STAT+: FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug…
Category: drug development
STAT+: Former Genentech scientist convicted of stealing trade secrets given to former JHL Biotech execs
A former Genentech principal scientist and her husband were convicted of stealing trade secrets and…
Opinion: Aduhelm’s accelerated approval offers a promising roadmap for rare neurological diseases
The FDA’s decision to grant accelerated approval to Biogen’s aducanumab (Aduhelm) for the treatment of…
Opinion: Patient advocacy groups and innovators must partner to advance new treatments
People living with debilitating conditions and life-threatening diseases are often put in the terrible position…
STAT+: Regulators in many European countries fail to ensure clinical trial data are available
Amid ongoing concerns over clinical trial transparency, a new report finds “notable gaps” in the…
STAT+: Nestle Health Science will split profits from Seres microbiome drug, if it’s approved
Seres Therapeutics has announced a new deal with its long-time partner, Nestle Health Science, to…
STAT+: The biotech scorecard for the third quarter: 12 stock-moving events to watch
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third…
12 lessons Covid-19 taught us about developing vaccines during a pandemic
The extraordinary drive to develop Covid-19 vaccines was like a moonshot — and like that fabled…
STAT+: Will Gilead’s early data for its CAR-T therapy give it an edge over Bristol Myers?
Gilead Sciences (GILD) released top-line trial data for its Yescarta treatment that may allow the…
Opinion: The PASTEUR Act can help win the war against superbugs
Look no further than the coronavirus pandemic to see an immediate and high-profile example of…
Drug-resistant bacteria pose a growing threat. Can new antibiotics be developed fast enough to combat them?
In 2016, a landmark report was issued on the global problem of antimicrobial resistance. The…
Opinion: FDA should lead the way on new ALS treatments, not Canada and Europe
Following the Food and Drug Administration’s recent decision to give the green light to aducanumab,…
STAT+: Scientists unshelve a decades-old antibiotic to fight a new foe — ovarian cancer
Ovarian cancer, which kills about 15,000 Americans every year, has historically been one of the…
Virtual Event: Biotech: Where are we now?
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET….
Opinion: Listen: Two Alzheimer’s experts with opposing viewpoints on Aduhelm
This week’s “First Opinion Podcast” is a special two-part episode focusing on the controversial —…
STAT+: Lawmakers revive legislation to accelerate the development of new antibiotics
After months of anticipation, a bipartisan group of U.S. lawmakers is reintroducing bills in the…
Q&A: The CEO of the Alzheimer’s Association on the approval of Aduhelm — and why critics should stop dwelling on the decision
Harry Johns is ready to stop talking about whether or not the Food and Drug…
STAT+: ‘A litany of flaws’: Advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval
Reacting to the controversial approval of the Biogen (BIIB) Alzheimer’s drug, a leading advocacy group…
Opinion: 6 ways the FDA’s approval of Aduhelm does more harm than good
Like many people, I was shocked when the Food and Drug Administration ignored the advice…
Opinion: The approval of aducanumab isn’t the end of the story. It’s just the beginning
People living with Alzheimer’s dementia — the forgetfulness, the confusion, and the ultimate erasure of…
STAT+: GSK pays up big for rights to TIGIT-targeted cancer immunotherapy from Iteos
Iteos Therapeutics said Monday that it has sold ownership rights to an experimental anti-TIGIT cancer…
Opinion: Unaffordable treatment for severe malaria highlights U.S. drug market pitfalls
When Eli Lilly announced in 2017 that it would stop producing quinidine, it was the…
STAT+: Vertex shelves second drug for inherited lung disease, raising concerns about future growth
Vertex Pharmaceuticals said Thursday that an experimental protein “corrector” drug — the highest-priority medicine in…
Virtual Event: The ASCO Recap, Live!
