// Biotech and Pharma Therapeutics

Eli Lilly’s diabetes drug Mounjaro back in stock amid heightened obesity interest
February 22, 2023 / Eli Lilly / Mounjaro / Drug Shortage / Type 2 Diabetes – Lilly has satisfied wholesalers’ backorders for Mounjaro and is continuingly shipping all six doses of the diabetes med, a company spokesperson said. Still, it’s too early to say the shortage of Mounjaro has completely ended. The FDA still lists Mounjaro on its drug shortage list as of an update Tuesday, although the agency doesn’t flag any specific supply issue. Read Full Article on Fierce Pharma >>
Mark Cuban Cost Plus Drug Company partners with diabetes management platform
February 21, 2023 / Mark Cuban / Diabetes / Diathrive Health / Cost Plus Drug Company – Diathrive Health offers individuals and employers personalized coaching via live messaging and video chat, as well as care plans, articles and videos to help manage diabetes. Users can access unlimited testing supplies at their desired frequency through a monthly subscription. Read Full Article on Mobi Health News >>
‘We beg you’: Biotechs plead for help and funds to find long COVID treatments
February 22, 2023 / Long COVID / Axcella Health / Flagship Pioneering / COVID-19 – Behind the unrelenting challenges of long COVID, which leaves many of the disease’s sufferers with exhaustion, sleep problems and brain fog, is just a handful of biotechs trying to drum up interest—and funds—to find a treatment. Read Full Article on Fierce Biotech >>
Pfizer’s maternal RSV vaccine filing gets priority review, setting up showdown with AstraZeneca, Sanofi
February 21, 2023 / Pfizer / Respiratory Syncytial Virus / RSV / FDA – In November, Pfizer stopped a pivotal trial of its bivalent RSV prefusion vaccine candidate RSVpreF early after an interim analysis. The study linked administration of RSVpreF during pregnancy to 81.8% efficacy against severe medically attended lower respiratory tract illness over the first 90 days of the baby’s life. And, while the study missed a co-primary endpoint, Pfizer had seen enough to race to regulators. Read Full Article on Fierce Biotech >>
Medicaid, with planned payment pilot, girds for influx of pricey gene therapies
February 21, 2023 / Medicaid / Gene Therapies / Inflation Reduction Act – An experimental model proposed by the Centers for Medicare and Medicaid Services last week could help state agencies better afford those medicines, as well as offer a testing ground for payment schemes that could apply to other pricey gene therapies. Yet the timeline for its implementation might mean it comes after the first sickle cell gene therapies reach market. Read Full Article on Biopharma Dive >>

// 4th Industrial Revolution

Why Blue Shield of California Made Its Wellvolution Platform Available to Medi-Cal Members
February 21, 2022 / Blue Shield / Wellvolution / Medi-Cal Members – Blue Shield of California (BSC) created its Wellvolution platform, a collection of wellbeing apps, with the intention of helping members with their diet, exercise, sleep and overall health. But until last month, it was only available for its commercial and Medicare members and not its Medi-Cal members. Read Full Article on MedCity News >>
Women’s telehealth program diminishes stigma via technology
February 21, 2023 / Women’s Health / Telehealth / Pregnancy – The program is called Listening to Women and Pregnant and Postpartum People, or LTWP. The technology vendors are REDCap and Twillio. It’s a mid-maturity program that is responding to behavioral health needs of pregnant women, and has recently expanded to newborn virtual home visitation for all mothers with births in the hospital. Read Full Article on Healthcare IT News >>
Vysioneer & Pfizer Partner on AI-Powered Oncology Clinical Trials
February 22, 2023 / Vysioneer / Pfizer / AI / Oncology / Clinical Trials – As part of the agreement, Vysioneer gains access to one of Pfizer’s oncology clinical trial datasets to apply Vysioneer’s advanced machine-learning techniques to facilitate the drug efficacy assessment process, thereby allowing Pfizer to assess drug efficacy with greater granularity and explore advanced biomarkers and novel endpoints. Read Full Article on HIT Consultant >>
VA awards millions to veteran suicide tech challenge winners
February 20, 2023 / Veterans / VA Awards / New Tech – Veterans, veteran service organizations, community-based organizations, health technology companies, startups and universities submitted concepts ranging from targeted virtual care programs to other promising suicide prevention technologies that connect veterans to healing and recovery, according to the VA. Read Full Article on Healthcare IT News >>
Zoom is helping MaineGeneral Health boost its telehealth success
February 20, 2023 / Zoom / MaineGeneral Health / Telehealth – MaineGeneral Health, a health system based in Augusta, Maine, had telemedicine technology in place at the beginning of the pandemic, but it was impressed with what others were doing with Zoom and soon turned to the video technology. Read Full Article on Healthcare IT News >>

