// Biotech and Pharma Therapeutics
Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment
July 10, 2023 / Women’s Health / Fertility Treatment / Ganirelix – Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health. Ganirelix Acetate Injection is available immediately from Fresenius Kabi in 250 mcg/0.5 mL prefilled syringes. Read Full Article on Biospace >>
July 10, 2023 / Women’s Health / Fertility Treatment / Ganirelix – Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health. Ganirelix Acetate Injection is available immediately from Fresenius Kabi in 250 mcg/0.5 mL prefilled syringes. Read Full Article on Biospace >>
FemTech: 5 Tips to Protect Reproductive Health Information
July 11, 2023 / FemTech / Reproductive Health / Healthcare / Women’s Health – With the widespread adoption of electronic health records (EHRs), a digital version of a patient’s paper chart, and hundreds of personal health apps, the overturned ruling has created an increase of security and privacy concerns in how medical information is documented, accessed, and utilized in the consumer domain. Read Full Article on HIT Consultant >>
July 11, 2023 / FemTech / Reproductive Health / Healthcare / Women’s Health – With the widespread adoption of electronic health records (EHRs), a digital version of a patient’s paper chart, and hundreds of personal health apps, the overturned ruling has created an increase of security and privacy concerns in how medical information is documented, accessed, and utilized in the consumer domain. Read Full Article on HIT Consultant >>
Nanobiotix licenses cancer treatment to J&J, extending runway
July 10, 2023 / Nanobiotix / J&J / Cancers / LianBio – French biotechnology company Nanobiotix will license an experimental cancer treatment to Johnson & Johnson’s Janssen arm in a deal announced Monday, giving the smaller drugmaker enough cash to fund operations into next year. Read Full Article on Biopharma Dive >>
July 10, 2023 / Nanobiotix / J&J / Cancers / LianBio – French biotechnology company Nanobiotix will license an experimental cancer treatment to Johnson & Johnson’s Janssen arm in a deal announced Monday, giving the smaller drugmaker enough cash to fund operations into next year. Read Full Article on Biopharma Dive >>
CVS Caremark, GoodRx Launch Program To Lower Drug Costs
July 12, 2023 / CVS Caremark / Drug Costs / GoodRx – CVS Caremark and GoodRx created a new program called Caremark Cost Saver, which will become available starting January 1, 2024. Through the program, eligible CVS Caremark commercially insured members will have access to GoodRx’s prescription pricing on generic medications. Read Full Article on Med City News >>
July 12, 2023 / CVS Caremark / Drug Costs / GoodRx – CVS Caremark and GoodRx created a new program called Caremark Cost Saver, which will become available starting January 1, 2024. Through the program, eligible CVS Caremark commercially insured members will have access to GoodRx’s prescription pricing on generic medications. Read Full Article on Med City News >>
J&J Gets Foothold in Head & Neck Cancer With Deal for Nanobiotix’s Lead Program
July 10, 2023 / J&J / Nanbiotix / Cancers / Janssen – Nanobiotix’s lead program could offer a new way of treating head and neck cancer, and preliminary data are expected next year. The biotech’s problem is that its cash reserves were projected to dry up sometime this summer. Johnson & Johnson is throwing a lifeline, striking a deal that lands rights to the cancer therapy while giving Nanobiotix enough financial support until the readout of key data in 2024.
Read Full Article on Med City News >>
July 10, 2023 / J&J / Nanbiotix / Cancers / Janssen – Nanobiotix’s lead program could offer a new way of treating head and neck cancer, and preliminary data are expected next year. The biotech’s problem is that its cash reserves were projected to dry up sometime this summer. Johnson & Johnson is throwing a lifeline, striking a deal that lands rights to the cancer therapy while giving Nanobiotix enough financial support until the readout of key data in 2024.
