// Biotech and Pharma Therapeutics
PIC Closes $35M Series A to Advance Novel Breast Cancer Therapeutic
October 19, 2022 / PIC / Breast Cancer / New Investors – Massachusetts-based PIC Therapeutics has closed a $35 million Series A financing round centered around the advancement of its lead asset, a novel therapeutic for advanced metastatic breast cancer, the company announced Wednesday. PIC’s main focus is its development-stage small molecule drug, an allosteric protein translation modulator targeting eIF4E. With the funds, the company hopes to take the drug into first-in-man, first-in-mechanism clinical studies. Read Full Article on BioSpace>>
October 19, 2022 / PIC / Breast Cancer / New Investors – Massachusetts-based PIC Therapeutics has closed a $35 million Series A financing round centered around the advancement of its lead asset, a novel therapeutic for advanced metastatic breast cancer, the company announced Wednesday. PIC’s main focus is its development-stage small molecule drug, an allosteric protein translation modulator targeting eIF4E. With the funds, the company hopes to take the drug into first-in-man, first-in-mechanism clinical studies. Read Full Article on BioSpace>>
Biora Therapeutics Shares Preclinical Data on Oral Delivery of Biologics at the 2022 Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference October 19, 2022 / San Diego / Biora Therapeutics / Injection Devices Conference – Biora Therapeutics, Inc, the biotech company that is reimagining therapeutics, today shared a poster presented at the Parenteral Drug Association (PDA) Universe of Pre-Filled Syringes and Injection Devices Conference. The meeting in Palm Springs, California, October 18-19, 2022 explored the latest technological advances with drug delivery devices. “Our platform is the first designed to use submucosal liquid jet injection to the small intestine for oral delivery of large molecules,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “One challenge with a completely novel delivery method is there are no existing models to follow for preclinical development. We are encouraged by the data from the early results for these preclinical models, which informs the ongoing development of our systemic therapeutics platform,” continued Dr. Singh. Read Full Article on Biospace>>
GSK polishes ‘crown jewel’ Shingrix with new long-term protection data in older adults October 19, 2022 / GSK / Shingrix / Shingles / Shingles Vaccine / –Overall, vaccination with Shingrix conferred “at least” 10 years of protection against shingles in adults ages 50 and older, GSK said Wednesday, citing interim results from the vaccine’s late-stage extension study Zoster-049. More specifically, Shingrix’s overall efficacy landed above 80% during a follow-up period of roughly six to 10 years post-immunization, the British drugmaker said. Read Full Article on Fierce Pharma>>
Johnson & Johnson signals job cuts amid consumer health separation, inflation pressure October 19, 2022 / Johnson & Johnson / Job Cuts / Layoffs / Restructuring –Overall, vaccination with Shingrix conferred “at least” 10 years of protection against shingles in adults ages 50 and older, GSK said Wednesday, citing interim results from the vaccine’s late-stage extension study Zoster-049. More specifically, Shingrix’s overall efficacy landed above 80% during a follow-up period of roughly six to 10 years post-immunization, the British drugmaker said. Read Full Article on Fierce Pharma>>
Merck KGaA faces probe in France over whether it misled patients about drug reformulation October 19, 2022 / Merck KGaA / Levothyroxine / Adverse Events / Reformulation –Seven months after France’s highest court confirmed an earlier ruling that the German company must compensate users who suffered problems from Levothyrox, the case has advanced at the judicial level. On Tuesday, a judge in Marseille opened a formal indictment to determine if the company provided misleading information when it switched the formulation of Levothyrox, a medicine also known as Euthyrox.Read Full Article on Fierce Pharma>>
// 4th Industrial Revolution
GE Healthcare and AMC Health to Partner in Remote Patient Monitoring to Provide Patients with Chronic and Post-Acute Care in the Home
