// Biotech and Pharma Therapeutics

Novartis Nabs Merck Veteran to Helm BioMedical Institutes
September 1, 2022 / Novartis / Business / Oncology – Merck veteran Fiona H. Marshall has been tapped as president of the Novartis Institutes for BioMedical Research (NIBR). She takes over from Jay Bradner, who will leave the company effective Oct. 31. The Swiss pharma giant continues to undergo a strategic restructuring that will result in the loss of thousands of jobs. That restructuring has led to the loss of several top executives at Novartis. Read Full Article on BioSpace >>
Horizon charts massive biologics expansion in Ireland, where it’ll add 350 new jobs
August 29, 2022 / Horizon / Business / Biotech – Horizon has submitted a planning application to grow its development and manufacturing facility in Waterford, Ireland, the rare and rheumatic disease specialist said Monday. The move, designed to load new drug substance biologics development and manufacturing firepower, will add another 320,000 square feet to the plant’s existing 44,000-square-foot fill-finish facility. The upgrade is expected to create around 350 new jobs “over time,” Horizon said. Read Full Article on Fierce Pharma >>
Neurocrine, with latest deal, gets a foothold in Europe
August 30, 2022 / Neurocrine / San Diego – JNeurocrine Biosciences, a San Diego-based drugmaker focused on neuroscience, said Tuesday that it has agreed to acquire a specialty pharmaceutical company in the U.K. to, among other reasons, more quickly establish a research and commercial foothold in Europe. Neurocrine is offering 27.5 British pence for each share of the target company, named Diurnal, reflecting a 144% premium to its share price at market’s close on Aug. 26 — the most recent business day in which shares were traded, as Monday was a bank holiday in the U.K. In total, the all-cash deal is valued at approximately 48.3 million British pounds, or roughly $56.5 million. Read Full Article on BioPharma Dive >>
Bayer’s BlueRock inks cardiovascular cell therapy delivery deal
August 30, 2022 / Bayer / Heart Failure – Bayer’s BlueRock Therapeutics has partnered with BioCardia on the delivery of cell therapies, paying a “sizable” upfront fee to access minimally invasive technology that could get its heart failure candidates to their targets. BlueRock is built on a platform for programming mature, differentiated cells back to induced pluripotent stem cells (iPSCs). By then re-differentiating the iPSCs, the biotech aims to replace cells damaged or lost to disease. BlueRock is applying the platform to a clutch of therapeutic areas, including cardiology. The cardiology program is seeking to replace the cells lost after a cardiac event to restore heart function. Read Full Article on Fierce Pharma >>
Sandoz, Amneal and Rhodes join Teva in nationwide generic Adderall shortage as demand spikes
August 30, 2022 / ADHD / Adderall / American Society of Health-System Pharmacists (ASHP) – An Adderall shortage that kicked off with Teva Pharmaceutical in early August has extended to three other generics giants as demand for the prescription ADHD medicine spikes. Alongside Teva, Amneal Pharmaceuticals, Purdue subsidiary Rhodes Pharmaceuticals and Novartis’ soon-to-be-spun-off generics unit Sandoz have generic extended-released Adderall on back order, according to a recent supply update from the American Society of Health-System Pharmacists (ASHP), which tracks current drug shortages. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Study shows workplace productivity improvements with One Drop type 2 diabetes tech
August 26, 2022 / Type 2 Diabetes / Artificial Intelligence – One Drop today announced positive results from a trial of its digital health platform for people with type 2 diabetes. Employees using the One Drop digital diabetes management platform experienced significant productivity and functioning gains and were less likely to experience presenteeism at follow-up compared to control groups. Read Full Article on Drug Delivery Business >>
Arch builds bridge to new class of medicines, leading $50M investment in the AI-enabled Vilya
August 30, 2022 / Artificial Intelligence / Drug Development / Biotech – Arch Venture Partners is bankrolling a biotech that could render high-throughput screening obsolete. The biotech, Vilya, starts life with a $50 million, Arch-led series A round and technology to design a new class of medicines. Vilya grew out of work led by David Baker, Ph.D., at the Institute of Protein Design to use computational design to expand the chemical space. Armed with the technology, the Seattle-based biotech plans to design novel artificial molecules with customized biologic-like properties that can hit difficult-to-drug therapeutic targets in a broad set of indications. Full Article on Fierce Biotech >>
New Partnership Helps Smart Stethoscopes Go Wide With Telehealth
August 22, 2022 / Telehealth / Home Exams / HHS – The telehealth company Caregility has turned to Eko Connect smart stethoscopes in a move that speaks to the rising importance of virtual exams in the healthcare system as a whole. The fledgling partnership between Caregility and Eko means that users of Caregility’s iConsult application can use Eko’s stethoscopes to listen to lung, heart, and other body sounds during virtual physical examinations. Read Full Article on HealthTech Insider >>
Australian startup Mindset Health launches hypnosis-based DTx app for smoking cessation
August 29, 2022 / Irritable Bowel Syndrome / Smoking Cessation / Mobile Apps – Australia-based digital therapeutics startup Mindset Health has unveiled its latest digital therapeutics offering to help people quit smoking within a month. Founded in 2018, Mindset Health is building a range of hypnosis-based DTx apps. Its first product, Nerva, is a digital hypnotherapy solution for treating irritable bowel syndrome. Read Full Article on MobiHealth News >>
Liquid-infused microstructured bioadhesives halt non-compressible hemorrhage
August 12, 2022 / Bioadhesives / Non-compressible Hemorrhage – Non-compressible hemorrhage is an unmet clinical challenge that accounts for high mortality in trauma. Rapid pressurized blood flows under hemorrhage impair the function and integrity of hemostatic agents and the adhesion of bioadhesive sealants. Here, we report the design and performance of bioinspired microstructured bioadhesives, formed with a macroporous tough xerogel infused with functional liquids. Read Full Article on Nature Communications >>

