Industry News

Roche lung cancer blockbuster wins approval in early-stage NSCLC

April 19, 2024
Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC following tumor resection

FDA accepts Vertex non-opioid pain med NDA

April 19, 2024
The NaV1.8 inhibitor also nabbed Breakthrough Therapy designation for diabetic peripheral neuropathy pain

Cerevel Parkinson’s drug gets phase 3 win ahead of AbbVie deal

April 18, 2024
The drugmaker shared positive late-stage trial results for its D1/D5 receptor in Parkinson’s disease

Takeda inks immuno-oncology partnership with Kumquat

April 18, 2024
The oncology biotech could receive $1.2 billion in milestone payments and royalties on future sales

Eli Lilly weight loss drug significantly improves sleep apnea symptoms

April 17, 2024
The drugmaker shared that the trials demonstrated a reduction of up to 63% in the apnea-hypopnea index

GSK antibiotic hits phase 3 goals in gonorrhea

April 17, 2024
Gepotidacin, a potential first-in-class oral antibiotic, is already armed with two positive trials in UTIs

Genentech cancer drug shows promise in earlier DLBCL treatment

April 16, 2024
In a phase 3 trial, Columvi plus chemo improved survival rates for patients with relapsed or refractory diffuse large B-cell lymphoma

Novartis Factor B inhibitor grabs priority review in IgAN

April 16, 2024
Fabhalta heads towards another indication with a phase 3 win in rare kidney disease

Genentech ends $3B Adaptimmune T-cell collab

April 15, 2024
The UK-based biotech received notice that the 2021 deal will be terminated in 180 days

EMA finds no link between GLP-1 drugs and suicidal thoughts

April 15, 2024
The review began in July 2023, after two patients in Iceland reported adverse events

Fujifilm to spend $1.2B on North Carolina CDMO expansion

April 12, 2024
The cell culture facility expansion will add large-scale production capacity as well as generate an additional 680 jobs by 2031

Florida judge dismisses Eli Lilly compounding suit

April 12, 2024
The judge said Lilly was attempting to use state laws to enforce federal regulations, which is the responsibility of the FDA

Vertex to buy Alpine for $4.9B

April 11, 2024
Key to the deal is Alpine’s lead molecule, a dual BAFF/APRIL antagonist in phase 3 trials for kidney disease

Novartis to license Arvinas protein degrader

April 11, 2024
The deal, which could reach $1.01 billion, gives Novartis access to a potential first-in-class prostate cancer treatment

Ginkgo Bioworks, Novo Nordisk expand partnership

April 10, 2024
The five-year deal aims to improve Novo's drug production and advance scalable manufacturing tech

Novartis reveals development layoffs

April 10, 2024
Novartis plans to cut up to 680 jobs in its drug development unit

BrainStorm, FDA align on ALS trial design

April 9, 2024
After withdrawing the BLA for its ALS candidate, BrainStorm will launch a phase 3b trial this year

Merck acquires ADC safety startup Abceutics

April 9, 2024
Abceutics focuses on payload-binding selectivity enhancers

AstraZeneca, Daiichi snag another FDA approval for cancer ADC

April 8, 2024
The recent approval makes Enhertu the first tumor-agnostic HER2-directed therapy

BMS schizophrenia drug improves symptoms in phase 3 trial

April 8, 2024
The drugmaker shares promising interim results regarding KarXT's long-term efficacy

J&J boosts medtech biz with $13.1B Shockwave deal

April 5, 2024
In a play to better its cardio health offerings, J&J will pick up a medical device maker active in CAD and PAD

Merck KGaA, Caris enter $1.4B ADC deal

April 5, 2024
The potential $1.4 billion deal gives Merck KGaA access to Caris' proprietary technologies to develop novel cancer ADCs

Basilea wins hard-fought FDA nod for antibiotic 

April 4, 2024
A decade after its European launch, Zevtera is now approved for three indications in the U.S.

Amylyx to withdraw ALS drug from market

April 4, 2024
The decision comes after Relyvrio failed to show benefit in a phase 3 trial

Acorda files for bankruptcy, sells assets to Merz

April 3, 2024
The deal will go through a court-structured 363 sale process, where Merz will serve as the "stalking horse" bidder

Genmab to acquire ProfoundBio in $1.8B deal

April 3, 2024
The acquisition grants Genmab access to three clinical-stage drugs and ProfoundBio’s ADC technology

Ipsen gets in on ADC action with Sutro deal

April 2, 2024
In a deal that could reach $900 million, Ipsen will pick up a preclinical ROR1 ADC asset

Verve pauses gene editing trial

April 2, 2024
The program is once again paused after a patient experienced temporary health issues

AstraZeneca gets FDA nod for rare blood disease therapy

April 1, 2024
Voydeya is approved as an add-on therapy to the standard-of-care for paroxysmal nocturnal hemoglobinuria

Eisai, Biogen submit sBLA for Leqembi IV maintenance dose, delay subcutaneous filing

April 1, 2024
The BLA for a subcutaneous maintenance dose is delayed 60 days while the partners await Fast Track designation