// Business & Markets

As commercial COVID pivot looms, Moderna logs $2.8B in demand-related expenses
February 23, 2023 / Moderna / Spikevax / COVID-19 / Earnings – For all of 2022, the mRNA specialist logged a $1.3 billion charge for inventory write-downs, plus $725 million for contract cancelations. Moderna paid another $776 million for unused manufacturing capacity and CDMO charges, representing total expenses tied to slouching demand of around $2.8 billion. Read Full Article on Fierce Pharma >>
Rubius, after layoffs and executive turnover, sets plan to dissolve
February 22, 2023 / Rubius / Layoffs / Biotech – Tougher funding conditions have forced biotechs to retrench over the past year by laying off staff or reducing research. More recently, some companies have opted to close entirely. Rubius is one of at least five biotechs that have announced plans to shut down in the past four months. Read Full Article on Biopharma Dive >>
Blood Clotting Biotech Hemab Hauls In $135M to Drug Rare Bleeding Disorders
February 21, 2023 / Blood Clotting / Rare Bleeding Disorder / Hemab Therapeutics – Clotting disorders can be treated by infusing patients with clotting proteins they lack, or with drugs that replace the function of these proteins. Gene therapies may soon become another option. Hemophilia A and B are perhaps the best-known clotting diseases, and both have benefited from decades of research while rarer bleeding disorders continue to lack treatment options, according to Benny Sorensen, CEO of Hemab Therapeutics. Read Full Article on MedCity News >>
Medicare Drug Negotiation Is the Model for the Future of Drug Pricing, Abarca CEO Says
February 20, 2023 / Medicare Drug / Drug Pricing / Abarca Health – While governments across the world have been negotiating drug prices for quite some time, this approach is pretty groundbreaking for the U.S. As one would expect, this change has sparked a huge debate — will the creation of this taxpayer-funded drug negotiation infrastructure be a failed experiment, or will it become the standard for the future of drug pricing in this country? Read Full Article on MedCity News >>
Amazon closes $3.9B acquisition of One Medical
February 22, 2023 / Amazon / One Medical / Gederal Trade Commission – “The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said in a statement. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.” Read Full Article on Mobi Health News >>

// Legal & Regulatory

Astellas has menopause accelerated approval ambition thwarted by FDA at last minute
February 20, 2023 / Astellas / FDA / Menopause / FDA Delay – Astellas’ bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment. Read Full Article on Fierce Biotech >>
First Gene Therapy for Hemophilia B, CSL’s HEMGENIX®, Approved by the European Commission
February 20, 2023 / First Gene Therapy / Hemophilia B – People living with hemophilia B currently require lifelong treatment of intravenous infusions of Factor IX to maintain sufficient levels, which can have a significant impact on their quality of life and wellbeing. According to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), there is ‘an unmet medical need for new therapeutic approaches that might free patients from the burden of frequent infusions, or episodically at the time of a bleeding event’. Read Full Article on BioSpace >>
FDA Approves Apellis’ Syfovre as First Treatment for Geographic Atrophy
February 20, 2023 / FDA / Geographic Atrophy / Apellis – GA causes areas of the retinal cells to waste away and die in some patients with age-related macular degeneration. The condition affects over five million worldwide and, until now, progressed relentlessly without any treatments to slow the decline in patient’s vision. Read on Biospace >>
FDA Approval of Travere Kidney Disease Drug Sets Up Blockbuster Expectations
February 21, 2023 / Travere Therapeutics / Kidney Failure – The regulatory decision for Travere’s drug makes it the second FDA-approved therapy for adults with immunoglobulin A nephropathy (IgAN), a condition that stems from the buildup of the disease’s namesake antibodies in the kidney, leading to organ damage. The Travere drug, known in development as sparsentan, will be commercialized under the name “Filspari.” Read on MedCity News >>
Needed for national security and competitiveness: a federal biodata infrastructure
February 22, 2023 / National Security / Biodata / Biden – An executive order from the Biden administration aims to build a robust bioeconomy “in a manner that benefits all Americans and the global community and maintains United States technological leadership and economic competitiveness.” The executive order acknowledged the importance of biodata to growing the U.S. bioeconomy and calls for “a biological data initiative.” Read on STAT News >>

