STAT+: Genetically targeted drug from Syndax Pharma shows remissions in leukemia patients
Syndax Pharmaceuticals said Tuesday that its genetically targeted cancer drug induced complete remissions in patients…
Category: drug development
.jpg)
‘We did need to throw a lot of spaghetti against the Covid window’: a biotech analyst on pandemic drug development
The pandemic has shined a spotlight on the biopharmaceutical industry, proving its value through the…
STAT+: WHO warns the world is still failing to develop desperately needed antibiotics
Despite mounting concern over antibiotic resistance, a new report finds that none of 43 antibiotics…
FDA wants more data on promising ALS drug, frustrating patients seeking faster access
People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait…
Opinion: Building the perfect wearable for clinical trials
The pace of innovation in wearable technology has never been faster. As often as once…
Huntington’s community grieves not just one therapeutic setback, but two
For the community of people affected by Huntington’s disease — a group that is no…
STAT+: Sage drug reduces muscle tremor but with significant side effects, study results show
Sage Therapeutics said Monday that its experimental pill was more effective than a placebo in…
STAT+: iTeos Therapeutics debuts first data on TIGIT-targeting cancer immunotherapy
ITeos Therapeutics offered the first look at clinical data for its experimental cancer antibody that…
STAT+: Revolution Medicines seeks to bolster case for its lead cancer drug
Revolution Medicines on Saturday presented updated data to bolster the case for its lead cancer…
STAT+: Natural killer cells, primed with an antibody, induce remissions in patients with advanced blood cancer
Two patients with advanced Hodgkin lymphoma were told their tumors were so resistant to treatment…
STAT+: Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors
Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental…
Opinion: Thank private risk-taking, not public funding, for Covid-19 vaccines, therapies
A growing chorus of lawmakers and activists is calling on the Biden administration to invalidate…
STAT+: FDA is rebuked by a federal agency for downgrading serious concerns over plant inspections
In a stern letter, the U.S. Office of Special Counsel rebuked the Food and Drug…
STAT+: The U.S. government doesn’t have patent rights to Gilead’s remdesivir, despite investing millions in research
American taxpayers may have provided $162 million toward researching the drug remdesivir, but the federal…
STAT+: Data for Delcath’s liver tumor device are positive, but lingering questions cloud path to approval
Delcath Systems said Wednesday that its liver-tumor treatment device achieved the primary goal of a…
STAT+: Most U.S. universities get an ‘F’ on ensuring access to drugs they discover
Despite large amounts of taxpayer funding, dozens of the largest U.S. universities failed to commit…
STAT+: Uniqure investigation clears hemophilia B gene therapy as cause of patient’s liver cancer
Uniqure, the Dutch gene therapy company, said Monday that its one-time treatment for hemophilia B…
STAT+: Pfizer hopes for a happy ending for an osteoarthritis drug with a troubled history
For more than a decade, Pfizer has run dozens of trials in hopes of eventually…
STAT+: Does a drug’s name affect how patients and doctors perceive it? The FDA wants to know
Drug makers may spend untold sums of money giving medicines zippy names. Now, regulators want…
STAT+: Translate Bio suffers a setback with mRNA-based treatment for cystic fibrosis
An inhaled mRNA-based treatment for patients with cystic fibrosis from Translate Bio failed to produce meaningful…
STAT+: A Rubius drug derived from red blood cells produces anti-tumor responses — and more questions
Two patients with cancer showed partial tumor shrinkage after infusions of a novel immune-boosting treatment…
STAT+: Bluebird says its gene therapy was ‘very unlikely’ to be cause of patient’s cancer
Bluebird Bio said Wednesday that it was “very unlikely” that its experimental gene therapy for…
STAT+: With data on a cancer drug derived from red blood cells looming, Rubius Therapeutics seeks to shed its bumbling image
Rubius Therapeutics is the can’t-do-anything-right biotech spinout from the high-profile venture capital firm Flagship Pioneering….
