// Biotech and Pharma Therapeutics
Bayer opens California plant to make cell therapies
October 10, 2023 / Bayer / California / Cell Therapies / Parkinson’s
The new facility is the latest investment from Bayer into cell and gene therapy. Bayer has been investing hundreds of millions of dollars into its Berkeley location, recently launching a Cell Culture Technology Center and cell therapy labs.
Sanofi pays $10M upfront in hope ‘biological map of proteins’ leads to drug discovery treasure
October 10, 2023 / Sanofi / AI / Drug Discovery / Biotech Deals
Sanofi’s ambition to become “the first pharma company powered by artificial intelligence at scale” came one step closer today in a deal with California’s BioMap worth over $1 billion in biobucks.
GSK partners with Chinese pharma to expand Shingrix sales
October 9, 2023 / GSK / Chongqing Zhifei / Shingrix Sales
GSK envisions the deal expanding Shingrix’s availability in China, where it said Zhifei oversees a network of more than 30,000 vaccination points. To support that distribution, GSK will co-promote the vaccine among doctors and at healthcare centers via awareness campaigns.
Biotech/Pharma Industry Locations: Leading With Life Sciences
October 10, 2023 / Life Sciences / Biotech
The 2023 Beyond Borders report from Ernst & Young noted that the biotech sector saw a 1% revenue dip in 2022, compared to a 35% increase in 2022. The report noted that the post-pandemic change was due to decreased demand for COVID-19 vaccines and antiviral treatments. EY also noted that without the revenue impact of COVID-19 products, the industry’s revenues increased 3.7% in 2022, compared with 5.2% growth in 2021.
Marion Biotech production remains suspended amidst lethal cough syrup allegations
October 12, 2023 / Cough Syrup / Marion Biotech
Eurofins CDMO Alphora Inc. is pleased to announce the launch of its Biologics initiative, as part of its vision to diversify and grow within the contract Fresh concerns had risen due to media reports hinting at reinstating production at Marion Biotech. News reports had indicated that the September 14 order issued by the state government had allowed partial production to begin at Marion Biotech. News Agency Reuters, on October 11, reported that the UP government had allowed Marion Biotech to resume production of most of the items and manufacturing industry in North America. The multiphase initiative aims to establish a facility at the 2070 Hadwen site within the Sheridan Research Park campus in Mississauga, ON, Canada.
// 4th Industrial Revolution
How AI is reshaping cancer care and diagnosis
October 10, 2023 / AI / Cancer Care / Healthcare / Northwell Health
Artificial intelligence could have profound implications for the field of oncology, concluded panelists speaking to journalist and moderator Katie Couric at the Constellation Forum 2023 at Northwell Health last week.
Mendel.ai launches medical record-focused chatbot and more digital health announcements
October 11, 2023 / Mendel.ai / Chatbot / Digital Health / BeMeHealth / Startup
Mendel.ai, a startup that uses artificial intelligence to help structure medical information, announced the launch of Hypercube, an AI-powered platform that integrates structured and unstructured text data, democratizes analytics, and allows a user to ask questions in free text and receive outcomes from specific patient data.
Philips Launches New Interoperability Capabilities for Comprehensive Patient View
October 10, 2023 / Philips / Patient Care / Data Barriers
Historically, data from medical device vendors has been siloed, leaving clinicians with the laborious task of referencing multiple sources to gain a complete clinical view of the patient. The inefficiencies caused by this disjointed process can impact a clinician’s ability to deliver timely diagnoses and treatments to patients. Philips is addressing technical obstacles associated with interoperability, such as device-specific connectivity protocols and security challenges across the organization, to help caregivers view, document, report, and analyze data before making care-related decisions.
Changi General Hospital leverages AI to spot curable hypertension
October 11, 2023 / AI / Hypertension
Its clinical laboratory with Japanese medical equipment manufacturer Shimadzu, Shimadzu-CGH Clinomics Centre (SC3), has recently started offering tests for identifying primary aldosteronism and salt-sensitive hypertension which are based on liquid chromatography with tandem mass spectrometry and AI. According to a press statement, this combination of analytical techniques offers higher analytical specificity and sensitivity and the capability to precisely measure hormone levels (particularly aldosterone and renin) in a patient’s blood sample.
Walgreens to launch direct virtual care to consumers
October 11, 2023 / Walgreens / Virtual Care / Telehealth
Insurance is not being accepted for these visits, Walgreens said. Most Walgreens Virtual Healthcare chat visits will be priced at $33 out-of-pocket, with pricing for video visits varying from $36 to $75.
// Business & Markets
Akero’s stock sinks as midphase cirrhosis fail sparks flash NASH crash
October 10, 2023 / Akero Therapeutics / NASH / Cirrhosis / Failed Trials
Akero Therapeutics’ nonalcoholic steatohepatitis (NASH) candidate has flunked a key test. The failure of FGF21 analog efruxifermin (EFX) to significantly reduce fibrosis in cirrhotic NASH patients sent Akero’s stock tumbling—and caused fallout that dragged a rival’s share price down, too.
