Don Tracy, Associate Editor

Accelerated approval was based on results from the Phase Ib Beamion-LUNG 1 trial (NCT04886804), which showed a 75% objective response rate in patients with unresectable or metastatic non-squamous non-small cell lung cancer treated with Hernexeos.

Gene Mack, CEO of Gain Therapeutics, outlines the company’s strategic approach to advancing GT-02287 through potential collaborations and financing options as they await critical Parkinson’s disease trial data.

Results from the Phase III CONVOKE trial (NCT05838625) showed that CT-155 demonstrated a favorable safety profile consistent with previous studies in patients with schizophrenia.

The settlement ends US mRNA patent disputes involving COVID-19 and influenza vaccines, while positioning GSK for additional payments and global royalty benefits if BioNTech’s acquisition of CureVac closes.

Eli Lilly’s investigational, once-daily oral GLP-1 receptor agonist orforglipron produced a 12% body weight reduction in a Phase III trial, slightly lower than Novo Nordisk’s Wegovy.

The company is streamlining its global workforce as part of a multi-year cost-cutting strategy, while raising its 2025 outlook on the strength of key pharmaceutical products.

Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one year and older.

Gene Mack, CEO, Gain Therapeutics, explains how the company’s Magellan AI platform analyzes novel protein binding sites to identify and design drug candidates beyond what’s currently available in the public domain.

Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.

The deal brings the FDA-approved neuroblastoma therapy Danyelza (naxitamab-gqgk) to SERB Pharmaceuticals and advances its expansion in rare and pediatric oncology.

Gene Mack, CEO, GAIN Therapeutics, highlights early Phase Ib data showing GT-02287 may enhance neuroprotection across a wider spectrum of Parkinson’s patients regardless of genetic status.

The AI-driven collaboration will use Syntekabio’s DeepMatcher platform to identify new therapeutic targets for MetaVia’s DA-1241 following promising Phase IIa trial (NCT06054815) results in patients with presumed metabolic dysfunction-associated steatohepatitis.

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.

The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed that patients treated with Breyanzi for relapsed or refractory marginal zone lymphoma demonstrated strong and lasting responses.

Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical treatment for chronic low back pain associated with degenerative disc disease.

Following the discontinuation of ALLO-647 due to a treatment-related death, Allogene will move forward with a streamlined outpatient regimen aimed at accelerating enrollment and regulatory review in the Phase II ALPHA3 trial (NCT06500273).

Gene Mack, CEO, GAIN Therapeutics, outlines how early trial results for GT-02287 are shaping the company’s strategy for advancing a potential new treatment for Parkinson’s disease.

Gene Mack, CEO, GAIN Therapeutics, shares how growing clinician confidence and strong early experiences helped accelerate enrollment in the company’s Phase Ib Parkinson’s disease trial.

Facing patent expiration for its blockbuster Keytruda, Merck aims to streamline operations with significant job cuts and continued R&D investments.

The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.

Biotech firm aims to streamline operations and reinvest in high-growth areas such as oncology and rare diseases as it targets $1.5 billion in savings by 2027.

A monthly roundup of business and people news in the pharmaceutical industry.

Approval is based on results from the Phase III VALIANT trial (NCT05067127), in which Empaveli demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and a significant reduction in C3 deposits in patients with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis.

The transaction brings larsucosterol, an investigational treatment for alcoholic hepatitis, under Bausch Health’s portfolio as the company advances its liver disease research and development efforts.

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and safety concerns surrounding gene therapies.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how positive Phase III results for Emrelis may position AbbVie as a key player in MET-high non-small cell lung cancer, expanding its presence in precision oncology and antibody-drug conjugates.

The newly formed biotech launches with five promising autoimmune candidates, $300 million in funding, and leadership from industry veterans.

The extended review for Elinzanetant is supported by data from the Phase III OASIS 1, 2, and 3 trials, which supported the drug’s efficacy in the treatment of moderate to severe vasomotor symptoms due to menopause.

Under terms of the deal, Bavarian Nordic shareholders will receive an all-cash offer at a premium, with plans to delist the company and accelerate its global vaccine strategy.

The regulatory actions were based on results from the Phase III MATTERHORN trial (NCT04592913), which showed that a perioperative Imfinzi-based regimen, given before and after surgery with chemotherapy, reduced the risk of disease progression, recurrence, or death by 29% in patients with early-stage gastric and gastroesophageal junction.