efficacy data. Read Full Article on BioSpace >>
September 20, 2022 / AVROBIO’s / Gene Therapy / Pediatric Designation –The designation provides AVROBIO with a pathway to initiate its own clinical study in cystinosis next year, Essra Ridha M.D., chief medical officer, told BioSpace in an interview. Ridha said the company aims to build on the success seen in a Phase I/II collaborator-initiated study that showed the gene therapy was not only safe and well-tolerated but also generated meaningful efficacy data. Read Full Article on BioSpace >>
AstraZeneca’s Alexion bet continues to pay off as danicopan improves hemoglobin levels in phase 3
September 16, 2022 / AstraZeneca / Alexion / Ultomiris / Soliris – The interim analysis of the phase 3 ALPHA trial looked at danicopan as an add-on C5 inhibitor therapy for 63 patients with a blood disease called paroxysmal nocturnal hemoglobinuria (PNH) who experience extravascular haemolysis (EVH). EVH occurs when a type of white blood cell normally found in the liver and spleen ingests antibody-coated red blood cells. Read Full Article on Fierce Biotech >>
September 16, 2022 / AstraZeneca / Alexion / Ultomiris / Soliris – The interim analysis of the phase 3 ALPHA trial looked at danicopan as an add-on C5 inhibitor therapy for 63 patients with a blood disease called paroxysmal nocturnal hemoglobinuria (PNH) who experience extravascular haemolysis (EVH). EVH occurs when a type of white blood cell normally found in the liver and spleen ingests antibody-coated red blood cells. Read Full Article on Fierce Biotech >>
Novartis dons ‘US-first’ mindset amid groupwide overhaul, layoffs and generics spinoff
September 22, 2022 / Novartis / Vasant Narasimhan / Kisqali / Leqvio – Novartis aims to become a top 5 drugmaker in the U.S. by 2027, the Swiss pharma said during an investor event Thursday. Novartis ranked as the fifth largest biopharma company by worldwide revenue in 2021, but it was only 10th in the U.S. To increase its U.S. presence, Novartis will adopt a “U.S.-first mindset,” increasing the share of U.S. patients in clinical trials and “building capability and talent” in the country, the company said. Read Full Article on Fierce Pharma >>
September 22, 2022 / Novartis / Vasant Narasimhan / Kisqali / Leqvio – Novartis aims to become a top 5 drugmaker in the U.S. by 2027, the Swiss pharma said during an investor event Thursday. Novartis ranked as the fifth largest biopharma company by worldwide revenue in 2021, but it was only 10th in the U.S. To increase its U.S. presence, Novartis will adopt a “U.S.-first mindset,” increasing the share of U.S. patients in clinical trials and “building capability and talent” in the country, the company said. Read Full Article on Fierce Pharma >>
Novocure Announces Creation of U.S. CNS Cancers Franchise Intended to Renew Focus on Growth in Glioblastoma Business
September 21, 2022 / Novocure / CNS Cancers Frachise – Frank Leonard, who served as Novocure’s Chief Development Officer since 2020, is named President, CNS Cancers U.S., effective September 19, 2022. Mr. Leonard will be responsible for the entirety of the U.S. CNS business including U.S. GBM Sales and Marketing, Regional Marketing, Learning & Development, Maxpoint, Government Affairs and U.S. CNS Medical teams. Pritesh Shah, Novocure’s Chief Commercial Officer, will retain responsibility for global commercial strategy and brand management, the EMEA and APAC regions and future indications. Read Full Article on BioSpace >>
September 21, 2022 / Novocure / CNS Cancers Frachise – Frank Leonard, who served as Novocure’s Chief Development Officer since 2020, is named President, CNS Cancers U.S., effective September 19, 2022. Mr. Leonard will be responsible for the entirety of the U.S. CNS business including U.S. GBM Sales and Marketing, Regional Marketing, Learning & Development, Maxpoint, Government Affairs and U.S. CNS Medical teams. Pritesh Shah, Novocure’s Chief Commercial Officer, will retain responsibility for global commercial strategy and brand management, the EMEA and APAC regions and future indications. Read Full Article on BioSpace >>
// 4th Industrial Revolution
Bayer launches groundbreaking collaboration with Perdue AgriBusiness to reduce carbon emissions and increase sustainability in the food value chain
