// Biotech and Pharma Therapeutics
Uber Health Launches Grocery & OTC Item Delivery to Patient Homes Nationwide
June 13, 2023 / Uber Health / Delivery / Healthcare
It was not that long ago that the medical community had a small arsenal of new drugs to prevent and treat COVID-19 in people most susceptible to severe disease. But the arrival of new variants, as well as the loss of two treatments for immunocompromised people, has amped up the urgency to develop a stronger generation of medicines.
Full circle for Paul Burton as Moderna exec returns to Amgen, this time for expanded CMO role
June 14, 2023 / Amgen / Moderna / Paul Burton / CMO
Amgen considered several candidates and held discussions with key stakeholders before selecting Burton as CMO, according to Reese. Burton will take the reins from SVP of Global Medical Darryl Sleep, M.D., who has been leading the chief medical office in an interim capacity since the organizational changes in March. Sleep will continue to lead the global medical aspect of the chief medical office when Burton joins.
Ferring, with manufacturing update, takes a step towards first gene therapy sales
June 13, 2023 / Gene Therapy / Sales / FDA
The gene therapy treats a high-risk form of the most common type of bladder cancer, known as non-muscle invasive bladder cancer, or NIMBC, that is unresponsive to Bacillus Calmette-Guérin therapy. It uses an adenovirus vector to deliver a gene for the immune-stimulating protein interferon alfa-2b, administered once every three months via a catheter to the bladder.
On lookout for next ALS biomarker success, Biogen pens pact with Israeli biotech
June 14, 2023 / Biogen / Amyotrophic Lateral Sclerosis / Licensing Deal / Biomarkers
NeuroSense is currently running a phase 2b trial of PrimeC—a formulation of the antibiotic ciprofloxacin and the nonsteroidal anti-inflammatory drug celecoxib—in ALS. The Israeli company revealed in a Securities and Exchange Commission filing yesterday that it has entered into an agreement for Biogen to assess PrimeC’s impact on neurofilaments, for which elevated levels are considered a biomarker for ALS.
Biogen Teams with NeuroSense to Explore ALS Neurofilament Biomarker
June 14, 2023 / Biogen / NeuroSense / ALS / Neurofilament / Biomarker
Under the agreement, which was inked in May but was revealed this week, Biogen will look at how PrimeC affects levels of plasma neurofilament—a protein shed by damaged neurons—in amyotrophic lateral sclerosis (ALS) patients enrolled in NeuroSense’s Phase IIb PARADIGM clinical trial. Biogen will provide the funds for the biomarker study and conduct its analysis.
// 4th Industrial Revolution
Sanofi goes ‘all in’ on AI with new app to support company’s manufacturing, R&D and more
June 14, 2023 / Sanofi / AI / Research & Development
The platform is a step in the company-wide “digital transformation and data demonstration journey” that aims to boost productivity, Hudson added. Sanofi is incorporating AI across teams including research, clinical operations and manufacturing.
Real-World Study Uses AI to Identify Undiagnosed Dementia in Primary Care
June 13, 2023 / AI / Healthcare / Life Sciences
Artificial Intelligence has been successfully integrated with various applications such as patient management, financial modeling, disease spread, therapeutic success forecasting, and image analysis through computer vision. These early AI applications were typically reactive, focusing on generating numerical model outputs. This document will delve deeper into how AI has evolved, the potential impact in healthcare and life sciences, and the recommendations for a responsible and effective implementation of this technology in order to protect patient safety and privacy.
Implementing point-of-care AI? 5 firm facts to keep in mind
June 7, 2023 / Bayer / Acuitas Therapeutics / Pfizer / Covid-19 / Vaccine / Gene Editing
If healthcare AI is to flourish outside of academic research settings and industry R&D departments, it will need to win over its most difficult-to-impress audience: healthcare workers in hospitals. And that’s not going to happen if these end-users aren’t offered three helps: early exposure to algorithm development, needs-adjusted training and adequate operational infrastructure. (The latter includes IT resources, technical support, internet access and such.)
Why telehealth is so critical for marginalized patient populations
June 12, 2023 / Telehealth / Healthcare
A 2019 survey by the Assistant Secretary for Planning and Evaluation’s Office of Health Policy found that the highest rates of telehealth visits happened among people with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and those earning less than $25,000 (26.7%).