October 19, 2022 / GE Healthcare / AMC Health / Digital Health / Remote Patient – GE Healthcare and AMC Health today announced a collaboration that allows clinicians to offer Remote Patient Monitoring (RPM) as a virtual care solution that extends patient care outside the hospital to the home environment. The combination of GE Healthcare’s acute patient monitoring capabilities in the hospital setting, along with AMC Health’s expertise in RPM solutions leveraging an FDA Class II 510(k)-cleared platform with analytics will extend the continuum of non-acute care for patients after being discharged from the hospital. “Pairing AMC Health’s Remote Patient Monitoring suite with GE Healthcare’s clinical monitoring offering will extend care beyond the clinical setting and enable more patients to continue to receive quality care from the comfort of their homes, delivering healthcare without limits,” said Ashutosh Banerjee, General Manager Diagnostic Cardiology and Remote Patient Monitoring, GE Healthcare. “AMC Health was selected as our partner due to their established and proven success engaging with patients to measure numerous biometrics in the home to extend the continuum of care.” Read Full Article on BioSpace >>
October 19, 2022 / GE Healthcare / AMC Health / Digital Health / Remote Patient – GE Healthcare and AMC Health today announced a collaboration that allows clinicians to offer Remote Patient Monitoring (RPM) as a virtual care solution that extends patient care outside the hospital to the home environment. The combination of GE Healthcare’s acute patient monitoring capabilities in the hospital setting, along with AMC Health’s expertise in RPM solutions leveraging an FDA Class II 510(k)-cleared platform with analytics will extend the continuum of non-acute care for patients after being discharged from the hospital. “Pairing AMC Health’s Remote Patient Monitoring suite with GE Healthcare’s clinical monitoring offering will extend care beyond the clinical setting and enable more patients to continue to receive quality care from the comfort of their homes, delivering healthcare without limits,” said Ashutosh Banerjee, General Manager Diagnostic Cardiology and Remote Patient Monitoring, GE Healthcare. “AMC Health was selected as our partner due to their established and proven success engaging with patients to measure numerous biometrics in the home to extend the continuum of care.” Read Full Article on BioSpace >>
3D LifePrints receives 510(k) approval for Cranio-Maxillofacial products
October 18, 2022 / 3D LifePrints / Cranio-Maxillofacial / Houston – Its EmbedMed Platform is an end-to-end solution for surgeons that digitises the surgical planning process and enables the rapid design and manufacture of patient-specific medical devices. Its functions includes the processing of patient input data from image scan data and as a pre-operative software tool for simulating and evaluating surgical planning options. The output files from the system can be provided digitally or as physical models and surgical guides for use in surgery. 3D LifePrints has launched in the USA with their base of operations at the Texas Medical Centre in Houston. After Houston, 3D LifePrints will be opening further facilities across the US starting with New York and in Orange County, California. Full Article on Med-Tech News >>
October 18, 2022 / 3D LifePrints / Cranio-Maxillofacial / Houston – Its EmbedMed Platform is an end-to-end solution for surgeons that digitises the surgical planning process and enables the rapid design and manufacture of patient-specific medical devices. Its functions includes the processing of patient input data from image scan data and as a pre-operative software tool for simulating and evaluating surgical planning options. The output files from the system can be provided digitally or as physical models and surgical guides for use in surgery. 3D LifePrints has launched in the USA with their base of operations at the Texas Medical Centre in Houston. After Houston, 3D LifePrints will be opening further facilities across the US starting with New York and in Orange County, California. Full Article on Med-Tech News >>
Birmingham: The emerging medical technology hotbed
October 19, 2022 /Birmingham / Clinical Trials / Health Data –Before taking this role, I knew that Birmingham and the West Midlands had the largest medtech cluster in the UK – with 1,000 businesses and a workforce of nearly 24,000 – but as an outsider looking in, I didn’t know why. A year into the job and I have the answer: the strengths that Birmingham and the West Midlands can offer, are the strengths the sectors is crying out for. Not just in R&D but in health data, clinical trials expertise, biomarker diagnostic development, and regulation and policy. Birmingham’s also a ‘world within a city’, representing the global population in terms of its ethnic profile and socioeconomic demographics. Significantly, we’re able to recruit 25% non-white representation in most clinical trials – we’re not just perfectly placed to use our population diversity but are actively doing it already. Read Article on Med-Tech News >>