September 21, 2022 / Bayer / Perdue AgriBusiness / Carbon Emissions – The collaboration – a first-of-its-kind under Bayer’s new ForGround platform – leverages the strengths and scale of both organizations to create a blueprint for businesses to assess their carbon footprint and rapidly scale up their ability to reduce Scope 3 emissions. Through the collaboration, Bayer and Perdue AgriBusiness, the international agricultural products and services business of Perdue Farms, are creating additional opportunities to help support farmers on their regenerative agriculture journey, benefiting their land and helping them produce more environmentally friendly foods and ingredients for businesses and consumers. Read Full Article on BioSpace >>
September 21, 2022 / Bayer / Perdue AgriBusiness / Carbon Emissions – The collaboration – a first-of-its-kind under Bayer’s new ForGround platform – leverages the strengths and scale of both organizations to create a blueprint for businesses to assess their carbon footprint and rapidly scale up their ability to reduce Scope 3 emissions. Through the collaboration, Bayer and Perdue AgriBusiness, the international agricultural products and services business of Perdue Farms, are creating additional opportunities to help support farmers on their regenerative agriculture journey, benefiting their land and helping them produce more environmentally friendly foods and ingredients for businesses and consumers. Read Full Article on BioSpace >>
Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences
September 21, 2022 / Novo Nordisk / Personalized Medicine / Artificial Intelligence / Machine Learning – Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence. Full Article on Fierce Biotech >>
September 21, 2022 / Novo Nordisk / Personalized Medicine / Artificial Intelligence / Machine Learning – Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence. Full Article on Fierce Biotech >>
3D Medical Printing Systems Market Research Report Analysis And Forecasts To 2030
September 21, 2022 / 3D Medical Printing / 2030 – A newly published report titled “3D Medical Printing Systems Market” by Global Market Vision throws light on the industry dynamics and current and future trends that play a key role in determining the business expansion. The report also highlights the key driving factors and restraints that are impacting the growth. For a comprehensive understanding, the professionals have reviewed the regulatory scenario, market entry strategies, best industry practices, pricing strategy, technology landscape, and consumption, sales, and demand outlook. Y-o-Y growth estimates have also been included to provide the users with accurate statistics and facts. This report will give the readers a bigger and see-through picture of the overall scenario. Read Full Article on The Nelson Post >>
September 21, 2022 / 3D Medical Printing / 2030 – A newly published report titled “3D Medical Printing Systems Market” by Global Market Vision throws light on the industry dynamics and current and future trends that play a key role in determining the business expansion. The report also highlights the key driving factors and restraints that are impacting the growth. For a comprehensive understanding, the professionals have reviewed the regulatory scenario, market entry strategies, best industry practices, pricing strategy, technology landscape, and consumption, sales, and demand outlook. Y-o-Y growth estimates have also been included to provide the users with accurate statistics and facts. This report will give the readers a bigger and see-through picture of the overall scenario. Read Full Article on The Nelson Post >>
Study looks at impact of artificial intelligence on primary health care
September 22, 2022 / Artificial Intelligence / Healthcare –AI and machine learning (a subfield of AI where patterns are learned from data) encompass a variety of techniques loosely focused on computers performing human-like “intelligent” tasks. AI methods are already used in applications ranging from advanced web search engines (Google) and recommendation systems (Netflix, Amazon) to understanding human speech (Siri and Alexa) and self-driving cars (Tesla). In primary health care settings, AI could be used for predicting patient outcomes based on anonymous electronic medical record (EMR) data or forecasting trends and identifying patterns too complex for humans to discern (e.g., infectious disease outbreaks in a community). Read Full Article on Medical Press >>
