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THE GOOD
Clinical Trials

Persica Pharmaceuticals' PP353 (aerobic Gram-positive bacteria and mycobacteria antbiotic, intradiscally administered) shows promising results in Ph1 trial for chronic low back pain with Modic Type 1 changes
Small molecule, antibiotic, chronic back pain - Read more

Amgen launches Ph3 Maritime program for MariTide (GLP-1 activator) targeting obesity or overweight without Type 2 diabetes
Antibody-peptide conjugate, obesity, type 2 diabetes - Read more

Celon Pharma touts positive Ph2 data for CPL'36 (PDE10A inhibitor), reducing levodopa-induced dyskinesia in Parkinson's disease patients in Ph2 trial.
Small molecule, Parkinson’s disease, levodopa-induced dyskinesia - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

Ajax Health partners with Boston Scientific and KKR to form newco FlowMod, developing heart failure treatment technology
Medical device, heart failure - Read more

THE GOOD
Fundraises

Lentitek £1M (≈$1.3M) investment and grants, developing LVV tech for cancer treatments
Cell therapy, gene therapy, lentiviral vector (LVV), cancer - Read more

Trimtech Therapeutics $31M Seed raise, developing CNS penetrant therapeutics for neurodegenerative diseases using protein degradation
Small molecule, neurodegenerative disease, protein degrader - Read more

Tenax Therapeutics $25M private placement, advancing Phase 3 clinical trials for cardiopulmonary therapies
Small molecule, pulmonary hypertension, heart failure, pulmonary arterial hypertension (PAH), cardiovascular disease - Read more

Nervonik $13M Series A, developing opioid-free peripheral nerve stimulation system for chronic pain treatment
Medical device, pain, peripheral nerve stimulation - Read more

Sanofi €1.5B ($1.6B) bond issue across 2 tranches for general corporate purposes
Big pharma public offering - Read more

CalciMedica $32.5M credit facility, developing CRAC channel inhibition therapies for inflammatory illnesses
Small molecule, inflammatory disease - Read more

Scinai Immunotherapeutics $10M standby equity purchase agreement to develop inflammation/immunology biologicals and provide CDMO services
Monoclonal antibody, COVID-19, psoriasis, CDMO - Read more

THE GOOD
Investments

CordenPharma investing >€1B ($1.1B) in peptide facilities, including >€500M ($541M) for new site in Switzerland's Basel region
CDMO (Contract Development & Manufacturing Organization), facility expansion, peptide manufacturing - Read more

Eli Lilly opens portal for site submissions to host four new US manufacturing facilities, part of $27B investment plan
Domestic manufacturing, injectables, facility build, new facility - Read more

Axplora opens flexible GMP payload manufacturing workshop in Le Mans, France with high-containment capabilities for cytotoxic materials
Small molecule, antibody-drug conjugate (ADC), cytotoxic payload manufacturing - Read more

THE GOOD
Mergers & Acquisition

Jazz Pharmaceuticals acquires Chimerix for $935M to gain promising rare brain tumor therapy
Small molecule, brain cancer, glioma - Read more

FairJourney Biologics acquires Charles River's San Francisco site, expanding US presence and antibody discovery capabilities.
Drug discovery, antibody, drug development, facility sale - Read more

THE GOOD
Patient Access

Novo Nordisk reduces Wegovy's price by 23% to $499 monthly for uninsured patients, following Eli Lilly's lead
GLP-1, obesity, drug pricing - Read more

Novo Nordisk also launches direct-to-consumer portal NovoCare for this lower-priced Wegovy
Direct-to-consumer - Read more

THE GOOD
Politics & Policy

Trump administration reverses decision to close FDA lab in St. Louis that ensures drug safety and potency
Lease terminations, Food & Drug Administration (FDA), lease termination reversal - Read more [Paywall]

Federal judge blocks NIH's plan to cut $4B in annual indirect research costs to universities from 50% to 15%
Indirect research funding - Read more