// Business & Markets

Biotech startup Ocean pivots from IPO to SPAC merger
August 31, 2022 / Ocean Biomedical / SPAC / IPO – Following a merger with Aesther Healthcare Acquisition, the combined company will hold an enterprise value of $345M. Ocean Biomedical, a small Rhode Island-based biotechnology company, will go public through a SPAC merger with Aesther Healthcare Acquisition Corp, pivoting from plans to list shares through a traditional initial public offering. Read Full Article on
BioPharma Dive >>
Novo Nordisk Shells Out $1.1B for Forma, Sickle Cell Drug
September 01, 2022 / Novo Nordisk / Sickle Cell / Acquisition – Novo Nordisk has entered into an agreement to acquire Forma Therapeutics for $1.1 billion, the company announced Thursday. The deal includes Forma’s lead development candidate, etavopivat. The drug is being assessed in the Phase II GLADIOLUS trial in patients with transfusion-dependent sickle cell disease (SCD) and thalassemia and in the Phase II/III HIBISCUS trial in SCD. Etavopivat is an oral, once-daily, selective pyruvate kinase-R (PKR) activator. It is being developed for anemia and red blood cell health in SCD patients. Read Full Article on BioSpace >>
Atlas Venture’s Bruce Booth on testing the IPO waters and putting the ‘tech’ in biotech
August 30, 2022 / Bruce Booth / Atlas Venture / Investments / Biotech – Though the recent market slump has scared many biotechnology startups from initial public offerings, it hasn’t scared venture capitalists like Bruce Booth, a partner at Atlas Venture. Booth has spent nearly two decades at Atlas, a Cambridge, Massachusetts-based venture firm and prolific creator of biotech startups, and consulted at McKinsey & Co. before that. Over that time, he’s seen investors abandon and return to the sector more than once, and built biotech companies in booming markets as well as downturns. His firm has raised two new funds since the beginning of the COVID-19 pandemic. Read Full Article on BioPharma Dive >>
Amgen bided its time to beat rival bidder in $3.7B ChemoCentryx buyout
September 1, 2022 / Autoimmune Disease / ChemoCentryx / Acquisition – Amgen spent two years to eventually scoop up rare disease drugmaker ChemoCentryx. In this case, patience was a virtue. Amgen was initially only considering a potential partnership instead of a full-on acquisition of ChemoCentryx, a securities filing (PDF) shows. But as biotech valuations cooled down late into the pandemic, the California drugmaker changed its mind. Read Full Article on Fierce Pharma >>
Costa Rica’s commitment to developing talent in industry 4.0
August 31, 2022 / Human Resources / Foreign Investment / Costa Rica – Availability of labour is an important factor for foreign investors, with the education and skill sets found within that labour force being a decisive driver when it comes to FDI site selection. Data from the UN Conference on Trade and Development’s World Investment Report 2020 and the World Economic Forum’s Global Competitiveness Report 2019 indicates that countries with a higher-skilled and better-educated workforce attract more greenfield FDI projects, but how does a country ensure its workforce is constantly receiving the right education and training to remain relevant to fast-evolving requirements in highly skill-based sectors? What actions should be taken so that a country’s talent remains up to speed with the current needs of multinational companies? Read Full Article on Pharmaceutical Technology >>