Read Full Article on Med City News >>
// 4th Industrial Revolution
In-space manufacturing startup aces pharma experiment in orbit
July 7, 2023 / Startup / Varda Space / Space – Varda’s spacecraft launched June 12 as part of a rideshare mission on a SpaceX Falcon 9 rocket, then completed several weeks of checkouts before starting a 27-hour drug-manufacturing experiment last week. When ground controllers gave the go-ahead, the mini-lab began growing crystals of ritonavir, a drug commonly used to treat HIV. Read Full Article on ARS Technica >>
July 7, 2023 / Startup / Varda Space / Space – Varda’s spacecraft launched June 12 as part of a rideshare mission on a SpaceX Falcon 9 rocket, then completed several weeks of checkouts before starting a 27-hour drug-manufacturing experiment last week. When ground controllers gave the go-ahead, the mini-lab began growing crystals of ritonavir, a drug commonly used to treat HIV. Read Full Article on ARS Technica >>
Google’s medical AI chatbot is already being tested in hospitals
July 8, 2023 / AI Chatbot / Google / Mayo Clinic – Google’s Med-PaLM 2, an AI tool designed to answer questions about medical information, has been in testing at the Mayo Clinic research hospital, among others, since April, The Wall Street Journal reported this morning. Med-PaLM 2 is a variant of PaLM 2, which was announced at Google I/O in May this year. PaLM 2 is the language model underpinning Google’s Bard. Read Full Article on The Verge >>
July 8, 2023 / AI Chatbot / Google / Mayo Clinic – Google’s Med-PaLM 2, an AI tool designed to answer questions about medical information, has been in testing at the Mayo Clinic research hospital, among others, since April, The Wall Street Journal reported this morning. Med-PaLM 2 is a variant of PaLM 2, which was announced at Google I/O in May this year. PaLM 2 is the language model underpinning Google’s Bard. Read Full Article on The Verge >>
Why telemedicine must play a central role in solving the specialist shortage
July 10, 2023 / Telemedicine / Specialist Shortage / Summus Global – It is difficult enough to find access – especially timely access – to needed medical specialists in large urban areas, but it can be next to impossible in rural communities. Virtual care has proven that it can be a big help in connecting patients with the right specialists, and in a timely manner. Read Full Article on Healthcare It News >>
July 10, 2023 / Telemedicine / Specialist Shortage / Summus Global – It is difficult enough to find access – especially timely access – to needed medical specialists in large urban areas, but it can be next to impossible in rural communities. Virtual care has proven that it can be a big help in connecting patients with the right specialists, and in a timely manner. Read Full Article on Healthcare It News >>
AI Accurately Predicts On- and Off-Target Activity of CRISPR Tools
July 10, 2023 / AI / CRISPR Tools / RNA-Targeting / Gene-editing – A new study published last week in Nature Biotechnology demonstrated that a deep learning (DL) tool can predict on- and off-target activity of RNA-targeting CRISPR tools, which may spur the development of new CRISPR-based therapies. Read Full Article on Health IT Analytics >>
July 10, 2023 / AI / CRISPR Tools / RNA-Targeting / Gene-editing – A new study published last week in Nature Biotechnology demonstrated that a deep learning (DL) tool can predict on- and off-target activity of RNA-targeting CRISPR tools, which may spur the development of new CRISPR-based therapies. Read Full Article on Health IT Analytics >>
Astellas buys rights to 4D Molecular’s technology in latest gene therapy deal
July 10, 2023 / Astellas / Gene Therapy / 4D Molecular Therapeutics – The deal gives Astellas the right to use technology created by 4D in developing a treatment for at least one rare single-gene eye disease. Astellas has options, for additional fees, to add two more genetic targets to the collaboration. Read Full Article on Biopharma Dive >>
July 10, 2023 / Astellas / Gene Therapy / 4D Molecular Therapeutics – The deal gives Astellas the right to use technology created by 4D in developing a treatment for at least one rare single-gene eye disease. Astellas has options, for additional fees, to add two more genetic targets to the collaboration. Read Full Article on Biopharma Dive >>
// Business & Markets
Digital health funding stays low as a new reality sets in
July 11, 2023 / Digital Health / Funding / Medicare – A new investigation out this morning reveals how UnitedHealth‘s acquisition of a popular Medicare Advantage algorithm developed by NaviHealth sparked internal dissent over denied care for seriously ill patients. Read Full Article on STAT News >>
July 11, 2023 / Digital Health / Funding / Medicare – A new investigation out this morning reveals how UnitedHealth‘s acquisition of a popular Medicare Advantage algorithm developed by NaviHealth sparked internal dissent over denied care for seriously ill patients. Read Full Article on STAT News >>
Novartis retreats from TIGIT, handing $300M candidate back to BeiGene