After the biggest meeting in cancer research, sit down with cancer’s biggest decision-maker: the director…
STAT+: Regeneron shareholders urged to boot board member over executive pay practices
Two prominent shareholder advisory firms are urging Regeneron Pharmaceuticals (REGN) shareholders to remove the board…
Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval
Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday,…
Opinion: Bad medicine: aducanumab is a lackluster drug with a high price tag
Controversy has swirled around aducanumab, an experimental drug developed by Biogen, long before the FDA…
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Opinion: FDA’s approval of aducanumab paves the way for ‘more momentous’ Alzheimer’s breakthroughs
The Food and Drug Administration yanked the fight against Alzheimer’s out of the mire with…
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Opinion: STAT+: SARS-CoV-2 brought the world to its knees. Its digital twin is helping bring us back
“Bad news wrapped up in protein.” That’s how the late Nobel Laureate Sir Peter Medawar…
STAT+: ‘We shouldn’t leave anybody behind’: Inequities in cancer genomics undercut promise of precision medicine
Translating the promise of cancer genomics into health equity has not yet become a reality,…
STAT+: In a possible sign of transparency, more leading universities are reporting clinical trial results
Over the past two years, many major U.S. universities have done a better job of…
STAT+: What deadline? Most clinical trials are still not reported on time to federal database
Amid ongoing calls for greater clinical trial transparency, a new analysis finds just 40% of…
STAT+: Lawmakers pitch a bill to create $30 billion in ‘biobonds’ to jumpstart drug development
In a bid to jumpstart drug development, a bipartisan group of lawmakers introduced a bill…
STAT+: European regulatory body plans ‘joint action’ to bolster clinical trial reporting
The Heads of Medicines Agencies, an umbrella group for regulators in 30 European Union countries,…
Opinion: Restore a better balance to public-private funding of biomedical research
The pharmaceutical industry says that if the U.S. reduces the astronomical drug prices paid by…
STAT+: Republican lawmakers tell Biden to reverse ‘disastrous decision’ to support Covid-19 IP waiver
Amid a furious debate over boosting global distribution of Covid-19 vaccines, more than a dozen…
Opinion: Luck is not a strategy: The world needs to start preparing now for the next pandemic
As countries grapple with the worst global pandemic in a century, it’s hard to think…
Opinion: STAT+: ‘Induced proximity’ is why I am optimistic about treating undruggable diseases
So-called undruggable proteins — those that supposedly can’t be targeted by pharmaceuticals — represent a…
Opinion: STAT+: The pharma industry needs to measure patient experience from the patients’ perspectives
The relationship between clinical outcomes and the patient experience — the sum of all of…
STAT+: CRISPR Therapeutics, Nkarta to jointly develop engineered natural killer cells as cancer treatments
Off-the-shelf treatments for cancer made from genetically engineered T cells and natural killer, or NK,…
STAT+: ‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
A new medication for children with a rare and life-threatening cancer called neuroblastoma had a…
STAT+: Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year
The controversial, but widely anticipated Biogen (BIIB) treatment for Alzheimer’s would only be cost-effective if…
STAT+: Affinia Therapeutics raises $110 million for gene therapy treatments
Affinia Therapeutics, a Waltham-based biotech working on gene therapies to treat diseases using technology developed…
STAT+: Sarepta’s more potent Duchenne treatment shows promise, greater toxicity, in small study
Sarepta Therapeutics said Monday that a second-generation medicine for patients with a certain type of…
STAT+: Amgen’s KRAS cancer drug had a bad week, but worry about pricing, not safety
Investors do not like surprises with negative overtones, so they reacted badly when Amgen announced…
Opinion: ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as…
STAT+: Glowing tumor-munching cells, captured on video, show the promise of a new approach to CAR-T cancer therapy
Wendell Lim stared at the video playing on his computer screen in amazement. In the…
STAT+: Trillium moves ‘don’t eat me’ cancer drug into new studies, but future clouded by modest tumor responses
Trillium Therapeutics on Wednesday is announcing an expanded slate of clinical trials meant to advance…
Biogen to expand access to its ALS drug, but move may come too late for some patients
After weeks of controversy, Biogen (BIIB) has agreed to provide an experimental drug for combating…
STAT+: New data point to benefits of Bristol’s novel psoriasis pill, but safety issues will be scrutinized
Last November and then again in February, Bristol Myers Squibb said its oral drug designed…