October 19, 2022 /Birmingham / Clinical Trials / Health Data –Before taking this role, I knew that Birmingham and the West Midlands had the largest medtech cluster in the UK – with 1,000 businesses and a workforce of nearly 24,000 – but as an outsider looking in, I didn’t know why. A year into the job and I have the answer: the strengths that Birmingham and the West Midlands can offer, are the strengths the sectors is crying out for. Not just in R&D but in health data, clinical trials expertise, biomarker diagnostic development, and regulation and policy. Birmingham’s also a ‘world within a city’, representing the global population in terms of its ethnic profile and socioeconomic demographics. Significantly, we’re able to recruit 25% non-white representation in most clinical trials – we’re not just perfectly placed to use our population diversity but are actively doing it already. Read Article on Med-Tech News >>
Intuitive’s robotic surgery volumes recovered in Q3; shares climb
October 18, 2022 / Surgical Robots / Intuitive / Da Vinci System – Intuitive Surgery, one of the largest U.S. makers of minimally invasive surgical robots, said surgeries performed by its Da Vinci robot rose 20% in the third quarter as an easing of the pandemic spurred patients to return to operating rooms. “Our core business strengthened in the quarter as acute pandemic impact softened,” CEO Gary Guthart told investors on Tuesday as the company reported its third-quarter earnings after the markets closed. Read Full Article on MedTech Dive >>
October 18, 2022 / Surgical Robots / Intuitive / Da Vinci System – Intuitive Surgery, one of the largest U.S. makers of minimally invasive surgical robots, said surgeries performed by its Da Vinci robot rose 20% in the third quarter as an easing of the pandemic spurred patients to return to operating rooms. “Our core business strengthened in the quarter as acute pandemic impact softened,” CEO Gary Guthart told investors on Tuesday as the company reported its third-quarter earnings after the markets closed. Read Full Article on MedTech Dive >>
Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations October 19, 2022 / Abbott / Q3 Device –Abbott Laboratories faced “a very challenging quarter… probably our most challenging,” CEO Robert Ford said Wednesday on an earnings call. The company, like its medtech peers, is grappling with hospital staffing shortages, foreign-exchange rate fluctuations and continued supply chain disruptions. Inflation continues to be a stubborn force globally, but we’ve started to see some moderating impacts in certain parts of our business compared to earlier in the year,” Ford said. “COVID remains as unpredictable as ever with intermittent surges continuing throughout the world.” Read Full Article on MedTech Dive>>
Revealing new insights from the Tumor Microenvironment with AI-powered digital pathology October 17, 2022 / AI / Cancer Treatment –Cancer treatment has significantly evolved since the approval of the first companion diagnostic, HercepTest, in 1998. Both targeted therapies and immunotherapies have revolutionized cancer treatment, benefiting greatly from precision biomarker strategies which enhance outcomes in selected patient populations. However, we are beginning to reach the limits of existing biomarker-driven treatment efficacy and development. Broadly, tissue-based biomarkers fall into two main categories, each with innate limitations which present challenges for drug development. Molecular biomarkers (e.g. EGFR, MSI, etc.) indicate a specific genetic alteration that leads to an abnormal phenotype but they fail to consider the heterogeneity of etiologies that can lead to similar abnormal phenotypes. Protein biomarkers are closer to the downstream manifestation of genetic alterations and immune-dysregulation but suffer from manual and subjective interpretations to establish score cut-offs. For example, PD-L1 expression level (i.e., CPS or TPS) offers an imperfect ability to predict treatment response. A significant percentage of potential responders are not identified using existing PD-L1 cut-offs and a portion of PD-L1 positive patients also fail to respond to therapy (1).Read Full Article on Fierce Biotech>>
// Business & Markets
Jazz Drops $50M for Exclusive Rights to Zymeworks’ Bispecific HER2 Hopeful