CDC rehires 180 recently fired probationary employees, some crucial for outbreak response
Centers for Disease Control and Prevention (CDC), public servant rehiring - Read more [Paywall]

THE GOOD
Product Launches

Johnson & Johnson launches Javelin catheter that clears blocked blood vessels by emitting sonic waves from its tip
Medical device, catheter, peripheral artery disease - Read more

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THE BAD
Clinical Trials

FDA hands clinical hold to BioNTech for Ph1/2a trial of BNT165e, a malarial vaccine targeting Plasmodium falciparum parasite
Vaccine, mRNA, malaria, clinical hold - Read more

IRLAB Therapeutics’ pirepemat (5-HT2A, 5-HT2C, 5-HT7 receptor antagonist) fails to hit statistical significance versus placebo in Parkinson’s disease Ph2b trial
Small molecule, Parkinson's disease - Read more

THE BAD
Criminal Acts

South Africa probes Novo Nordisk and Sanofi for potential anti-competitive practices with insulin pen patents and designs
Insulin, diabetes, insulin pen, anticompetitive - Read more

THE BAD
Earnings & Finances

Bayer expects Xarelto (factor Xa inhibitor) sales drop, to the tune of 4%, due to generic competition
Small molecule, symptomatic peripheral artery disease, coronary artery disease, generic - Read more

THE BAD
Lawsuits

Novo Nordisk joins lawsuit against FDA on GLP-1 compounding, but for a different reason - accusing the agency of “undermin[ing] the investments [Novo Nordisk]” has made in developing these meds by allowing compounding in the first place
Drug shortage, GLP-1, obesity, compounding - Read more [Paywall]

Halozyme claims Merck & Co.'s new injectable Keytruda infringes patents for enzyme, potentially extending top-selling drug's patent protection
Monoclonal antibody, lymphoma, cancer, drug formulation - Read more

THE BAD
Layoffs

ALX Oncology cuts 30% of staff, redirecting resources from research to focus on evorpacept cancer therapy trials
Fusion protein, gastric cancer - Read more

THE BAD
Market Reports

Physician survey (commissioned by LEO Pharma) reveals chronic hand eczema is poorly understood and hard to manage, with no FDA-approved treatments available
Eczema, chronic hand eczema - Read more

THE BAD
Partnerships

Bristol Myers Squibb’s subsidiary MyoKardia drop collab with Fulcrum Therapeutics, which was focused on cardiomyopathy target discovery
Small molecule, arrhythmogenic right ventricular cardiomyopathy, drug discovery - Read more

THE BAD
Politics & Policy

Bavarian Nordic CEO warns relocating pharma manufacturing to US could take 5-10 years, despite political pressure
Domestic manufacturing, tariffs - Read more [Paywall]

THE BAD
Strategic Plans

Roche restructures Philadelphia-based Spark Therapeutics after terminating hemophilia A gene therapy program, writing off $4.8 billion acquisition.
Gene therapy, hemophilia A, corporate restructuring - Read more

THE UGLY
Politics & Policy

NIH cancels several LGBTQ+ health research grants, citing they no longer support agency priorities
Federal research funding, LGBTQ+ - Read more

Justice Department moves to drop lawsuit challenging Idaho's abortion ban in emergency rooms, reversing Biden administration stance
Abortion, Women's health - Read more [Paywall]

THE UGLY
Public Health

CDC deploys Epidemic Intelligence Service to assist Texas with growing measles outbreak, now at 159 cases with 22 hospitalizations
Measles, infectious disease, infectious disease outbreak - Read more

THE UGLY
Warning Letters, Form 483

FDA warns Granules about destroyed documents, bird infestations, and poor maintenance at Indian manufacturing plant
Quality concerns, GMP violations - Read more

THE UGLY
Withdrawals & Recalls

Philips recalls arterial repair implant after 20 injuries prompted FDA's highest-risk classification and removal orders.
Medical device, medical device injuries, endovascular implant - Read more

You’re all caught up on the latest Pharma & Biotech News!

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