// Research & Development

RxE2 Releases Diversity Now, the First Protocol to Achieve Diversity in Clinical Trials According to the FDA Guidelines for Race and Ethnicity Diversity Plans
February 20, 2023 / RxE2 / Diversity Now / FDA / Clinical Trials – Based on the RxE2 model, pharmacists are engaged early to ensure that underrepresented populations are educated about clinical trials, and referred, recruited, and retained in clinical trials. RxE2 is already working with a network of approximately 3500 independent community pharmacies, accessing more than 18 million pharmacy records and 1.5 million unique and diverse patients. Read Full Article on Biospace >>
Astellas has menopause accelerated approval ambition thwarted by FDA at last minute
February 20, 2023 / Astellas / Menopause / FDA / FDA Delay – Astellas’ bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment. Read Full Article on Fierce Biotech >>
Moderna’s Latest Partnership Combines mRNA with Gene Editing
February 22, 2023 / Moderna / mRNA / Gene Editing – As the cliff approaches for COVID-19 vaccine and therapeutic makers, Moderna is busy filling its pipeline with non-pandemic assets. The mRNA vaccine maker forged a collaboration Wednesday with next-gen gene editor Life Edit Therapeutics. Life Edit’s technology will combine with Moderna’s mRNA platform to develop in vivo gene editing therapeutics against thus far undisclosed “challenging genetic diseases,” according to the announcement. Read Full Article on Biospace >>
Regenative Labs announces updates on retrospective study of wharton’s jelly applications to the knee
February 20, 2023 / Regenative Labs / Wharton / Knee Degeneration – Also known as osteoarthritis (OA), knee degeneration is the most common joint disease amongst adults in the world. Currently, there are 33 million adults in the United States living with OA; the number is expected to nearly double in the next decade. Read Full Article on Biospace >>
Takeda’s Vedolizumab Clears Phase III in aGvHD
February 20, 2023 / Takeda / aGvHD / Vedolizumab – In the vedolizumab arm, 85.5% of patients reached the primary efficacy outcome of intestinal aGvHD-free survival, 180 days after allogeneic hematopoietic stem cell transplantation (allo-HSCT), as compared to 70.9% among placebo comparators. The between-group difference was statistically significant, according to the announcement. Read Full Article on Biospace >>

// Politics

From biotech to politics: Former Roivant Sciences CEO Vivek Ramaswamy launches GOP presidential bid
February 22, 2023 / Biotech / Politics / Roivant Sciences / Presidential Bid – Vivek Ramaswamy, the founder and former CEO of Roivant Sciences, announced he is running for the Republican presidential nomination Tuesday night. Ramaswamy made the announcement on Tucker Carlson Tonight and followed it up with a three-and-a-half minute campaign launch video on Twitter. Read Full Article on MM+M >>
‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system
February 23, 2023 / Abortion Pill / Drug Approval System / Supreme Court – His concern was about more than abortion pills themselves. After his stint in Congress, Jim Greenwood had spent 15 years as the president and CEO of one of the biopharma industry’s main lobbying groups. He figured that the 20-year-old approval of mifepristone might be in jeopardy. If an attempted ban prevailed in court, he knew, it could undermine the country’s infrastructure for evaluating all drugs. “Could states ban vaccines of one kind or another? It’s a slippery slope,” he said, adding, “There are lots of anti-vaxxers in lots of state legislatures.” Read Full Article on STAT News >>
Sanders calls Moderna ‘greedy’ over COVID vaccine price hike plan
February 20, 2023 / Moderna / COVID / Vaccine / Sanders – 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 Spectrum News >>
Social Security and Medicare: Troubling math, tough politics
February 21, 2023 / Social Security / Medicare / Politics / Biden – Not President Joe Biden, who is already telling voters his upcoming federal budget proposal will “defend and strengthen” the programs. Not Republican House Speaker Kevin McCarthy, who has declared cuts to the programs off the table in negotiations to raise the federal debt limit. Read Full Article on The Seattle Times >>
Political fight erupts over toxic spill
February 22, 2023 / Political Fight / Toxic Spill / Ohio – It’s been nearly three weeks since a Norfolk Southern train carrying hazardous materials derailed in East Palestine, Ohio, and the tiny town may soon become subject to those wanting to mine political capital. Transportation Secretary Pete Buttigieg will be in the town on Thursday, following weeks of GOP figures blasting him for not visiting. Read Full Article on The Hill >>