// Biotech and Pharma Therapeutics

Faced with safety issues over inflammation drug, AstraZeneca spinout Aristea closes shop
February 10, 2023 / Biotech closure / Inflammation – Things seemed to be going well for Aristea as recently as last November, with the biotech taking on board a crop of clinical experts as it looked to expand its pipeline. The company’s lead asset, a CXCR2 antagonist dubbed RIST4721, was undergoing phase 2 trials for four neutrophil-mediated diseases: a rare inflammatory disorder called palmoplantar pustulosis (PPP), a painful skin condition called hidradenitis suppurativa, a genetic disorder called familial Mediterranean fever and Behcet’s disease, which causes inflammation of the blood vessels. Read Full Article on Fierce Biotech >>
Christi Shaw, leader of Gilead’s cancer cell therapy unit, to depart
February 17, 2023 / Christi Shaw / Cancer Cell Therapy / Gilead – Shaw who took the Kite role in part by the experience of watching her sister fight cancer. Under her leadership, the once-embattled division, which makes personalized CAR-T treatments for blood cancers, has begun to be a significant contributor to Gilead’s overall business. Read Full Article on STAT News >>
Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight
February 13, 2023 / Amgen / Sanofi / Regeneron Pharma / Praluent – One month after the Big Biotech drummed up support from AbbVie, Bristol Myers Squibb and others for its Supreme Court bid, a slew of drugmakers on the opposite side of the argument are coming down in favor of Sanofi and Regeneron. Read Full Article on Fierce Pharma >>
Pfizer update Lyme disease vaccine candidate
February 17, 2023 / Pfizer / Lyme Disease / Vaccine – The research is investigating the safety, efficacy and immunogenicity of Lyme disease vaccine candidate, VLA15. Participants – representing approximately half of the total recruited participants in the trial – are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. Read Full Article on Pharma Times >>
Fierce Pharma Asia—Takeda’s trial win, Biogen’s pipeline pivot and Astellas’ Super Bowl debut
February 17, 2023 / Fierce Pharma Asia / Takeda / Biogen / Astellas – Takeda’s third-generation tyrosine kinase inhibitor Iclusig decisively beat Novartis’ Gleevec in a type of leukemia. Biogen returned a BTK inhibitor to China’s InnoCare Pharma after paying $125 million upfront to get access to the medicine. Astellas made its first ad appearance during the Super Bowl. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

AI can be a big help to healthcare workers, but there are legal issues to consider
February 16, 2022 / AI / Healthcare / Legal / Burnout – As burnout among healthcare workers continues to be a major concern, the use of artificial intelligence, EHRs and other automation tools may be able to have a positive impact on hospitals and health systems. Read Full Article on Healthcare IT News >>
Talkspace Launches New Mental Health Portal for Employers
February 16, 2023 / Talkspace / Mental Health / Employers – New York City-based Talkspace serves employers, payers and consumers, and provides self-guided mental health programs, therapy and psychiatry. Its new product, Talkspace Engage, aims to help employers promote their mental health benefits to their employees, a challenge that many companies struggle with, said Erin Boyd, chief growth officer of enterprise at Talkspace. Read Full Article on MedCity News >>
What the metaverse and virtual reality can contribute to healthcare
February 17, 2023 / Metaverse / Virtual Reality / Healthcare – Medical practitioners can test out the effectiveness of new surgical methods in the metaverse before attempting on real patients, for example. And as an extension of telehealth, medical professionals can use virtual reality to access patients and examine them virtually. Read Full Article on Healthcare IT News >>
FemTech: Samsung Adds Menstrual Cycle Tracking Capabilities to Galaxy Watch5
February 14, 2023 / Women’s Health / Cycle Tracking / Galaxy Watch 5 / FDA – The Cycle Tracking feature has also been registered with the Food and Drug Administration (FDA) and complies with CE Marking requirements. The proprietary algorithm uses body temperature and other key fertility indicators to determine each user’s unique fertility status. Natural Cycles leverages its technology and algorithm to power the Cycle Tracking feature available on the Samsung Health app with the Galaxy Watch5 series. Read Full Article on HIT Consultant >>
RTLS & AI: Solving the Riddle of Healthcare Inefficiency
February 16, 2023 / AI / Healthcare / RTLS – Most RTLS systems depend on a combination of tags, sensors, and software. Tags are attached to any vital assets that need to be tracked including equipment, supplies, devices, and even people. These tags come in a variety of sizes and will vary in range and data quality. Sensors gather data from the tags and feed that data into either an onsite or cloud-based data hub. A software platform, usually with a custom-built data visualization element, will then process that data. Read Full Article on Healthcare IT Today >>