// Legal & Regulatory

Sanofi, after long research journey, wins FDA approval for rare disease drug
September 1, 2022 / FDA / Rare Disease – Sanofi has won Food and Drug Administration approval to sell Xenpozyme, the first treatment specifically for an extremely rare genetic disease known as acid sphingomyelinase deficiency, or ASMD. The condition affects less than 120 people in the U.S., almost two-thirds of whom are children, Sanofi said Wednesday. Infants with the most severe form usually die before they reach the age of three. Read on BioPharma Dive >>
U.S. FDA Accepts Astellas’ New Drug Application for Fezolinetant
August 18, 2022 / FDA / Women’s Health – Astellas Pharma Inc. (“Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. Read on Drugs.com >>
AstraZeneca Wins Injunction, Blocking Former Exec from Joining GSK
September 1, 2022 / Legal / Cancer – A High Court judge in London granted AstraZeneca an injunction, temporarily blocking a former executive from joining rival pharma GlaxoSmithKline, according to a report by the Financial Times. The court order comes two weeks after AstraZeneca filed a lawsuit against the former exec in order to keep sensitive information from leaking to his new employer GSK, according to a Bloomberg report. The case is set to go on trial next month. Read on BioSpace >>
Sanofi, seeking to stem bleeding at hemophilia A unit, gets FDA priority review for rival to Roche
August 30, 2022 / FDA / Hemophilia – Sanofi and Sobi established the investigational factor VIII therapy, also known as BIVV001, as a potential disruptor of the hemophilia A market when they released their phase 3 results in March. The data drop showed patients who received a weekly prophylactic dose of efanesoctocog alfa for 52 weeks had a median annualized bleed rate (ABR) of 0. The mean ABR came in at 0.71. Read on Fierce Biotech >>
Smart Scale That Detects Fluid Build Up Now Has FDA Clearance
August 24, 2022 / Digital Health Products / Regulatory / Medical Devices – Bodyport, a biomarker-guided digital therapeutics company, has announced the FDA clearance of its biomarker platform, the Bodyport Cardiac Scale. The new solution is designed to non-invasively measure hemodynamic biomarkers that offer insights into heart health and the fluid status of the body. What is really innovative about this solution is its simplicity of use; patients can have their hemodynamic biomarker assessed by simply measuring their weight on the scale. Read on HealthTech Insider >>

