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Industry News
FDA approves Amgen T-cell engager for small cell lung cancer
May 17, 2024
Imdelltra is the first FDA-approved therapy targeting DLL3 in ES-SCLC
Bayer shares phase 3 trial wins for menopause symptom drug
May 17, 2024
The non-hormonal treatment reduced frequency and severity of hot flashes in a pair of phase 3 trials
Biogen, Ionis discontinue development of ALS drug
May 16, 2024
The drug failed improve clinical outcomes related to function, breathing or strength in a phase 1/2 trial
Eying atopic dermatitis, J&J buys Proteologix
May 16, 2024
J&J will pay up to $850 million and pick up two promising bispecific antibodies
BioMarin announces 170 layoffs
May 15, 2024
Months after revealing it would narrow its R&D focus, the drugmaker is reducing its workforce
FDA delays review of Ascendis hypoparathyroidism drug
May 15, 2024
The agency has extended the PDUFA goal date for TransCon PTH by three months, tacking on more delays to the once-rejected treatment
AbbVie, Gilgamesh partner on psychiatric therapies
May 14, 2024
In a deal that could exceed $2 billion, the partners will develop neuroplastogens for mood and anxiety disorders
Novo hemophilia A drug meets phase 3 goals
May 14, 2024
Both dosing regimens reduced bleeds, teeing up the FVIIIa mimetic biAb for a late 2024 regulatory submission
Takeda, AC Immune ink Alzheimer’s licensing deal
May 13, 2024
Despite previous Alzheimer’s misses, AC Immune tries again
Merck halts anti-TIGIT combo arm in melanoma trial
May 13, 2024
In a phase 3 trial, the Keytruda plus vibostolimab combo triggered several immune-mediated adverse experiences
Shionogi buys rights to Maze Pompe drug
May 10, 2024
The GYS1 inhibitor could become the first oral therapy for Pompe disease
MacroGenics reports patient deaths in prostate cancer ADC trial
May 10, 2024
The company is investigating deaths from pneumonitis and pleural effusion, but a phase 3 trial is still on the table
Isomorphic Labs, Google DeepMind introduce new AI molecule predicting model
May 9, 2024
The AlphaFold 3 is the first AI system to outperform traditional physics-based tools in biomolecular structure prediction
Novo Nordisk, Metaphore partner to develop obesity drugs
May 9, 2024
The companies will utilize Metaphore's MIMIC platform, a machine learning technology designed to mimic molecular interactions accurately
Catalent, Siren Biotechnology ink gene therapy manufacturing partnership
May 8, 2024
Facing FTC scrutiny over its $16.5 billion merger with Novo Holdings, Catalent signs up to manufacture adeno-associated viral vector-based therapies for cancer
Pfizer halts part of DMD trial following patient death
May 8, 2024
The drugmaker had previously paused the trial in 2021 following a patient death in the phase 1b study
Vertex advances pipeline with NDA submission for cystic fibrosis
May 7, 2024
After Casgevy's historic approval as the first gene-edited cell therapy for sickle cell disease, Vertex remains busy
FTC extends review of Novo-Catalent deal
May 7, 2024
Both companies have received a 'second request' for info from the FTC regarding the proposed $16.5 billion deal
GlycoMimetics AML drug misses in phase 3 trial
May 6, 2024
Uproleselan, a potential a first-in-class e-selectin antagonist, did not achieve a statistically significant improvement in overall survival
AstraZeneca completes gene editing investment pact with Cellectis
May 6, 2024
AstraZeneca now has a total equity stake of 44% in French-biotech Cellectis
Novartis to buy radiopharma company Mariana
May 3, 2024
In a deal that could reach $1.75 billion, Novartis picks up a pipeline of novel radioligand therapies to treat cancers
FDA grants Amolyt hypoparathyroidism drug Fast Track designation
May 3, 2024
The drug was a driving force behind AstraZeneca's recent $1.05 billion acquisition of Amolyt
Emergent to axe employees, close plants
May 2, 2024
The company will lay off 300 employees and close two plants as part of the "next phase" of its operational restructuring
Moderna abandons Metagenomi gene editing deal
May 2, 2024
Amid a challenging first quarter, Moderna looks to strategically prioritize R&D investments
Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation
May 1, 2024
The oral granules can be sprinkled on food, providing a new administration option for those who have difficulty swallowing
FDA to host listening session for AdComm improvements
May 1, 2024
The agency seeks public feedback on diversifying perspectives and streamlining committee processes.
Novartis, PeptiDream expand peptide discovery pact
April 30, 2024
Novartis could shell out up to $2.7 billion in a quest to expand its radioligand pipeline
Pfizer-Genmab ADC wins full approval in cervical cancer
April 30, 2024
Tivdak is the first ADC with demonstrated overall survival data to be granted full FDA approval in this patient population
X4 Pharma wins FDA nod to treat rare immunodeficiency disease
April 29, 2024
Xolremdi is the first therapy specifically indicated for patients with WHIM
Addex, Janssen epilepsy drug falls short in phase 2 trial
April 29, 2024
The novel mGluR2 PAM medication failed to delay the time for patients to reach baseline seizure count
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