// Biotech and Pharma Therapeutics

With PCSK9 pill, Merck aims to succeed where others failed
March 7, 2023 / PCSK9 / Merck / Cholesterol – Merck & Co. is betting a daily pill can work just as well as powerful cholesterol-lowering injections, revealing this week an aggressive plan to study in a series of large and expensive clinical trials an experimental drug it’s developing. The drug, dubbed MK-0616, is what’s known as a PCSK9 inhibitor and targets a cell receptor in the liver that’s involved in regulating levels of LDL, or “bad,” cholesterol.Read Full Article on Biopharma Dive >>
Armed with $60M series A and Lilly’s backing, Volastra enters clinic via Amgen cancer med
March 7, 2023 / Volastra / Amgen / Bristol Myers Squibb / Eli Lilly – The lead asset in question is sovilnesib, a small-molecule K1F18A inhibitor that Volastra has licensed from Amgen. The med is currently proceeding through a phase 1 trial in patients with advanced solid tumors, having already picked up fast-track designation from the FDA to treat platinum-resistant, high grade serous ovarian cancer. Volastra is also tacking on $60 million in series A funds nearly two years after the company unveiled an expanded seed round. Read Full Article on Fierce Biotech >>
Merck’s cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2
March 6, 2023 / Merck & Co. / Acceleron Pharma / Sotatercept / PCSK9 drugs – For years, Merck & Co.’s most consequential clinical updates have often concerned Keytruda, the goldmine cancer treatment that’s redefined success for the company. But a new crop of cardiovascular readouts is continuing to build hope of fresh revenue streams to replace its oncology blockbuster. Entering the last day of the American College of Cardiology’s annual conference, the Big Pharma is trotting out new phase 2 data of its anti-PCSK9 drug, finding that it reduced particular kinds of cholesterol by up to 61% compared to placebo. Read Full Article on Fierce Biotech >>
Organ Preservation Company Rakes In $24M to Expand Commercial Footprint
March 7, 2023 / Organ Preservation / Paragonix Technologies / Medical Devices – The Cambridge, Massachusetts-based company provides transplant centers and organ procurement organizations (OPOs) with medical devices designed for the preservation and transportation of donor organs. The traditional method of preservation requires the organ to be transported in a cooler of crushed ice. Due to unstable temperatures, many facilities that receive organs preserved in this manner report that they arrive frozen and damaged, said Paragonix CEO Lisa Anderson. Read Full Article on MedCity News >>
By cutting insulin prices, Eli Lilly avoids paying big Medicaid rebates
March 6, 2023 / Eli Lilly / Medicaid / Insulin – Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week. Read Full Article on STAT News >>

// 4th Industrial Revolution

Why ChatGPT In Healthcare Could Be a Huge Liability, Per One AI Expert
March 7, 2022 / ChatGPT / Healthcare / AI – One healthcare AI expert thinks ChatGPT could have dangerous implications for the field if it’s not used with the proper context. People already turn to sources like Reddit and TikTok when they have a question about a medical concern they’re experiencing — Americans putting too much trust in ChatGPT to answer these questions could make this phenomenon a much bigger problem. Read Full Article on MedCity News >>
‘Pan-variant’ COVID vaccine could defang future strains thanks to machine learning
March 9, 2023 / COVID Vaccine / Pan-Variant / Booster – A new approach to vaccines with a machine learning twist could put an end to boosters and seasonal variant shots, according to MIT researchers. This “pan-variant” vaccine would ignore the virus itself but quickly control infections by cracking down on infected cells. Read Full Article on Techcrunch >>
Zocdoc Partners With Zaya Care for Pregnancy, Postpartum Services
March 8, 2023 / Zocdoc / Zaya Care / Pregnancy / Postpartum – Zocdoc, which provides quick access to a person’s local in-network provider, has teamed up with maternal healthcare startup Zaya Care to provide insurance-covered pregnancy and postpartum care for patients in New Jersey and New York, the companies announced Wednesday. Read Full Article on MedCity News >>
AI Offers Personalized Care Recommendations to Curb Heart Disease Risk
March 6, 2023 / AI / Heart Disease – Researchers have validated a causal artificial intelligence model designed to identify a patient’s inherited risk of coronary artery disease (CAD) and provide personalized recommendations for reducing their blood pressure or low-density lipoprotein (LDL) cholesterol to address that risk, according to a study presented at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology. Read Full Article on Healthcare IT Analytics >>
OpenAI CEO invests $180 million in biotech startup to reverse aging
March 9, 2023 / OpenAI / Invest / Startups – OpenAI CEO Sam Altman has turned out to be the investor that paid $180 million to get biotech startup Retro Biosciences off the ground, MIT Technology Review reported. The biotech company came out of stealth mode in 2022 and had plans to use genetic engineering to make cells younger.Read Full Article on Interesting Engineering >>

