NEWS

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

1 day ago

Novartis to Acquire Pikavation Therapeutics from Synnovation for ~$3B

Shots: Novartis has entered into a definitive agreement with Synnovation to acquire Pikavation Therapeutics (Synnovation’s subsidiary) & its portfolio of PI3Kα inhibitor programs, incl. SNV4818, a P-I/II asset for HR+/HER2- metastatic breast cancer & other solid tumors As per the deal, Synnovation will receive $2B upfront, & ~$1B in development, regulatory, & commercial milestones, representing…

1 day ago

Embecta to Acquire Owen Mumford for ~£150M

Shots: Embecta has entered into a definitive agreement to acquire Owen Mumford, expanding drug-delivery capabilities & strengthening global presence in the chronic care market As per the deal, Embecta will acquire Owen Mumford for ~£150M (~$199.9M), incl. £100M (~$133.2M) upfront & up to £50M (~$66.6M) in sales-based milestones tied to Aidaptus, with closing expected in…

1 day ago

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Shots: Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance In the RCT (therapy start: M1 vs M7), M12…

1 day ago

Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

Shots: Trial assessed retatrutide vs PBO, alongside lifestyle intervention in T2D adults (n=537) inadequately controlled with diet & exercise alone & mean disease duration of 2.5yrs.; pts started at 2mg QW, with dose escalation at Q4W till assigned doses of 4mg, 9mg, or 12mg are reached Trial met its 1EP, showing superior A1C reduction at…

1 day ago

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…

1 day ago

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…

2 days ago

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Pfizer has reported P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC Trial met its 1EP, showing improved rPFS with a hazard ratio surpassing the pre-specified target of 0.63, as most pts remained progression-free; consistent benefit was observed across tumors with both…

2 days ago

AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Shots: AL-S Pharma has reported the global P-II (AP-101-02) trial data assessing AP-101 (IV, Q3W) vs PBO in 73 pts with sporadic ALS (n=52) & SOD1 mutations (n=21) for 24wks., followed by 24wk. OLE phase, where all pts received AP-101, & 16wk. safety follow-up Trial met its 1EP for safety & tolerability, with AP-101 showing…

2 days ago

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…

2 days ago

NEWS

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Novartis to Acquire Pikavation Therapeutics from Synnovation for ~$3B

Embecta to Acquire Owen Mumford for ~£150M

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

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