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- Biotech & Pharma Updates | November 26 - December 1, 2024
Biotech & Pharma Updates | November 26 - December 1, 2024
bluebird bio's Skysona blood cancer risk comes under FDA scrutiny, BeiGene lands a first-line Tevimbra (PD-1) approval, PTC Therapeutics to sell their PRV for $150M, BMS joins the 340B lawsuit party + 36 more stories

FDA launches probe into risk of blood cancers associated with bluebird bio’s Skysona gene therapy. | Gif: arkansasrazorbacks on Giphy
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
BeiGene nabs EU approval for first-line use of Tevimbra (PD-1 targeting) in oesophageal, stomach cancers
Monoclonal antibody, oesophageal squamous cell carcinoma, gastric or gastroesophageal junction adenocarcinoma, cancer - Read more
Kelun-Biotech sac-TMT (TROP2 targeting) ADC approved by Chinese NMPA for trip-neg breast cancer
Antibody-drug conjugate, breast cancer - Read more
Novartis’ Kisqali (CDK4/6 inhibitor) lands broader EU approval in breast cancer
Small molecule, breast cancer - Read more
AOP Health’s Rapiblyk (adrenergic receptor antagonist) nabs FDA approval for severe heart condition
Small molecule, supraventricular tachycardia - Read more
Corxel Pharmaceuticals’ varenicline tartrate (nicotinic acetylcholine receptor agonist) nasal spray nabs Chinese NMPA approval
Small molecule, dry eye syndrome - Read more [Press release in Chinese]
Chia Tai-Tianqing Pharmaceutical’s bevacizumab (VEGF-A targeting) biosimilar + anlotinib hydrochloride (tyrosine kinase inhibitor) approved by Chinese NMPA in endometrial cancer
Monoclonal antibody, endometrial cancer, small molecule - Read more [Press release in Chinese]
THE GOOD
Business Development
PTC Therapeutics sells $150M priority review voucher obtained from recent Kebilidi gene therapy approval
Gene therapy, aromatic l-amino acid decarboxylase deficiency, rare pediatric disease priority review voucher - Read more
Idorsia nears buyers for Tryvio (dual endothelin receptor antagonist) global rights
Small molecule, hypertension - Read more
Grand Biopharmaceutical buys China (including Hong Kong & Macau) commercial rights to TenNor Therapeutics’ TNP-2198 anti-infective
Small molecule, helicobacter pylori infection - Read more [Press release in Chinese]
Medvisis buys Switzerland and Liechtenstein commercial rights to Formosa Pharmaceuticals’ APP13007
Small molecule, post-operative inflammation and pain after ocular surgery - Read more
Rophibio signs Middle East biosimilar distribution deal with Sudair Pharma
Biologic, biosimilar - Read more [Press release in Korean]
DongKoo Bio & Pharma signs medicine supply deal with Mongolia
Essential medicine, diabetes, hypertension, antifungal applications - Read more
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⬇️ More Good News ⬇️
THE GOOD
Clinical Trails
S.BIOMEDICS touts positive 12 month data in Ph1/2a trial for human embryonic stem cell-derived cell therapy in treating Parkinson’s disease
Cell therapy, Parkinson’s disease, stem cell derived, ventral midbrain dopaminergic progenitor cells - Read more
Faron Pharmaceuticals posts positive Ph2 interim results for bexmarilimab (Clever-1 targeting) + azacitidine in certain liquid cancers
Monoclonal antibody, leukemia, myelodysplastic syndrome, cancer - Read more
MicuRx Pharmaceuticals showcases positive Ph3 data of MX-4 antibiotic (injectable contezolid water-soluble prodrug formulation) in treating complex infections
Small molecule, complex skin and soft tissue infections - Read more
Hansoh Pharma’s HS-10374 (TYK2 inhibitor) delivers positive Ph2 results in plaque psoriasis
Small molecule, plaque psoriasis - Read more
Minghui Pharmaceutical touts positive topline Ph3 results for MH004 (pan-JAK inhibitor) in atopic dermatitis
Small molecule, atopic dermatitis - Read more
GNT Pharma showcases positive Ph2 & Ph3 data for nelonemdaz (free radical reducer, selective NMDA receptor 2b antagonist) in treating stroke
