// Biotech and Pharma Therapeutics

AbbVie, Novartis and more win national coverage in China even as Pfizer’s Paxlovid gets left out
January 18, 2023 / China / Drug Reimbursement / Drug Prices / Pfizer – Once again, biopharma companies offered hefty discounts to secure national reimbursement in China in the hopes that wider coverage in a fast-growing pharmaceutical market can offset price concessions. This time around, some companies are walking away with more deals than others. In one of the largest drug price negotiations in China in recent years, 111 innovative drugs scored spots on the country’s National Reimbursement Drug List (NRDL) for the first time after offering an average of 60.1% discount, China’s National Healthcare Security Administration said (Chinese) Wednesday. Read Full Article on Fierce Pharma >>
Gilead fosters growth with plans for new research center in California hometown
January 18, 2023 / Gilead Sciences / R&D / California / Headquarters – Gilead Sciences is expanding with a new research center that’s plotted in headquarters Foster City, California, as it races to develop 10 new transformative therapies. Coming off the recent acquisition of U.K. biotech MiroBio and a $1.76 billion license option deal with MacroGenics, the Big Pharma needs ample space to collaborate with other teams, which is why Gilead is setting out to construct the new research spot, Flavius Martin, M.D., Gilead’s executive vice president of research, said in a Jan. 17 company post. Read Full Article on Fierce Biotech >>
Amarin, in spat with activist investor, says Sarissa has ‘no plan and no new ideas’
January 19, 2023 / Amarin / Sarissa Capital / Activist Investor / Vascepa – On Thursday, Amarin responded to Sarissa’s most recent critique of its board refreshment process, which the investor had called a “sham.” For roughly a year—since the Connecticut-based investor became Amarin’s top shareholder—the drugmaker has resisted Sarissa’s increasingly public efforts to secure shareholder representation on its board of directors. Read Full Article on Fierce Pharma >>
Editas, in next restructuring step, to sell cell therapy work to Shoreline
January 19, 2023 / Editas / Cell Therapy / Shoreline – One of the leading developers of CRISPR-based gene editing medicines, Editas has been held back by research delays, clinical setbacks and significant executive turnover. Gilmore O’Neill, the company’s fourth CEO since 2019, recently revealed a strategic shift that will refocus Editas’ resources on an experimental treatment for sickle cell disease and beta thalassemia, as well as early-stage research on inside-the-body gene editing. As a result, the company said it would stop investing in its inherited eye disease medicines and in NK cell therapies, and instead search for a partner to take them forward. Read Full Article on BioPharma Dive >>
Pfizer pledges to sell all its products at cost to poor countries
January 17, 2023 / Pfizer / Covid-19 / Paxlovid / Antibiotics – Pfizer has expanded its program to provide drugs at cost to the world’s poorest countries from 23 patented medicines to its entire suite of approximately 500 products. The New York pharma giant first revealed its initiative, dubbed “An Accord for a Healthier World,” last May. At the time, the program included Pfizer’s COVID-19 oral antiviral Paxlovid and the company’s other patented vaccines and drugs. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

AbbVie to Develop mRNA Modulators Using Anima Biotech Platform
January 17, 2023 / Abbievie / Drug Discovery / RNA / mRNA / News / OMICs – AbbVie has agreed to discover and develop mRNA biology modulators for three targets in oncology and immunology by applying Anima Biotech’s mRNA Lightning platform, through an up to $582 million collaboration announced by the companies. Read Full Article on Genetic Engineering & Biotechnology News >>
HC3 warns of Clop ransomware targeting medical images
January 19, 2023 / HC3 / Ransomware / Telemedical – While Clop ransomware has been around since 2019 and experienced several arrests, the ransomware-as-a-service operation has had difficulties getting victims to pay the ransom. HC3, which released several ransomware warnings in 2022, including one about the exceptionally aggressive Hive ransomware that seeks to delete healthcare data backups, says that Clop has been infecting files and disguising them to look like medical documents to be reviewed. Read Full Article on Healthcare IT News >>
After a big telehealth buy, Horizon Health Alliance now serves 70% of patients virtually
January 18, 2023 / Telehealth / Horizon Health Alliance / Healthcare – Through a vendor-selection process, Horizon Health Alliance chose Amwell. Amwell’s virtual care approach and past implementation projects fit Horizon’s strategic vision of patient care, while addressing the major barriers it hoped to alleviate. Read Full Article on Healthcare IT News >>
3D Spatial Colorectal Cancer Maps Combine Molecular and Histological Features
January 20, 2023 / Cancer / Colorectal Cancer / Imaging – Researchers at Harvard Medical School have combined histology with cutting-edge single-cell imaging technologies to create large-scale 2D and 3D spatial maps of colorectal cancer. The maps layer extensive molecular information on top of histological features to provide new information about the structure of the cancer, as well as how it forms, progresses, and interacts with the immune system. Read Full Article on Genetic Engineering & Biotechnology News >>
AI Discovers Drugs That May Disrupt Biotech and Pharma
January 17, 2023 / AI / Drug Discovery / Healthcare – Artificial intelligence (AI) chatbots like ChatGPT by OpenAI have brought awareness to the general public of the power of machine learning. At the same time, a quiet AI revolution in drug discovery is rapidly advancing that may impact both our mental and physical health–in a good way. Recently, a number of pioneering companies with new drug treatments discovered using AI are in the clinical trial phase. Read Full Article on Psychology Today >>