September 22, 2022 / Artificial Intelligence / Healthcare –AI and machine learning (a subfield of AI where patterns are learned from data) encompass a variety of techniques loosely focused on computers performing human-like “intelligent” tasks. AI methods are already used in applications ranging from advanced web search engines (Google) and recommendation systems (Netflix, Amazon) to understanding human speech (Siri and Alexa) and self-driving cars (Tesla). In primary health care settings, AI could be used for predicting patient outcomes based on anonymous electronic medical record (EMR) data or forecasting trends and identifying patterns too complex for humans to discern (e.g., infectious disease outbreaks in a community). Read Full Article on Medical Press >>
How a pediatric hospital’s rare disease sequencing system is unlocking the whole genome
September 22, 2022 / Rare Disease Sequencing / Pediatric – Children’s Mercy is claiming to build “the most advanced genomic sequencing system in the world” through its novel use of 5-base sequencing. Since launching three years ago, the system has already provided 1,000 children with rare disease diagnoses based on its genome sequencing. Read Full Article on MedCity News >>
September 22, 2022 / Rare Disease Sequencing / Pediatric – Children’s Mercy is claiming to build “the most advanced genomic sequencing system in the world” through its novel use of 5-base sequencing. Since launching three years ago, the system has already provided 1,000 children with rare disease diagnoses based on its genome sequencing. Read Full Article on MedCity News >>
// Business & Markets
Walgreens To Buy The Rest Of Shields Specialty Pharmacy For $1.37 Billion
September 20, 2022 / Mergers & Acquisitions / Private Equity / Retail – Walgreens Boots Alliance is buying the rest of the specialty pharmacy company Shields Health Solutions for $1.37 billion. The nation’s largest drugstore chain said it has “entered into a definitive agreement to acquire the remaining 30% stake” of Shields from equity holders in the specialty pharmacy company that include private equity firm Welsh, Carson, Anderson & Stowe and the company’s founder and board chairman Jack Shields. The deal is expected to close by the end of the 2022 calendar year. Read Full Article on Forbes >>
September 20, 2022 / Mergers & Acquisitions / Private Equity / Retail – Walgreens Boots Alliance is buying the rest of the specialty pharmacy company Shields Health Solutions for $1.37 billion. The nation’s largest drugstore chain said it has “entered into a definitive agreement to acquire the remaining 30% stake” of Shields from equity holders in the specialty pharmacy company that include private equity firm Welsh, Carson, Anderson & Stowe and the company’s founder and board chairman Jack Shields. The deal is expected to close by the end of the 2022 calendar year. Read Full Article on Forbes >>
Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries
September 22, 2022 / Pfizer / Global Pharma – Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand. Through Global Fund’s framework and mechanism, eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach. Additional contractual details of the agreement were not disclosed. Read Full Article on BioSpace >>
September 22, 2022 / Pfizer / Global Pharma – Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand. Through Global Fund’s framework and mechanism, eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach. Additional contractual details of the agreement were not disclosed. Read Full Article on BioSpace >>
Puma pounces on failed Takeda drug, snapping up cancer prospect for knockdown price
September 21, 2022 / Puma Biotechnology / Takeda / Small Cell Lung Cancer / Breast Cancer – Puma Biotechnology has gone looking for gems in Takeda’s castoffs, emerging from its rummaging with an aurora kinase A inhibitor that failed a phase 3 trial in 2015 but has since moved the needle in another study. The biotech landed a global license for $7 million upfront plus up to $287.3 million in milestones. Read Full Article on Fierce Biotech >>
September 21, 2022 / Puma Biotechnology / Takeda / Small Cell Lung Cancer / Breast Cancer – Puma Biotechnology has gone looking for gems in Takeda’s castoffs, emerging from its rummaging with an aurora kinase A inhibitor that failed a phase 3 trial in 2015 but has since moved the needle in another study. The biotech landed a global license for $7 million upfront plus up to $287.3 million in milestones. Read Full Article on Fierce Biotech >>
GSK plays the white knight, paying $66M to rescue Spero’s oral antibiotic after FDA rejection
September 22, 2022 / GSK / Spero Therapeutics / Antibiotics / Licensing – GSK is riding to the rescue of Spero Therapeutics’ oral antibiotic prospect, paying $66 million upfront for near-global rights to a drug candidate that needs to undergo another phase 3 trial following its recent rejection by the FDA. Spero is studying the drug as a treatment for complicated urinary tract infections. Read Full Article on Fierce Biotech >>