October 19, 2022 / Jazz / Zymework / HER2 – Jazz Pharmaceuticals and Zymeworks Inc entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2, the companies announced Wednesday. The deal will give Jazz exclusive commercialization and development rights over zanidatamab in the U.S., Europe, Japan and all other territories that aren’t yet covered by existing licenses. Aside from the $50 million upfront payment, Jazz is putting $325 million more on the line if it decides to continue the collaboration. Read Full Article on BioSpace >>
October 19, 2022 / Jazz / Zymework / HER2 – Jazz Pharmaceuticals and Zymeworks Inc entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2, the companies announced Wednesday. The deal will give Jazz exclusive commercialization and development rights over zanidatamab in the U.S., Europe, Japan and all other territories that aren’t yet covered by existing licenses. Aside from the $50 million upfront payment, Jazz is putting $325 million more on the line if it decides to continue the collaboration. Read Full Article on BioSpace >>
Advaxis and Ayala Merge to Hone In on Desmoid Tumors, Prostate Cancer
October 19, 2022 / Advaxis / Ayala / Prostate Cancer / Reverse Merger –Advaxis and Ayala Pharmaceuticals announced Wednesday they have entered into a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer. In a conference call, Kenneth A. Berlin, president and CEO of Advaxis, said that Advaxis had been looking for a deal with a clinical-stage asset, and after the merger, they will “have $20 million in cash and a highly skilled team.” Read Full Article on BioSpace >>
October 19, 2022 / Advaxis / Ayala / Prostate Cancer / Reverse Merger –Advaxis and Ayala Pharmaceuticals announced Wednesday they have entered into a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer. In a conference call, Kenneth A. Berlin, president and CEO of Advaxis, said that Advaxis had been looking for a deal with a clinical-stage asset, and after the merger, they will “have $20 million in cash and a highly skilled team.” Read Full Article on BioSpace >>
Advaxis spies merger with Ayala as route back to Nasdaq
October 19, 2022 / Ayala Pharma / Advaxis / M&A FDA – With $20 million on hand and the second part of a potentially registrational phase 2/3 study just getting underway, Ayala was facing a potential cash crunch. But Advaxis may have solved its problems—in return for the hope of a return to the Nasdaq. Ayala is merging with Advaxis, linking arms—and bank accounts—as each looks to propel its lead program. The two companies will prioritize the development of AL102 to treat desmoid tumors and ADXS-504 for patients with prostate cancer. Advaxis CEO Kenneth Berlin said in a release that the combined cash will likely be enough to get through key clinical milestones in 2023. Read Full Article on Fierce Biotech >>
October 19, 2022 / Ayala Pharma / Advaxis / M&A FDA – With $20 million on hand and the second part of a potentially registrational phase 2/3 study just getting underway, Ayala was facing a potential cash crunch. But Advaxis may have solved its problems—in return for the hope of a return to the Nasdaq. Ayala is merging with Advaxis, linking arms—and bank accounts—as each looks to propel its lead program. The two companies will prioritize the development of AL102 to treat desmoid tumors and ADXS-504 for patients with prostate cancer. Advaxis CEO Kenneth Berlin said in a release that the combined cash will likely be enough to get through key clinical milestones in 2023. Read Full Article on Fierce Biotech >>
Pfizer, Merck and J&J Back UK Startup Mining the Dark Genome for Autoimmune Therapies
October 19, 2022 / Pfizer / Merck / J&J / Startup / Autoimmune – Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round to mine the dark genome for precision medicines for autoimmune diseases. The financing, announced Wednesday, will allow U.K.-based Nucleome, an Oxford University spinout, to decode the dark matter of the human genome in order to develop novel therapeutic approaches. Using its drug discovery platform technology, Nucleome aims to identify direct genetic links to disease-associated genes.Read Full Article on BioSpace >>
October 19, 2022 / Pfizer / Merck / J&J / Startup / Autoimmune – Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round to mine the dark genome for precision medicines for autoimmune diseases. The financing, announced Wednesday, will allow U.K.-based Nucleome, an Oxford University spinout, to decode the dark matter of the human genome in order to develop novel therapeutic approaches. Using its drug discovery platform technology, Nucleome aims to identify direct genetic links to disease-associated genes.Read Full Article on BioSpace >>
