// Biotech and Pharma Therapeutics
Eli Lilly’s Mounjaro is primed to overtake Novo Nordisk’s popular diabetes and obesity duo: report
Approved in May of last year for Type 2 diabetes, Mounjaro has already had a strong launch. In the first quarter, it clobbered expectations, posting $569 million in sales.
AstraZeneca Mulls China Unit Spin-Off Amid Rising Tensions
Amid growing geopolitical tensions, AstraZeneca reportedly plans to spin out its China business and have it separately listed in Hong Kong, the Financial Times revealed Sunday, citing three people familiar with the matter.
Attovia, a new California biotech, launches with plans to rethink how drugs bind their targets
Many of these drugs focus on the same GPCRs, with hosts of others long considered “undruggable.” That’s changing now as companies like Attovia take advantage of advances in protein engineering to design new types of medicines against GPCRs or other difficult targets.
Pfizer’s Talzenna snags broader prostate cancer nod than AstraZeneca and Merck’s rival PARP med
The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited.
Flagship’s latest startup aims to take the guesswork out of small molecule drugs
Small molecules are the bedrock of the pharmaceutical industry. But they remain frustratingly difficult to develop, as even promising compounds can work differently than envisioned once tested in humans.
// 4th Industrial Revolution
Cell and gene therapy manufacturing: the next generation of startups
For companies specializing in cell or gene therapies, an equally pressing concern is figuring out how to reliably make their products. Unlike small molecule or antibody drugs, genetic medicines typically involve a variety of specialized parts woven together through a complex process.
TikTok Reveals Consumers Want Engaging Healthcare Content
Technology has drastically changed the way we consume information in our daily lives. That goes for healthcare information, too. Dated, static educational pamphlets featuring dense explanations of illnesses and medical procedures just won’t cut it anymore. Most patients now have a smartphone and the internet right in their pocket or readily accessible at home, and patients expect, and deserve, to receive healthcare information that speaks their language, both literally and figuratively.
How RPM can solve many patient and provider problems in rural areas
Telemedicine in these areas provides chronic patients, for example, with access to medical specialists without traveling an extended distance, and can allow providers to identify particular social determinants of health such as lack of access to food.
The Rise of Chat in Healthcare and Remaining Concerns
Chat technology is beginning to be embraced by healthcare organizations to better serve patients, reduce staff burnout, increase internal efficiencies, and improve the overall patient experience. Although widely used in many other industries, its adoption is just beginning to take off in healthcare. In fact, as healthcare leaders increasingly prioritize patient access, chat’s success in other businesses has spurred the rapid onboarding of chat solutions to help address healthcare-specific engagement and accessibility challenges.
Enveda Biosciences unveils new AI algorithm to unlock nature’s chemical code
Enveda Biosciences, a biotechnology company discovering new medicines from natural sources, released the details of one of its foundational AI models, MS2Mol, in a pre-print posted on ChemRxiv. MS2Mol is designed to predict the structure of metabolites, which are the building blocks and breakdown products of the cell. Despite their essential role in all cell processes, it is estimated that less than 1% of all naturally-occurring metabolites are known to science.
// Business & Markets
Lilly Aims to Boost Immuno Business with $2.4B DICE Buy
To deepen its autoimmune disease portfolio, Eli Lilly is acquiring California-based biopharma DICE Therapeutics for more than $2 billion, the pharmaceutical giant announced Tuesday.
Pieris stock deflates as AstraZeneca stops trials of asthma drug in response to toxicology signal
AstraZeneca has pulled the plug on clinical trials of its asthma candidate elarekibep after seeing data from a toxicology study. Pieris Pharmaceuticals, which licensed the inhaled IL-4 receptor alpha inhibitor to AstraZeneca, attributed the decision to “lung findings” from a 13-week nonclinical assessment.
Thermo Fisher Cuts 88 Jobs in San Diego in Fourth Round of Layoffs This Year
Two months after it announced plans to close three sites in San Diego, Thermo Fisher Scientific plans to cut 88 workers in the area, according to a Worker Adjustment and Retraining Notification (WARN) notice filed in California.
UniQure’s stock plummets after data drop for Huntington’s disease gene therapy
The stock plummet is tied to an interim data release for a phase 1/2 clinical trial assessing uniQure’s investigational gene therapy for Huntington’s disease, a rare inherited brain disorder that progressively breaks down nerve cells. The therapy, known as AMT-130, was previously scrutinized after safety signals prompted a pause in dosing for two groups in an open-label, European phase 1/2 trial of the drug.
Nutcracker Therapeutics lays off 12 employees less than 18 months after $167M series C
The layoffs were relayed June 15, according to the sources, less than 18 months after the biotech closed a mammoth $167M series C round. A spokesperson for the company refused to confirm or deny the layoffs but said that no programs were being cut from the pipeline. Nutcracker has roughly 140 employees, according to the company’s LinkedIn page.