// Business & Markets

AbbVie CEO Gonzalez scored $26M in 2022 pay as cash cow Humira neared patent cliff
March 7, 2023 / Richard Gonzalez / AbbVie / CEO pay / Humira – For 2022, AbbVie granted Gonzalez a pay package worth $26.3 million, an increase of nearly 10% over his 2021 compensation, a securities filing shows. Big jumps in equity awards more than offset slumps in cash incentive payments and pension value for Gonzalez. AbbVie’s board praised its chairman and CEO for driving “top-tier business performance.” Read Full Article on Fierce Pharma >>
Merck pays $50 million for early-stage Epstein-Barr vaccine
March 8, 2023 / Merck / Epstein-Barr Vaccine – Merck & Co. has added another experimental vaccine to its pipeline, paying $50 million to Opko Health for a preclinical candidate aimed at the Epstein-Barr virus, which causes mononucleosis and is linked to multiple sclerosis and some types of cancer. Read Full Article on Biopharma Dive >>

March 7, 2023 / Sanofi / Job Satisfaction / Facilities / COVID-19 – Sanofi is moving its flagship New Jersey site in Bridgewater roughly 15 miles northeast to Morristown—and all 1,900 employees are coming along for the ride, a company spokesperson confirmed. The site’s relocation marks the latest stop on a global campaign to modernize Sanofi’s workspaces, he said. Read Full Article on Fierce Pharma >>
Rapport Therapeutics Snags $100M for Precision Approach to Neurological Diseases

March 7, 2023 / Rapport Therapeutics / Neurological Diseases / Johnson & Johnson – Rapport Therapeutics, a clinical-stage biotech aiming to develop precision medicines for neurological disorders, launched Tuesday with $100 million in Series A financing from Third Rock Ventures, ARCH Venture Partners and Johnson & Johnson Innovation (JJDC). Read Full Article on Biospace >>
Cidara Therapeutics Announces Closing of Public Offerings of Common Stock and Preferred Stock and Full Exercise of Underwriter’s Option to Purchase Additional Shares in Public Offering of Common Stock

March 7, 2023 / Cidara Therapeutics / Common Stock / San Diego – The securities described above were offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). The offering was made only by means of a prospectus and prospectus supplements. Final prospectus supplements and the accompanying prospectus relating to the offerings have been filed with the SEC and are available for free on the SEC’s website. Read Full Article on Biospace>>

// Legal & Regulatory

Independent Panel Recommends Polivy in First Line LBCL Despite FDA Reservations

MArch 10, 2023 / FDA / Roche – An independent panel voted to approve Genentech (Roche)’s Polivy (polatuzumab vedotin-piiq) as a first-line treatment for large B-cell lymphoma (LBCL) after FDA staff raised concerns regarding the efficacy and risk-benefit profile of the treatment earlier in the week.Read Full Article on Biospace >>
Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for Zuranolone
March 8, 2023 / Sage Therapeutics / Biogen / FDA – Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023. Read Full Article on Biospace >>
FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency
March 6, 2023 / FDA / Makena / Pregnancy – While the causes of early labor aren’t well understood, certain factors are associated with it, including lifestyle, a short cervix and a prior history of preterm births. In 2021, roughly 1 out of every 10 births in the U.S. was preterm — the highest rate since at least 2007, according to the Centers for Disease Control and Prevention. Read on Biopharmadive >>
FDA widens Lilly’s Verzenio breast cancer reach, removes test and menopausal status demands
March 6, 2023 / Eli Lilly / Verzenio / Breast Cancer / FDA – Thanks to two FDA nods, Eli Lilly’s Verzenio doesn’t need results from a biomarker test to treat certain patients with early breast cancer, and it can reach metastatic disease regardless of menopausal status. Read on Fierce Pharma >>
Controversial drug for premature birth is withdrawn by manufacturer after battle with FDA
March 7, 2023 / Premature Birth / FDA – After months of anticipation, the manufacturer of a controversial drug for premature births has agreed to withdraw its treatment, capping an unusual battle with the U.S. Food and Drug Administration over its authority to have medicines removed from the market. Read on STAT News >>