September 22, 2022 / GSK / Spero Therapeutics / Antibiotics / Licensing – GSK is riding to the rescue of Spero Therapeutics’ oral antibiotic prospect, paying $66 million upfront for near-global rights to a drug candidate that needs to undergo another phase 3 trial following its recent rejection by the FDA. Spero is studying the drug as a treatment for complicated urinary tract infections. Read Full Article on Fierce Biotech >>
Johnson & Johnson opens 400-person R&D facility to strengthen Bay Area presence
September 20, 2022 / Johnson & Johnson / Janssen Pharmaceuticals / San Francisco / Facilities – Johnson & Johnson’s Technology, Innovation and Janssen units have moved in together to a new R&D facility in San Francisco’s Bay Campus. The nearly 200,000-square-foot space will be home to up to 400 employees, more than doubling J&J’s presence in this R&D hot spot. Read Full Article on Fierce Biotech >>
September 20, 2022 / Johnson & Johnson / Janssen Pharmaceuticals / San Francisco / Facilities – Johnson & Johnson’s Technology, Innovation and Janssen units have moved in together to a new R&D facility in San Francisco’s Bay Campus. The nearly 200,000-square-foot space will be home to up to 400 employees, more than doubling J&J’s presence in this R&D hot spot. Read Full Article on Fierce Biotech >>
Rivus raises $132M series B as obesity, NASH prospects for metabolic drug heat up
September 22, 2022 / Rivus Pharmaceuticals / NASH / Venture Capital / Fatty Liver Disease – Charlottesville, Va.-based Rivus emerged in July 2021 with $35 million and ambitions to treat metabolic disorders, including the tricky nonalcoholic steatohepatitis (NASH) indication, via weight loss. Almost half of American adults live with cardio-metabolic diseases, which can often be driven by obesity. Rivus is designing controlled metabolic accelerators (CMAs) to activate mitochondrial uncoupling, a natural process by which the body generates heat, to selectively reduce fat. It’s not the first industry attempt to reduce energy expenditure in obesity, though CMAs are made to avoid the muscle mass loss that has been seen with other therapeutics. Read Full Article on Fierce Biotech >>
September 22, 2022 / Rivus Pharmaceuticals / NASH / Venture Capital / Fatty Liver Disease – Charlottesville, Va.-based Rivus emerged in July 2021 with $35 million and ambitions to treat metabolic disorders, including the tricky nonalcoholic steatohepatitis (NASH) indication, via weight loss. Almost half of American adults live with cardio-metabolic diseases, which can often be driven by obesity. Rivus is designing controlled metabolic accelerators (CMAs) to activate mitochondrial uncoupling, a natural process by which the body generates heat, to selectively reduce fat. It’s not the first industry attempt to reduce energy expenditure in obesity, though CMAs are made to avoid the muscle mass loss that has been seen with other therapeutics. Read Full Article on Fierce Biotech >>
// Legal & Regulatory
U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit
September 22, 2022 / Merck & Co. / Patent –Two Merck patents were involved in the suit. The first, U.S. Patent No. 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is set to expire on Nov. 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second, U.S. Patent No. 8,414,921, covers the co-formulation of sitagliptin and metformin found in JANUMET and is set to expire Jan. 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity. Read on BioSpace>>
September 22, 2022 / Merck & Co. / Patent –Two Merck patents were involved in the suit. The first, U.S. Patent No. 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is set to expire on Nov. 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second, U.S. Patent No. 8,414,921, covers the co-formulation of sitagliptin and metformin found in JANUMET and is set to expire Jan. 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity. Read on BioSpace>>
J&J’s Talc Solution under Legal Review; Novartis Appeals to Supreme Court
September 21, 2022 / J&J / Supreme Court – A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits. If the court panel deems J&J’s formation of LTL Management an illegitimate business move, the life sciences giant must defend itself in courtrooms across the country against allegations that its talc-based products contributed to the development of cancer in some people. Read on BioSpace >>