Lilly spies value in biotech bear market, snapping up hearing loss gene therapy player Akouos for $487M October 18, 2022 / Eli Lilly / Akouos / Cell & Gene Therapy / Gene Therapy – Eli Lilly has capitalized on the biotech bear market to snap up hearing loss gene therapy player Akouos for $487 million upfront. The deal will give Lilly control of a treatment for a genetic form of hearing loss that is advancing toward a phase 1/2 trial just ahead of Decibel Therapeutics’ rival candidate. Boston-based Akouos’ pipeline is led by AK-OTOF, a gene therapy for the treatment of hearing loss due to mutations in the OTOF gene. The candidate, which the biotech estimates could benefit up to 7,000 people, is built on a synthetic adeno-associated virus vector library and a minimally invasive delivery method that together are designed to overcome the challenges of getting gene therapies to the inner ear. Read Full Article on Fierce Biotech >>
// Legal & Regulatory
FDA pauses PTC’s phase 2 Huntington’s trial despite green light from regulators abroad
October 19, 2022 / PTC Therapeutics / FDA / Huntington’s Disease / Clinical Research – The FDA has pumped the brakes on PTC Therapeutics’ Huntington’s disease trial in the U.S. even as studies kick into gear in other countries. The agency has requested additional data before it will allow the phase 2 study of PTC518 to proceed, the biotech revealed in an Oct. 18 release. PTC has therefore paused enrollment in the U.S. while it holds discussions with the regulator. Read on Fierce Biotech >>
October 19, 2022 / PTC Therapeutics / FDA / Huntington’s Disease / Clinical Research – The FDA has pumped the brakes on PTC Therapeutics’ Huntington’s disease trial in the U.S. even as studies kick into gear in other countries. The agency has requested additional data before it will allow the phase 2 study of PTC518 to proceed, the biotech revealed in an Oct. 18 release. PTC has therefore paused enrollment in the U.S. while it holds discussions with the regulator. Read on Fierce Biotech >>
FDA nixes EUA ambitions for Eiger’s COVID treatment, proposes full approval pathway instead
October 10, 2022 / FDA / Covis’ Makena / Withdraw –Makena (hydroxyprogesterone caproate), as well as five generic forms of the drug, is the only drug approved by the FDA to decrease the risk of preterm birth in women with a singleton pregnancy with a history of spontaneous preterm birth. AMAG Pharmaceuticals marketed the drug until Covis acquired it in Oct. 2020. Specifically, the drug is an injectable progestin therapy to decrease preterm births, or births that occur before 37 weeks of pregnancy have been completed. Preterm babies can develop health issues, including respiratory distress syndrome, neonatal sepsis and intraventricular hemorrhage. Read on Fierce Biotech >>
October 10, 2022 / FDA / Covis’ Makena / Withdraw –Makena (hydroxyprogesterone caproate), as well as five generic forms of the drug, is the only drug approved by the FDA to decrease the risk of preterm birth in women with a singleton pregnancy with a history of spontaneous preterm birth. AMAG Pharmaceuticals marketed the drug until Covis acquired it in Oct. 2020. Specifically, the drug is an injectable progestin therapy to decrease preterm births, or births that occur before 37 weeks of pregnancy have been completed. Preterm babies can develop health issues, including respiratory distress syndrome, neonatal sepsis and intraventricular hemorrhage. Read on Fierce Biotech >>
Biogen’s ALS ambitions on pause as FDA delays approval decision by 3 months
October 17, 2022 / Biogen / Amyotrophic Lateral Sclerosis / FDA / Ionis Pharma – The long and winding road Biogen’s tofersen has taken to FDA approval just got longer, with the agency delaying its decision on the amyotrophic lateral sclerosis (ALS) drug until April.
Biogen’s tofersen plans were almost derailed a year ago by a phase 3 study that revealed the antisense medicine failed to improve the functional status of SOD1-ALS patients compared to placebo after six months, causing the 108-subject study to miss its primary endpoint. Read on Fierce Biotech >>
October 17, 2022 / Biogen / Amyotrophic Lateral Sclerosis / FDA / Ionis Pharma – The long and winding road Biogen’s tofersen has taken to FDA approval just got longer, with the agency delaying its decision on the amyotrophic lateral sclerosis (ALS) drug until April.