// Business & Markets

Sun Pharma Strikes $576M Deal to Get Hair Loss Drug to Rival Lilly, Pfizer Meds
January 19, 2023 / Sun Pharma / New Deal / Lilly / Pfizer / FDA – As Concert Pharmaceuticals prepares for an FDA submission for its experimental treatment for hair loss, it has also been exploring potential partnerships to help sell the drug in the U.S. But instead of a collaboration, Concert has agreed to be acquired in a transaction that places its lead program in the hands of a larger company with the resources to commercialize it globally. Sun Pharmaceuticals is buying Concert in a $576 million deal. According to financial terms announced Thursday, Sun will pay $8 for each share of Lexington, Massachusetts-based Concert, which represents a premium of about 33% over the biotech’s average share price in the past month. Concert shareholders could earn even more. Read Full Article on MedCity News >>
Leap Therapeutics Acquires Flame Biosciences
January 17, 2023 / Leap Therapeutics / Flame Biosciences / Biotech – Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, and Flame Biosciences, Inc., a privately-held biotechnology company, today announced that the companies have entered into a definitive merger agreement pursuant to which Leap has acquired Flame and its assets, including FL-301, its clinical stage anti-Claudin18.2 monoclonal antibody, FL-302, its preclinical anti-Claudin18.2/CD137 bispecific monoclonal antibody, FL-501, its preclinical anti-GDF15 monoclonal antibody, and net cash of approximately $50 million as of December 31, 2022. Read Full Article on BioSpace >>
Bayer feeling more heat from activist investors, this time from Bluebell
January 17, 2023 / Bayer / Activist Investor / Monsanto / Werner Baumann – Since making an ill-advised $63 billion buy of Monsanto in 2018, Bayer has faced heaps of pressure from investors that have called for the company to oust its leadership and to restructure. Now comes new pressure from a familiar source. Bluebell Capital Partners has bought an undisclosed stake in the company and is agitating for a breakup, sources told Reuters. Read Full Article on Fierce Pharma >>
M&A: Arrive Health Acquires UPMC Enterprises Pharmacy Technology
Jaunary 18 2023 / Healthcare / Arrive Health / UPMC / AI – UPMC Enterprises and UPMC pharmacy experts have developed and deployed technology to support medication adherence. The AI virtual assistant and integrated workflow tools allow care teams to prioritize patients who are at risk of skipping their medications and drive continuous engagement through automated conversation flows. With these tools, UPMC has demonstrated meaningful results, including a 200% improvement in refill-rate, a 32% reduction in 7-day readmissions, and the elimination of thousands of pharmacy calls per month. Read Full Article on Hit Consultant >>
3 biotech executives on the year ahead: deals, drug pricing and the down market
January 19, 2023 / ABIO-X / Ovid Therapeutics / LifeMine Therapeutics / Drug Pricing – The J.P. Morgan Healthcare Conference is arguably the most important annual event for many in the drugmaking industry, offering companies both large and small a venue to talk strategy, stoke investor interest and lay the groundwork for future deals. Yet, the overall tone of this year’s conference, which wrapped up last week and was the first to be in-person since the start of the pandemic, was “muted,” according to a small group of biotechnology executives who were in attendance. Read Full Article on Biopharma Dive >>