September 21, 2022 / J&J / Supreme Court – A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits. If the court panel deems J&J’s formation of LTL Management an illegitimate business move, the life sciences giant must defend itself in courtrooms across the country against allegations that its talc-based products contributed to the development of cancer in some people. Read on BioSpace >>
FDA threatens to clamp down on another PI3K blood cancer drug—this time a full approval
September 22, 2022 / PI3K / Drug Safety / Advisory Committee / Chronic Lymphocytic Leukemia – In a briefing document prepared for an FDA oncology advisory committee meeting set to take place Sept. 23, the FDA laid bare its concerns over the toxicity of Secura Bio’s Copiktra and how the drug could detrimentally impact the life expectancy of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read on Fierce Pharma >>
September 22, 2022 / PI3K / Drug Safety / Advisory Committee / Chronic Lymphocytic Leukemia – In a briefing document prepared for an FDA oncology advisory committee meeting set to take place Sept. 23, the FDA laid bare its concerns over the toxicity of Secura Bio’s Copiktra and how the drug could detrimentally impact the life expectancy of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read on Fierce Pharma >>
Eli Lilly’s Retevmo wins FDA nod to treat all cancer types with rare RET biomarker
September 22, 2022 / Retevmo / Eli Lily / NSCLC / Biomaker – Two years after blessing Eli Lilly’s Retevmo to treat lung and thyroid cancers caused by a specific biomarker, the FDA has authorized the drug to be used across all tumor types that bear the biomarker. Wednesday’s action by the United States regulator covers all cancers driven by alterations in the rearranged during transfection (RET) gene. Retevmo is available for all locally advanced or metastatic solid tumors, following prior systemic treatment or with no other treatment alternatives. Read on Fierce Pharma >>
September 22, 2022 / Retevmo / Eli Lily / NSCLC / Biomaker – Two years after blessing Eli Lilly’s Retevmo to treat lung and thyroid cancers caused by a specific biomarker, the FDA has authorized the drug to be used across all tumor types that bear the biomarker. Wednesday’s action by the United States regulator covers all cancers driven by alterations in the rearranged during transfection (RET) gene. Retevmo is available for all locally advanced or metastatic solid tumors, following prior systemic treatment or with no other treatment alternatives. Read on Fierce Pharma >>
Nerviano Medical Sciences S.r.l. Announces Collaboration and Option to License Agreement with Merck
September 21, 2022 / Nerviano / License Agreement – NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors. NMS-293 is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ). Read on BioSpace >>
September 21, 2022 / Nerviano / License Agreement – NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors. NMS-293 is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ). Read on BioSpace >>
Seagen’s Tukysa picks up FDA priority review after Merck buyout talks said to sputter
September 20, 2022 / Seagen / Tukysa / Herceptin / Metastatic Colorectal Cancer – Seagen’s Tukysa has snagged a priority review alongside Roche’s Herceptin for adults with previously treated HER2-positive colorectal cancer, the company said Monday. The speedy regulatory tag comes a little more than two months after Seagen unveiled full results on the Tukysa-Herceptin combo from its pivotal phase 2 Mountaineer trial at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer. Read on Fierce Pharma >>
September 20, 2022 / Seagen / Tukysa / Herceptin / Metastatic Colorectal Cancer – Seagen’s Tukysa has snagged a priority review alongside Roche’s Herceptin for adults with previously treated HER2-positive colorectal cancer, the company said Monday. The speedy regulatory tag comes a little more than two months after Seagen unveiled full results on the Tukysa-Herceptin combo from its pivotal phase 2 Mountaineer trial at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer. Read on Fierce Pharma >>
Facing ‘imminent’ Gilenya generics and a $300M sales hit, Novartis takes patent fight to Supreme Court