// Business & Markets

Veradigm and HealthVerity Partner to Advance Real-World Evidence for Cardiovascular Disease and Diabetes
February 13, 2023 / Cardiovascular / Diabetes / Veradigm / HealthVerity – The registry captures data on coronary artery disease (CAD), heart failure (HF), atrial fibrillation (AF), hypertension (HTN) and peripheral arterial disease (PAD). It follows cardiac patients across their journey, tracking key measures, including patient demographics, plan of care, cardiac events and comorbidities, exams, procedures, lab values, related medications, and more. Read Full Article on HIT Consultant >>
Mineralys, amid signs of thawing IPO market, upsizes offering to raise $192M for race with AstraZeneca
February 10, 2023 / Mineralys Therapeutics / IPO / Blood Pressure / Antihypertensive Drugs – Mineralys filed to test the long-frosty IPO waters last month and updated its paperwork with its targeted offering figures last week. Now, the developer of a high blood pressure drug has revealed the fundraising is going better than expected. Having set out to sell 10 million shares for $14 to $16 each, the biotech is set to shift 12 million shares and hit the top end of its target range. Read Full Article on Fierce Biotech >>
Chutes & Ladders—Former Roche pharma chief tapped to be new Bayer CEO
February 10, 2023 / Bayer / Astellas Pharma / Johnson & Johnson / Merck & Co – Bayer AG made a seismic hire this week, naming former Roche pharmaceutical chief Bill Anderson as the company’s new CEO. The news comes just two months after Anderson announced his departure from the company. As a result, current Bayer chief Werner Baumann will depart his post early, pacifying investors who felt he hasn’t been up to snuff. The move caps off a 35-year career for Baumann at Bayer. Read Full Article on Fierce Biotech >>
Insulet acquires Bigfoot’s insulin pump patents for $25M
February 13, 2023 / Bigfoot / Insulin / Insulet – Insulet and Bigfoot offer two distinct forms of diabetes-management care: Insulet’s Omnipod system that delivers insulin via a wearable, tubeless pump dubbed the Pod; and a remote controller called the Personal Diabetes Manager (PDM). Read Full Article on Mobi Health News >>
Medication risk analysis company MDI Health raises $20M
February 16, 2023 / Medication risk / MDI Health – “MDI Health is driven by our mission to help end the preventable suffering of patients caused by an outdated one-size-fits-all approach to medication treatment,” Avishai Ben-Tovim, CEO and cofounder of MDI Health, said in a statement. “The ongoing support and new funding from our investors equips us with the fuel we need to accelerate that mission.” Read Full Article on Mobi Health News >>

// Legal & Regulatory

Ahead of next month’s FDA decision, Emergent aces AdComm for over-the-counter Narcan nod
February 16, 2023 / Emergent BioSolutions / Narcan / Naloxone / U.S. FDA – The FDA is set to decide on the OTC approval pivot by March 29. If cleared next month, Emergent’s Narcan—a nasal spray—would become the first naloxone to successfully transform its prescription-status approval into an over-the-counter one. Emergent was first to file with its supplemental application for an OTC nod and won priority review last December. Read Full Article on Fierce Pharma >>
French court hands Novartis and Roche another win in battle over antitrust allegations involving eye drug
February 17, 2023 / French Court / Novartis / Roche / Antitrust Allegations – French appeals court has overturned a record fine levied three years ago against Novartis and Roche for allegedly engaging in anti-competitive practices, the second time this month the companies defeated a country’s antitrust authorities. Read Full Article on Stat News >>
U.S. Patent Office Re-Institutes Post Grant Review of Seagen Patent in Dispute between Daiichi Sankyo and Seagen
February 17, 2023 / U.S. Patent Office / Daiichi Sankyo / Seagen – “We are very pleased that the PGR will be reinstituted given the PTO’s determination that our petition presented compelling evidence of unpatentability of the ’039 patent,” said Naoto Tsukaguchi, Corporate Officer and General Counsel, Daiichi Sankyo, Co., Ltd. Read on Biospace >>
Blueprint told to stop sketching as FDA slaps partial hold on phase 1/2 trial
February 10, 2023 / Blueprine Medicines / Solid Tumor / FDA / Clinical hold – The company did not disclose how many of the events occurred but said in an announcement Friday that all were grade 1 except for one grade 3 incident. The visual side effects consisted of light sensitivity and blurred vision. All events were resolved with “dose interruption or reduction,” and there have been no trial discontinuations due to the side effects, according to Blueprint. Read on Fierce Biotech >>
Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly’s arrival
February 15, 2023 / Concert Pharma / Sun Pharma / Alopecia / Breakthrough Therapy – Concert secured the breakthrough-therapy status back in 2020 as it raced deuruxolitinib to become the first janus kinase (JAK) inhibitor approved for moderate to severe alopecia areata. However, in June 2022, Lilly and Incyte’s JAK inhibitor Olumiant was approved for the moderate version of the disease, causing the FDA to look again at Concert’s tag. Read on Fierce Biotech >>