// Research & Development

Young Blood Alters Gene Expression in Old Brain Cells
March 9, 2023 / Gene Expression / Brain Cells – Heterochronic parabiosis is a well-known aging intervention in mouse studies, and some studies have shown that factors in young blood improve brain health while other studies have shown that factors in old blood cause harm to this organ. While some work has focused on the changes to the proteins in blood (proteome), these researchers note that the proteome is only part of the equation: exosomes, lipids, and other nonprotein factors are also likely to be having an effect. Read Full Article on Lifespan.io >>
Merck Vaccines Pipeline Gets Boost Via Deal for Opko Candidate for Epstein-Barr
March 8, 2023 / Merck / Vaccines / Opko Health – Epstein-Barr is among the most common viruses, but no vaccines are available to prevent its infection. Merck is joining the pursuit for a vaccine by striking a deal with Opko Health, paying $50 million for global rights to a preclinical program whose multi-pronged approach could overcome failures encountered by earlier efforts to neutralize the pathogen. Read Full Article on MedCity News >>
Merck drug data suggest ‘new direction’ for rare blood vessel disease
March 6, 2023 / Merck / Blood Vessel Disease – An experimental medicine for a rare blood vessel disorder improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.Read Full Article on Biopharma Dive>>
Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine
March 7, 2023 / Moderna / mRNA / Cancer Vaccine – Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, the company’s president, Stephen Hoge, said Monday at Cowen’s 43rd Annual Healthcare Conference in Boston. Read Full Article on Biospace >>
Lilly-Backed Volastra Enters Clinic with Amgen’s KIF18A Inhibitor
March 7, 2023 / Eli-Lilly / Amgen / Volastra Therapeutics – Concurrently, the New York-based biotech has secured $60 million in Series A funding. The financing round was led by Eli Lilly, along with founding investors Polaris Partners and ARCH Venture Partners. Droia Ventures, Vida Ventures, Meyers ventures, Cornell University and Catalio Capital Management also participated in the Series A. Read Full Article on Biospace >>

// Politics

Biden’s plan to extend Medicare solvency targets prescription drugs

March 7, 2023 / Biden / Medicare / Prescription Drugs – The plan — part of Biden’s 2024 budget proposal set to be released Thursday – would further reduce what Medicare pays for prescription drugs and raise taxes on Americans earning over $400,000. Congress sets the U.S. budget, meaning the proposal is unlikely to be adopted as is. Read Full Article on Biopharma Dive>>
Biden proposes expanding Medicare drug negotiation program
March 7, 2023 / Biden / Medicare / Drug Prices – The Biden administration will propose expanding Democrats’ new drug pricing law by allowing Medicare to negotiate prices for more drugs, making drugs eligible for negotiation sooner, and expanding penalties for drug price hikes to the commercial market in its budget this year, according to a summary. Read Full Article on STAT News >>
DeSantis Slams Biden For Vaccination Rule Barring Djokovic From Miami Open
March 8, 2023 / Biden / Vaccine / DeSantis – Florida Gov. Ron DeSantis (R) on Tuesday blasted President Joe Biden for a rule preventing tennis superstar Novak Djokovic from participating in the upcoming Miami Open tournament without a COVID-19 vaccination.Read Full Article on Huffpost >>
US Pulls Mexico Into Formal Talks On Corn Biotech Policy
March 6, 2023 / Biotech Policy / Mexico – The Office of the U.S. Trade Representative excalated discussions over Mexico’s plan to block genetically modified corn, invoking the North American trade pact Monday to move informal meeting to technical consultations after months of unsuccessful talk. Read Full Article on Law360 >>
US Nears USMCA Dispute With Mexico Concerning GMO Corn
March 6, 2023 / USMCA / Mexico / GMO Corn – The U.S./Mexico GMO ban debate has been called into question again, this time in the form of technical consultations. The Government of Mexico will consult with the U.S. regarding Mexico’s lack of compliance in the United States–Mexico–Canada Agreement (USMCA), according to a press release from the Office of the U.S. Trade Representative (USTR). Read Full Article on agweb >>