// Legal & Regulatory
Feds Warn Healthcare Providers About ‘Obscure’ Ransomware Gang
The Health Sector Cybersecurity Coordination Center (HC3), which was created by the Department of Health and Human Services, recently warned healthcare providers about a “relatively unknown” ransomware gang that is beginning to attack organizations in the healthcare sector.
Sanofi prevails over Boehringer Ingelheim in legal battle over Zantac liabilities
Years later, with Boehringer facing litigation in the U.S. from users of the heartburn treatment, the company has tried to gain indemnification from the French drugmaker for future liabilities on those cancer claims.
With new lawsuits, Novo Nordisk aims to crack down on compounded versions of Ozempic, Wegovy
Three weeks after the FDA warned that some pharmacies are making unauthorized versions of Novo Nordisk’s highly demanded diabetes and obesity drugs, the company has filed suit against five outlets in the United States.
Lilly and Boehringer Drugs Approved as New Options for Type 2 Diabetes in Kids
The pediatric go-ahead for Jardiance and Synjardy provides a new class of oral medicines for children with Type 2 diabetes, who have fewer treatment options than adult patients, “even though the disease and symptom onset generally progress more rapidly in children,” Michelle Carey, the FDA’s associate director for therapeutic review for the Division of Diabetes, Lipid Disorders and Obesity, Center for Drug Evaluation and Research, said in a statement.
BMS Follows Merck’s Lead, Sues Government Over Drug Pricing Negotiation
Friday, Bristol Myers Squibb filed a lawsuit against the Biden administration, alleging that an upcoming Medicare drug negotiation program violates the First and Fifth Amendments of the U.S. Constitution, according to a report by Reuters.
// Research & Development
AstraZeneca drops another GLP-1 after phase 1 data bust market-beating diabetes hopes
The candidate, dubbed AZD0186, had been undergoing a phase 1 study in Type 2 diabetes. The Big Pharma had high hopes for the oral therapy, which it had believed could “provide greater efficacy and tolerability than other assets currently in development or available,” a company spokesperson told Fierce Biotech this morning.
Dementia Risk Prediction Models May Have Limited Clinical Utility
A study published last week in JAMA Network Open demonstrated that four widely used predictive models for estimating ten-year dementia risk have limited clinical value and utility, indicating that more accurate algorithms are needed to help target patients for dementia prevention.
First Wave BioPharma Reaches Enrollment Target for Phase 2 SPAN Adrulipase Clinical Trial in Cystic Fibrosis
June 13, 2023 / BioPharma / Phase 2 / Clinical Trial / Cystic Fibrosis
First Wave BioPharma, Inc., a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has achieved the enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
Ex-Novartis NASH drug clears clinical test, fueling Boston’s pursuit of Akero, 89bio
Boston Pharmaceuticals has posted early evidence that its ex-Novartis candidate works in nonalcoholic steatohepatitis (NASH). But with Akero Therapeutics and 89bio taking rival drugs to the cusp of phase 3, it’s unclear whether the biotech can differentiate BOS-580 from more advanced candidates.
CDC advisory panel examines GSK and Pfizer RSV vaccines, set to vote today on recommended use
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will vote this afternoon on recommendations for the use of new respiratory syncytial virus (RSV) shots from GSK and Pfizer.
Gov. Newsom’s No-Bid Covid Contract with McKinsey & Co. Continues
In 2021, the Washington Post published an alarming article about California Governor Gavin Newsom’s no-bid contracts with Blue Shield and McKinsey & Company, how he outsourced much of California’s vaccine rollout during the Covid crisis, and how “private contractors cost taxpayers millions of dollars, while demonstrating few clear results and papering over weaknesses in the country’s public health system.”
AstraZeneca seeks to minimize political risk: looks to China for new site
With growing geopolitical turmoil, pharma company AstraZeneca sees it as a good idea to have a foothold in China.
Drugmaker industry group sues to stop Medicare drug price negotiation
In a suit filed Wednesday in the US District Court for the Western District of Texas, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, along with the National Infusion Center Association and the Global Colon Cancer Association, argue that the negotiation provision is unconstitutional in several ways.
The conspiracy candidate: What RFK Jr.’s anti-vaccine crusade could look like in the White House
He sees America as a divided place, where an elite few conspire to crush the rest, where doctors poison the public, and where few institutions or experts can be trusted. “People should be scared,” he tells me.
Judge rules Arkansas ban on gender-affirming care for transgender minors violates US Constitution
A federal judge struck down Arkansas’ first-in-the-nation ban on gender-affirming care for children as unconstitutional Tuesday, the first ruling to overturn such a prohibition as a growing number of Republican-led states adopt similar restrictions.