September 20, 2022 / Novartis / Gilenya / Patent Litigation / US Supreme Court – Back in June, the appeals court overturned a prior decision in favor of the Swiss drug giant. In doing so, the court sided with Chinese generics maker HEC Pharma and found a patent on the multiple sclerosis drug is invalid, opening the prospect of early competition. Since Gilenya is Novartis’ third biggest drug by sales, the decision carries real commercial weight. If generics launch this year, Novartis expects a $300 million hit to its 2022 revenue guidance, the company said Wednesday. Novartis’ effort to petition the Supreme Court could take several months, the company said. Read on Fierce Pharma >>
September 20, 2022 / Novartis / Gilenya / Patent Litigation / US Supreme Court – Back in June, the appeals court overturned a prior decision in favor of the Swiss drug giant. In doing so, the court sided with Chinese generics maker HEC Pharma and found a patent on the multiple sclerosis drug is invalid, opening the prospect of early competition. Since Gilenya is Novartis’ third biggest drug by sales, the decision carries real commercial weight. If generics launch this year, Novartis expects a $300 million hit to its 2022 revenue guidance, the company said Wednesday. Novartis’ effort to petition the Supreme Court could take several months, the company said. Read on Fierce Pharma >>
// Research & Development
Hibernating bears’ ability to regulate insulin narrowed down to eight proteins
September 21, 2022 / Insulin / Washington State University / Hibernating Bears – Feeding honey to hibernating bears helped researchers find the potential genetic keys to the bears’ insulin control, an advance that could ultimately lead to a treatment for human diabetes. Every year, bears gain an enormous amount of weight, then barely move for months, behavior that would spell diabetes in humans, but not for bears whose bodies can turn insulin resistance on and off almost like a switch. In the hunt for the bears’ secret, scientists observed thousands of changes in gene expression during hibernation, but now a research team has narrowed that down to eight proteins. Read Full Article on Science Daily >>
September 21, 2022 / Insulin / Washington State University / Hibernating Bears – Feeding honey to hibernating bears helped researchers find the potential genetic keys to the bears’ insulin control, an advance that could ultimately lead to a treatment for human diabetes. Every year, bears gain an enormous amount of weight, then barely move for months, behavior that would spell diabetes in humans, but not for bears whose bodies can turn insulin resistance on and off almost like a switch. In the hunt for the bears’ secret, scientists observed thousands of changes in gene expression during hibernation, but now a research team has narrowed that down to eight proteins. Read Full Article on Science Daily >>
Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans
September 20, 2022 / Merck & Co. / Clinical Hold / FDA / HIV – The agency slapped the hold on trials of islatravir to both treat and prevent HIV in December 2021, citing decreases in total lymphocyte and CD4+ T-cell counts in some patients receiving the therapy. The previous month, Merck had pumped the brakes on trials of another potential HIV asset, dubbed MK-8507, over similar concerns. Now, the FDA has given the green light to three new phase 3 trials of a 0.75-mg dose of islatravir in combination with Merck’s approved HIV drug Pifeltro. One study will evaluate the drugs in previously untreated adults with HIV-1 infection, while two more trials will evaluate it as a switch in antiretroviral therapy in adults with HIV-1 infection who are virologically suppressed. Studies of higher doses of islatravir remain on ice. Read Full Article on Fierce Biotech >>
September 20, 2022 / Merck & Co. / Clinical Hold / FDA / HIV – The agency slapped the hold on trials of islatravir to both treat and prevent HIV in December 2021, citing decreases in total lymphocyte and CD4+ T-cell counts in some patients receiving the therapy. The previous month, Merck had pumped the brakes on trials of another potential HIV asset, dubbed MK-8507, over similar concerns. Now, the FDA has given the green light to three new phase 3 trials of a 0.75-mg dose of islatravir in combination with Merck’s approved HIV drug Pifeltro. One study will evaluate the drugs in previously untreated adults with HIV-1 infection, while two more trials will evaluate it as a switch in antiretroviral therapy in adults with HIV-1 infection who are virologically suppressed. Studies of higher doses of islatravir remain on ice. Read Full Article on Fierce Biotech >>
Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies
September 21, 2022 / FDA Clearance / IMT-009 – “We are thrilled to advance IMT-009 to the clinic as we believe it represents a new wave of immuno-oncology agents with transformative potential in both hematological malignancies and solid tumors,” said Seng-Lai “Thomas” Tan, Ph.D., Chief Scientific Officer of Immunitas Therapeutics. “Based on compelling preclinical data demonstrating its dual-action mechanism and non-overlapping biology with other immune checkpoint pathways, IMT-009 will be investigated as a monotherapy and in combination with other cancer therapies.” Read Full Article on BioSpace >>
September 21, 2022 / FDA Clearance / IMT-009 – “We are thrilled to advance IMT-009 to the clinic as we believe it represents a new wave of immuno-oncology agents with transformative potential in both hematological malignancies and solid tumors,” said Seng-Lai “Thomas” Tan, Ph.D., Chief Scientific Officer of Immunitas Therapeutics. “Based on compelling preclinical data demonstrating its dual-action mechanism and non-overlapping biology with other immune checkpoint pathways, IMT-009 will be investigated as a monotherapy and in combination with other cancer therapies.” Read Full Article on BioSpace >>
Fennec finally pushes drug to prevent chemotherapy-induced hearing loss across the FDA finish line
September 21, 2022 / Fennec Pharmaceutical / FDA / Hearing Loss / Cisplatin – With one drug in its pipeline, 26-year-old Fennec Pharmaceuticals of North Carolina has had a lot riding on its treatment for chemotherapy-induced hearing loss. Finally, 18 years after it was designated as an orphan drug and following two complete response letters, the FDA has approved Pedmark. With news of the green light, Fennec’s share price jumped by 16%. Pedmark becomes the first therapy to prevent cisplatin ototoxicity, the ear poisoning that can affect those who undergo platinum-based chemo. The intravenous sodium thiosulfate drug is for pediatric patients between 1 month and 18 years old. Roughly 10,000 kids with solid-tumor cancers in the U.S. and Europe in this age group are treated annually with cisplatin chemotherapy. Read Full Article on Fierce Pharma >>
September 21, 2022 / Fennec Pharmaceutical / FDA / Hearing Loss / Cisplatin – With one drug in its pipeline, 26-year-old Fennec Pharmaceuticals of North Carolina has had a lot riding on its treatment for chemotherapy-induced hearing loss. Finally, 18 years after it was designated as an orphan drug and following two complete response letters, the FDA has approved Pedmark. With news of the green light, Fennec’s share price jumped by 16%. Pedmark becomes the first therapy to prevent cisplatin ototoxicity, the ear poisoning that can affect those who undergo platinum-based chemo. The intravenous sodium thiosulfate drug is for pediatric patients between 1 month and 18 years old. Roughly 10,000 kids with solid-tumor cancers in the U.S. and Europe in this age group are treated annually with cisplatin chemotherapy. Read Full Article on Fierce Pharma >>
Period tracking app Flo releases anonymous mode and more digital health briefs
September 16, 2022 / Women’s Health / Digital Health – Period tracking app Flo released its previously announced anonymous mode, which the company said will allow users to access the app without associating their name, email address and technical identifiers with their health data. Flo partnered with security firm Cloudflare to build the new feature and released a white paper detailing its technical specifications. Anonymous mode has been localized into 20 languages, and it’s currently available for iOS users. Flo said Android support will be added in October. Read Full Article on Mobi Health News >>
September 16, 2022 / Women’s Health / Digital Health – Period tracking app Flo released its previously announced anonymous mode, which the company said will allow users to access the app without associating their name, email address and technical identifiers with their health data. Flo partnered with security firm Cloudflare to build the new feature and released a white paper detailing its technical specifications. Anonymous mode has been localized into 20 languages, and it’s currently available for iOS users. Flo said Android support will be added in October. Read Full Article on Mobi Health News >>
// Politics
Chutes & Ladders—Biden lands on leader for new agency that will oversee ‘cancer moonshot’ initiatives