// Legal & Regulatory

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study
January 20, 2023 / Eli Lilly / Alzheimer’s / FDA / FDA Approval – The FDA has granted accelerated approval to two Alzheimer’s disease drugs so far. Eli Lilly’s amyloid plaque-busting therapy won’t become the third. The Lilly drug still has a chance to pass regulatory muster, but it will take more data and more time. Lilly announced the complete response letter Thursday evening. According to the company, the FDA rejection cited the submission’s lack of data from patients who have been treated with the drug, donanemab, for at least 12 consecutive months. The agency wants to see such data from at least 100 patients. Read Full Article on Med City News >>
Pharmalittle: Lilly and AbbVie exit U.K. drug-pricing program; J&J scales back Covid-19 vaccine production
January 17, 2023 / Eli Lilly / AbbVie / Drug Pricing / Covid-19 / Vaccine – After Mobilizing to quickly develop and manufacture a Covid-19 Vaccine, Johnson & Johnson has vastly scaled back efforts to produce the shots as it faces slumping demand, the Wall Street Journal reports. In recent months, J&J terminated manufacturing agreements with companies that helped produce the shot, such as Catalent and Sanofi. Meanwhile a partnership with Merck to help make the shots, forged at the urging of the U.S. government, has not lived up to expectations. Read Full Article on STAT News >>
CDC probes possible safety risk for Pfizer’s new COVID shot, sees no need to change vaccine practices
January 17, 2023 / Pfizer / COVID-19 / CDC / BioNTech – Throughout the whirlwind COVID-19 vaccine rollouts in the U.S., federal officials have kept a close eye on reports of adverse events. Now, after tracking potential stroke risk for Pfizer’s new shot, the government is sharing its findings. The Centers for Disease Control and Prevention (CDC) recommends no changes to COVID-19 vaccine practices after data from its Vaccine Safety Datalink flagged a possible risk of ischemic strokes in people 65 and older who received Pfizer and BioNTech’s updated COVID-19 vaccine booster. The totality of evidence suggests a “very unlikely” clinical risk, the agency said in a Friday statement. Read on Fierce Pharma >>
FDA fires back at conservative group’s lawsuit over abortion pill approval
January 18, 2023 / FDA / Abortion / Mifepristone – In the months since the Supreme Court reversed the landmark Roe vs. Wade decision, the discourse surrounding abortions has reached a fever pitch. Now, after anti-abortion groups asked the courts to reverse the FDA’s 2000 approval of medical termination drug Mifeprex (mifepristone), the agency is pushing back. In a recent filing in Texas federal court, the FDA said the plaintiffs are challenging its regulatory action “long after the limitations period has expired.” Read on Fierce Pharma >>
Is the first NASH drug approval nearing? Intercept stages comeback as FDA sets decision date
January 19, 2023 / NASH / Ocaliva / Intercept Pharmaceuticals –A treatment for non-alcoholic steatohepatitis may finally be around the corner—and contender Intercept Pharmaceuticals hopes it won’t disappoint for a second time. Intercept’s obeticholic acid has moved one step closer toward its goal of becoming the first NASH therapy in the U.S. The FDA has accepted Intercept’s latest application for the drug in patients with NASH-related pre-cirrhotic liver fibrosis, the company said Thursday. Read on Fierce Pharma >>

// Research & Development

Game-changing T cell treatment delivers dramatic cancer-fighting results
January 17, 2023 / Cancer / T Cell / Clinical Investigation – Immune checkpoint inhibitors such as Keytruda and Opdivo work by unleashing the immune system’s T cells to attack tumor cells. Their introduction a decade ago marked a major advance in cancer therapy, but only 10% to 30% of treated patients experience long-term improvement. In a paper published online today in The Journal of Clinical Investigation (JCI), scientists at Albert Einstein College of Medicine describe findings that could bolster the effectiveness of immune-checkpoint therapy. Read Full Article on The Brighterside >>
Moderna Announces mRNA-1345, an Investigational Respiratory Syncytial Virus (RSV) Vaccine, Has Met Primary Efficacy Endpoints in Phase 3 Trial in Older Adults
January 17, 2023 / Moderna / mRNA / New Vaccine – Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an investigational mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults. Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms. Based on these results, Moderna intends to submit for regulatory approval in the first half of 2023. Read Full Article on BioSpace >>
J&J packs up HIV vaccine after failing phase 3 trial/strong>
January 18, 2023 / Johnson & Johnson / Janssen / HIV / Vaccine – The world’s largest pharma by revenue said Wednesday that the trial’s data safety monitoring board found that the shot did not perform any better than placebo. As a result, the Mosaico study will end. Penny Heaton, M.D., Janssen’s global vaccine lead, said in a release that the company was disappointed. “We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine,” she said. Read Full Article on Fierce Biotech >>
Loading mRNA into extracellular vesicles reduces wrinkles in mice
January 17, 2023 / Drug Delivery / Messenger RNA / Dermatology / Lipid Nanoparticle Drug Delivery Tech – Scientists at the University of Texas MD Anderson Cancer Center have shown that extracellular vesicles (EVs) can deliver mRNA to the skin of mice, advancing efforts to establish the delivery vehicle as an alternative to lipid nanoparticles (LNPs). LNPs underpin mRNA COVID-19 vaccines and many investigational candidates based on the delivery of the nucleic acid. However, studies have linked LNPs to cytotoxicity, poor biodistribution, lack of target specificity and immunogenicity—potentially because of the use of surface PEGylation to improve half-life—and spurred interest in alternative ways of getting mRNA to target cells. Read Full Article on Fierce Pharma >>
Roche’s Tecentriq/Avastin Combo Scores a First in Liver Cancer
January 19, 2023 / Roche / Avastin / Liver Cancer – Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) met the primary efficacy endpoint in early-stage hepatocellular carcinoma (HCC) in the Phase III IMbrave050 study, the company announced Thursday. In a statement, Levi Garraway, M.D., Ph.D., CMO and head of global product development at Roche, said IMbrave050 is the “first Phase III study to show that a cancer immunotherapy combination reduced the risk of disease returning” in patients with early-stage HCC. Read Full Article on BioSpace >>

