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THE GOOD
Approvals & Labels

Novo Nordisk’s Wegovy get’s MHRA approval for new indication; “reduce the risk of overweight and obese adults suffering serious heart problems or strokes“
GLP-1, obesity, weight loss, heart disease, stroke - Read more

Pfizer, BioNTech’s updated COVID-19 shot receives MHRA go-ahead
COVID-19 vaccine - Read more

Arcutis Biotherapeutics’ supplement NDA to the FDA for psoriasis med
Small molecule, scalp and body psoriasis - Read more

THE GOOD
Clinical Trials

Pfizer’s hemophilia A gene therapy overcomes safety concerns to succeed in Ph3; long-term efficacy remains an open question
Gene therapy, hemophilia A - Read more

Gilead Sciences touts full data set of their stellar Ph3 HIV prevention twice-yearly shot (to the tune of 100% efficacy)
Small molecule, human Immunodeficiency virus, AIDS - Read more

OSE Immunotherapeutics’ positive Ph2 data in ulcerative colitis
Monoclonal antibody, ulcerative colitis - Read more

Vigi Neuroscience’s positive interim Ph1 data in Alzheimer’s disease
Small molecule, microglial dysfunction, Alzheimer’s disease - Read more

Transposon Therapeutics shows-off positive Ph2 ALS/dementia therapy data
Small molecule, amyotrophic lateral sclerosis, frontotemporal dementia - Read more

Sonnet Biotherapeutics posts “encouraging” Ph1b/2a peripheral neuropathy data
Protein, interleukin-6, chemotherapy-induced peripheral neuropathy - Read more

THE GOOD
Earnings & Finances

Samsung Bioepis (biosimilar division of Samsung Biologics) Q2 earnings up 107% year-over-year
Biosimilar, manufacturing, CDMO - Read more

Viking Therapeutics stock jumps on reporting less-than-expected quarterly losses per share
GLP-1, GIP, obesity, weight loss - Read more

THE GOOD
Fundraises

Autobahn Therapeutics oversubscribed $100M Series C
Small molecule, major depressive disorder, bipolar disorder depression - Read more

CellCentric raises $35M from RA Capital Management
Small molecule, multiple myeloma, cancer - Read more

TMRW Life Sciences $28M Series D
Fertility, sperm storage, egg storage, embryo storage - Read more

Oisín Biotechnologies $15M Series A (led by AbbVie Ventures)
Anti-aging, longevity, proteo-lipid vehicle - Read more

Verastem Oncology $55M public offering
Small molecule, ovarian cancer - Read more

PK MED €1.5M ($1.6M) non-dilutive financing
Drug delivery, injectable smart implants, rheumatology, bone marrow transplant - Read more

THE GOOD
IPOs

Actuate Therapeutics makes another change to planned IPO, slightly boosting available shares
Small molecule, pancreatic cancer - Read more

Hangzhou Jiuyuan applies for IPO on Hong Kong stock exchange
GLP-1, biosimilar, obesity, diabetes - Read more [Paywall]

THE GOOD
Lawsuits

Sanofi settles 2018 Minnesota insulin pricing lawsuit by offering heavily discounted insulin
Drug pricing, diabetes, insulin - Read more

CVS and its PBM settle drug rebate allegations via $45M to Illinois
Drug rebate, drug pricing, pharmacy benefit manager - Read more [Paywall]

THE GOOD
Mergers & Acquisitions

Palvella Therapeutics, Pieris Pharmaceuticals merger announcement
Small molecule, genetic skin conditions, microcystic lymphatic malformations, cutaneous venous malformations - Read more

THE GOOD
Partnerships

Novartis and Dren Bio sign bispecific antibody discovery and development partnership
Bispecific antibody, drug discovery, cancer - Read more

BioNTech and Triasek enter 3D-printed oral RNA therapeutics partnership
RNA, drug delivery - Read more

GSK in-licenses “doggybone DNA” from CDMO Touchlight, terms not disclosed
CDMO, DNA, mRNA, platform technology - Read more

Orange Grove Bio commercialization accelerator pact with Polsky Center for Entrepreneurship and Innovation
Translational, company incubation, venture capital - Read more

Catalyst Pharmaceuticals, Kye Pharmaceuticals licensing, supply, and commercialization agreement for DMD small molecule in Canada
Small molecule, Duchenne Muscular Dystrophy - Read more

THE GOOD
Politics & Policy

Republican-led states can’t challenge abortion pill access, according to 9th U.S. Circuit Court of Appeals
Abortion, mifepristone - Read more

THE GOOD
Public Health

Global Pandemic Fund gets US backing of $667M, 1/3rd of $2B total
Pandemic response, pandemic preparedness - Read more

THE GOOD
Regulatory

FDA finalizes guidance on using electronic health data
Clinical trials, electronic health records - Read more [Paywall]

THE GOOD
Research

Brain area responsible for placebo effect mapped in mice
Placebo effect - Read more

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THE BAD
Approvals & Labels

Prior to adcomm, FDA expresses doubt regarding AstraZeneca’s lung cancer filing for Imfinzi
Monoclonal antibody, lung cancer, advisory committee - Read more

THE BAD
Clinical Trials

Biogen, Sage Therapeutics essential tremor study axed after Ph2 flunk
Small molecule, essential tremor - Read more

THE BAD
Company Shutdown

Asarina Pharma winds down after failed partner search
Small molecule, Tourette syndrome - Read more

THE BAD
Layoffs

Merck & Co. report layoffs, 75-80 people - Read more [Paywall]

THE BAD
Politics & Policy

Reauthorization of FDA’s pediatric PRV program remains uncertain as US Congress summer recess looms
Rare pediatric disease designation and priority review voucher - Read more [Paywall]

THE BAD
Strategic Plans

Assertio Holdings faces activist investor; board shake-up demanded
Small molecule, neurology, pain management - Read more [Paywall]

THE UGLY
Accidents & Natural Disasters

What is going on? One of Novo Nordisk’s Denmark sites has a “minor fire”; fourth this year - Read more

THE UGLY
Politics & Policy

PBMs CVS Caremark, Optum Rx, Express Scripts throw blame at pharma manufacturers during Congress questioning session
Pharmacy benefit manager, drug pricing - Read more

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

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