TLDR Biotech aims to be your one-stop source for biotech and pharma updates - all with one daily email.

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MINOR HOUSEKEEPING
How these updates are formatted

The newsletter is split into three main sections:

• THE GOOD - good news (eg. fundraises, product approvals)

• THE BAD - negative news (eg. clinical trial failures, layoffs)

• THE UGLY - negative but atypical news (lawsuits, product recalls, scandals)

Within each of the three above parts, there are additional sections for easier navigation:

• Eg. There will be multiple “The Good” sections covering things like Fundraises, Approvals, Partnerships etc.

• There will be also additional tags within these sections (Eg. fundraises may mention Stage, product approvals may mention drug name and disease area.)

See something you want to get into further? Click the Read More (goes out to either a news article or a press release).

One last thing; I know paywalls can be annoying, so there’s a [Paywall] tag for any news stories behind one.

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THE GOOD
Approvals & Labels

Bristol Myers Squibb lands FDA ok for colorectal cancer treatment
Small molecule, colorectal cancer - Read more

Takeda also lands a colorectal cancer approval, but this one’s in Europe
Small molecule, metastatic colorectal cancer - Read more

Bristol Myers Squibb lands EMA approval for subcutaneous Opdivo format
Monoclonal antibody, cancer - Read more

Botanix excess sweat disorder gel gets FDA green light
Small molecule, topical get, primary axillary hyperhidrosis - Read more

Kyowa Kirin’s rare disease therapy gets a NICE (National Institute for Health and Care Excellence) recommendation
Monoclonal antibody, X-linked hypophosphataemia - Read more

Lexicon Pharmaceuticals doesn’t have “give up” in their lexicon; resubmits type 1 diabetes NDA
Small molecule, type 1 diabetes, chronic kidney disease (CKD) - Read more 

Roche’s Genentech scores FDA approval for rare disease treatment
Monoclonal antibody, paroxysmal nocturnal hemoglobinuria - Read more

argenx’s FDA approval for CIDP rare disease therapy
Antibody fragment, chronic inflammatory demyelinating polyneuropathy - Read more

THE GOOD
Business Development

Melodia Therapeutics croons (and pays cash-money to) Alivexis for a pre-clinical cathepsin C inhibitor
Upfront + biobucks = $275M
Small molecule, inflammatory diseases, vasculitis - Read more

THE GOOD
Clinical Trials

No sleeping on this; Eli Lilly’s presents positive Ph3 data, aims for GIP/GLP-1 label expansion towards sleep apnea
GIP/GLP-1, obesity, sleep apnea - Read more

Vertex Pharmaceuticals showcases new Ph1/2 data for their islet cell replacement therapy
Stem cell derived cell therapy, type 1 diabetes - Read more

THE GOOD
Fundraises

Rapafusyn Pharmaceuticals $28M Series A
Macrocyclic molecular glues, drug discovery - Read more

Coeptis Therapeutics $4.3M Series A
Cell therapy, cancer, autoimmune, infectious disease - Read more

THE GOOD
IPOs

Tectonic Therapeutics debuts on NASDAQ via reverse merger with AVROBIO
Protein, pulmonary hypertension - Read more

THE GOOD
Partnerships

Indian biopharma Biocon’s looking for a partner to test Ozempic (Novo Nordisk) generics in China
GLP-1, biosimilar, obesity, diabetes - Read more

Biovac signs Africa vaccine collab with Sanofi, EuBiologics
Vaccines, polio, meningitis - Read more

THE GOOD
Patient Access

The Price is Right as Vertex Pharmaceuticals and NHS reach reimbursement deal
Small molecule, cystic fibrosis - Read more

THE GOOD
Research

AI can accelerate clinical trial enrolments?; study
AI, clinical trial screening, clinical trial eligibility - Read more

THE BAD
Layoffs

Ginkgo Bioworks cuts staff by 158 (with more in the pipe)
Cell programming, synthetic biology - Read more

Former Xellia Pharmaceuticals site (now owned by Hikma Pharmaceuticals) sees >200 jobs cut
Manufacturing, generics - Read more

THE BAD
Mergers & Acquisitions

Evotec SE preps defence against potential takeover attempts; insider sources - Read more [Paywall]

THE BAD
Regulatory

It was likely CBER’s Peter Marks & patient groups versus the rest of the FDA when it came down to approving Sarepta Therapeutics’ DMD therapy
Gene therapy, Duchenne Muscular Dystropy - Read more

THE UGLY
Lawuits

3rd-party web-tracking on hospital websites is A-ok according to recent federal judge ruling
HIPAA, HHS - Read more

THE UGLY
Marketing

Self-regulation may be inadequate for pharma marketing in the UK; “Persistent and severe misconduct” - Read more

THE UGLY
Public Health

Covid-19 mistakes might be happening again with bird flu
Bird flu, avian flu, pandemic response - Read more

THE UGLY
Warnings Letters, Form 483

Dr. Reddy’s has a terrible month - two Form 483s across two different sites
Pharmaceutical manufacturing, APIs - Read more [Paywall]

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

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