Biogen’s tofersen plans were almost derailed a year ago by a phase 3 study that revealed the antisense medicine failed to improve the functional status of SOD1-ALS patients compared to placebo after six months, causing the 108-subject study to miss its primary endpoint. Read on Fierce Biotech >>
FDA approves single-vial version of GSK’s Menveo vaccine, ending need for reconstitution
October 18, 2022 / GSK / Menveo / Vaccine- Clinical-stage biotechnology firm Nanoscope Therapeutics has received Fast Track designation (FTD) from the US Food and Drug Administration (FDA) for its optogenetic monotherapy, MCO-010, to treat retinitis pigmentosa (RP). MCO-010, the lead asset of the company, is an ambient-light activatable multi-characteristic opsin (MCO) monotherapy, which has been designed to restore vision in blind patients. It has also received orphan drug designations from the US FDA for the treatment of RP and Stargardt. Read on Fierce Pharma >>
October 18, 2022 / GSK / Menveo / Vaccine- Clinical-stage biotechnology firm Nanoscope Therapeutics has received Fast Track designation (FTD) from the US Food and Drug Administration (FDA) for its optogenetic monotherapy, MCO-010, to treat retinitis pigmentosa (RP). MCO-010, the lead asset of the company, is an ambient-light activatable multi-characteristic opsin (MCO) monotherapy, which has been designed to restore vision in blind patients. It has also received orphan drug designations from the US FDA for the treatment of RP and Stargardt. Read on Fierce Pharma >>
Pfizer takes Vyndaqel copay fight to Supreme Court, decrying ‘staggeringly overbroad’ anti-kickback rule
October 17, 2022 / Pfizer / US Supreme Court / Kickbacks / Rare Diseases –After two legal defeats, Pfizer is taking its copay assistance lawsuit for costly rare heart disease drug tafamidis to the Supreme Court. Once again, the company is challenging the U.S. Department of Health and Human Services’ (HHS’) interpretation of anti-kickback law. Pfizer is asking the Supreme Court to decide whether a proposed program to help Medicare patients pay out-of-pocket costs for its tafamidis drugs—Vyndaqel and Vyndamax—would violate U.S. anti-kickback laws. An HHS opinion in 2019 ruled against Pfizer, finding that such an arrangement would break a criminal ban on financial support to patients for a federally reimbursed healthcare product. Pfizer sued to overturn the ruling, but two courts have since sided with the U.S. government. Read on Fierce Pharma >>
October 17, 2022 / Pfizer / US Supreme Court / Kickbacks / Rare Diseases –After two legal defeats, Pfizer is taking its copay assistance lawsuit for costly rare heart disease drug tafamidis to the Supreme Court. Once again, the company is challenging the U.S. Department of Health and Human Services’ (HHS’) interpretation of anti-kickback law. Pfizer is asking the Supreme Court to decide whether a proposed program to help Medicare patients pay out-of-pocket costs for its tafamidis drugs—Vyndaqel and Vyndamax—would violate U.S. anti-kickback laws. An HHS opinion in 2019 ruled against Pfizer, finding that such an arrangement would break a criminal ban on financial support to patients for a federally reimbursed healthcare product. Pfizer sued to overturn the ruling, but two courts have since sided with the U.S. government. Read on Fierce Pharma >>
// Research & Development
Tempo Bioscience Expands Patient-Relevant Blood-Brain-Barrier Models for Drug Development October 19, 2022 / Tempo Bioscience / Drug Development – Tempo-iBMEC™ and Tempo-iPeri™ are critical for establishing patient-relevant blood-brain-barrier models to improve the drug development process for a growing number of therapeutic modalities (e.g., small molecules, biologics, gene therapies, CAR-T/NK therapies, siRNA/mRNA therapies). Combining these new products with existing products from Tempo, the human blood-brain-barrier is shown to be an orchestrated, dynamic and regulated barrier. Read Full Article on BioSpace >>
Bill & Melinda Gates Institute licenses 2 of Merck’s TB antibiotic candidates October 11, 2022 / Merck & Co. / The Bill & Melinda Gates Foundation / Antibiotics / Tuberculosis – Tuberculosis has become increasingly difficult to treat as antibiotic resistance rises and the pipeline of antibiotics in development thins out. Now, Merck & Co. and the Bill & Melinda Gates Medical Research Institute are teaming up to tackle the challenge, inking a global licensing deal for two preclinical tuberculosis (TB) antibiotics with hopes of combating resistance and cutting treatment times. Read Full Article on Fierce Biotech >>
INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines for INKmune