Small molecule, ischemic stroke - Read more [Press release in Korean]
THE GOOD
Fundraises
Celosia Therapeutics $16.75M Series A, gene therapies for ALS
Gene therapy, amyotrophic lateral sclerosis - Read more
Oxford Vacmedix announces Series B contribution from Prostate Cancer Research charity, amount undisclosed
Cancer vaccine, lung cancer, prostate cancer, ovarian cancer - Read more
THE GOOD
Investments
Sanofi opens up $590M “Modulus” vaccine, biologics plant in Singapore
Manufacturing, biologics, vaccine, pandemic response - Read more
Mount Sinai Health System opens doors of brand new, 12-floor “AI and Human Health” research centre
Research & development, AI - Read more
THE GOOD
Market Reports
Life Science CEOs look to have a positive future disposition on growth, expanded hiring; KPMG survey
Company building, hiring - Read more
THE GOOD
Partnerships
Saniona, Acadia Pharmaceutical development + licensing pact for SAN711 (GABAA-α3 positive allosteric modulator) in neurological conditions, first target indication is essential tremor
Small molecule, essential tremor, neurological disease - Read more
Oxford Nanopore, UK Biobank to build a “world first” epigenetic dataset
Epigenetics, genome sequencing, early disease detection - Read more
Univercells, Quantoom Biosciences and Brazil’s Oswaldo Cruz Foundation sign MoU on “advanc[ing] the development of RNA-based vaccines and therapies”
RNA, vaccine, research & development - Read more
Silo Pharma, Kymanox enter development partnership for ketamine-loaded implant device targeting pain management
Small molecule, fibromyalgia, chronic pain, medical device - Read more
THE GOOD
Regulatory
EMA launches new platform aimed at centralizing and tracking European drug shortage data
Drug shortages - Read more
THE GOOD
Research
Animal studies provide hope for treating proliferative vitreoretinopathy using mRNA therapy developed by Massachusetts Eye and Ear and CureVac
mRNA, proliferative vitreoretinopathy - Read more
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⬇️ The Bad News ⬇️
THE BAD
Approvals & Labels
Advanz Pharma dealt blow in Europe as Ocaliva (farnesoid X receptor agonist) conditional marketing approval (undoubtably) revoked
Small molecule, primary biliary cholangitis - Read more
Applied Therapeutics’ govorestat (aldose reductase inhibitor) handed CRL by FDA, stock plummets
Small molecule, classic galactosemia - Read more
THE BAD
Clinical Trials
Outlook Therapeutics outlook not good as Lytenava (anti-VEGF) fails non-inferiority endpoint in Ph3
Monoclonal antibody, wet age-related macular degeneration (AMD) - Read more
THE BAD
Lawsuits
Bristol Myers Squibb joins the 340B lawsuit party alongside Eli Lilly & Johnson & Johnson
340 drug discount program, drug pricing - Read more
THE BAD
Layoffs
Novartis plans 139 layoff at New Jersey HQ, mainly field sales roles
Big pharma - Read more
Idorsia plans approximately 270 R&D-focused job cuts at Allschwil, Switzerland HQ
Small molecule, hypertension, research & development - Read more
Kronos Bio ditches current CEO, plans whopping 83% workforce reduction by year end
Small molecule, cancer, autoimmune - Read more
Recursion lays off undisclosed numbers after merger with Exscientia
Small molecule, drug design, AI - Read more [Paywall]
THE BAD
Strategic Plans
Portage Biotech continues the dreaded “seeking strategic alternatives” as part of Q3 earnings report
Small molecule, cancer - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Regulatory
EMA issues safety recommendations for Astellas’ Veoza (NK3R antagonist) following potential drug-induced livery injury reports
Small molecule, menopause - Read more
FDA launches probe into risk of blood cancers associated with bluebird bio’s Skysona gene therapy
Gene therapy, early active cerebral adrenoleukodystrophy (CALD) - Read more
You’re all caught up on the latest Pharma & Biotech News!

Hope you had a good long weekend - now back to work! | Gif: theoffice on Giphy
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