// Politics

Drug prices are obscene, and Murphy is blocking the smart solution
January 15, 2023 / Drug Prices / Politics / Chronic Illness – Lisa Wetzel-Trainor, a freelance writer with a chronic illness, had long feared what would happen if she lost the insurance coverage she gets through her husband, a public school teacher. She’d have to pay the full cost of a drug she needs to manage her debilitating brain fog from severe ADHD: More than $1,000 a month. Then it happened, during the pandemic. Her husband had to change jobs, their new insurance didn’t cover the drug, Vyvanse, for which there’s no generic alternative, and she had to stop taking it entirely. She switched to another drug that’s in scarce supply, worsens her anxiety and doesn’t work nearly as well. And she still pays $150 a month at the pharmacy. Read Full Article on NJ.com >>
Marijuana legalization moving through legislature
January 18, 2023 / Marijuana Legalization / Legislature / State Residents Approve – Recreational marijuana may be on the verge of becoming reality in Minnesota if the state Legislature approves a bill introduced in the House of Representatives earlier this month. “Minnesotans are ready,” said Rep. Zack Stephenson (DFL-Coon Rapids), the bill’s chief author in the House. “Cannabis should not be illegal in Minnesota. Minnesotans deserve the freedom and respect to make responsible decisions about cannabis themselves.” A majority of Minnesota voters, 53 percent, polled in an MPR News/Star Tribune/KARE 11 survey conducted last September said the state should legalize marijuana for recreational use. However, that support is divided along party lines, with 70 percent of Democrats in favor and 65 percent of Republicans opposed. Read Full Article on TimberJay >>
Gov. Ron DeSantis proposes permanent ban on Covid mandates in Florida
January 18, 2023 / Politics / Ron DeSantis / Covid-19 / Vaccine – The legislation would prohibit vaccine and mask requirements in schools, mask requirements at businesses and the so-called vaccine passports showing proof of vaccinations. It would also bar employers from hiring or firing employees based on whether they have been vaccinated, and would prohibit the firing or de-licensing of medical professionals who might disagree on Covid protocols. Read Full Article on NBC News >>
North Dakota lawmakers consider bill to stem drug prices for public employees
January 17, 2023 / North Dakota / Lawmakers / Drug Prices – High prices at the pharmacy counter have become a fact of life for many North Dakotans, but advocates for older adults say the state can cut prescription drug costs by following Canada’s lead. Several state lawmakers and AARP representatives have rallied behind Senate Bill 2031, a complex proposal that aims to slash drug prices for the nearly 60,000 current and retired public employees and their dependents who are insured through the North Dakota Public Employees Retirement System, or PERS. Read Full Article on Bismarck Tribune >>
Tampa General experts share innovations in health care at Senate Committee hearing
January 19, 2023 / Florida / Healthcare / Senate – The Senate Committee on Health Policy this week hosted two panel discussions — one on the benefits of hospital care at home and another on effective techniques heath care providers can use as an alternative to Emergency Departments. Tampa General had expert presence on both panels: Dr. Peter Chang, vice president of Healthcare Design at Tampa General Hospital (TGH) and assistant professor in the Division of Cardiology in the USF Health Morsani College of Medicine; and Dr. Jason Wilson, director of the Division of Emergency Medicine in the USF Health Morsani College of Medicine and medical director of Transitions of Care for Emergency Medicine at Tampa General Hospital.Read Full Article on Florida Politics >>