July 11, 2023 / Novartis / BeiGene / TIGIT / Licensing Deals – Novartis may have insisted earlier this year that it hadn’t given up on anti-TIGIT checkpoint inhibitors, but, now, the Swiss Big Pharma seems to have had a change of heart. Having paid $300 million to enter the TIGIT space by acquiring ociperlimab in 2021, Novartis is now handing the candidate back to BeiGene. Read Full Article on Fierce Biotech >>
July 11, 2023 / Novartis / BeiGene / TIGIT / Licensing Deals – Novartis may have insisted earlier this year that it hadn’t given up on anti-TIGIT checkpoint inhibitors, but, now, the Swiss Big Pharma seems to have had a change of heart. Having paid $300 million to enter the TIGIT space by acquiring ociperlimab in 2021, Novartis is now handing the candidate back to BeiGene. Read Full Article on Fierce Biotech >>
Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports
July 5, 2023 / Moderna / China / mRNA / Vaccine Development – Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. Now, as the commerce minister of the world’s second largest economy signals the potential for new development opportunities for Western firms in the country, mRNA wunderkind Moderna is getting in on the action. Read Full Article on Fierce Pharma >>
July 5, 2023 / Moderna / China / mRNA / Vaccine Development – Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. Now, as the commerce minister of the world’s second largest economy signals the potential for new development opportunities for Western firms in the country, mRNA wunderkind Moderna is getting in on the action. Read Full Article on Fierce Pharma >>
Eisai’s US CEO and Alzheimer’s lead Ivan Cheung telegraphs retirement days after Leqembi’s full FDA nod
July 11, 2023 / Eisai / Biogen / Leqembi / Alzheimer’s Disease – Ivan Cheung, who also serves as the Japanese pharma’s American CEO, will retire at the end of the month, Eisai said in a Tuesday release. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s head honcho Haruo Naito—has taken up the lead Alzheimer’s disease mantle, the company added. Read Full Article on Fierce Pharma >>
July 11, 2023 / Eisai / Biogen / Leqembi / Alzheimer’s Disease – Ivan Cheung, who also serves as the Japanese pharma’s American CEO, will retire at the end of the month, Eisai said in a Tuesday release. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s head honcho Haruo Naito—has taken up the lead Alzheimer’s disease mantle, the company added. Read Full Article on Fierce Pharma >>
Septerna snags $150M series B for pipeline of GPCR therapies tackling hard-to-drug targets
July 11, 2023 / Septerna / Emerging Biopharma / Series B / GPCR – Septerna has secured $150 million in a series B fundraise, money that will go toward two newly unveiled programs including moving its first G-protein-coupled receptor (GPCR) drug into the clinic. Read Full Article on Fierce biotech >>
July 11, 2023 / Septerna / Emerging Biopharma / Series B / GPCR – Septerna has secured $150 million in a series B fundraise, money that will go toward two newly unveiled programs including moving its first G-protein-coupled receptor (GPCR) drug into the clinic. Read Full Article on Fierce biotech >>
// Legal & Regulatory
Novartis to appeal district court ruling on heart drug patent
July 10, 2023 / Novartis / District Court / Heart Drug – Novartis plans to appeal a U.S. district court ruling that invalidated a key patent protecting the Swiss pharmaceutical company’s top-selling medicine, the heart drug Entresto. Read Full Article on Biopharma Dive >>
July 10, 2023 / Novartis / District Court / Heart Drug – Novartis plans to appeal a U.S. district court ruling that invalidated a key patent protecting the Swiss pharmaceutical company’s top-selling medicine, the heart drug Entresto. Read Full Article on Biopharma Dive >>
FDA grants first full approval for an Alzheimer’s drug in 20 years
July 6, 2023 / FDA / Alzheimer’s Drug / Drug Approval – The FDA on Thursday granted traditional approval to an Alzheimer’s drug for the first time in more than two decades. Read Full Article on Politico >>
July 6, 2023 / FDA / Alzheimer’s Drug / Drug Approval – The FDA on Thursday granted traditional approval to an Alzheimer’s drug for the first time in more than two decades. Read Full Article on Politico >>
European regulators probe suicide risk to Ozempic, other Novo drug Saxenda
July 10, 2023 / European / Ozempic / Novo / Diabetes – The Icelandic drug agency reported two cases of suicide “ideation,” one from a person taking Saxenda, a daily weight-loss shot containing liraglutide, and another on Ozempic, the weekly diabetes shot containing semaglutide that is also widely used for weight loss. A third person had thoughts of self-injury while taking Saxenda, the EMA said. Read on Biopharma Dive >>
July 10, 2023 / European / Ozempic / Novo / Diabetes – The Icelandic drug agency reported two cases of suicide “ideation,” one from a person taking Saxenda, a daily weight-loss shot containing liraglutide, and another on Ozempic, the weekly diabetes shot containing semaglutide that is also widely used for weight loss. A third person had thoughts of self-injury while taking Saxenda, the EMA said. Read on Biopharma Dive >>