October 19, 2022 / INmune Bio / INKmune / Solid Tumor Efficacy – INmune Bio, Inc., a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announces positive solid tumor data in multiple cancer lines resistant to NK killing that can be overcome with administration of INKmune. Solid tumors represent approximately 90% of adult human cancers while the majority of cell therapies focus on the 10% of cancers that are hematologic tumors, or “liquid tumors.” The current data provides insights into why the Company believes that INKmune arms Natural Killer (NK) to override immunosuppression and hypoxia in an active Tumor Microenvironment (TME) to kill solid tumors. Read Full Article on BioSpace >>
October 19, 2022 / INmune Bio / INKmune / Solid Tumor Efficacy – INmune Bio, Inc., a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announces positive solid tumor data in multiple cancer lines resistant to NK killing that can be overcome with administration of INKmune. Solid tumors represent approximately 90% of adult human cancers while the majority of cell therapies focus on the 10% of cancers that are hematologic tumors, or “liquid tumors.” The current data provides insights into why the Company believes that INKmune arms Natural Killer (NK) to override immunosuppression and hypoxia in an active Tumor Microenvironment (TME) to kill solid tumors. Read Full Article on BioSpace >>
Experimental Ebola shots to be used in Uganda outbreak: reports
October 19, 2022 / Ebola / Oxford University / Serum Institute of India / WHO – Almost exactly a month ago, health officials declared an Ebola outbreak in the East African country. There aren’t any approved vaccines or treatments for the Sudan species of Ebola currently afflicting the area—the largest outbreak of its kind since 2000. It’s one of four known Ebola viruses to cause hemorrhagic fever, with the latest outbreak having already infected at least 60 people and caused 24 deaths to date. The counts are both likely underestimates as Ebola cases and deaths prior to the outbreak declaration aren’t included. Vaccines developed by U.S.-based Sabin Vaccine Institute and Oxford University in the U.K. “are ready to be shipped” to Uganda, the country’s WHO representative Yonas Tegegn Woldemariam is reported as saying to the Associated Press. The Eastern African country is finalizing protocols for the study before the National Drug Authority administers import permits for the shots, the AP said. Read Full Article on Fierce Biotech >>
October 19, 2022 / Ebola / Oxford University / Serum Institute of India / WHO – Almost exactly a month ago, health officials declared an Ebola outbreak in the East African country. There aren’t any approved vaccines or treatments for the Sudan species of Ebola currently afflicting the area—the largest outbreak of its kind since 2000. It’s one of four known Ebola viruses to cause hemorrhagic fever, with the latest outbreak having already infected at least 60 people and caused 24 deaths to date. The counts are both likely underestimates as Ebola cases and deaths prior to the outbreak declaration aren’t included. Vaccines developed by U.S.-based Sabin Vaccine Institute and Oxford University in the U.K. “are ready to be shipped” to Uganda, the country’s WHO representative Yonas Tegegn Woldemariam is reported as saying to the Associated Press. The Eastern African country is finalizing protocols for the study before the National Drug Authority administers import permits for the shots, the AP said. Read Full Article on Fierce Biotech >>
J&J, flush with blood cancer assets, cuts one from the pipeline
October 18, 2022 / Johnson & Johnson / Janssen / Blood Cancer / Hematologic Cancer – Johnson & Johnson has not shied away from its blood cancer ambitions, with six phase 1 assets bubbling at the base of the company’s oncology pipeline. But not all the early contenders have made it this far. The company has cut JNJ-6665—a dihydroorotate dehydrogenase inhibitor—according to an updated pipeline (PDF) revised for the company’s third-quarter report on Tuesday. A spokesperson for J&J told Fierce Biotech the asset had been axed “as part of a strategic portfolio decision.” JNJ-6665 had been in the middle of a phase 1 trial for patients with acute myeloid leukemia and myelodysplastic syndrome. Read Full Article on Fierce Biotech >>
