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Home » Topics » Europe, BioWorld

Europe, BioWorld
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European Union flag with wooden gavel

Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now

Sep. 5, 2024
By Nuala Moran
Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.
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3D illustration of RNA

Haya, Lilly target metabolic disorders with $1B lncRNA pact

Sep. 4, 2024
By Nuala Moran
The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders.
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Dyne data deliver on dystrophin; stock stalls on side effects

Sep. 3, 2024
By Karen Carey
While Dyne Therapeutics Inc.’s DYNE-251 demonstrated high levels of dystrophin expression and functional improvement in boys with Duchenne muscular dystrophy who are amenable to exon 51 skipping, investors focused on three serious adverse events related to the drug, driving shares (NASDAQ:DYNE) down by 31% on Sept. 3.
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Blood pressure gauge, ECG and medication

George’s triple-drug hypertension combo succeeds in phase III

Sep. 3, 2024
By Nuala Moran
George Medicines Ltd. has published positive data from two phase III studies showing GMRx2, a low-dose triple-drug combination treatment for hypertension, is superior to dual combinations of its components.
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Sanofi BTK inhibitor tolebrutinib hits phase III endpoints in MS

Sep. 3, 2024
By Tamra Sami
Sanofi SA’s brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib, met the primary endpoint in the phase III Hercules trial in non-relapsing secondary progressive multiple sclerosis (nrSPMS). The first compound to show reduction in disability accumulation in MS, tolebrutinib delayed the time to onset of confirmed disability progression in people with nrSPMS, a population for which there are currently no approved therapies.
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3D dollar sign

Cumulus raising $50M, spinning GPR68 small molecules into GIO

Aug. 29, 2024
By Nuala Moran
Cumulus Oncology Ltd. is in the thick of raising a $50 million series A round as its model of sourcing novel drug targets emerging from academia, shaping them up for clinical development, and spinning them into startups, gathers pace. At the same time, Nodus Oncology Ltd., the first spinout created around an acquired asset, has just reached in vivo proof of concept with its lead DNA damage response inhibitor, and it, too, is looking to raise a series A to take the program through to the end of phase I.
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Bringing it all back home: Lindy and Novartis cut a nearly $1B deal

Aug. 28, 2024
By Lee Landenberger
Novartis Pharma AG continues to cut some of the biggest collaboration deals of the year through a new agreement with privately held subsidiary Lindy Biosciences Inc. The two plan to create self-administered injections for some Novartis medicines that are currently infused intravenously.
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Microbiome illustration

Microbiotica entering clinic with live bacterial therapeutics

Aug. 27, 2024
By Nuala Moran
Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.
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Stamp with EU flag

EU clears Regeneron’s Ordspono, Merck’s Winrevair, ARS’ Eurneffy

Aug. 26, 2024
By Nuala Moran
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
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Fighting for innovation in an era of price controls

Aug. 23, 2024
The ever-contentious issue of drug pricing creates a tug-of-war between biopharma’s innovation machine and the general population’s need for accessible and affordable drugs. BioWorld has covered the issue of drug pricing from insulin caps and the early days of the IRA to failed legal challenges and the recent rollout of the Centers for Medicare & Medicaid Services’ negotiated prices. Read our collection of 2024 stories.
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