FDA clears more chemotherapy imports from China’s Qilu amid shortage of key cancer meds
July 12, 2023 / FDA / Qilu Pharmaceutical / Apotex / Cisplatin – After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Read on Fierce Pharma >>
July 12, 2023 / FDA / Qilu Pharmaceutical / Apotex / Cisplatin – After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Read on Fierce Pharma >>
FDA Lifts Partial Hold on Curis Drug, Clearing Way for Phase 2 Leukemia Study
July 9, 2023 / FDA / Phase 2 Leukemia Study / Clinical Trial –A Curis clinical trial under a partial FDA hold for more than a year is now cleared to resume, and the biotech is working with clinical sites to enroll patients whose blood cancers exhibits certain mutations. Read on Med City News >>
July 9, 2023 / FDA / Phase 2 Leukemia Study / Clinical Trial –A Curis clinical trial under a partial FDA hold for more than a year is now cleared to resume, and the biotech is working with clinical sites to enroll patients whose blood cancers exhibits certain mutations. Read on Med City News >>
// Research & Development
UPMC Researchers Create Algorithm that Accurately Identifies High-Risk Surgical Patients
July 10, 2023 / UPMC / High-risk patients – Improving overall health of patients prior to surgery through prehabilitation can go a long way in improving outcomes for high-risk patients,” said Aman Mahajan, M.D., Ph.D., M.B.A., chair of Anesthesiology and Perioperative Medicine, Pitt School of Medicine, and director of UPMC Perioperative and Surgical Services. “However, identifying high-risk patients can be challenging for busy clinicians, who have to integrate the wealth of health data available and frequently perform additional testing and clinical assessments. Read Full Article on HIT Consultant >>
July 10, 2023 / UPMC / High-risk patients – Improving overall health of patients prior to surgery through prehabilitation can go a long way in improving outcomes for high-risk patients,” said Aman Mahajan, M.D., Ph.D., M.B.A., chair of Anesthesiology and Perioperative Medicine, Pitt School of Medicine, and director of UPMC Perioperative and Surgical Services. “However, identifying high-risk patients can be challenging for busy clinicians, who have to integrate the wealth of health data available and frequently perform additional testing and clinical assessments. Read Full Article on HIT Consultant >>
Gut punch: First Wave’s challenger to AbbVie fails phase 2 again
July 13, 2023 / Creon / Cystic Fibrosis / Clinical Trial Data – First Wave BioPharma’s bid to challenge AbbVie for a gastrointestinal market has suffered a setback, with the biotech telling investors “it is likely the primary efficacy endpoint was not achieved.” Read Full Article on Fierce Biotech >>
July 13, 2023 / Creon / Cystic Fibrosis / Clinical Trial Data – First Wave BioPharma’s bid to challenge AbbVie for a gastrointestinal market has suffered a setback, with the biotech telling investors “it is likely the primary efficacy endpoint was not achieved.” Read Full Article on Fierce Biotech >>
Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine
July 10, 2023 / Merck & Co / Moderna / Cancer Vaccine / mRNA – After a major phase 2 win that stirred up much excitement within the oncology community, Merck & Co. has officially formulated a pivotal trial plan for its Moderna-partnered personalized cancer vaccine, mRNA-4157. Read Full Article on Fierce Biotech >>
July 10, 2023 / Merck & Co / Moderna / Cancer Vaccine / mRNA – After a major phase 2 win that stirred up much excitement within the oncology community, Merck & Co. has officially formulated a pivotal trial plan for its Moderna-partnered personalized cancer vaccine, mRNA-4157. Read Full Article on Fierce Biotech >>
Roche’s Ocrevus Subcutaneous Injection Matches IV Infusion in Phase III MS Trial
July 13, 2023 / Roche / IV Infusion / Phase III MS Trial – Data from the Phase III OCARINA II trial showed that the subcutaneous formulation of Genentech’s Ocrevus (ocrelizumab) met the study’s primary endpoint, eliciting a similar pharmacokinetic profile as its intravenous formulation in patients with multiple sclerosis, the company announced Thursday. Read Full Article on Biospace >>
July 13, 2023 / Roche / IV Infusion / Phase III MS Trial – Data from the Phase III OCARINA II trial showed that the subcutaneous formulation of Genentech’s Ocrevus (ocrelizumab) met the study’s primary endpoint, eliciting a similar pharmacokinetic profile as its intravenous formulation in patients with multiple sclerosis, the company announced Thursday. Read Full Article on Biospace >>
Telehealth proves successful for opioid use disorder treatment
July 11, 2023 / Telehealth / Opioids – Opioid addiction and overdose-related deaths reached an all-time high in 2022. The opioid crisis has strained health systems, overwhelmed emergency responders and placed a heavy burden on social services. Read Full Article on Healthcare It News >>
