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- Biotech & Pharma Updates | June 28 - July 1, 2024
Biotech & Pharma Updates | June 28 - July 1, 2024
Eli Lilly makes another radiopharma deal, Samsung's Stelara biosimilar gets FDA approval, Boehringer Ingelheim begins Ph1 for "first-in-class" obesity treatment, Takeda sheds over 200 MA-based staffers, and lone Ph1 ultra-rare disease gene therapy patient makes stellar improvements
Eli Lilly continues radiopharma tear with $140M Radionetics deal | Gif: The Simpsons
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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.
⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Pierre Fabre’s Obgemsa (viberon) passes the EMA vibe check, approved
Small molecule, overactive bladder (OAB) syndrome - Read more
Idorsia also lands EMA approval for resistant hypertension
Small molecule, resistant hypertension - Read more
Samsung Bioepis’ Stelara (J&J) biosimilar handed FDA approval
Monoclonal antibody, biosimilar, severe plaque psoriasis - Read more
THE GOOD
Business Development
Eli Lilly signs another radiopharma deal, this time with Radionetics
Radionetics to receive $140M, Eli Lilly gets option to acquire Radionetics for $1B after “exercise period”
Radiopharmaceuticals, cancer - Read more
Tonix Pharmaceuticals lands up to $34M US DOD contract
Small molecule, broad-spectrum antiviral, Defense Threat Reduction Agency - Read more
Esperion Therapeutics signs away cholesterol med royalties to OMERS Life Sciences for approximately $304.7M
Small molecule, cholesterol, hypercholesterolemia - Read more
uniQure sells gene therapy manufacturing site to Genezen
uniQure to receive $25M (stock & debt)
Gene therapy, manufacturing hemophilia B - Read more
THE GOOD
Clinical Trials
Boehringer Ingelheim, Gubra begin Ph1 for novel “first-in-class” obesity treatment
Peptide, triple agonist, obesity - Read more
Dianthus Therapeutics releases pre-clinical data in support of Ph2 asset
Monoclonal antibody, myasthenia gravis (gMG), chronic demyelinating polyneuropathy (CIDP) - Read more
Ovid Therapeutics, Graviton Biosciences present Ph1 safety data
Small molecule, cerebral cavernous malformations - Read more
Lone patient in ultra-rare disease Ph1 makes positive progress, potential roadmap for individualized rare disease treatments
AAV gene therapy, spastic paraplegia type 50 (SPG50) - Read more
THE GOOD
Fundraises
Freeflow Ventures $90M Fund close
Human health challenges, early-stage venture capital - Read more
Kanvas Biosciences $12.5M Fundraise
Spatial biology, microbiome-based therapeutic - Read more
N-Power Series B (undisclosed amount)
Clinical trials network, clinical trial recruitment - Read more
THE GOOD
Investments
Veranova invests $30M into ADC manufacturing facility
CDMO, antibody-drug conjugates, API - Read more
Partners Group buys majority stake in FairJourney Biologics
CRO, antibody research - Read more
THE GOOD
IPOs
Artiva Biotherapeutics rides cell therapy autoimmune wave to an IPO (this time for real?)
NK cell therapy, allogeneic, autoimmune - Read more
THE GOOD
Lawsuits
GSK settles another Zantac suit
Small molecule, heartburn, cancer - Read more
THE GOOD
Partnerships
Merck & Co. and Orion tacks licensing agreement onto existing drug discovery partnership
Orion to potentially receive: $30M R&D milestones, $625M regulatory milestones, $975M sales milestones
Small molecule, cancer - Read more
THE GOOD
Patient Access
Huzzah! FDA announces cisplatin no-longer in short supply
Drug shortage, small molecule, chemotherapy, cancer - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
TRACON Pharmaceuticals drop sarcoma asset after Ph2 miss
Monoclonal antibody, sarcoma, cancer - Read more
THE BAD
Layoffs
Aerovate Therapeutics cuts “nearly all” staff after Ph2b failure
Small molecule, pulmonary arterial hypertension - Read more
Takeda continues shedding staff in MA, 220 employees - Read more [Paywall]
Dexcom lays off a whopping 535 staffers in San Diego
Medical device, diabetes sensor - Read more
Ovid Therapeutics cuts 17 employees (43% of staff)
Small molecule, epilepsy, neurological disorder - Read more
THE BAD
Partnership
Bristol Myers Squibb ends $650M ADC strategic partnership with Eisai
Antibody-drug conjugate, solid tumors, cancer - Read more
THE BAD
Patient Access
Walgreens’ plan to shutter “significant portion” of stores could exacerbate pharmacy access issues in underprivileged communities - Read more
THE BAD
Regulatory
FDA needs to be more transparent about CRLs after recent spate of third-party manufacturer-related rejections; opinion
Outsourced manufacturing, complete response letter - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Criminal Acts
The Cassava Sciences drama continues, internal investigation squared on two senior employees
Small molecule, Alzheimer’s, research fraud - Read more
THE UGLY
Lawsuits
J&J talc subsidiary bankruptcy plan marches on despite plaintiffs attempted restraining order
Talc powder, ovarian cancer - Read more
THE UGLY
Politics & Policy
FTC comes out swinging, goes after multiple “bogus” Teva Pharmaceutical patents
Drug patents, Orange Book, biosimilar - Read more [Paywall]
THE UGLY
Withdrawals & Recalls
FDA doesn’t hold back on ventilator recalls, Class 1’s for Baxter, Philips, Zoll
Medical device, ventilator, sleep apnea - Read more
You’re all caught up on the latest Pharma & Biotech News!
Wimbledon is in full swing as of yesterday. | Gif: wimbledon on Giphy
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