// Research & Development

AstraZeneca’s Evusheld not recommended for certain adults
February 16, 2023 / AstraZeneca / Evusheld / Vaccine – NICE has been analysing Evusheld when the treatment is used to prevent COVID-19 infection in adults who are at high risk of severe infection. Among these individuals are those with immunodeficiency, people who have had a solid organ transplant and patients with cancer. Read Full Article on Pharma Times >>
GSK vaccine R&D head touts consistency of RSV data but is mum on restarting maternal trial
February 15, 2023 / GSK / RSV / Adult Vaccines / Pfizer – GSK’s head of vaccine R&D, Phil Dormitzer, M.D., Ph.D., can almost taste regulatory success as the company soon approaches an FDA deadline for a decision on its respiratory syncytial virus (RSV) vaccine in older adults. If approved, it could become the first in the world. Read Full Article on Fierce Biotech >>
Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures
February 16, 2023 / Cell Therapy / Kidney Transplant / Talaris Therapeutics – Talaris’s lead therapeutic candidate, FCR001, is comprised of immune and stem cells from the organ donor. These cells are intended to reprogram the transplant recipient’s immune system to tolerate the new organ. The hope was that this one-time cell therapy would enable a patient to avoid the need for lifelong immunosuppressive therapies, which increase the risk of infections and other complications. Read Full Article on Med City News >>
Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium
February 16, 2023 / Merck / AstraZeneca / Cancer / Clinical Oncology – Results from the primary endpoint of investigator-assessed radiographic progression-free survival (rPFS), which showed that LYNPARZA in combination with abi/pred significantly reduced the risk of disease progression or death by 34% compared to placebo plus abi/pred (median rPFS 24.8 months versus 16.6 months, respectively, HR=0.66 [95% CI, 0.54-0.81]; p<0.0001), were previously presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium and published in NEJM Evidence. Read Full Article on Biospace >>
Pharmalittle: Pfizer scraps half of participants in Lyme vaccine trial over quality issues; Ginkgo CEO may have possible conflict of interest
February 17, 2023 / Pfizer / Lyme Vaccine / Ginkgo – Pfzer discontinued a significant percentage of participants in the U.S. who had been enrolled in a Phase 3 study testing a vaccine against Lyme disease due to violations of good clinical practice at certain trail sites run by a third party, STAT says. Read Full Article on STAT News >>

// Politics

Republicans are using the FTC’s Lina Khan as an excuse for opposing drug pricing bills
February 16, 2023 / Republicans / FTC / Drug Pricing Bills / Lina Khan – The Senate Commerce Committee held a hearing Thursday on a bipartisan bill that aims to get the drug middlemen to tell the FTC how much money they make through pharmacy fees and “spread pricing,” a practive of charging insurers more for drufs than the PBMs pay pharmacies, and pocketing the difference. Read Full Article on STAT News >>
Government steps up efforts to drive innovation in pharmaceutical sector
February 8, 2023 / Joe Biden / Inflation Reduction Act / PhRMA / Drug Costs – The government has begun stakeholder consultations to identify ‘moonshot’ projects and role of industry as it plans to roll out its latest budget proposal to promote research and innovation in the pharmaceutical sector to be taken up through centres of excellence. “We are in the process of identifying seven centres of excellence (CoE) which will undertake research in moonshot areas,” N Yuvaraj, joint secretary, department of pharmaceuticals, to ET. Read Full Article on Economic Times >>
Here’s another sign the Biden administration is taking a harsher stance on hospital consolidation
February 17, 2023 / Biden / Hospital Consolidation – When Democrats passed the Affordable Care Act more than a decade ago, they hoped that getting doctors and hospitals to take on a role akin to insurers would encourage them to lower health care costs by averting expensive hospitalizations and avoiding redundant or excess services. Read Full Article on STAT News >>
Congress turns sights to hospital “dishonest billing”
February 16, 2023 / Biden / Insulin / Drug Prices – We’ve written before that there’s a growing target on hospitals’ backs now that pharma took its beating in the IRA. Now, a particular hospital-focused issue is gaining Congress’s attention: what critics dub “dishonest billing.” Read Full Article on AXIOS >>
Medicare politics are on a crash course with reality
February 16, 2023 / Medicare / Politics / Healthcare – Medicare spending is expected to more than double by 2033 — climbing to $1.6 trillion, or over 4% of the entire U.S. economy, according to an estimate released yesterday by the Congressional Budget Office. Read Full Article on AXIOS >>