// Research & Development

Fat to Brain Communications Clarified
September 1, 2022 / Fatty Liver Disease / Diabetes / Atherosclerosis / Obesity – Scientists at Scripps Research Institute have discovered sensory neurons near the spine that carry messages from fat or adipose tissue to the brain. This discovery overthrows the prevailing notion that circulating hormones are the sole messengers between adipose and brain cells. The findings were reported in the journal Nature (“The role of somatosensory innervation of adipose tissues“). Read Full Article on Genetic Engineering & Biotech News >>
Amgen says KRAS drug beat chemo in lung cancer study
August 31, 2022 / Chemotherapy / Cancer – Amgen’s cancer drug Lumakras outperformed chemotherapy in a closely watched late-stage clinical trial, the biotechnology company said Tuesday afternoon, helping validate a first-of-its-kind approval for the targeted therapy last year. In a brief statement, Amgen said treatment with Lumakras extended progression-free survival — a measure of how long patients go without their cancer growing — versus the chemotherapy docetaxel in patients with a certain type of lung cancer who had previously received other drugs. Read Full Article on BioPharma Dive >>
New Molecular Mechanism That Regulates Insulin Uncovered
September 1, 2022 / Insulin / Type 1 Diabetes / Type 2 Diabetes – Scientists at the Research Center for Molecular Medicine of the Austrian Academy of Sciences have demonstrated that targeting the chromatin protein SMNDC1 will stimulate alpha cells to produce insulin. The study findings are published in the journal Cell Reports in a paper titled, “SMNDC1 links chromatin remodeling and splicing to regulate pancreatic hormone expression.” Read Full Article on Genetic Engineering & Biotechnology News >>
AstraZeneca, matching Lilly, reports positive heart failure data for diabetes pill
August 29, 2022 / Heart Failure / Diabetes – AstraZeneca said its diabetes pill Farxiga reduced the risk of death and hospitalization in heart failure patients with both mild and severe forms of the condition in two large clinical trials, a finding that could help it compete with a rival pill sold by Boehringer Ingelheim and Eli Lilly. Taken together, the two trials showed that patients taking Farxiga — which was initially approved as a drug to reduce blood sugar in patients with Type 2 diabetes — were 14% less likely to die from cardiovascular causes, 10% less likely to die from any cause, and 29% less likely to be hospitalized because of heart failure complications, when compared to placebo. Read Full Article on Biopharma Dive >>
Seeking to accelerate R&D response, philanthropist puts up $171M to create pandemic antiviral center
August 31, 2022 / COVID-19 / Cumming Global Centre for Pandemic Therapeutics – COVID-19 largely caught the world off guard, leading to a mad scramble to repurpose and develop drugs to curb the impact of SARS-CoV-2. Geoffrey Cumming wants to ensure that next time is different—and is donating 250 million Australian dollars ($171 million) over the next 20 years to make it happen. Read Full Article on Fierce Biotech >>

// Politics

Inflation is (finally) hitting health care
August 30, 2022 / Labor / Statistics – Since 2000, health care costs, including medical services, insurance, medication, and medical equipment, have typically increased more quickly than other costs in the overall economy. Over the last two decades, health care costs have increased 110.3% while prices for all consumer goods and services increased by 71%. However, the usual trend has been reversed this year, with health care costs increasing at a lower rate than overall inflation. According to an analysis of Bureau of Labor Statistics data by the Kaiser Family Foundation, health care costs increased by 4.8% in July compared to the same time last year, while overall prices increased by 8.5%. Read Full Article on Advisory >>
Consumers frustrated with health insurance coverage, costs
August 25, 2022 / U.S. Congress / Insurance – Americans worry about insurance coverage costs and would like to see more solutions around transparency and out-of-pockets costs from healthcare institutions. That’s according to a new PhRMA/Ipsos poll, which uncovered some frustrations over paying for and navigating the healthcare system. Many frustrations with healthcare hinge on inadequate health insurance coverage, the confusion with navigating insurance barriers to access, and the unexpected expenses and coverage issues patients experience. Conducted among 2,510 American adults, the poll found a bipartisan supermajority (87%) of Americans feel politicians have lost touch with what the public needs from their healthcare. Read Full Article on Healthcare Finance >>
Hackers have laid siege to U.S. health care and a tiny HHS office is buckling under the pressure
August 28, 2022 / HIPAA / Office for Civil Rights / Hackers – Cyber crooks steal medical information of tens of millions of people in the U.S. every year, a number that is rising fast as health care undergoes its digital transformation. It leads to millions of dollars in losses for hospitals, insurers and other health care organizations, threatens care delivery and exposes patients to identity theft. But the Department of Health and Human Services’ Office for Civil Rights, which is tasked with investigating breaches, helping health care organizations bolster their defenses, and fining them for lax security, is poorly positioned to help. Read Full Article on Politico >>
How the Inflation Reduction Act could impact cancer care
August 26, 2022 / Inflation Reduction Act / Business Group on Health – For the first time, cancer is now the top condition driving health care costs for large employers, according to a new survey from the Business Group on Health. However, the recently passed Inflation Reduction Act, which allows Medicare to negotiate certain prescription drug prices, could potentially impact the cost of cancer care in the future. Read Full Article on Advisory >>