September 16, 2022 / Chutes and Ladders / FDA / Scorpion Therapeutics / Sanofi – President Joe Biden has landed on a leader for his new federal biotech agency aimed at overseeing his ambitious “cancer moonshot” initiatives. Renee Wegrzyn, a veteran of the federal government and current executive at Ginkgo Bioworks, is slated to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is the manifestation of Biden’s larger ambitions for reducing the cancer death rate—shaving it 50% over the next 25 years, to be exact. For comparison, from 2001 to 2020, the cancer death rate dropped 27%. Read Full Article on Fierce Biotech >>
September 16, 2022 / Chutes and Ladders / FDA / Scorpion Therapeutics / Sanofi – President Joe Biden has landed on a leader for his new federal biotech agency aimed at overseeing his ambitious “cancer moonshot” initiatives. Renee Wegrzyn, a veteran of the federal government and current executive at Ginkgo Bioworks, is slated to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is the manifestation of Biden’s larger ambitions for reducing the cancer death rate—shaving it 50% over the next 25 years, to be exact. For comparison, from 2001 to 2020, the cancer death rate dropped 27%. Read Full Article on Fierce Biotech >>
Biden admin says Supreme Court should reject Amgen’s petition to take up Repatha patent case
September 22, 2022 / Amgen / Regeneron Pharmaceuticals / Sanofi / US Supreme Court – In a Supreme Court brief (PDF), the U.S. Solicitor General, Elizabeth B. Prelogar, said Amgen’s petition “should be denied.” After reviewing the case, the government backed an appeals court’s ruling that Amgen’s patent claims at issue are invalid because “undue experimentation” would be required to “enable their full scope.” Amgen first sued Sanofi and Regeneron back in 2014, alleging patent infringement when the partners sought approval for their PCSK9 cholesterol drug Praluent. At the time, Amgen asked the court to back broader protections on antibody drugs such as its own PCSK9 medicine Repatha. Read Full Article on Fierce Pharma >>
September 22, 2022 / Amgen / Regeneron Pharmaceuticals / Sanofi / US Supreme Court – In a Supreme Court brief (PDF), the U.S. Solicitor General, Elizabeth B. Prelogar, said Amgen’s petition “should be denied.” After reviewing the case, the government backed an appeals court’s ruling that Amgen’s patent claims at issue are invalid because “undue experimentation” would be required to “enable their full scope.” Amgen first sued Sanofi and Regeneron back in 2014, alleging patent infringement when the partners sought approval for their PCSK9 cholesterol drug Praluent. At the time, Amgen asked the court to back broader protections on antibody drugs such as its own PCSK9 medicine Repatha. Read Full Article on Fierce Pharma >>
The Biden Biotech Boom Is About To Send This 6.8% Dividend Soaring
September 17, 2022 / Biden / Politics / – Some major—and almost totally ignored—news from Washington, D.C., is about to upend the biotech world, turning America into “the world’s pharmacy” in short order—and giving us a chance to buy a solid 6.8% dividend for just 91 cents on the dollar. That might sound hard to believe for woebegone biotechs, which have fallen further than the S&P 500 this year, going by the performance of the benchmark iShares Biotechnology ETF (IBB IBB -1.1%). That’s despite the sector’s importance during the pandemic—and despite the fact that some 10,000 Americans turn 65 every day, sharply increasing demand for pharmaceuticals as the senior cohort grows. Read Full Article on Forbes >>
September 17, 2022 / Biden / Politics / – Some major—and almost totally ignored—news from Washington, D.C., is about to upend the biotech world, turning America into “the world’s pharmacy” in short order—and giving us a chance to buy a solid 6.8% dividend for just 91 cents on the dollar. That might sound hard to believe for woebegone biotechs, which have fallen further than the S&P 500 this year, going by the performance of the benchmark iShares Biotechnology ETF (IBB IBB -1.1%). That’s despite the sector’s importance during the pandemic—and despite the fact that some 10,000 Americans turn 65 every day, sharply increasing demand for pharmaceuticals as the senior cohort grows. Read Full Article on Forbes >>
Government forms committee to regulate marketing practices of pharma companies September 21, 2022 / Government / Regulate Marketing / Promoting Drugs and Products – The government has constituted a high-level committee to hammer out a legal mechanism to address the issue of pharmaceutical companies giving inducements for promoting their drugs and products. The five-member committee chaired by Dr VK Paul, NITI Aayog member (health) will also review various other issues pertaining to the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). Read Full Article on The Economic Times >>