Singapore smart vending machines offer teleconsultations for pharma-only meds
June 13, 2023 / Singapore / Teleconsultations / Pharmacy
CGH pharmacists sought to transform the way pharmacy-only medicines are being dispensed in Singapore. They intended to provide customers with “timely and convenient access” to these medicines while also empowering them to manage their own health.
// Business & Markets
Novo Nordisk to invest over $2B in drug ingredient production
June 12, 2023 / Novo Nordisk / Drug Development / Diabetes / Obesity
Novo has worked to increase its manufacturing capacity for the past couple of years, targeting capacity for new and future oral and injectable medications to head off supply crunches like it has had with Ozempic and Wegovy
Pfizer refiles Seagen deal paperwork with regulators
June 6, 2023 / Novo Holdings / Gurnet Point / Collaboration / Paratek
The regulatory clock for the Federal Trade Commission to review Pfizer’s proposed acquisition of cancer drug developer Seagen will now run through mid-July, setting up four more weeks of suspense for investors waiting to see whether the agency takes issue with the $43 billion deal.
Inventiva stock climbs 25% on delayed data from phase 2 liver disease trial
June 14, 2023 / Clinical Trial Data / NASH / Fatty Liver Disease / Emerging Biopharma
Inventiva finally has data from a midphase clinical trial of lanifibranor in patients with Type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). Almost four years behind schedule, the investigator-initiated study has linked the candidate to reductions in liver fat—and triggered a 25% jump in the biotech’s share price.
Novartis inks $3.2B Chinook buyout to lift kidney disease plans
June 12, 2023 / Novartis / Chinook Therapeutics / Chronic Kidney Disease / Mergers & Acquisitions
Novartis wants to give a $3.2 billion lift to its kidney disease pipeline. While working to generate phase 3 data on its own IgA nephropathy candidate, the Swiss drugmaker has seized the chance to buy Chinook Therapeutics for a pair of late-stage programs targeting the rare, progressive chronic kidney disease.
Forward Pharma A/S Implements Ratio Change for American Depositary Shares
June 7, 2023 / Forward Pharma / American Depositary Shares
Forward Pharma A/S has announced a modification in the ratio of its American Depositary Shares (ADSs) to ordinary shares. The Board of Directors approved a change from 14 ordinary shares per ADS to 4000 ordinary shares per ADS. This adjustment is equivalent to a 1-for-285.714 reverse stock split of the ADSs. The change in ratio will not affect the total number of ordinary shares in the ADS program, the market value of the ADSs, or the company’s market capitalization. The new ratio will take effect on June 8, 2023, and no fractional ADSs will be issued, with holders receiving a cash payment instead.
// Legal & Regulatory
Merck Gets FDA Fast Track for Efinopegdutide, Previews NASH Data Versus Novo’s Semaglutide
June 14, 2023 / Merck / FDA / NASH / Efinopegdutide / Novo
Monday, Merck announced that its GLP-1/glucagon receptor co-agonist efinopegdutide had won the FDA’s Fast Track designation for treating non-alcoholic steatohepatitis.
J&J Settles Stelara Issue with Teva, Alvotech
June 13, 2023 / J&J / Teva / Alvotech / Settlement
Monday, Alvotech and Teva signed a settlement agreement with Johnson & Johnson, winning them a license for AVT04, their proposed biosimilar to Stelara (ustekinumab). Under the deal, AVT04 is allowed to enter the U.S. market no later than February 21, 2025.
U.S. District Court for the District of New Jersey Rules in Favor of Merck in Patent Infringement Lawsuit Related to BRIDION® (sugammadex)
June 13, 2023 / U.S.District Court / New Jersey / Lawsuit
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Harvard Pilgrim Healthcare sued for data breach
June 14, 2023 / Harvard Pilgrim / Healthcare / Lawsuit / Data Breach
Attorneys for Valeria Salerno Gonzales, a member of HPHC, filed a four-count, 32-page lawsuit for a jury trial against HPHC and Point32Health in Massachusetts court alleging damages and future damages to the health insurer’s upwards of 2.5 million members, according to a report Tuesday in The Harvard Crimson.
