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Industry News
EMA issues negative opinion on Eisai-Biogen Alzheimer's drug
July 26, 2024
Concerned about serious adverse events, CHMP gives Leqembi the thumbs down
FDA approves Sun Pharma hair loss drug
July 26, 2024
Leqselvi is a twice-daily oral JAK inhibitor
BioMarin gets expanded approval for CLN2 disease drug
July 25, 2024
Brineura, the only approved treatment for CLN2 disease, can now be used in presymptomatic children
Novartis signs bispecific antibodies deal with Dren Bio
July 25, 2024
The potential $3 billion deal will focus on finding new therapeutic options for cancer
BeiGene opens $800M U.S. biologics site
July 24, 2024
The new biologics facility comes on the heels of the the U.S. approval for Tevimbra.
FDA issues harsh warning letter to Indian CDMO Brassica
July 24, 2024
The agency blasts the troubled facility in Tarapur for "significant" CGMP violations
Agilent to buy Canadian CDMO Biovectra
July 23, 2024
The lab services and equipment provider will acquire Biovectra in a deal worth $925 million
Grünenthal acquires Valinor Pharma
July 23, 2024
After years of changing hands, the constipation drug Movantik has settled with German drugmaker in a $250 million deal
Janssen stops development of Addex epilepsy drug
July 22, 2024
Following disappointing top-line phase 2 data shared back in April, Janssen has discontinued development of its Addex-partnered glutamate mGlu2 receptor in epilepsy
J&J seeks FDA nod for Spravato depression drug as monotherapy
July 22, 2024
J&J has high hopes for Spravato, expecting annual sales to reach between $1 billion and $5 billion
Genentech refillable eye implant shows efficacy for DME and DR
July 19, 2024
The FDA has also accepted Susvimo's supplemental Biologics License Application (sBLA) to treat DME and DR
Paratek antibiotic delivers in post-marketing trial
July 19, 2024
Nuzyra is approved for once-daily oral and IV use to treat bacterial pneumonia and serious skin infections
FDA rejects accelerated approval for Agenus colorectal cancer drug
July 18, 2024
The agency's recommendation includes adding a BOT monotherapy arm in the phase 3 study
Orexo nasal opioid overdose rescue drug is rejected by FDA, again
July 18, 2024
In response to April 2024 FDA comments, Orexo optimized the instructions for use and completed a new Human Factors study
Genentech shares positive data for oral weight loss drug
July 17, 2024
The study also highlighted the pharmacokinetic profile of CT-996, supporting a once-daily oral dosing regimen
Bayer's prostate cancer combo drug boosts survival in phase 3
July 17, 2024
Nubeqa is already approved for use in combination with docetaxel for mHSPC and for non-metastatic castration-resistant prostate cancer.
Vertex inks licensing deal with Orum Therapeutics
July 16, 2024
In a deal worth up to $325 million, the two will work on developing degrader-antibody conjugates for gene editing
AbbVie sells cystic fibrosis compounds to Sionna Therapeutics
July 16, 2024
Sionna will prioritize the advancement of the compounds in combination with its own NBD1 stabilizers
Lexeo Therapeutics shares promising results for heart gene therapy
July 15, 2024
While management of Friedreich ataxia cardiomyopathy typically involves medications, there are no treatments targeting the root cause
Lupin divests U.S. Women's Health Business to Evofem
July 15, 2024
Lupin could earn up to $84 million based on future performance milestones
AbbVie seeks new indication for blockbuster JAK inhibitor
July 12, 2024
If approved, the drug will compete against Genentech's Actemra in giant cell arteritis
Pfizer advances once-daily obesity pill
July 12, 2024
The drugmaker will conduct dose optimization studies in the second half of 2024 of its GLP-1 tablet, danuglipron
Ipsen inks $1B ADC licensing deal with Foreseen
July 11, 2024
In its second ADC deal this year, Ipsen will pick up a potential first-in-class ADC that targets a novel tumor associated antigen
FDA rejects Novo Nordisk once-weekly insulin
July 11, 2024
The agency's requests in the CRL were related specifically to the type 1 diabetes indication
Elevar to resubmit liver cancer drug to FDA
July 10, 2024
The NDA was rejected last year due to GMP deficiencies and incomplete BIMO inspections
Zevra edges closer to FDA review of resubmitted rare disease drug
July 10, 2024
The Genetic Metabolic Diseases Advisory Committee will meet to review the once-rejected NDA for arimoclomol
FDA approves updated Roche nAMD drug
July 9, 2024
Initially approved in 2021, Susvimo was recalled in 2022 due to performance issues
FTC releases long-awaited report on PBMs
July 9, 2024
The interim staff report details how PBMs "profit at the expense of patients"
Eli Lilly to buy Morphic, picking up IBD asset
July 8, 2024
The $3.2 billion deal will give Lilly a promising mid-stage rival to Takeda's IBD blockbuster
Novo Holdings co-leads $114M financing round for Myricx Bio
July 8, 2024
Backed by the largest European biotech Series A this year, Myricx will advance its proprietary ADC platform
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