Biotech Bankruptcies Skyrocket
October 11, 2023 / Biotech / Bankruptcies
This year has seen a record high 28 biotech bankruptcies so far, SEC filings show. And more will come by year’s end, according to James Cassel, chairman and co-founder of Miami-based investment banking firm Cassel Salpeter & Co., which helps companies through bankruptcy processes. The most recent filing came from Infinity Pharmaceuticals on Sept. 28. The company entered a merger agreement with MEI Pharma in February to advance three clinical oncology candidates, only to have the agreement fail in July, which resulted in Infinity laying off 78% of its workforce and declaring bankruptcy.
With Ozempic, Wall Street moves on from a whole other class of medicines
October 11, 2023 / Ozempic / Wall Street
Athersys inches closer to bankruptcy as stroke cell therapy fails interim analysis
October 10, 2023 / Athersys / Ischemic Stroke / Cell Therapy / Failed Trials
Astria scratches dealmaking itch, paying Ichnos $15M to join eczema race led by Amgen, Sanofi
October 12, 2023 / Atopic Dermatitis / Eczema / Licensing Deals
Ichnos Sciences has finally found a buyer for its OX40 eczema program. Astria Therapeutics has taken the other side of the deal, paying $15 million upfront to secure a spot at the back of a race led by Amgen and Sanofi.
// Legal & Regulatory
Alnylam abandons Onpattro expansion in US as FDA spurns rare heart disease bid
October 9, 2023 / Alnylam / Complete Response Letter / U.S. FDA / Rare Diseases
Despite an endorsement from an advisory committee, the FDA has come to a different conclusion on the benefit-risk profile for Alnylam’s Onpattro in the rare heart disease transthyretin amyloidosis cardiomyopathy (ATTR-CM).
GSK inks clutch of Zantac settlements as cancer-related litigation swells
October 11, 2023 / GSK / Zantac / Litigation / Pfizer
GSK resolved a group of claims in California over heartburn medication Zantac. But the company is hardly out of the woods in the wide-ranging litigation.
Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run
October 12, 2023 / FDA / Pfizer / Lyme Disease / New Study
Care Access had disagreed with Pfizer and Valneva’s decision to remove more than 3,000 participants from the study over alleged violations of Good Clinical Practice, an international ethical and scientific standard clinical researchers must follow during trials.
Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer
October 12, 2023 / Pfizer / FDA / Non-small Cell Lung Cancer / BRAF
The FDA has approved Pfizer’s Braftovi and Mektovi for treating metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutations, the agency said Wednesday.
FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue
October 12, 2023 / FDA / FDA Approval / Drug Manufacturing / Alvotech
The FDA on Thursday denied to approve Alvotech’s AVT04, which it was proposing as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), marking the fourth regulatory rejection for the Iceland-based company since last year.
// Research & Development
AstraZeneca reveals new research to improve drug discovery
October 6, 2023 / AstraZeneca / Drug Discovery
AstraZeneca (AZ) researchers have revealed thousands of associations between rare genetic variants and plasma proteins, which could improve future drug discovery research and treatment approaches.
Novo Nordisk’s Star Diabetes & Obesity Drug Shows Promise in Kidney Disease
October 11, 2023 / Novo Nordisk / Diabetes / Obesity / Kidney Disease
NIH funds research for three experimental ALS drugs
October 6, 2023 / NIH / ALS Drugs / Prilenia Therapeutics / Clene Nanomedicine / Rapa Therapeutics
The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support development of treatments for rare neurodegenerative diseases.
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial
October 12, 2023 / Crohn’s Trail / Eli Lilly / Johnson & Johnson
A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies.
Study reveals diagnosis and treatment inequalities in NHS heart care
October 10, 2023 / Heart Care / Europe
Researchers at the University of Leeds have revealed several inequalities in NHS heart care in diagnosis and treatment of four of the most common heart conditions in the UK.
// Politics
European Commission orders Illumina to divest Grail
October 12, 2023 / European / Illumina
Illumina has been expecting the EC’s divestment instructions while maintaining that the commission does not have jurisdiction over the merger. The gene-sequencing industry leader is appealing the jurisdictional issue with the European Court of Justice.
Aaron Rodgers Calls For “Mr. Pfizer” Travis Kelce To Debate Him On COVID Vaccine Along With Dr. Fauci & RFK Jr.
October 10, 2023 / NFL / Covid Vaccine
One thing in particular that has stood out is Rodgers calling Travis Kelce “Mr. Pfizer” after the Kansas City Chiefs star appeared in a commercial encouraging people to get their flu shots and COVID boosters at the same time.
Congress eyes endgame for PBM legislation
October 12, 2023 / Congress / PBM Legislation
Historic levels of dysfunction and infighting may be roiling Congress these day, but there is at least one area where lawmakers appear primed to act as soon as they can: Cracking down on pharmacy benefit managers.
SCOTUS to hear three cases that could impact healthcare
October 6, 2023 / SCOTUS / Healthcare / Medicare / Medicaid
All three cases have to do with how federal agencies operate and what authority they have to make and enforce rules, as well as how those agencies are funded. Depending on how the cases are decided, it could mean that agencies will no longer have the authority to make rules regarding things like what counts as necessary preventative care required under the Affordable Care Act.
Congress and agencies to tackle transparency in healthcare AI, despite mixed industry reactions
October 6, 2023 / Congress / Healthcare AI / Biden
President Biden and other officials have expressed support for artificial intelligence innovation over the past year, provided that it is guided toward positive uses. Within healthcare, that has meant maintaining coverage and improving outcomes for patients, not taking access away.