FDA Approves BeiGene’s Tevimbra for Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma
Approval of Tevimbra was supported by the RATIONALE-305 Phase III trial, which demonstrated a significant overall survival benefit in patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Subcutaneous Form of Bristol Myers Squibb's Opdivo Qvantig for Multiple Solid Tumor Indications
Approval was based on results from the Phase III CheckMate-67T trial, which demonstrated non-inferior pharmacokinetics compared to intravenous Opvido.
Our Top 5 Social Media Posts of 2024
Check out our top five most engaged social media posts from the year 2024.
The Affects of ENV-101 on IPF
John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.
FDA Approves Hikma’s Generic GLP-1 Agonist for Type 2 Diabetes
Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes, alongside diet and exercise.
FDA Approves Ionis Pharmaceuticals’ Tryngolza for Familial Chylomicronemia Syndrome
Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.
FDA Grants Accelerated Approval to Pfizer’s Braftovi Combination for Metastatic Colorectal Cancer
Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.
How Pharma’s Checks and Balances Can Help Fight Its Public Perception
What can we do to prevent such blatant black eyes to the industry so many of us love?
Pharma Marketing's Top Movers and Shakers in 2024
These professionals in the healthcare marketing sector have been chosen by their peers for making big moves and taking on larger roles.
FDA Updates Guidelines on Compounding Tirzepatide Injections as GLP-1 Shortage Ends
Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing, or dispensing of compounded tirzepatide injections to end within 90 days.
Shuttle Pharmaceuticals, UCFS Strike Sponsored Research Agreement
Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of prostate cancer.
HCPs Hope GLP-1s will be Approved for Sleep Apnea and Other Conditions, New Survey Reveals
Sermo’s survey also reveals some troubling aspects about the public’s relationship with these medications.
Merck Obtains Global License for Hansoh’s HS-10535
The molecule is an investigational pre-clinical oral GLP-1 receptor agonist.
FDA Grants Breakthrough Therapy Designation to Gilead’s Trodelvy for Extensive-Stage Small Cell Lung Cancer
Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive extensive-stage small cell lung cancer.
FDA Approves Celltrion’s Stelara Biosimilar for Multiple Indications
Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.
Merck, Johnson & Johnson Submit Biologics License Applications for Pediatric Respiratory Syncytial Virus, Ulcerative Colitis
New biologics license applications seek FDA approval for Merck’s clesrovimab to protect infants and children from respiratory syncytial virus and Johnson & Johnson’s Simponi for the treatment of ulcerative colitis.
FDA Approves Organon’s Vtama Cream, 1% for Atopic Dermatitis
Approval of Vtama for atopic dermatitis provides a steroid-free treatment option for adults and pediatric patients.
AbbVie Agrees to Acquire Nimble Therapeutics
This will bring Nimble’s psoriasis and inflammatory bowel disease treatment under AbbVie’s pipeline.
FDA Grants Breakthrough Therapy Designation to GSK’s Jemperli for Locally Advanced Mismatch Repair Deficient/Microsatellite Instability-High Rectal Cancer
The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a 100% clinical complete response rate in patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.
FDA Approves Checkpoint Therapeutics’ Unloxcyt for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Approval of Unloxcyt was based on results from the CK-301-101 trial, which showed the drug is the first FDA-approved PD-L1–blocking antibody to produce clinically meaningful and durable objective response rates in patients with metastatic or locally advanced cutaneous squamous cell carcinoma.
Gilead Appoints Dietmar Berger as Chief Medical Officer
Berger joins Gilead with over 25 years of global drug development experience and will oversee the company’s virology, oncology, and inflammation portfolio.
FDA Grants Breakthrough Therapy Designation to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis
The regulatory action was supported by results from the Phase III HERCULES trial, which demonstrated a 31% reduction in six-month confirmed disability progression in non-relapsing secondary progressive multiple sclerosis.
Hall-of-Famer Brian Dawkins Teams with CORE Kidney to Promote Proper Testing
Eli Lilly and Boehringer Ingelheim are also participating in the campaign, which will feature a float in the 2024 Rose Parade.
NFL Alumni Partners with CDC for GEAR UP Against Cancer Campaign
The two organizations are promoting education and the importance of screenings.
The Impact of the Presidential Election on Pharma: Q&A with Arthur Wong
The industry is facing an uncertain regulatory landscape in the coming year.
AbbVie Completes Acquisition of Aliada Therapeutics
This acquisition will bring Aliada’s Alzheimer’s treatment under AbbVie’s pipeline.
Mastering Your AI Budget for 2025 Success
Because the AI space is changing rapidly, it’s essential that companies are budgeting correctly and using their investments strategically.
AbbVie Emotional Impact Report Details Experiences of Underrepresented Patient Groups with CLL
The report details the experiences of Hispanic, Black, and Asian patients.
Omnicom Acquires Interpublic
Both firms were heavily focused on pharma and healthcare marketing during the previous year.
How to Build and Maintain Relationships with High-Profile Clients
For pharma manufacturers, the primary requirement for working with high-profile clients is matching their organizational level of urgency and organization.