October 18, 2022 / Johnson & Johnson / Janssen / Blood Cancer / Hematologic Cancer – Johnson & Johnson has not shied away from its blood cancer ambitions, with six phase 1 assets bubbling at the base of the company’s oncology pipeline. But not all the early contenders have made it this far. The company has cut JNJ-6665—a dihydroorotate dehydrogenase inhibitor—according to an updated pipeline (PDF) revised for the company’s third-quarter report on Tuesday. A spokesperson for J&J told Fierce Biotech the asset had been axed “as part of a strategic portfolio decision.” JNJ-6665 had been in the middle of a phase 1 trial for patients with acute myeloid leukemia and myelodysplastic syndrome. Read Full Article on Fierce Biotech >>
// Politics
How one pharma insider sees the drug pricing reform law: the impact will ‘vary by product and by company’
October 20, 2022 / Drug Pricing / Reformed Law / US Congress – After years of stops and starts, a law was finally passed in Congress this summer to address the rising cost of prescription medicines. The Inflation Reduction Act allows the federal government to negotiate prices for some costly drugs, but only a small number that cost the government the most money. But those medicines can’t have any competing products on the market, and negotiations can’t begin until a small-molecule drug has been available for at least nine years and a biologic for 13 years. Moreover, the process does not start until 2026. A separate policy aimed at moderating price growth would make drugmakers pay back Medicare if they hike prices faster than inflation. And in 2025, Medicare beneficiaries will see their costs capped at $2,000 per year. Read Full Article on Stat News >>
October 20, 2022 / Drug Pricing / Reformed Law / US Congress – After years of stops and starts, a law was finally passed in Congress this summer to address the rising cost of prescription medicines. The Inflation Reduction Act allows the federal government to negotiate prices for some costly drugs, but only a small number that cost the government the most money. But those medicines can’t have any competing products on the market, and negotiations can’t begin until a small-molecule drug has been available for at least nine years and a biologic for 13 years. Moreover, the process does not start until 2026. A separate policy aimed at moderating price growth would make drugmakers pay back Medicare if they hike prices faster than inflation. And in 2025, Medicare beneficiaries will see their costs capped at $2,000 per year. Read Full Article on Stat News >>
FDA staffers pull no punches on Makena as Covis’ preterm birth drug faces expert panel reckoning
October 17, 2022 / Makena / FDA – More than a decade after Makena’s accelerated approval in 2011, Covis has failed to prove its effectiveness, officials from the FDA’s Center for Drug Evaluation and Research (CDER) said. That gives the agency a strong case for the drug’s removal from the U.S. market, they added. The remarks formed part of an opening salvo at this week’s meeting of the agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee, which is due to help decide Makena’s fate by Wednesday. Read Full Article on Fierce Pharma >>
October 17, 2022 / Makena / FDA – More than a decade after Makena’s accelerated approval in 2011, Covis has failed to prove its effectiveness, officials from the FDA’s Center for Drug Evaluation and Research (CDER) said. That gives the agency a strong case for the drug’s removal from the U.S. market, they added. The remarks formed part of an opening salvo at this week’s meeting of the agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee, which is due to help decide Makena’s fate by Wednesday. Read Full Article on Fierce Pharma >>
Biden’s Strategy to Curb China Is Hardening
October 14, 2022 / Biden / China / US Restrictions – Sweeping new US restrictions were announced last Friday on sales of semiconductors and chipmaking equipment to China. The consequent market meltdown is tantamount to the fact they add up to the most drastic round of technology curbs on Beijing to date. Chip stocks erased more than $240 billion in global market value at one point this week. Stocks later recovered, but the rout left a dawning realization that US policy on China has hardened, and a new front has been opened. Read Full Article on Bloomberg >>
October 14, 2022 / Biden / China / US Restrictions – Sweeping new US restrictions were announced last Friday on sales of semiconductors and chipmaking equipment to China. The consequent market meltdown is tantamount to the fact they add up to the most drastic round of technology curbs on Beijing to date. Chip stocks erased more than $240 billion in global market value at one point this week. Stocks later recovered, but the rout left a dawning realization that US policy on China has hardened, and a new front has been opened. Read Full Article on Bloomberg >>