July 11, 2023 / Telehealth / Opioids – Opioid addiction and overdose-related deaths reached an all-time high in 2022. The opioid crisis has strained health systems, overwhelmed emergency responders and placed a heavy burden on social services. Read Full Article on Healthcare It News >>
// Politics
How will the price of Eisai and Biogen’s Leqembi impact Medicare? Sen. Sanders wants to know
July 12, 2023 / Leqembi / Alzheimer’s / Bernie Sanders / Biogen – Five weeks after getting no response from the U.S. Department of Health and Human Services on his request for more information on the potential financial impact of Eisai and Biogen’s newly approved Alzheimer’s treatment Leqembi, Sen. Bernie Sanders (I-Vt.) is applying more pressure. Read Full Article on Fierce Pharma >>
July 12, 2023 / Leqembi / Alzheimer’s / Bernie Sanders / Biogen – Five weeks after getting no response from the U.S. Department of Health and Human Services on his request for more information on the potential financial impact of Eisai and Biogen’s newly approved Alzheimer’s treatment Leqembi, Sen. Bernie Sanders (I-Vt.) is applying more pressure. Read Full Article on Fierce Pharma >>
Biden’s NIH nominee is languishing in Congress — alarming public health advocates
July 10, 2023 / Biden / NIH nominee / Public Health – Sen. Bernie Sanders’ rare move to delay President Biden’s health care nominees has put the drug pricing firebrand and the White House in a standoff — and public health advocates worry the feud could squeeze out an otherwise uncontroversial pick to lead the country’s top science agency. Read Full Article on STAT News >>
July 10, 2023 / Biden / NIH nominee / Public Health – Sen. Bernie Sanders’ rare move to delay President Biden’s health care nominees has put the drug pricing firebrand and the White House in a standoff — and public health advocates worry the feud could squeeze out an otherwise uncontroversial pick to lead the country’s top science agency. Read Full Article on STAT News >>
Biden Administration Takes Action Against Junk Insurance, Surprise Bills
July 9, 2023 / Biden / New Bills / Junk Insurance – Junk insurance refers to short-term health plans that are often lacking in coverage like mental health and prescription drugs, and they don’t have consumer protections like coverage of pre-existing conditions. These plans “leave families surprised by thousands of dollars in bills, often because the insurance plan claims they have a pre-existing condition that isn’t covered,” according to a White House fact sheet. These plans were limited to three months by the Obama administration, but the Trump administration allowed members to stay on the plans for 12 months and renew them for three years. Read Full Article on Med City News >>
July 9, 2023 / Biden / New Bills / Junk Insurance – Junk insurance refers to short-term health plans that are often lacking in coverage like mental health and prescription drugs, and they don’t have consumer protections like coverage of pre-existing conditions. These plans “leave families surprised by thousands of dollars in bills, often because the insurance plan claims they have a pre-existing condition that isn’t covered,” according to a White House fact sheet. These plans were limited to three months by the Obama administration, but the Trump administration allowed members to stay on the plans for 12 months and renew them for three years. Read Full Article on Med City News >>
White House announces new plan to address the growing threat of xylazine in overdose crisis
July 11, 2023 / White House / Overdose Crisis / Drug Crisis – In recent years, xylazine, which is commonly known as “tranq,” has helped to accelerate the already-deadly U.S. drug crisis. The drug is increasingly being mixed into illicit opioids like fentanyl, contributing to overdose spikes across the country, particularly in northeastern cities like Philadelphia and New York. Read Full Article on STAT News >>
July 11, 2023 / White House / Overdose Crisis / Drug Crisis – In recent years, xylazine, which is commonly known as “tranq,” has helped to accelerate the already-deadly U.S. drug crisis. The drug is increasingly being mixed into illicit opioids like fentanyl, contributing to overdose spikes across the country, particularly in northeastern cities like Philadelphia and New York. Read Full Article on STAT News >>
Merck applies more pressure against IRA, asking for decision without trial in fight with US government
July 12, 2023 / Merck / Inflation Reduction Act / Drug Prices / Department of Health and Human Services – Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday in federal court in Washington, D.C. for a decision without a trial. Read Full Article on Fierce Pharma >>
July 12, 2023 / Merck / Inflation Reduction Act / Drug Prices / Department of Health and Human Services – Merck is bringing more heat in its battle against drug price negotiation provisions in the Inflation Reduction Act (IRA), filing Tuesday in federal court in Washington, D.C. for a decision without a trial. Read Full Article on Fierce Pharma >>