New FDA Draft Guidance Signals Acceptance of Decentralized Trials (When Done Right)
June 12, 2023 / FDA / Decentralized Trials / Clinical Trials
Naturally risk-averse industries like the life sciences need health authority acceptance before trying new approaches and especially before committing to wholesale operational change, even if the outcome has great potential. Consider decentralized clinical trials (DCTs) – a new model for conducting research. DCTs saw a sudden uptick during the Covid-19 pandemic but they are still not ubiquitous industry wide despite their significant benefits.
// Research & Development
CVS’ departure highlights challenges, opportunities for retail clinical trials
June 12, 2023 / CVS Health / Clinical Trials
CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
Death triggers pause of 2seventy CAR-T cell therapy leukemia trial
June 14, 2023 / 2seventyBio / Acute Myeloid Leukemia / Cell Therapy / Gene Therapy
A2seventy, bluebird bio’s oncology spinoff, designed the cell therapy to address safety problems that have held back the application of the modality to AML. The cancer cells express multiple surface antigens, but they are also found on healthy myeloid lineage and progenitor cells, raising the question of how to take out AML without causing intolerable side effects.
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).
Acadia gives once-rejected Prader-Willi drug a second chance
June 14, 2023 / San Diego Biotech / Acadia / Prader-Willi / FDA
The drug is an intranasal form of carbetocin, which is used to treat excessive bleeding after childbirth. Levo had been developing it for Prader-Willi as its effects appear to be stronger than the hormone oxytocin, levels of which are low in the brains of people with the disease. Oxytocin deficiency is believed to be associated with the constant sense of hunger, or hyperhagia, that characterizes Prader-Willi, a condition with no approved treatments.
Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race
June 13, 2023 / Valneva / Phase 3 / Merck / Vaccine
Data from a Phase III study showed Valneva’s chikungunya vaccine candidate VLA1553 can elicit a strong immune response and could be an effective protective option against the mosquito-borne disease caused by the chikungunya virus, the French company announced Tuesday.
How California’s New Legislation Could Affect Healthcare M&A Activity
June 13, 2023 / California Legislation / Healthcare / M&A
Healthcare dealmakers must prepare for a new law and a recently introduced bill in the California Senate. Both aim to increase oversight in the healthcare M&A space, which is a legislative trend other states are beginning to participate in too.
Bio-tech mogul Vivek Ramaswamy thinks his anti-woke 2024 campaign can beat both DeSantis and Trump. Is he in over his head?
June 14, 2023 / Bio-Tech / Vivek Ramaswamy / 2024 Election
When he announced his campaign for president in February, it may have been easy to dismiss Vivek Ramaswamy’s unlikely candidacy as a vanity bid put on by a rich man looking to raise his profile, position himself for a Cabinet slot or build a mailing list for a future run for a less-prestigious office.
Why Greedhead Pharma Interests Are Suing the Government
June 12, 2023 / Greedhead Pharma / Lawsuit / U.S. Government / Medicare
Last week the Chamber of Commerce and Merck both sued the Health and Human Services Department, or HHS, and the Centers for Medicare and Medicaid Services, or CMS, to halt the first-ever round of Medicare drug-price negotiations. A third lawsuit, by the Pharmaceutical Research and Manufacturers of America, a lobby group, will likely follow. If Big Pharma could sue Congress, it would do that, too, because its real beef is with last year’s Inflation Reduction Act, which established a procedure for Medicare to negotiate over how much it pays for the massive quantity of drugs it purchases.
NDP tables pharmacare bill to pressure government
June 6, 2023 / Lawmakers / Drug Makers / Drug Costs
In what party leader Jagmeet Singh describes as an effort to pressure the Liberal government on the file, the NDP has tabled legislation to establish a universal single-payer pharmacare system in Canada. “This is a first step towards universal medication coverage for all,” Singh told a news conference. “We believe no one should have to choose between buying their medication or buying their groceries, and this bill will move us towards that.”
NDP attempts to prod Liberals into action on pharmacare by tabling its own bill
June 13, 2023 / NDP / Liberals / New Bill / Pharmacare / Legislation
The NDP and Liberals struck a confidence-and-supply agreement last year that would see the NDP support the government on key votes to hold an election off until 2025 in exchange for progress on NDP priorities