STAT+: Drug makers urge Biden to reject proposal to waive patent rights on Covid-19 products
More than two dozen of the largest pharmaceutical companies are urging President Biden to reject…
STAT+: FDA reviews accelerated approvals as two drug makers withdraw bladder cancer indications
For the second time in less than a month, a drug maker has pulled an…
STAT+: European Commission probes Teva for allegedly using patents to thwart competition
In its latest bid to ensure competition among drug makers, the European Commission has opened…
STAT+: Kronos Bio speeds development of genetically targeted leukemia drug with unique trial design
Kronos Bio said Thursday that it had reached an agreement with the Food and Drug…
STAT+: FDA releases a new plan to bring its data skills up to speed
When Ram Iyer started his new job at the Food and Drug Administration in 2020,…
Opinion: The Biden administration’s pandemic agenda must not ignore superbugs
What if another devastating pandemic came on the heels of Covid-19? Unfortunately, that looks increasingly…
STAT+: A surprise FDA advisory panel imperils Fibrogen’s experimental anemia pill
Fibrogen was expecting the Food and Drug Administration to complete a review of its experimental…
STAT+: The vial is not half empty: New report lays out ways to address the issue of discarded drugs
File this under ‘Waste not, want not.’ In response to the cost of medicines, a…
STAT+: A U.S. court ruling may force biologics makers to review patent protections
In a decision with broad implications for the pharmaceutical industry, a U.S. appeals court recently…
Opinion: Three steps can help companies speed FDA approval of new drugs
Drug developers see Food and Drug Administration approval as a difficult uphill climb, requiring large…
To get ahead of variants, Covid-19 drug makers use evolutionary biology as a guide
Before becoming a Covid-19 drug, each candidate was just a tiny fragment of someone’s immune…
Opinion: Ultra-rare but not forgotten: New drug development paradigms to treat the rarest of diseases
In addition to the most visible effects of Covid-19 — tragic deaths, lingering illness, economic…
Novartis and the Gates Foundation aim to create a more practical gene therapy for sickle cell patients around the world
Novartis and the Bill and Melinda Gates Foundation are joining forces to discover and develop…
STAT+: After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
In response to criticism, a top Food and Drug Administration official maintained that creating a…
Bluebird suspends studies of sickle cell gene therapy following cancer diagnoses in two more treated patients
Bluebird Bio said Tuesday that it has suspended clinical trials involving its gene therapy for…
STAT+: Moncef Slaoui, departing Warp Speed, raises $250 million to test his R&D philosophy in a new company
Moncef Slaoui, who headed the Operation Warp Speed vaccine-development effort under the Trump administration, is…
STAT+: In mid-stage study, KalVista pill halts swelling attacks caused by rare, genetic disease
KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced…
Opinion: Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
As the Food and Drug Administration moves closer to a decision about whether to approve…
STAT+: FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’
Merck (MRK) may have readily turned its Keytruda cancer drug into a medical and financial…
STAT+: 5 burning questions on the business of big genetics based on 23andMe’s filing to go public
It seemed a foregone conclusion: Despite the early popularity of companies offering health and ancestry…
In a major setback, Merck to stop developing its two Covid-19 vaccines and focus on therapies
Merck said Monday it will stop developing both of the current formulations of the Covid-19…
STAT+: Former Merck employee arrested for stealing trade secrets on cancer research
A former Merck (MRK) cancer researcher was arrested and charged with stealing a raft of…
STAT+: In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position
WASHINGTON — Health secretary Alex Azar suddenly appointed a new top lawyer at the Food…
STAT+: Eli Lilly says drug slowed Alzheimer’s decline in preliminary study
An experimental medicine appeared to slow the decline of patients with the early symptoms of…
STAT+: Sarepta gene therapy for Duchenne muscular dystrophy stumbles with failed study outcome
Sarepta Therapeutics on Thursday announced mixed results from the first randomized clinical trial of its…
STAT+: With biotech funding at ‘all-time high,’ Scorpion scoops up $162 million
Just over two months after announcing its debut with $108 million in funding, Boston startup…
STAT+: 3 pharma trends to watch in 2021
To say this past year has been like no other is an understatement. But for…