Competition Is Brewing Between ADCs and Bispecifics
Two late‑stage therapies—Summit/Akeso’s bispecific ivonescimab and Merck/Kelun‑Biotech’s ADC sac‑TMT—are poised to compete in non‑small cell lung cancer. Recent ASCO data show sac‑TMT plus Keytruda cut progression risk by 65%, while ivonescimab plus chemotherapy reduced death risk by 34% and achieved a 79% 12‑month survival rate. Both drugs are on fast‑track FDA pathways, with ivonescimab’s PDUFA deadline in November and sac‑TMT receiving a priority‑review voucher. Analysts suggest the modalities may also be combined rather than strictly rival.
Amid a Flurry of Biotech Deals, China Looks to Keep Innovation at Home
China’s new Order 818, dubbed the "tech track," launched on May 1 to fast‑track cell, gene and regenerative therapies outside the traditional drug‑approval process. The pathway lets qualifying treatments skip three‑phase trials after meeting safety and preliminary‑efficacy thresholds, provided they partner with...
Will Obesity Drugs Save Pfizer From Its Post-COVID Slump?
Pfizer’s post‑COVID revenue surge has evaporated, and a wave of patent expirations will shave $1.5 billion off earnings this year, rising to $4.5 billion by 2027. To offset the loss, the company has poured roughly $80 billion into acquisitions and licensing, most notably...
GSK, Takeda and Others Notch Key Clinical Wins in Tough-to-Treat Diseases
Pharma giants reported breakthrough trial data across three hard‑to‑treat areas. GSK and Ionis’ antisense drug bepirovirsen achieved a 19% functional cure rate in a Phase 3 hepatitis B study, positioning it for fast‑track FDA approval and $2 billion‑plus sales. Takeda’s oral TYK2 inhibitor...
Pharma Is Betting Big on PD-1/VEGF Bispecifics. But Are Companies Chasing the Wrong Target?
Pharma has poured billions into PD‑1/VEGF bispecific antibodies after ivonescimab outperformed Keytruda in a 2024 lung‑cancer trial. A China‑based phase 3 study showed the drug cut death risk by 34% versus chemotherapy plus a PD‑1 inhibitor, reigniting investor enthusiasm. However, analysts...
When the ISS Comes Down, Will Its Drug R&D Be Lost in Space?
The International Space Station’s microgravity lab helped Merck secure FDA approval for a subcutaneous formulation of its blockbuster drug Keytruda, showcasing space‑enabled protein crystal research. Over the past decade the ISS National Lab has hosted more than 250 pharma projects,...
As Amyloid Falls Out of Favor, Here’s Where Alzheimer’s R&D Is Headed Next
The Alzheimer’s drug development pipeline has expanded to 158 agents across 192 trials, with disease‑modifying strategies now representing 73% of the portfolio. Amyloid‑targeting candidates have dropped to 16% of the pipeline, while inflammation, immune modulation, neurotransmitter, and tau approaches are...
AstraZeneca Aims for a New Blockbuster Run in Cardio Disease
AstraZeneca has received FDA approval for Baxfendy, a first‑in‑class aldosterone synthase inhibitor targeting hypertension, marking its entry into a new blockbuster arena beyond its oncology stronghold. The drug is positioned as the cornerstone of the company’s next‑generation cardiovascular, renal and...
Can AI Crack Pharma’s Drug Repurposing Goldmine?
The FDA has opened a public comment period, ending June 11, to gather ideas on how to accelerate drug repurposing using existing therapies. It aims to identify candidates that already meet evidence standards or show early efficacy, reducing the need for...
Longevity Science Picks up Steam in Pharma
Longevity science is moving from fringe research into mainstream drug development, with Life Biosciences' ER‑100 becoming the first epigenetic reprogramming therapy to enter human trials. Retro Biosciences and Lysoway Therapeutics have also advanced neurodegeneration candidates into Phase 1, targeting autophagy pathways....
Vertex’s Journavx Made History, but Left a Void in the Pain Space
Vertex Pharmaceuticals secured FDA approval for Journavx, the first novel non‑opioid pain drug in decades, amid the ongoing opioid crisis and Purdue Pharma’s recent multi‑billion‑dollar settlement. The medication targets the NaV1.8 sodium channel and quickly reached one million prescriptions, but...
The ‘Secret Sauce’ for Hiring for Biotech CEOs
BioNTech is hunting a new chief executive as it pivots from a single‑product COVID‑19 vaccine maker to an oncology powerhouse. Consulting founder Stella Vnook argues the company should look outside its ranks, citing the need for fresh strategic perspective. Vnook’s...
Can a Chaotic FDA Still Deliver on Faster Drug Development?
Recent leadership upheaval at the FDA, including the departure of Commissioner Martin Makary, has sparked concerns about the agency’s ability to maintain momentum on accelerating early‑stage clinical trials in the United States. Nonetheless, industry insiders like Parexel’s Tala Fakhouri argue...
Who’s Winning Pharma’s Innovation Race? The Rankings Are Out.
Eli Lilly became the first pharma firm to exceed a $1 trillion market value and now leads Idea Pharma’s Global Innovation and Invention indexes, topping both for the first time. The company’s 45% revenue surge is driven by blockbuster weight‑loss drugs and a...
Big Pharma Is Gambling on Specialized R&D. Will It Pay Off?
Big pharmaceutical firms are pivoting from broad, diversified pipelines to highly specialized research areas to offset looming revenue gaps from patent expirations and the Inflation Reduction Act’s shortened drug earnings life. Companies such as AstraZeneca are concentrating on nucleic‑acid therapeutics,...